Clinical trial register · European Union · CTIS

Clinical Trials in Poland, 2026

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

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Source: EMA Clinical Trials Information System (CTIS). Showing the 2557 most recently authorised of 12637 total CTIS records — a stated recency window, not the full historical archive. Synced 16 Oct 2026, 03:17 UTC

2557

Shown in this register

most recently authorised

12,637

Total on CTIS

full historical archive

779

Phase III

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Top member states

Spain 1071 France 924 Germany 907 Italy 776 Poland 609 Netherlands 560

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All 28 states

Trials with a site in Poland

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase II

A Phase 2, Multicentre, Randomised, Double-masked, Placebo-controlled, Parallel-group, Dose-range Finding Study, to Assess the Efficacy and Safety of Oral STL303 in Adults with Geographic Atrophy Secondary to Age-related Macular Degeneration

2026-525738-40-00Geographic Atrophy Secondary to Age-related Macular Degener…

DrugSTL303

Sitala Bio Limited

Eye Diseases

Poland, Czechia

14/10/2026

Phase III

A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) versus Docetaxel in Participants with KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum-based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)

2025-524079-22-00KRAS G12D-mutated Locally Advanced (Unresectable) or Metast…

DrugSetidegrasib

Astellas Pharma Global Development Inc.

Neoplasms

Italy, Poland, Spain, France, Belgium, Germany

12/10/2026

Phase II

A Phase 2, multicentre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of LAD603 in patients with systemic lupus erythematosus

2026-527200-24-00Systemic lupus erythematosus

Almirall S.A.

Immune System Diseases

Poland, Spain, Hungary, Bulgaria

09/10/2026

Phase III

An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination with Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

2026-526026-40-00human immunodeficiency virus type 1 (HIV-1)

DrugsGS-3242·B/F/TAF·Lenacapavir

Gilead Sciences Inc.

Virus Diseases

Portugal, Poland, Germany, Spain

09/10/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Arterial Hypertension (PAH)

2025-525114-38-00Pulmonary Arterial Hypertension (PAH)

Ns Pharma Inc.

Respiratory Tract Diseases

France, Germany, Poland, Italy, Belgium, Spain, Greece

08/10/2026

Phase III

A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants with Obesity or Overweight With at Least One Weight Related Comorbidity Without Type 2 Diabetes Mellitus

2025-523379-41-00Obesity or Overweight, Weight-Related Comorbidity, without …

DrugLenbelintide

AstraZeneca AB

Nutritional and Metabolic Diseases

Italy, Czechia, Germany, Bulgaria, France, Poland

08/10/2026

Phase III

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants with Active Primary Sjögren’s Disease

2026-525556-28-00Active Primary Sjögren’s Disease

DrugTelitacicept

Vor Biopharma Inc.

Immune System Diseases

Poland, Spain, Hungary, Italy, Netherlands, Romania, Belgium, France, Bulgaria, Germany

06/10/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Idiopathic Hypersomnia (IH) Followed by an Open-label Extension

2025-523822-42-00Idiopathic hypersomnia (IH)

DrugPitolisant

Harmony Biosciences Management Inc.

Nervous System Diseases

France, Germany, Belgium, Spain, Italy, Poland

06/10/2026

Phase III

A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment with AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible (TE NDMM) (DURGA-6)

2026-525367-40-00Newly Diagnosed Multiple Myeloma

DrugsAZD0120·Melphalan·Lenalidomide

AstraZeneca AB

Neoplasms

Germany, Spain, Norway, Italy, Denmark, France, Poland

06/10/2026

Phase III

A Randomized, Double-Blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects with PAH and Functional Limitations Despite Optimized Therapy with Available PAH Medications

2025-524596-24-00Pulmonary Arterial Hypertension (PAH)

DrugTacrolimus

Vivus B.V., Vivus LLC

Respiratory Tract Diseases

Italy, France, Czechia, Poland, Latvia, Germany, Spain

05/10/2026

Phase III

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants with Type 2 Diabetes Mellitus and Obesity or Overweight

2025-524616-11-00Obesity or overweight Diabetes Mellitus, Type 2

DrugLenbelintide

AstraZeneca AB

Nutritional and Metabolic Diseases

Spain, Poland, Slovakia, Germany

05/10/2026

Phase III

A Phase 3, Parallel, Randomized, Modified Double-Blind, Active-Controlled, Multi-Arm Study to Assess the Safety and Immunogenicity of a Combination Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Recombinant Spike and High-Dose Inactivated Influenza Vaccine with Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older

2026-526221-18-00COVID-19, Influenza

DrugNaCl

Sanofi Vaccines US Inc.

Virus Diseases

Belgium, Poland, Spain, Portugal, France, Germany

05/10/2026

Phase II

A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy

2026-525638-43-00Immunoglobulin A nephropathy (IgAN)

Argenx

Not possible to specify

Spain, Poland, Czechia, Belgium, Italy

05/10/2026

Phase III

A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin compared with Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients

2026-525642-30-00Hypercholesterolaemia

DrugsAZD0780·Rosuvastatin

AstraZeneca AB

Nutritional and Metabolic Diseases

Germany, Bulgaria, Hungary, Denmark, Poland, Spain

05/10/2026

Phase III

A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)

2025-524067-20-00Primary Biliary Cholangitis (PBC)

DrugSaroglitazar Magnesium

Zydus Therapeutics Inc.

Digestive System Diseases

Ireland, Greece, Estonia, Netherlands, Bulgaria, Slovakia, Poland, Latvia, Croatia, Spain, France, Italy

05/10/2026

Phase III

A randomized, double-blind, placebo-controlled, 2-arm multicenter Phase III study to assess the efficacy and safety of ianalumab in participants with Sjogren's disease with high symptom burden (THALASSA)

2025-522271-29-00Sjögren's disease

DrugsTenofovir Alafenamide·Entecavir·Ianalumab

Novartis Pharma AG

Immune System Diseases

Austria, Portugal, Slovakia, Italy, Poland, Hungary, Spain, Czechia, France, Netherlands, Germany

05/10/2026

Phase I/II

A Phase Ib/II, open-label, safety and tolerability trial of obrixtamig in combination with ZL-1310 in patients with poorly differentiated NEC

2026-525634-27-00Extrapulmonary neuroendocrine carcinoma of large cell histo…

DrugsZL-1310·Obrixtamig·Tocilizumab·Atezolizumab

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

Poland, France, Belgium, Germany, Netherlands, Spain

05/10/2026

Phase III

A prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of subcutaneous immunotherapy with polymerized grass pollen extracts in patients with grass pollen–induced allergic rhinitis/rhinoconjunctivitis with or without mild-to-moderate asthma

2026-526100-73-00Grass pollen induced moderate-to-severe allergic rhinitis o…

Inmunotek S.L.

Immune System Diseases

Poland, Spain

01/10/2026

Phase III

C3671017 A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS VACCINE IN CHILDREN AT HIGH RISK OF RSV DISEASE

2026-525797-19-00Prevention of lower respiratory tract disease caused by res…

DrugVaxzevria

Pfizer Inc.

Respiratory Tract Diseases

Spain, Poland

01/10/2026

Phase I

EVALUATION OF PHARMACOKINETICS, PHARMACODYNAMICS, AND TOLERABILITY OF A NOVEL NICOTINE THERAPY IN HEALTHY SMOKERS

2026-527188-14-00nicotine dependence

Flik Therapeutics Inc.

Nervous System Diseases

Poland

01/10/2026

Phase I/II

A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029, as Monotherapy and in Combination with Standard Therapies in Participants with Relapsed or Refractory, or Newly Diagnosed Acute Myeloid Leukemia (AML) with NPM1 Mutations, KMT2A or NUP98 Rearrangements

2026-526409-14-00Acute Myeloid Leukemia

DrugsPosaconazole·Daunorubicin·Cytarabine·Azacitidine

Charm Therapeutics Limited

Neoplasms

France, Germany, Spain, Poland, Netherlands

30/09/2026

Phase III

A Phase 3, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living with Overweight or Obesity without Diabetes (RISE-1)

2025-524861-26-00Overweight or Obesity Without Diabetes.

DrugOlatorepatide

Regeneron Pharmaceuticals Inc.

Nutritional and Metabolic Diseases

Romania, Poland, Hungary, Germany, Spain

29/09/2026

Phase III

A Phase 3, Randomized, DoubleBlind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension (PALM-PAH)

2026-525265-48-00Pulmonary Arterial Hypertension

DrugTreprostinil Palmitil

Insmed Inc.

Cardiovascular Diseases

Germany, Hungary, Belgium, France, Italy, Sweden, Austria, Poland, Lithuania, Spain, Romania, Greece

29/09/2026

Phase III

A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants with Atrial Fibrillation (ROXI-EVEREST)

2025-521617-97-00Atrial Fibrillation (AF)

DrugsCenvacibart·Apixaban

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

Portugal, Germany, Italy, Czechia, Austria, Spain, Belgium, Netherlands, Poland, Sweden, Greece, Latvia, Hungary, Bulgaria, Romania

29/09/2026

Phase III

A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, versus Placebo in Participants with Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)

2025-521618-25-00Atrial Fibrillation (AF)

DrugsAmrecibart·Cenvacibart

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

Spain, Bulgaria, Hungary, Poland, Romania, Sweden, Germany, Italy, Latvia, Netherlands, Portugal

29/09/2026

Phase II

A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants with COPD

2026-525216-34-00Chronic Obstructive Pulmonary Disease (COPD) exacerbations

Expedition Therapeutics Inc.

Respiratory Tract Diseases

Italy, Germany, Spain, Poland, Czechia, Romania, Hungary, Denmark, Bulgaria

29/09/2026

Phase III

A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants with Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)

2025-522954-37-00Peripheral Artery Disease

DrugsAmrecibart·Cenvacibart·Rivaroxaban

Regeneron Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Spain, Slovakia, Hungary, Czechia, Romania, Estonia, Austria, France, Belgium, Sweden, Italy, Latvia, Poland, Bulgaria, Greece, Germany, Denmark, Lithuania, Netherlands

29/09/2026

Phase III

A Multicenter, Phase 2/3, Dose Range Finding Study to Evaluate the Efficacy and Safety of Atumelnant in Adults with ACTH-Dependent Cushing’s Syndrome (ADCS) Including an Open-Label Extension for Long-Term Assessment. (EQUILIBRIUM-ADCS)

2025-522648-42-01• ACTH-Dependent Cushing’s Syndrome. • Pituitary-dependent …

DrugsAtumelnant·Hydrocortisone

Crinetics Pharmaceuticals Inc.

Not possible to specify

Sweden, Austria, Spain, Poland, Netherlands, Italy, Germany, France

28/09/2026

Phase III

C4931004 - A Phase 3, Randomized Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Catch-Up Vaccination Regimen of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Children and Adolescents

2025-523445-10-00Pneumoccoccal Immunisation

Pfizer Inc.

Bacterial Infections and Mycoses

Poland, Finland

28/09/2026

Phase III

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-OLE).

2026-526139-20-00Symptomatic genetic and familial dilated cardiomyopathy.

DrugDanicamtiv

Kardigan Inc.

Cardiovascular Diseases

Poland, Sweden, Belgium, France, Spain, Hungary, Denmark, Italy, Netherlands

28/09/2026

Phase III

A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients with Generalized Myasthenia Gravis (EMERGE)

2026-525298-38-00generalized Myasthenia gravis

DrugClaseprubart

Dianthus Therapeutics Inc.

Immune System Diseases

Czechia, Portugal, Austria, Bulgaria, Germany, France, Latvia, Poland, Italy, Spain, Denmark

28/09/2026

Phase III

A Phase II/III Multicenter, Randomized, Masked, Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of Two Doses of OCUL101, an Anti-VEGF and Anti-Complement C5, Bi-specific Humanized Antibody-Like “trap” in Participants with Neovascular Age-Related Macular Degeneration with or without Geographic Atrophy – STAT Study

2026-526648-11-00Neovascular age-related macular degeneration (nAMD)

DrugAflibercept

Shenzhen Oculgen Biomedical Technology Co. Ltd.

Eye Diseases

Latvia, Poland, Czechia, Hungary

24/09/2026

Phase II

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Participants with Refractory Chronic Cough

2026-526087-20-00Refractory Chronic Cough

DrugNalbuphine

Trevi Therapeutics Inc.

Respiratory Tract Diseases

Poland

24/09/2026

Phase II

A Phase 2b, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Clinical Study to Evaluate the Efficacy and Safety of ATH-063 Induction Therapy in Patients with Biologic Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC)

2024-520183-33-00Active Ulcerative Colitis

Athos Therapeutics Inc.

Digestive System Diseases

Poland

24/09/2026

Phase III

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma (TROPION-Urothelial04).

2025-525030-57-00High-risk muscle invasive urothelial carcinoma (MIUC) origi…

DrugsMycophenolate Mofetil·Infliximab·Rilvegostomig·Enfortumab Vedotin

AstraZeneca AB

Neoplasms

Italy, Poland, Spain, France, Germany

23/09/2026

Phase III

LUMIOS - A Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to assess the efficacy, safety and tolerability of cenerimod in adult patients with systemic lupus erythematosus and active lupus nephritis in combination with background therapy

2025-522984-14-00Systemic lupus erythematosus and active lupus nephritis

DrugCenerimod

Viatris Innovation GmbH

Immune System Diseases

Germany, Spain, Poland, Bulgaria, Romania

23/09/2026

Phase III

A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants with Moderate-to-Severe Face and Neck Atopic Dermatitis

2025-525133-31-00Face and Neck Atopic Dermatitis

DrugLebrikizumab

Almirall S.A.

Skin and Connective Tissue Diseases

Poland, Germany, Portugal, France, Spain, Denmark

22/09/2026

Phase II

A Phase 2b, Randomized, Placebo-controlled, Double-blind, Dose-ranging Trial to Assess the Efficacy and Safety of Ontunisertib in Patients with Fibrostenosing Crohn’s Disease

2026-525197-19-00Fibrostenosing Crohn’s Disease

DrugOntunisertib

Agomab Spain S.L.U.

Digestive System Diseases

France, Germany, Poland, Spain, Czechia, Denmark, Austria, Italy, Belgium, Netherlands

21/09/2026

Phase III

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants with Obesity or Overweight

2026-525408-82-00Chronic Weight Management

DrugMaridebart cafraglutide

Amgen Inc.

Nutritional and Metabolic Diseases

Czechia, Spain, Poland, Denmark, Germany, Italy, Belgium, Finland

21/09/2026

Phase III

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants with Obesity or Overweight with Type 2 Diabetes Mellitus

2025-524788-19-00Chronic Weight Management

DrugMaridebart cafraglutide

Amgen Inc.

Nutritional and Metabolic Diseases

Germany, Hungary, Czechia, Italy, Poland, Bulgaria

21/09/2026

Phase III

A randomized, open-label, multicenter, Phase 3 study to investigate mocertatug rezetecan compared with chemotherapy in participants with endometrial cancer after platinum-based chemotherapy and immunotherapy

2025-523362-25-00Neoplasms, Endometrial

DrugsDoxorubicin·Paclitaxel

Glaxosmithkline Research & Development Limited

Neoplasms

Denmark, Netherlands, Italy, Spain, France, Portugal, Greece, Poland, Germany, Belgium, Norway, Czechia

21/09/2026

Phase II

A Phase 2b, randomized, placebo-controlled, observer-blind study in adults 60 years and older to evaluate the efficacy, safety, and immunogenicity of a bivalent protein vaccine candidate against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)

2026-526177-42-00Infections and infestations

Sanofi Vaccines US Inc.

Virus Diseases

Estonia, Spain, Germany, Czechia, Poland, Finland, Netherlands

21/09/2026

Phase II

Randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of 2 dose levels of the oral ghrelin receptor agonist AC01 over 12 weeks in patients with chronic advanced heart failure with reduced ejection fraction (HFrEF)

2025-524469-25-00chronic advanced heart failure with reduced ejection fracti…

AnaCardio AB

Cardiovascular Diseases

Czechia, Slovakia, Spain, Bulgaria, Netherlands, Italy, Poland, Germany, Sweden, Hungary

21/09/2026

Phase III

A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults with Idiopathic Pulmonary Fibrosis (SURPASS-IPF)

2025-524493-42-00Idiopathic Pulmonary Fibrosis

DrugsDeupirfenidone·Pirfenidone

Puretech Lyt 100 Inc.

Respiratory Tract Diseases

Greece, Italy, Czechia, France, Portugal, Denmark, Spain, Poland, Germany, Romania, Belgium, Netherlands

18/09/2026

Phase II

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)

2025-524384-20-00Atopic dermatitis (AD)

DrugSoquelitinib

Corvus Pharmaceuticals Inc.

Skin and Connective Tissue Diseases

Italy, Czechia, Germany, Poland, Spain, Bulgaria

18/09/2026

Phase III

A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

2025-524202-15-00Recurrent Platinum-Sensitive Ovarian Cancer

DrugsPegfilgrastim·Doxorubicin·Paclitaxel·Bevacizumab

Genmab A/S

Neoplasms

Czechia, Netherlands, Lithuania, Ireland, Finland, Hungary, Spain, Greece, Italy, France, Germany, Poland

18/09/2026

Phase III

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily oral ASC30 in Adult Participants with Obesity or Overweight with Weight-Related Comorbidities (AURORA-1)

2026-526172-23-00Obesity or Overweight

DrugASC30

Ascletis Pharma (China) Co. Ltd.

Nutritional and Metabolic Diseases

Germany, Greece, Czechia, Poland

18/09/2026

Phase III

A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination with the Modified Gemcitabine and nab-Paclitaxel Regimen Versus the Standard Gemcitabine and nab-Paclitaxel Regimen for the Treatment of Patients with Metastatic Pancreatic Ductal Adenocarcinoma Cancer (MAPKeeper 301)

2026-525617-31-00Metastatic Pancreatic Ductal Adenocarcinoma

DrugsGemcitabine·Paclitaxel

Immuneering Corp.

Neoplasms

Spain, Czechia, Hungary, Belgium, Poland, Germany, France, Italy, Romania

17/09/2026

Phase III

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants with Obesity or Overweight with Type 2 Diabetes Mellitus (AURORA-2)

2026-526336-39-00Obesity or Overweight with Type 2 Diabetes Mellitus

DrugASC30

Ascletis Pharma (China) Co. Ltd.

Nutritional and Metabolic Diseases

Germany, Czechia, Greece, Poland

17/09/2026

Phase III

Zenagamtide use for the reduction of risk of major adverse cardiovascular events in people with established atherosclerotic cardiovascular disease and either overweight or obesity (AMBIENCE)

2026-525182-53-00Atherosclerotic cardiovascular disease and either overweigh…

Novo Nordisk A/S

Cardiovascular Diseases

Denmark, Czechia, Greece, France, Italy, Germany, Spain, Poland, Netherlands, Bulgaria

16/09/2026

Phase III

A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator’s Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy.

2026-526654-14-01Newly Diagnosed Multiple Myeloma

DrugsRamantamig·Velcade·Bortezomib·Daratumumab

Janssen Cilag International

Neoplasms

Greece, Portugal, Italy, France, Netherlands, Czechia, Germany, Poland, Spain

16/09/2026

Phase III

A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study Of Inebilizumab In Participants With Autoimmune Hepatitis

2025-522393-37-00Autoimmune Hepatitis (AIH)

DrugInebilizumab

Amgen Inc.

Digestive System Diseases

Belgium, Germany, Hungary, Czechia, Bulgaria, France, Netherlands, Italy, Poland, Greece, Portugal, Spain

16/09/2026

Phase II

J2S-MC-GZMV: A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

2026-525480-41-00Pulmonary Disease, Chronic Obstructive

DrugBrenipatide

Eli Lilly & Co.

Respiratory Tract Diseases

Denmark, France, Romania, Czechia, Poland, Hungary, Germany, Austria

15/09/2026

Phase II

Interventional, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose trial of Lu AF28996 in adults with Parkinson’s disease experiencing motor fluctuations.

2025-524655-30-00Parkinson’s disease

H. Lundbeck A/S

Nervous System Diseases

Czechia, France, Spain, Poland, Italy, Germany, Sweden

15/09/2026

Phase III

An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C plus Standard Medical Treatment to Prevent Infections in Participants with Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma (Sigma).

2026-526803-31-00Secondary Antibody Deficiency Associated with Chronic Lymph…

Grifols Therapeutics LLC

Immune System Diseases

Italy, Poland, Czechia, France, Spain

14/09/2026

Phase I

A Study to Evaluate the Safety, Tolerability, and Activity of a Novel Oral Anticancer Drug (FLC‑436) in Patients With Refractory or Relapsed Solid Malignancies

2026-526215-10-00Refractory or Relapsed Solid Malignancies

Fileclo Sp. z o.o.

Neoplasms

Poland

14/09/2026

Phase II

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants with Moderate-to-Severe Atopic Dermatitis

2026-526184-38-00Atopic Dermatitis

DrugENV-294

Enveda Therapeutics Inc.

Skin and Connective Tissue Diseases

Germany, Czechia, Bulgaria, Poland, Spain

10/09/2026

Phase I

A PHASE I FIRST-IN-HUMAN, OPEN-LABEL, MULTICENTER STUDYTO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF SIM0505 IN ADULT PARTICIPANTS WITH ADVANCED SOLID TUMORS

2026-525888-40-00Advanced solid tumors

Nextcure Inc.

Neoplasms

Italy, Poland, France, Spain

09/09/2026

Phase III

C6491013 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Once-Monthly PF-08653944 in Adults with Overweight or Obesity (VESPER 6)

2026-525318-75-00Overweight or Obesity

DrugBerobenatide

Pfizer Inc.

Nutritional and Metabolic Diseases

Spain, France, Germany, Poland, Italy

09/09/2026

Phase II

A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

2026-526241-98-00Uncontrolled Moderate to Severe Eosinophilic Asthma

DrugKT-621

Kymera Therapeutics Inc.

Immune System Diseases

Austria, Germany, Belgium, Romania, Italy, Slovakia, Poland, Spain

09/09/2026

Phase I

A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers

2025-523601-16-00Lymphoma, Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Foll…

Eli Lilly & Co.

Hemic and Lymphatic Diseases

Spain, Poland, Italy, France, Germany

08/09/2026

Phase III

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants with Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line chemotherapy (DeLLphi-315)

2026-525489-23-00Relapsed Extensive-Stage Small Cell Lung Cancer After Plat…

DrugsSiltuximab·Tarlatamab

Amgen Inc.

Neoplasms

Romania, Poland, Germany, Greece, Netherlands, Hungary, Portugal, France, Belgium, Italy, Spain

08/09/2026

Phase IV

A double-blind, randomised, 30-week placebo-controlled phase IV study to assess the efficacy and safety of osilodrostat in patients with hypertension caused by hypercortisolaemia due to Cushing’s Syndrome

2025-524649-28-00Cushing's syndrome

DrugOsilodrostat

Recordati AG

Hormonal diseases

Germany, Bulgaria, France, Romania, Italy, Poland, Spain

08/09/2026

Phase II

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants with Sjogren’s Disease-Associated Sensorimotor or Sensory Polyneuropathy

2026-526218-10-00Sjogren’s Disease-Associated Sensorimotor Polyneuropathy (S…

Argenx

Immune System Diseases

Germany, Estonia, Lithuania, Portugal, Slovakia, Hungary, Romania, Poland, Spain, Austria, Belgium, France, Bulgaria

08/09/2026

Phase I

A trial to learn how safe anifrolumab is, how it moves throughout the body over time, and how it affects the body of adults with systemic lupus erythematosus

2026-526171-32-00Systemic Lupus Erythematosus

AstraZeneca AB

Immune System Diseases

Poland, Hungary

07/09/2026

Phase I

A Study of RO7806767 as Single Agent and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

2026-525215-13-00Advanced Solid Tumors

F. Hoffmann-La Roche AG

Neoplasms

Spain, Poland, Romania, Hungary, Germany, Italy, Belgium, Netherlands, Denmark, France

07/09/2026

Phase II

A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (aged 6 to 23 months) with Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled with Topical Therapy

2025-525027-27-00Atopic Dermatitis

Galderma S.A.

Skin and Connective Tissue Diseases

Poland

04/09/2026

Phase II

Randomized, Double blind, Phase II Trial of Vortosiran to Evaluate Safety, Tolerability, and Pharmacodynamic Efficacy in Participants with Prior Venous Thromboembolism After Completion of Initial Anticoagulant Therapy (Cohort A) and in Cancer Patients at High Risk of Venous Thromboembolism (Cohort B)

2026-525479-15-00Venous Thromboembolism

DrugRBD4059

Ribocure Pharmaceuticals AB

Cardiovascular Diseases

Poland, Romania, France, Bulgaria

04/09/2026

Phase III

A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy

2026-525913-30-00Immune system diseases

DrugsBelumosudil·Ixazomib·Imatinib·Sirolimus

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Belgium, Czechia, Hungary, Sweden, Lithuania, Croatia, Netherlands, Slovakia, Poland, Austria, Norway, France, Italy, Bulgaria, Spain, Germany, Romania, Slovenia, Estonia, Portugal, Greece, Denmark

02/09/2026

Phase III

A phase III, randomized, prospective, double-blind, parallel design, multi-arm, multicenter study to compare the efficacy and safety of alogliptin and empagliflozin combination therapy versus alogliptin alone and empagliflozin alone in metformin-treated participants with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise (ODISSEIA 2026).

2025-524606-15-00Type 2 Diabetes mellitus

Tecnimede-Sociedade Tecnico-Medicinal S.A.

Nutritional and Metabolic Diseases

Poland, Germany, Portugal, Italy, Spain

02/09/2026

Phase III

A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).

2025-524014-29-00Newly Diagnosed Multiple Myeloma

DrugsAZD0120·Isatuximab·Bortezomib·Daratumumab

AstraZeneca AB

Neoplasms

Poland, Italy, Denmark, France, Sweden, Germany, Spain

01/09/2026

Phase III

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants with Genetically Diagnosed Spinal Muscular Atrophy

2025-523857-32-00Spinal Muscular Atrophy

DrugSalanersen

Biogen Idec Research Limited

Nervous System Diseases

Portugal, Italy, Belgium, Croatia, Hungary, Germany, Ireland, France, Norway, Poland

31/08/2026

Phase II

Efficacy and safety of once-weekly subcutaneous UBT251 in participants with type 2 diabetes – a dose-finding study

2026-525465-42-00Type 2 diabetes (T2D)

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Spain, Hungary, Romania, Slovakia, Poland, Germany

31/08/2026

Phase III

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB COMPARED WITH INVESTIGATOR’S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER

2025-524263-21-01Resected Stage II-III Kirsten rat sarcoma virus oncogene ho…

DrugsDivarasib·Nivolumab·Pembrolizumab

F. Hoffmann-La Roche AG

Neoplasms

France, Spain, Austria, Greece, Portugal, Ireland, Belgium, Italy, Poland, Germany, Netherlands

28/08/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE-791 in Subjects with Idiopathic Pulmonary Fibrosis

2025-521901-42-00Idiopathic Pulmonary Fibrosis (IPF)

Contineum Therapeutics Inc.

Respiratory Tract Diseases

Italy, Belgium, Denmark, Austria, Greece, Germany, France, Netherlands, Portugal, Poland, Spain

26/08/2026

Phase II

C6461010 - An Interventional, Open-Label, Phase 2 Study to Investigate the Safety and Efficacy of PF-08634404 Monotherapy or in Combination in Adult Participants with Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer

2025-524825-42-00Early-Stage Resectable or Locally Advanced Unresectable Non…

DrugsPF-08634404·Pemetrexed·Paclitaxel·Carboplatin

Pfizer Inc.

Neoplasms

Spain, France, Italy, Ireland, Germany, Poland

26/08/2026

Phase II

A Phase 2a, proof-of-concept, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to assess the efficacy and safety of ACT-777991 in adults with non-segmental vitiligo

2025-524865-25-00Non-segmental vitiligo

Idorsia Pharmaceuticals Ltd.

Skin and Connective Tissue Diseases

Czechia, Poland

26/08/2026

Phase III

A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis

2025-524757-14-00Ocular Myasthenia Gravis

DrugRozanolixizumab

UCB Biopharma

Immune System Diseases

Hungary, France, Greece, Poland, Spain, Italy, Germany

25/08/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension

2025-523821-17-00narcolepsy

DrugPitolisant

Harmony Biosciences Management Inc.

Nervous System Diseases

Belgium, Italy, Germany, France, Spain, Poland

25/08/2026

Phase II

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults with Moderate-to-Severe Atopic Dermatitis

2026-525673-39-00Atopic Dermatitis (AD)

Apollo Therapeutics Limited

Skin and Connective Tissue Diseases

Hungary, Czechia, Germany, Bulgaria, Poland, Spain

25/08/2026

Phase II

Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)

2025-524905-34-00Solid tumor

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Greece, Hungary, Poland, Belgium, Spain, Netherlands, Germany, France, Portugal, Italy, Romania

25/08/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)

2025-524928-21-00Pancreatic Adenocarcinoma

DrugRMC-9805

Revolution Medicines Inc.

Neoplasms

Sweden, Spain, France, Poland, Italy, Norway, Belgium, Germany, Czechia, Austria, Netherlands, Denmark

24/08/2026

Phase III

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (both in Combination with the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women with HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3)

2025-524846-85-00HR-positive, HER2-negative, inoperable locally advanced o…

DrugsRibociclib·Letrozole

Laboratorios Farmaceuticos Rovi S.A.

Neoplasms

Romania, Spain, Bulgaria, Czechia, Latvia, Poland, Croatia, Slovakia

21/08/2026

Phase III

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

2025-524669-25-00Polycythemia Vera

Deciphera Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Austria, Czechia, Italy, Portugal, Germany, France, Hungary, Spain, Poland

21/08/2026

Phase III

A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

2025-524934-24-00Neoplasms, Gastrointestinal Stromal

Glaxosmithkline Research & Development Limited

Neoplasms

Italy, Portugal, Germany, Sweden, Poland, Romania, Finland, Greece, Norway, Spain, Netherlands, France, Hungary

21/08/2026

Phase III

A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

2025-524641-27-00High-Grade Serous Ovarian, Fallopian Tube, or Primary Perit…

DrugsTopotecan·Doxorubicin·Gemcitabine·Paclitaxel

K-Group Beta Inc.

Neoplasms

Germany, Spain, Italy, Belgium, Poland, France, Ireland

21/08/2026

Phase II

A Randomized, Double-Blind, Phase 2 Trial Evaluating the Efficacy, Safety and Tolerability of Primary Cardioprotection with Dapagliflozin in Patients with Newly Diagnosed Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation

2026-525418-67-00Multiple Myeloma

DrugDapagliflozin

Instytut Hematologii I Transfuzjologii

Hemic and Lymphatic Diseases

Poland

21/08/2026

Phase III

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

2025-523252-31-00High Risk Smoldering Multiple Myeloma (HR-SMM)

DrugsLinvoseltamab·Daratumumab

Regeneron Pharmaceuticals Inc.

Neoplasms

Italy, Spain, Poland, France, Norway, Greece, Germany

20/08/2026

Phase III

JS2-MC-GZMI: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEW-MDD- 2)

2025-522310-24-00Depressive Disorder, Major

Eli Lilly & Co.

Mental Disorders

Poland, Greece, Spain, Germany

19/08/2026

Phase I/II

A Phase 1/2 Trial of TER-2013 in Patients with Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

2025-525036-34-00Solid Tumours

DrugsImlunestrant·Fulvestrant

Terremoto Biosciences Inc.

Neoplasms

Spain, Ireland, Hungary, Romania, France, Portugal, Belgium, Poland

18/08/2026

Phase III

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis

2025-524756-54-00Ocular Myasthenia Gravis

DrugRozanolixizumab

UCB Biopharma

Immune System Diseases

Hungary, Greece, Italy, Spain, Germany, Poland, France

18/08/2026

Phase II

A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate Safety, and Pharmacodynamics of Repeated Subcutaneously Administered RBD1119 in Participants with CAD

2026-525901-10-00Coronary artery disease

Ribocure Pharmaceuticals AB

Cardiovascular Diseases

Sweden, Poland

18/08/2026

Phase II

A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination with Lenvatinib versus Lenvatinib in Participants with Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

2025-524591-30-00Hepatocellular Carcinoma

Akeso Biopharma Co. Ltd.

Neoplasms

Poland, France, Spain, Italy

18/08/2026

Phase III

A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered via Intravitreal Injection in Participants with Neovascular Age-related Macular Degeneration

2025-523500-72-00Neovascular Age-related Macular Degeneration (nAMD)

Amgen Inc.

Eye Diseases

Slovakia, Latvia, Czechia, Poland, Spain, Hungary, Lithuania

17/08/2026

Phase III

C4931007 - A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

2025-523447-35-02Pneumoccoccal Immunisation

Pfizer Inc.

Bacterial Infections and Mycoses

Spain, Finland, Poland, Germany, Greece, Hungary, Italy

17/08/2026

Phase III

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

2025-524445-27-00Metastatic castration-resistant prostate cancer (mCRPC)

DrugsBNT324·Prednisone·Docetaxel

BioNTech SE

Male Urogenital Diseases

Belgium, Spain, Italy, Poland, Germany, Hungary

17/08/2026

Phase I

A Two-part study to learn the amount of polymyxin E1 in the body over time formed after a single inhaled dose of colistimethate sodium (CMS) in healthy adults (Part 1) and after single inhaled and vein-infused doses of CMS in adults with non‑cystic fibrosis bronchiectasis (NCFB) (Part 2)

2025-524324-22-00Non-cystic fibrosis bronchiectasis

Zambon S.p.A.

Respiratory Tract Diseases

Belgium, Poland, Bulgaria

17/08/2026

Phase II

A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)

2025-525033-31-00heart failure

DrugCRD-4730

Cardurion Pharmaceuticals Inc.

Cardiovascular Diseases

Latvia, Slovakia, Lithuania, Hungary, Italy, Netherlands, Spain, Poland, Bulgaria, Czechia

14/08/2026

Phase II

A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients with Severe Asthma not Adequately Controlled with Medium to High Dose ICS/LABA Therapy (PANAIRAMA)

2023-509125-41-00Severe asthma

DrugSalbutamol

Kinaset Therapeutics Inc.

Respiratory Tract Diseases

Czechia, Bulgaria, Romania, Hungary, Germany, Poland, Greece

14/08/2026

Phase III

SERAFA-1: A Single arm, Open label, Multicentre, Phase IIIb Study Of Camizestrant plus Ribociclib in 1st line Treatment of ER-positive, HER2-negative Advanced Breast Cancer Patients

2025-523444-12-00Breast Cancer

AstraZeneca AB

Neoplasms

Poland, Spain, France, Germany, Italy

13/08/2026

Phase III

Prognostic value assessment of PSMA-T4 examination in the group of patients with triple-negative breast cancer (TNBC) qualified to radical therapy

2025-525110-29-01triple-negative breast cancer

Narodowe Centrum Badan Jadrowych

Neoplasms

Poland

12/08/2026

Phase II

Evaluation of the efficacy, safety, and tolerability of lutetium-177-labeled PSMA ligand in patients with progression of adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial

2026-525776-26-00adenoid cystic carcinoma of the salivary glands

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Otorhinolaryngologic Diseases

Poland

12/08/2026

Phase III

Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity

2025-524626-18-00Overweight and obesity

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Netherlands, Belgium, Greece, Poland, Spain, Denmark, France, Bulgaria, Sweden

10/08/2026

Phase III

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs

2025-523333-26-00Graves' Disease (GD)

Argenx

Hormonal diseases

Italy, Czechia, Spain, Denmark, Belgium, Romania, Latvia, France, Germany, Greece, Sweden, Poland, Lithuania, Bulgaria

07/08/2026

Phase II

[22961] A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.

2025-523807-31-00Atrial fibrillation

Bayer AG

Cardiovascular Diseases

Belgium, Netherlands, Germany, Poland, Italy, Hungary, Bulgaria

06/08/2026

Phase III

ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study with Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit from Continued Treatment

2025-523307-29-00Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hyper…

DrugBenralizumab

AstraZeneca AB

Respiratory Tract Diseases

Denmark, Belgium, France, Italy, Netherlands, Austria, Poland

04/08/2026

Phase II

A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)

2025-525016-41-00Idiopathic Pulmonary Fibrosis

AstraZeneca AB

Respiratory Tract Diseases

Poland, Hungary, Netherlands, Germany, Spain, Greece, Bulgaria, Italy, France, Denmark

04/08/2026

Phase III

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Placebo in Adults with Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)

2025-523935-20-00type 2 diabetes mellitus

AstraZeneca AB

Nutritional and Metabolic Diseases

Poland, Germany, Bulgaria, Czechia

04/08/2026

Phase I

A study of enzomenib investigating potential drug-drug interactions and the effect of liver impairment in adult patients with advanced cancer

2025-524652-63-00Advanced Cancer

Sumitomo Pharma America Inc.

Neoplasms

Spain, Bulgaria, Poland, Romania

04/08/2026

Phase III

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared with Elecoglipron Alone and Dapagliflozin Alone, in Adults with Type 2 Diabetes Mellitus (Eluminate-5)

2025-523941-81-00type 2 diabetes mellitus

AstraZeneca AB

Nutritional and Metabolic Diseases

Slovakia, Poland, Czechia, Germany, Hungary, Greece, Denmark

03/08/2026

Phase III

A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

2025-523884-39-00Systemic sclerosis

DrugNerandomilast

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Skin and Connective Tissue Diseases

Denmark, Hungary, Sweden, Netherlands, Germany, Belgium, France, Greece, Norway, Finland, Czechia, Portugal, Bulgaria, Spain, Austria, Romania, Croatia, Poland, Estonia, Italy, Lithuania

03/08/2026

Phase III

A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease

2026-525922-39-00Moderately to Severely Active Crohn’s Disease

Janssen Cilag International

Immune System Diseases

Norway, Romania, Austria, Italy, Slovakia, Germany, Hungary, Netherlands, Belgium, France, Portugal, Czechia, Poland, Spain, Greece

03/08/2026

Phase III

A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis

2026-525923-26-00Moderately to Severely Active Ulcerative Colitis

DrugsJNJ-78934804·Guselkumab

Janssen Cilag International

Immune System Diseases

France, Bulgaria, Romania, Slovakia, Norway, Denmark, Greece, Italy, Austria, Poland, Netherlands, Czechia, Germany, Belgium, Spain, Hungary, Portugal

03/08/2026

Phase I/II

A Phase I/II, randomized, placebo-controlled, multi-arm, dose-finding study to evaluate the safety, efficacy and immunogenicity of an Acne mRNA vaccine candidate in adults with moderate to severe acne 18 to 45 years of age

2025-521740-38-00Acne

DrugAcne mRNA vaccine

Sanofi Vaccines US Inc.

Skin and Connective Tissue Diseases

Spain, Germany, Poland

29/07/2026

Phase IV

Effectiveness of Trazodone on Emotional Blunting in Patients with Major Depressive: a Phase IV, Open-label, clinical study

2025-523267-38-00Major depressive disorder (MDD)

Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Mental Disorders

Bulgaria, Poland, Hungary

29/07/2026

Phase III

A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)

2026-526304-79-00Heart failure with preserved ejection fraction (HFpEF) and …

AstraZeneca AB

Cardiovascular Diseases

Spain, Hungary, Germany, Poland, Italy, Bulgaria, Netherlands, Austria, Romania, Sweden, France, Greece, Slovakia, Czechia

29/07/2026

Phase II

A Phase 2 Study of Alisertib in Combination with Paclitaxel in Patients with Small Cell Lung Cancer

2026-525382-47-00Small Cell Lung Cancer (SCLC)

DrugPaclitaxel

Puma Biotechnology Inc.

Neoplasms

France, Poland, Spain

28/07/2026

Phase III

A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

2025-522488-14-00Participants with obesity with or without type 2 diabetes

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Greece, Portugal, France, Slovakia, Bulgaria, Netherlands, Romania, Italy, Austria, Poland, Hungary, Spain, Czechia, Belgium

27/07/2026

Phase III

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants with Obesity or Overweight with or without Type 2 Diabetes Mellitus (Embold)

2025-524688-19-00Participants Living with Obesity or Overweight with at leas…

AstraZeneca AB

Nutritional and Metabolic Diseases

Spain, Germany, Italy, Poland

27/07/2026

Phase III

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

2025-523960-19-00Advanced or Metastatic HR+/HER2- Breast Cancer

BeOne Medicines I GmbH

Neoplasms

Poland, Italy, Germany, France, Spain

27/07/2026

Phase III

An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam

2025-524054-34-00Spinal Muscular Atrophy

DrugSalanersen

Biogen Idec Research Limited

Nervous System Diseases

Finland, Spain, Italy, Poland, Ireland, Germany, France

24/07/2026

Phase II

A randomised active-controlled trial to assess the safety and pharmacodynamics of two blinded doses of vortosiran and open-label apixaban in patients with non-valvular atrial fibrillation

2026-525417-31-00non-valvular atrial fibrillation

DrugsRBD4059·Apixaban

Ribocure Pharmaceuticals AB

Cardiovascular Diseases

Norway, Denmark, Poland, Sweden

24/07/2026

Phase III

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

2025-523994-41-00Chronic kidney disease (CKD) in adults, with specified rang…

DrugsElecoglipron·Dapagliflozin

AstraZeneca AB

Cardiovascular Diseases

Czechia, Italy, Hungary, Romania, Bulgaria, Sweden, Denmark, Poland, Spain, Norway, Finland, Greece, France, Germany

24/07/2026

Phase III

Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)

2025-525097-11-00Multiple myeloma

DrugsTalquetamab·Teclistamab·Daratumumab·Lenalidomide

Polish Myeloma Consortium

Hemic and Lymphatic Diseases

Poland

23/07/2026

Phase III

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

2026-525727-24-00No medical condition

Chemo Research S.L.

Not possible to specify

Sweden, Czechia, Spain, Hungary, Poland, Finland, Romania

23/07/2026

Phase I/II

A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants with Refractory Rheumatoid Arthritis

2025-520666-22-00Refractory, difficult-to-treat Rheumatoid Arthritis

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

Poland, Italy, Spain, Germany

22/07/2026

Phase III

A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Oral Semaglutide in Adults with Type 2 Diabetes Mellitus (Eluminate-2)

2025-523933-24-00type 2 diabetes mellitus

AstraZeneca AB

Nutritional and Metabolic Diseases

Poland, Hungary, Italy, Bulgaria, Germany

22/07/2026

Phase III

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

2026-525242-29-00Primary Sclerosing Cholangitis

DrugElafibranor

Ipsen Bioscience Inc.

Digestive System Diseases

Spain, Sweden, Germany, Romania, Finland, Portugal, Austria, Italy, Denmark, Czechia, France, Netherlands, Poland, Belgium, Norway

21/07/2026

Phase III

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens

2025-524336-19-00HIV-1

DrugsCobicistat·Doravirine·Ritonavir·Tenofovir DF

Gilead Sciences Inc.

Virus Diseases

Poland, Italy, France, Spain, Germany, Netherlands

21/07/2026

Phase III

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

2025-524335-39-00HIV-1

DrugsTeropavimab·Zinlirvimab·Rilpivirine·Cabotegravir

Gilead Sciences Inc.

Virus Diseases

Netherlands, Poland, Germany, France, Spain, Italy

21/07/2026

Phase III

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice-daily Delgocitinib Cream in Adult Participants with Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

2025-524873-17-00Lichen Sclerosus

DrugDelgocitinib

Leo Pharma A/S

Skin and Connective Tissue Diseases

Italy, France, Spain, Poland, Germany

21/07/2026

Phase III

A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

2025-522227-99-00Huntington’s Disease

DrugVotoplam

Novartis Pharma AG

Nervous System Diseases

Norway, Poland, Spain, Sweden, Bulgaria, Netherlands, Finland, Portugal, Austria, Italy, Greece, Ireland, Czechia, France, Romania, Belgium, Germany, Denmark, Slovakia, Hungary

20/07/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

2025-524711-36-00Narcolepsy Type 1

DrugALKS 2680

Alkermes Inc.

Nervous System Diseases

Sweden, Finland, Belgium, Spain, Austria, Netherlands, France, Norway, Germany, Italy, Poland

20/07/2026

Phase III

Phase 3 Single-Arm Open-Label Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent Subjects (age 12 to <18 years) with Homozygous Familial Hypercholesterolemia (SPRUCE)

2025-523662-24-00Homozygous Familial Hypercholesterolemia (HoFH)

DrugZodasiran

Arrowhead Pharmaceuticals Inc.

Cardiovascular Diseases

Netherlands, Denmark, Norway, Sweden, Poland

20/07/2026

Phase I

A study comparing the new drugs PG511/PG521/PG531 produced by Celon Pharma SA with the drug PG203 in healthy volunteers.

2025-524936-20-00Treatment of psychotic disorders like schizophrenia Treatme…

Celon Pharma S.A.

Mental Disorders

Poland

20/07/2026

Phase II

An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension due to Interstitial Lung Disease

2026-525810-80-00Pulmonary hypertension secondary to interstitial lung disea…

Tectonic Operating Company Inc.

Cardiovascular Diseases

Poland, Romania, Spain

17/07/2026

Phase II

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to-Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid

2025-524682-24-00Ulcerative Colitis

Microbial Resource Management Health

Digestive System Diseases

Czechia, Poland, Italy

16/07/2026

Phase III

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

2025-524648-37-00Metastatic colorectal cancer

Merck Healthcare KGaA

Neoplasms

Belgium, Germany, France, Denmark, Poland, Spain, Netherlands, Italy, Austria

14/07/2026

Phase III

A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults and Adolescents with Focal Segmental Glomerulosclerosis

2025-524448-36-00Focal segmental glomerulosclerosis (FSGS)

DrugPegcetacoplan

Apellis Pharmaceuticals Inc.

Female Urogenital Diseases and Pregnancy Complications

France, Portugal, Spain, Slovakia, Italy, Germany, Poland

14/07/2026

Phase III

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

2025-525088-34-00Metastatic Pancreatic Adenocarcinoma

Revolution Medicines Inc.

Digestive System Diseases

Poland, Belgium, Norway, Sweden, Austria, Germany, Denmark, Netherlands, France, Italy, Spain

14/07/2026

Phase II

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease

2025-524139-38-00Antibody-mediated Kidney Disease

DrugSurovatamig

AstraZeneca AB

Immune System Diseases

France, Germany, Italy, Belgium, Poland, Spain

13/07/2026

Phase II

Phase II, Multicenter, Randomized Study to Evaluate Safety and Efficacy of MRD-guided Therapy with Reduced versus Standard Dose of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (REBEL)

2025-525096-83-00Relapsed/refractory Multiple myeloma

DrugPomalidomide

Polish Myeloma Consortium

Hemic and Lymphatic Diseases

Poland

13/07/2026

Phase I/II

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

2025-525105-20-00Multiple Myeloma (MM), Multiple Myeloma (MM)

DrugEtentamig

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Germany, Poland, Czechia, Belgium, France, Greece, Sweden, Portugal, Italy

13/07/2026

Phase II

Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

2025-522939-33-00AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthe…

DrugEmpasiprubart

Argenx

Immune System Diseases

Greece, Italy, Germany, Belgium, Netherlands, Spain, Poland

08/07/2026

Phase III

Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)

2023-505575-69-01Osteosarcoma

DrugCabozantinib

Institut Gustave Roussy

Neoplasms

Sweden, Poland, Denmark, Finland, Netherlands, Italy, France, Spain

08/07/2026

Phase III

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Xembify versus Gamunex-C in Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

2025-522165-30-00Chronic inflammatory demyelinating polyradiculoneuropathy (…

Grifols Therapeutics LLC

Nervous System Diseases

Romania, Czechia, Poland

07/07/2026

Phase III

Multicenter, randomized, double-blind, parallel-group clinical study comparing RD03/2016 (levoFloxacin and ketorolac trometAmol) eye drops vs Leviosa® (levofloxacin and dexamethaSone 21-phosphaTe) eye drops for 7 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. (FAST 7)

2026-525594-39-00Cataract

DrugLevofloxacin

Ntc S.r.l.

Eye Diseases

Spain, Poland, Greece, Sweden, Italy

07/07/2026

Phase III

A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)

2025-523369-32-00Fibrosing interstitial lung disease

DrugNerandomilast

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Respiratory Tract Diseases

Belgium, Greece, Germany, France, Finland, Spain, Czechia, Poland, Italy, Netherlands, Denmark, Portugal

07/07/2026

Phase III

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination with Pomalidomide and Dexamethasone Versus Standard of Care in Patients with Multiple Myeloma who Have Received One to Three Prior Lines of Therapy

2025-524028-23-00Multiple Myeloma

F. Hoffmann-La Roche AG

Neoplasms

France, Germany, Italy, Greece, Denmark, Czechia, Spain, Poland

07/07/2026

Phase II

A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MTX-474 in the Treatment of Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

2025-523288-39-00Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Mediar Therapeutics Inc.

Immune System Diseases

Netherlands, Romania, Poland, France, Italy, Spain

06/07/2026

Phase III

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

2024-518016-39-00Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

Denmark, Sweden, Poland, Estonia, Portugal, Latvia, Spain, Hungary, Germany, Finland, Italy, Belgium, France

06/07/2026

Phase III

2024-518213-25-00Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

Germany, Romania, Greece, Norway, Netherlands, Poland, Lithuania, Czechia, Slovakia, Spain

06/07/2026

Phase III

"A Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma after 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide"

2025-523815-12-00Relapsed or Refractory Multiple Myeloma

Janssen Cilag International

Neoplasms

Poland, Spain, Czechia, France, Italy, Germany, Greece

01/07/2026

Phase II

A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose‑ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) versus Placebo in Participants of 4 to Less than 12 Years of Age with Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF) (FAROS)

2025-524914-26-00Asthma

AstraZeneca AB

Respiratory Tract Diseases

Czechia, Poland, Hungary

01/07/2026

Phase III

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

2025-522167-15-00Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)

DrugBevacizumab

Genmab A/S

Neoplasms

Finland, Belgium, Hungary, France, Denmark, Austria, Germany, Italy, Spain, Czechia, Norway, Poland

01/07/2026

Phase III

Phase III, Open-label Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Efficacy, and Immunogenicity of Benralizumab in Children with Eosinophilic Disease (CLIPS)

2023-508533-14-00Eosinophilic Disease

DrugBenralizumab

AstraZeneca AB

Immune System Diseases

Poland, Netherlands, France

30/06/2026

Phase III

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

2025-521769-29-00Pulmonary Hypertension Associated with Interstitial Lung Di…

DrugTreprostinil Palmitil

Insmed Inc.

Respiratory Tract Diseases

Greece, France, Italy, Belgium, Denmark, Germany, Poland, Czechia, Portugal, Austria, Spain, Romania

30/06/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

2025-524855-30-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…

Merck Healthcare KGaA

Skin and Connective Tissue Diseases

Germany, Romania, France, Bulgaria, Belgium, Spain, Poland, Greece, Italy, Czechia

29/06/2026

Phase III

2025-523871-44-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…

DrugEnpatoran

Merck Healthcare KGaA

Immune System Diseases

Spain, Belgium, France, Germany, Slovakia, Romania, Bulgaria, Italy, Poland, Greece

29/06/2026

Phase I/II

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) inhibitors in Combination with Ivonescimab with or without Other Anti-Cancer Agents in Patients with Solid Tumors

2025-524623-50-00Solid Tumors

DrugsElironrasib·RMC-9805·Erbitux·Ivonescimab

Revolution Medicines Inc.

Neoplasms

France, Poland, Ireland, Spain, Greece, Germany, Italy, Sweden, Belgium

29/06/2026

Phase III

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

2025-525009-18-00Pancreatic Ductal Adenocarcinoma

Incyte Corp.

Neoplasms

Poland, Italy, Netherlands, Sweden, Denmark, Finland, Spain, France, Germany, Belgium, Norway, Austria

26/06/2026

Phase IV

Phase IV study evaluating the efficacy and safety of the venetoclax + rituximab (VR) regimen in patients with relapsed chronic lymphocytic leukemia in Polish clinical practice

2025-524795-35-00Adult with chronic lymphocytic leukemia/small lymphocytic l…

DrugsVenetoclax·Rituximab

Uniwersytet Medyczny W Lublinie

Hemic and Lymphatic Diseases

Poland

26/06/2026

Phase I

A Phase 1 Study of LBL-051 in Patients with Refractory Autoimmune Disease

2026-525621-20-00B-cell–mediated autoimmune diseases

Oblenio Bio Inc.

Immune system processes

Germany, Romania, Poland

25/06/2026

Phase III

A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS

2025-523726-40-00Multiple Sclerosis

F. Hoffmann-La Roche AG

Immune System Diseases

Spain, France, Poland, Italy

24/06/2026

Phase II

A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants with Non-Cystic Fibrosis Bronchiectasis (NCFB).

2025-523403-29-00Non-cystic fibrosis bronchiectasis

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

Poland, Spain, France, Netherlands, Germany

23/06/2026

Phase III

Multicenter Interventional Study Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature paediatric patients compared with daily growth hormone

2025-523832-38-00Small for gestational age (SGA) and idiopathic short statur…

DrugsSomatrogon·Somatropin

Schneider Children's Medical Center Of Israel

Musculoskeletal Diseases

Greece, Poland, France, Czechia

23/06/2026

Phase II

An Open-Label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis

2025-524164-37-00Relapsing-Remitting Multiple Sclerosis (RRMS)

DrugOcrelizumab

F. Hoffmann-La Roche AG

Nervous System Diseases

Poland, Germany, France

23/06/2026

Phase III

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

2025-521353-16-00Hereditary Angioedema

DrugDopamine

Adarx Pharmaceuticals Inc.

Immune System Diseases

Poland, Italy, Hungary, France, Austria, Czechia, Belgium, Spain, Bulgaria, Germany, Croatia

22/06/2026

Phase III

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis

2025-524322-18-00Non-active Secondary Progressive Multiple Sclerosis (SPMS)

DrugOrelabrutinib

Zenas Biopharma (USA) LLC

Nervous System Diseases

Germany, Bulgaria, Netherlands, Sweden, Portugal, Croatia, Italy, Austria, Spain, Poland, France, Denmark, Hungary, Romania, Estonia, Slovakia, Belgium, Czechia, Norway, Lithuania, Greece, Slovenia

22/06/2026

Phase II

An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab for Bladder Preservation in Participants with Muscle-invasive Bladder Cancer (EV-209).

2025-524488-18-00Muscle-invasive Bladder Cancer

Astellas Pharma Global Development Inc.

Neoplasms

Germany, France, Poland, Italy, Spain

22/06/2026

Phase II

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants with Moderately to Severely Active Ulcerative Colitis

2025-523479-49-00Colitis ulcerative

Merck Sharp & Dohme LLC

Digestive System Diseases

Italy, Greece, Netherlands, Poland, Germany, France

22/06/2026

Phase I

A Study to Learn How Different Amounts of the Study Intervention Called PF-07832837 are Tolerated and Act in the Body in Healthy Adults and Patients

2025-524150-34-00Atopic Dermatitis

Pfizer Inc.

Skin and Connective Tissue Diseases

Poland

18/06/2026

Phase III

IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis

2025-522373-10-00Progressive pulmonary fibrosis and Idiopathic pulmonary fib…

DrugAdmilparant

Bristol-Myers Squibb Services Unlimited Company

Respiratory Tract Diseases

Finland, Portugal, Hungary, Ireland, Poland, Greece, France, Belgium, Denmark, Italy, Spain, Netherlands, Austria, Germany

17/06/2026

Phase II

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis, including a 52-Week Main Treatment Period and a 156-Week Extension Treatment Period

2025-522294-11-00Systemic sclerosis

Galderma S.A.

Skin and Connective Tissue Diseases

Poland, Italy, Bulgaria, France, Greece, Spain, Croatia

17/06/2026

Phase III

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

2024-519787-40-00Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, E…

AstraZeneca AB

Neoplasms

France, Italy, Spain, Hungary, Poland, Belgium, Germany, Netherlands

16/06/2026

Phase I/II

A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)

2025-520626-37-00Metastatic Prostate Cancer

AstraZeneca AB

Neoplasms

Belgium, Spain, Poland, Italy, Netherlands

16/06/2026

Phase III

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

2025-522643-18-00Stage I NSCLC

DrugsPembrolizumab Formulated with Berahyaluronidase Alfa·Intismeran autogene

Merck Sharp & Dohme LLC

Neoplasms

Greece, Poland, Italy, Hungary, Germany, Netherlands, France, Spain

16/06/2026

Phase II

A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants with Inflammatory Bowel Disease

2025-524640-35-00Ulcerative colitis (Inflammatory Bowel Disease)

DrugsSPYPBO-101·SPY001·SPY002·SPY003

Spyre Therapeutics Inc.

Digestive System Diseases

Croatia, Poland, Austria, Czechia, Italy, Slovakia, Bulgaria, Greece, Belgium, Spain, Hungary, Germany, Lithuania, France, Romania

16/06/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

2025-522038-29-00Locally advanced, unresected (unresectable or medically ino…

DrugsCalderasib·Durvalumab

Merck Sharp & Dohme LLC

Neoplasms

Italy, Netherlands, France, Germany, Spain, Poland, Greece

12/06/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

2025-523674-16-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Glaxosmithkline Research & Development Limited

Nutritional and Metabolic Diseases

Greece, Germany, Belgium, Netherlands, Poland, Italy, France, Spain, Bulgaria, Austria

12/06/2026

Phase II

J6Z-MC-IIBD - A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease J6Z-MC-CD01 - A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared with Mirikizumab in Adults with Moderately to Severely Active Crohn’s Disease

2025-524112-11-00J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD…

DrugMirikizumab

Eli Lilly & Co.

Digestive System Diseases

Italy, Germany, Hungary, Poland, Belgium

11/06/2026

Phase II

J6E-MC-KWAM: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

2025-524404-29-00Ulcerative Colitis, Active Severe, Ulcerative Colitis, Acti…

Eli Lilly & Co.

Digestive System Diseases

Latvia, Portugal, Greece, France, Czechia, Italy, Poland, Slovakia, Hungary, Croatia, Lithuania

10/06/2026

Phase III

A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.

2025-522777-10-00Follicular Lymphoma

Merck Sharp & Dohme LLC

Neoplasms

France, Spain, Germany, Greece, Italy, Poland

09/06/2026

Phase III

A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

2025-522176-86-01Moderate Calcific Aortic Valve Stenosis (CAVS)

Kardigan Inc.

Cardiovascular Diseases

Norway, Czechia, Portugal, Austria, Poland, France, Spain

08/06/2026

Phase I/II

A Phase 1b/2 Open-label Study Evaluating different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-based regimens in First-line Extensive Stage Small Cell Lung Cancer

2025-521032-11-00Small cell lung cancer extensive stage

Merck Sharp & Dohme LLC

Neoplasms

Germany, Poland, Greece, Italy, France, Spain

08/06/2026

Phase II

J5D-MC-FPAC: A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata

2025-524727-41-00Alopecia Areata

Eli Lilly & Co.

Immune System Diseases

Poland, Netherlands

08/06/2026

Phase III

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer

2025-522818-23-00Small Cell Lung Cancer (SCLC)

DrugsZL-1310·Topotecan

Zai Lab (US) LLC

Neoplasms

Belgium, Czechia, Germany, Denmark, Greece, Netherlands, Poland, Spain, Austria, Italy, France

08/06/2026

Phase II

C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

2024-518587-12-00MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (C…

DrugTilrekimig

Pfizer Inc.

Respiratory Tract Diseases

Spain, Germany, Poland, Czechia, Greece, Italy, Bulgaria, France, Hungary

08/06/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

2025-523675-39-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Glaxosmithkline Research & Development Limited

Nutritional and Metabolic Diseases

Belgium, Greece, Poland, France, Spain, Bulgaria, Italy, Germany, Austria, Netherlands

08/06/2026

Phase IV

A randomised, double-blind, three parallel-group, placebo controlled superiority trial assessing the effect of intravenous versus oral iron supplementation on physical performance, quality of life and cognitive function in iron deficient FRAIL elderly IndiviDuals with cardiovascular disease (FRAIL-ID trial)

2025-521570-34-00Frailty with Iron Deficiency in Elderly Patients with Cardi…

Wroclaw Medical University

Nutritional and Metabolic Diseases

Poland

05/06/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

2025-523912-35-00Narcolepsy Type 2

Alkermes Inc.

Nervous System Diseases

Spain, Netherlands, Belgium, Italy, France, Austria, Czechia, Germany, Sweden, Poland

04/06/2026

Phase I/II

A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis.

2025-523939-18-00Amyotrofic Lateral Sclerosis (ALS)

DrugRiluzole

Nura Bio Inc.

Nervous System Diseases

Poland, Netherlands, Italy, Spain

03/06/2026

Phase III

A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)

2025-524575-22-00Neovascular age-related macular degeneration (NVAMD)

Eyebiotech Limited

Eye Diseases

Spain, Poland, Estonia, Latvia, Germany

03/06/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

2025-523911-13-00Narcolepsy Type 1

Alkermes Inc.

Nervous System Diseases

Italy, France, Netherlands, Spain, Belgium, Austria, Czechia, Finland, Germany, Sweden, Norway, Poland

02/06/2026

Phase III

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

2025-523670-17-00Systemic lupus erythematosus

AstraZeneca AB

Immune System Diseases

Poland, Germany, Italy, France, Spain

02/06/2026

Phase III

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS FACTOR VIII PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A WITHOUT INHIBITORS

2025-522434-32-00Hemophilia A Without Inhibitors

F. Hoffmann-La Roche AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Austria, Poland, Netherlands, Spain, Denmark, Italy, Germany, Hungary

01/06/2026

Phase III

A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per period, to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

2022-502365-26-00Asthma

DrugSalbutamol

Novartis Pharma AG

Respiratory Tract Diseases

Poland, France, Slovakia, Spain, Hungary, Germany, Romania

01/06/2026

Phase III

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A

2025-522435-33-00Hemophilia A

F. Hoffmann-La Roche AG

Hemic and Lymphatic Diseases

Hungary, Spain, Ireland, Poland, Austria, Germany, Denmark, Belgium, Netherlands, Italy, France

01/06/2026

Phase III

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

2025-524241-27-00Treatment-naїve mantle cell lymphoma (MCL)

DrugsOrelabrutinib·Bendamustine·Rituximab

Innocare Pharma Inc.

Neoplasms

Poland, France, Czechia, Spain, Romania

01/06/2026

Phase III

A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive

2025-523555-66-00Myelofibrosis

DrugsPelabresib·Ruxolitinib

Novartis Pharma AG

Neoplasms

Belgium, Germany, Austria, Poland, Spain, Italy, Netherlands, Czechia, France

29/05/2026

Phase II

J5D-MC-FPAD: A Phase 2a, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants with Non-Segmental Vitiligo

2025-524726-18-00Vitiligo, Non-Segmental Vitiligo (NSV)

Eli Lilly & Co.

Immune System Diseases

Poland, Belgium

29/05/2026

Phase III

Efficacy and Tolerability of N-AVD compared to BrECADD in patients with advanced Hodgkin Lymphoma (N-BRAVE)

2026-525263-41-00Hodgkin lymphoma

Polska Grupa Badawcza Chloniakow

Neoplasms

Poland

29/05/2026

Phase II

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults with Generalized Myasthenia Gravis

2025-523950-15-01Generalized Myasthenia Gravis

Vertex Pharmaceuticals Inc.

Nervous System Diseases

Poland

29/05/2026

Phase I

A First-in-Human, Open-label, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of NBIM-1008 in Patients with Rheumatoid Arthritis

2025-525113-22-00Rheumatoid Arthritis

Neurocrine Biosciences Inc.

Immune System Diseases

Poland, Romania

29/05/2026

Phase I/II

Prospective, multicentre, two-arms, I/II phase study to Optimise and Personalise Immunological Therapy of relapsed chronic lymphocytic leukaemia patients (OPTIC)

2024-513917-11-01Adult patients with chronic lymphocytic leukemia/small lymp…

DrugsObinutuzumab·Daratumumab·Venetoclax

Uniwersytet Medyczny W Lublinie

Hemic and Lymphatic Diseases

Poland

29/05/2026

Phase I/II

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma

2025-523005-15-00Non-Hodgkin Lymphoma

Merck Sharp & Dohme LLC

Neoplasms

Poland, Italy, France, Germany, Spain

28/05/2026

Phase II

An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous Afimkibart Clinical Trials

2025-523579-47-00moderate to severe rheumatoid arthritis (RA)

DrugAfimkibart

F. Hoffmann-La Roche AG

Immune System Phenomena

Italy, Spain, Germany, France, Denmark, Poland, Belgium

27/05/2026

Phase III

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease

2025-521590-13-00Moderately to Severely Active Crohn’s Disease

Janssen Cilag International

Immune System Diseases

Slovakia, Germany, Denmark, France, Spain, Italy, Netherlands, Belgium, Poland, Sweden, Austria, Czechia, Hungary

27/05/2026

Phase II

An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

2025-521757-16-00Hallucinations and Delusions Associated with Alzheimer’s Di…

Maplight Therapeutics Inc.

Mental Disorders

Italy, Poland, Czechia, Portugal, Bulgaria, France, Slovakia, Romania, Hungary

27/05/2026

Phase II

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma (r/r MM)

2025-524181-26-00relapsed/refractory multiple myeloma

DrugCemsidomide

C4 Therapeutics Inc.

Hemic and Lymphatic Diseases

Italy, France, Spain, Poland

25/05/2026

Phase III

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

2025-523576-23-00Unresectable Stage III non-small cell lung cancer without p…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

France, Ireland, Germany, Greece, Bulgaria, Spain, Netherlands, Italy, Sweden, Romania, Hungary, Belgium, Austria, Poland

22/05/2026

Phase II

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

2025-525013-23-00Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)

DrugPembrolizumab

Eikon Therapeutics Inc.

Neoplasms

Germany, Spain, Netherlands, Romania, Greece, Italy, Austria, Belgium, Bulgaria, France, Hungary, Poland

21/05/2026

Phase II

An Open-Label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-Sponsored AMG 732 Studies and are Primary Proptosis Non-responders or who Relapsed During the Safety Follow-up

2025-523280-38-00Thyroid Eye Disease

Amgen Inc.

Eye Diseases

Spain, Poland, France, Italy, Greece

20/05/2026

Phase III

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib

2025-524078-40-00Chronic Spontaneous Urticaria

Novartis Pharma AG

Skin and Connective Tissue Diseases

Germany, Spain, France, Poland, Bulgaria, Czechia

20/05/2026

Phase III

A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

2025-523259-72-00Hidradenitis Suppurativa (HS)

Novartis Pharma AG

Immune System Diseases

Portugal, Greece, Germany, Hungary, France, Spain, Bulgaria, Slovakia, Poland, Czechia, Belgium, Italy, Denmark

20/05/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (delpacibart zotadirsen) for the Treatment of DMD with Gene Mutations Amenable to Exon 44 Skipping

2025-523087-20-00Duchenne muscular dystrophy

DrugAOC 1044

Avidity Biosciences Inc.

Musculoskeletal Diseases

Italy, Germany, France, Spain, Belgium, Poland, Netherlands

20/05/2026

Phase II

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

2025-524005-32-00Rheumatoid arthritis

Elevara Medicines Limited

Immune System Diseases

Czechia, Bulgaria, Hungary, Netherlands, Poland, Spain

19/05/2026

Phase I

An Early-Stage Study in Multiple Clinics of how Afimkibart May Affect the Body’s Processing of Medicines that Rely on Cytochrome P450 Enzymes in Patients with Ulcerative Colitis

2025-524060-38-00Active Ulcerative Colitis (UC)

F. Hoffmann-La Roche AG

Digestive System Diseases

Germany, Poland, Belgium

19/05/2026

Phase II

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants with Moderate to Severe Atopic Dermatitis

2025-523464-20-00Moderate to Severe Atopic Dermatitis

Janssen Cilag International

Immune System Diseases

Germany, Poland

19/05/2026

Phase III

A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)

2025-521632-12-00Patients on Factor Xa inhibitor treatment needing an urgent…

VarmX B.V.

Hemic and Lymphatic Diseases

Belgium, Germany, Italy, France, Czechia, Bulgaria, Hungary, Spain, Netherlands, Poland, Austria, Estonia, Romania, Portugal, Lithuania

19/05/2026

Phase II

PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases

2025-523425-17-00Proteinuric kidney diseases

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Nutritional and Metabolic Diseases

Portugal, Greece, Italy, Poland, Estonia, Slovakia, Sweden, Denmark, Belgium, Norway, Romania, France, Spain, Germany, Netherlands, Croatia

19/05/2026

Phase III

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

2025-523735-19-00Metastatic Microsatellite Stable Colorectal Cancer

DrugsINCA33890·Calcium folinate·Fluorouracil·Oxaliplatin

Incyte Corp.

Neoplasms

Poland, France, Denmark, Norway, Spain, Germany, Belgium, Netherlands, Austria, Italy

19/05/2026

Phase II

A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency.

2025-521816-20-00Exocrine Pancreatic Insufficiency

DrugZenpep

Aimmune Nestle Health Science US R&D LLC

Nutritional and Metabolic Diseases

Poland, Hungary, Spain, Bulgaria, Italy

18/05/2026

Phase III

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

2025-524316-11-00Primary Progressive Multiple Sclerosis (PPMS)

DrugOrelabrutinib

Zenas Biopharma (USA) LLC

Nervous System Diseases

Italy, Finland, Bulgaria, Greece, Belgium, Estonia, Portugal, Spain, Germany, France, Czechia, Slovakia, Romania, Croatia, Poland, Austria, Netherlands, Denmark, Sweden, Hungary

18/05/2026

Phase II

A phase II, multicenter, open-label, single arm study to evaluate the safety and efficacy of asciminib in pediatric participants newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation

2025-522138-29-00Philadelphia positive Chronic Myeloid leukemia in Chronic P…

Novartis Pharma AG

Neoplasms

Spain, France, Germany, Poland, Italy, Netherlands, Greece, Hungary

18/05/2026

Phase IV

A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.

2025-524289-56-00Asthma

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

Germany, Romania, Italy, Bulgaria, Poland, Slovakia, Spain, France

18/05/2026

Phase III

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%

2025-523586-18-00Non-Small Cell Lung Cancer

DrugPembrolizumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Portugal, Norway, Sweden, Bulgaria, France, Belgium, Austria, Germany, Finland, Poland, Romania, Netherlands, Spain, Italy, Hungary, Czechia

15/05/2026

Phase I/II

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients with Generalized Myasthenia Gravis

2025-525127-27-00Generalized Myasthenia Gravis

Aurinia Pharmaceuticals Inc.

Immune System Diseases

Poland, Spain, Denmark

15/05/2026

Phase I/II

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

2026-525248-13-00Advanced Solid Tumors

Eikon Therapeutics Inc.

Neoplasms

France, Spain, Norway, Italy, Germany, Austria, Poland, Finland, Belgium, Denmark, Portugal

15/05/2026

Phase III

NeoAdjuvant Dynamic marker - Adjusted Personalized Therapy comparing sacituzumab govitecan+pembrolizumab vs. SoC chemotherapy in clinical stage II-III, triple-negative early breast cancer (ADAPT-TN-IV)

2024-516734-35-00triple-negative early breast cancer

DrugsSacituzumab Govitecan·Pembrolizumab

WSG Women's Cancer Study Group GmbH

Neoplasms

Germany, Poland

15/05/2026

Phase III

Efficacy and safety of NNC0487-0111 s.c. once-weekly compared to semaglutide s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 8)

2024-520446-31-00Participants with overweight or obesity, and type 2 diabetes

DrugSemaglutide

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Germany, Croatia, Portugal, Hungary, Bulgaria, Romania, Poland

15/05/2026

Phase II

A Phase 2, Open-label Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) who Have Received at least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

2025-521976-80-00Relapsed or Refractory Multiple Myeloma (RRMM)

Janssen Cilag International

Neoplasms

Poland, Italy

14/05/2026

Phase III

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants with Relapsed/Refractory Primary Central Nervous System Lymphoma

2025-523389-26-00Relapsed/refractory primary central nervous system lymphoma

DrugsTirabrutinib·Temozolomide·Rituximab

Deciphera Pharmaceuticals Inc.

Nervous System Diseases

Czechia, Germany, Italy, Belgium, Spain, Poland, Austria, France, Hungary

14/05/2026

Phase III

A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia

2025-524810-28-00Acute Promyelocytic Leukemia

DrugArsenic Trioxide

Quetzal Therapeutics LLC

Neoplasms

Germany, Poland, Spain, Romania, Italy, France

13/05/2026

Phase III

A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.

2025-523869-22-00advanced or metastatic extrapulmonary neuroendocrine carcin…

DrugsObrixtamig·Tocilizumab·Carboplatin

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

Portugal, Spain, Poland, Sweden, Italy, Czechia, France, Netherlands, Finland, Denmark, Austria, Germany, Belgium, Norway

13/05/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants with Prurigo Nodularis

2025-523404-74-00Prurigo Nodularis

Innocare Pharma Inc.

Skin and Connective Tissue Diseases

Belgium, Poland, Germany, France, Austria

13/05/2026

Phase III

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

2025-523106-32-00Obesity or Overweight and Type 2 Diabetes

F. Hoffmann-La Roche AG

Nutritional and Metabolic Diseases

Germany, Romania, Czechia, Poland, Hungary, France, Spain, Italy

13/05/2026

Phase III

DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.

2025-520565-51-00small cell lung cancer

DrugsObrixtamig·Tocilizumab·Atezolizumab·Carboplatin

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

Czechia, Sweden, Poland, Netherlands, Greece, Latvia, Finland, Norway, Belgium, Austria, Portugal, Romania, Italy, Estonia, France, Ireland, Germany, Spain, Bulgaria, Hungary

12/05/2026

Phase III

A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs

2025-522586-30-00Psoriatic Arthritis

DrugZasocitinib

Takeda Development Center Americas Inc.

Musculoskeletal Diseases

Germany, Belgium, Spain, Czechia, Croatia, Portugal, Poland, Latvia, Bulgaria, France, Estonia, Hungary, Italy

12/05/2026

Phase II

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

2025-523895-22-00Non-small cell lung cancer (NSCLC), Cervical cancer (CC), M…

DrugsBNT324·Pumitamig

Dualitybio Inc.

Neoplasms

Italy, Poland, France, Spain, Germany

12/05/2026

Phase I

A Study to Assess the Safety of RG6496 in Huntington’s Disease Gene Expansion Carriers with the Selected Genetic Variant (POINT-HD)

2025-520631-17-00Huntington’s Disease Gene Expansion Carriers

F. Hoffmann-La Roche AG

Nervous System Diseases

Italy, Poland, Denmark, Germany, Portugal, Spain

11/05/2026

Phase III

A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk (MEDICI Study)

2025-524265-24-00Dyslipidemia at High to Very High Cardiovascular Risk

A. Menarini International Licensing S.A.

Hemic and Lymphatic Diseases

Spain, Poland, Netherlands, Italy, Slovakia, Czechia, Germany

11/05/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infections in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy ("PROTECT")

2025-522854-37-00Prevention of a Major infection in patients with Hypogammag…

Octapharma Pharmazeutika Produktionsgesellschaft mbH

Immune System Diseases

Czechia, Lithuania, Greece, Poland, Germany, Latvia, Bulgaria, Italy

11/05/2026

Phase III

J5E-MC-JZXB - FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer

2025-522255-25-00Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neop…

Eli Lilly & Co.

Neoplasms

Netherlands, Hungary, France, Austria, Poland, Italy, Denmark, Romania, Greece, Norway, Czechia, Belgium, Spain, Ireland, Germany

11/05/2026

Phase III

A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies

2025-522983-33-00Chronic rhinosinusitis with nasal polyps

DrugItepekimab

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

Germany, Netherlands, Portugal, Denmark, Sweden, Finland, France, Spain, Austria, Italy, Hungary, Romania, Belgium, Czechia, Poland

11/05/2026

Phase III

2025-523104-71-00Obesity or Overweight Without Type 2 Diabetes

F. Hoffmann-La Roche AG

Nutritional and Metabolic Diseases

Poland, Hungary, France, Belgium, Italy, Netherlands, Czechia, Germany, Spain

07/05/2026

Phase I

PHARMACOKINETICS OF PETRELINTIDE FOLLOWING ADMINISTRATION TO PARTICIPANTS WITH IMPAIRED HEPATIC FUNCTION

2025-523641-10-00Healthy / hepatic impaired volunteers only study to assess …

Zealand Pharma A/S

Not possible to specify

Slovakia, Poland

06/05/2026

Phase I

Phase 1b Study of Tarlatamab + ZL-1310 +/- Anti-PD-L1 in Small Cell Lung Cancer

2025-522888-15-00Small Cell Lung Cancer

Amgen Inc.

Neoplasms

Spain, Germany, Poland, Belgium, France

05/05/2026

Phase III

Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

2025-523443-35-00Persistent Corneal Epithelial Defect (PCED)

Dompe' Farmaceutici S.p.A.

Eye Diseases

Czechia, Italy, Netherlands, Poland, Germany, Spain, Hungary, France

05/05/2026

Phase II

A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease

2025-524001-33-00Graves’ Disease

Immunovant Sciences GmbH

Immune System Diseases

Italy, Greece, Germany, Hungary, Poland, Czechia, Netherlands, Spain, Belgium, Bulgaria, Latvia

05/05/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight with Weight-Related Comorbidities Who Do Not Have Diabetes

2025-523486-17-00Obesity

DrugRibupatide

Kailera Therapeutics Inc.

Nutritional and Metabolic Diseases

Bulgaria, Hungary, Spain, Germany, Czechia, Poland

05/05/2026

Phase III

A Multicenter, Randomized, Operationally Seamless Phase 2/3 Study to Evaluate the Efficacy and Safety of BMN 333 versus Vosoritide in Children with Achondroplasia

2025-523811-12-00Achondroplasia

DrugVosoritide

Biomarin Pharmaceutical Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Poland, Italy, Romania, France, Norway

05/05/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

2025-523552-31-00Systemic Lupus Erythematosus

Janssen Cilag International

Immune System Diseases

Denmark, Hungary, Portugal, Italy, Norway, Greece, Slovakia, Czechia, France, Poland, Bulgaria, Germany, Spain, Romania, Finland

05/05/2026

Phase II

A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration

2025-523704-77-00Geographic atrophy secondary to age-related macular degener…

Novartis Pharma AG

Eye Diseases

Bulgaria, Romania, Germany, Czechia, Spain, Poland, Italy, Hungary, France

04/05/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight and Diabetes

2025-523510-87-00Obesity

DrugRibupatide

Kailera Therapeutics Inc.

Nutritional and Metabolic Diseases

Hungary, Poland, Bulgaria, Germany, Czechia, Spain

04/05/2026

Phase II

Randomised, placebo-controlled, double-blind, parallel-group Phase II study to evaluate the efficacy and safety of oral BI 3000202 in patients with moderate to severe systemic lupus erythematosus (SLE)

2025-523488-39-00Systemic lupus erythematosus

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Immune System Diseases

Bulgaria, Romania, Germany, Spain, Hungary, Poland, Croatia, Netherlands

04/05/2026

Phase III

A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants with Advanced RCC who have progressed on or after both PD-1/L1 and VEGF-TKI therapies in sequence or in combination (LITESPARK-034)

2024-516993-31-00Renal Cell Carcinoma

Merck Sharp & Dohme LLC

Neoplasms

Denmark, Spain, Netherlands, Germany, France, Czechia, Poland, Italy, Greece

04/05/2026

Phase I

First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants with Atopic Dermatitis

2025-524205-32-00Atopic Dermatits

Regeneron Pharmaceuticals Inc.

Skin and Connective Tissue Diseases

Belgium, Czechia, Germany, Poland

30/04/2026

Phase II

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.

2025-520997-21-00Psoriatic arthritis

Merck Sharp & Dohme LLC

Musculoskeletal Diseases

Poland, Germany, Spain

30/04/2026

Phase III

A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Standard Regimens in Participants with Relapsed Refractory Multiple Myeloma (DURGA-4)

2025-523285-25-00Relapsed or Refractory Multiple Myeloma

DrugsAZD0120·Carfilzomib·Pomalidomide·Bortezomib

AstraZeneca AB

Neoplasms

Norway, Poland, Spain, Germany, France, Italy

30/04/2026

Phase I/II

A Phase 1b/2a, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MB-001 in Participants With Moderately to Severely Active Ulcerative Colitis

2025-524719-35-00Ulcerative Colitis

Mage Biologics Inc.

Digestive System Diseases

Poland

29/04/2026

Phase III

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living with Obesity Who Do Not Have Diabetes

2025-523511-11-00Obesity

Kailera Therapeutics Inc.

Nutritional and Metabolic Diseases

Poland, Bulgaria

29/04/2026

Phase I

Phase I clinical trial evaluating the safety, tolerability, and absorption of a topical product containing latanoprost acid in healthy participants.

2025-522468-34-00Androgenetic alopecia

Bioresearch Pharma S.A.

Skin and Connective Tissue Diseases

Poland

29/04/2026

Phase III

An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.

2024-520218-23-00Pulmonary Arterial Hypertension

Inhibikase Therapeutics Inc.

Cardiovascular Diseases

Spain, Poland, Italy, Belgium, Latvia, Denmark, Czechia, Germany, France, Netherlands, Portugal, Ireland, Austria, Greece, Lithuania

28/04/2026

Phase III

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long‑term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

2025-524160-38-00Renal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dM…

Merck Sharp & Dohme LLC

Neoplasms

Czechia, Spain, Poland, Belgium, Finland, Germany, France, Netherlands, Hungary, Denmark

28/04/2026

Phase III

A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter clinical trial to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole in maintenance of healing in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D

2025-522750-39-00Erosive esophagitis (EE) due to gastroesophageal reflux dis…

Cinclus Pharma Holding AB (publ)

Digestive System Diseases

Hungary, Germany, Romania, Bulgaria, Czechia, Poland

28/04/2026

Phase III

Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity

2023-509176-42-00Obesity and T2D

DrugsCagrilintide·Semaglutide

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Slovakia, Austria, Spain, Romania, Portugal, Italy, Denmark, Belgium, Sweden, Poland, Netherlands, Croatia, Hungary, Bulgaria

28/04/2026

Phase III

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/ GOG-3102)

2023-508047-40-00Ovarian cancer

Merck Sharp & Dohme LLC

Neoplasms

Norway, Ireland, Spain, Greece, France, Poland, Denmark, Austria, Hungary, Belgium, Czechia, Finland, Germany, Italy, Sweden

28/04/2026

Phase III

Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients with Lennox-Gastaut Syndrome

2025-522552-20-00Lennox-Gastaut Syndrome

Epygenix Therapeutics Inc.

Nervous System Diseases

Italy, Spain, Hungary, Romania, Czechia, Poland

28/04/2026

Phase III

Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants with Alzheimer’s Disease Dementia

2024-517388-22-00Agitation in Alzheimer's Disease Dementia

Exciva GmbH

Nervous System Diseases

Italy, Slovakia, Spain, Poland, Czechia, Germany

28/04/2026

Phase III

A Phase 3, Parallel-group Treatment, Blinded, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Pegtibatinase Administered Subcutaneously in Addition to Standard of Care in Participants with Classical Homocystinuria due to Cystathionine Beta Synthase Deficiency (HARMONY)

2023-504135-40-00Classical Homocystinuria

Travere Therapeutics Inc.

Nutritional and Metabolic Diseases

Belgium, Ireland, Spain, Italy, Germany, France, Portugal, Poland

27/04/2026

Phase II

A Phase IIb, multicentre, randomised, doubleblind, placebocontrolled, three-arm parallel-group study to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis

2024-514246-37-00Idiopathic pulmonary fibrosis (IPF)

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

Belgium, Germany, Italy, Czechia, Bulgaria, Netherlands, France, Portugal, Poland, Spain, Romania

27/04/2026

Phase III

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants with Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)

2024-519298-21-00Cancer-Associated Thrombosis (CAT).

DrugCenvacibart

Regeneron Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Belgium, Czechia, France, Romania, Germany, Poland, Bulgaria, Spain

27/04/2026

Phase IV

A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

2025-522362-78-00severely active ulcerative colitis (US) and CD (Crohn’s dis…

DrugMirikizumab

Eli Lilly & Co.

Immune System Diseases

Spain, Denmark, Germany, Italy, Poland

27/04/2026

Phase II

The MAVRiC Study: A Phase II Study of Disease Risk Mutation-guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab

2024-518858-17-00Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CL…

DrugsAcalabrutinib·Venetoclax

AstraZeneca AB

Neoplasms

Italy, Austria, Spain, Ireland, Czechia, Poland

27/04/2026

Phase I/II

Study of IBI3009 alone or in combination with other therapies for extensive-stage small cell lung cancer

2025-523972-21-00Extensive-Stage Small Cell Lung Cancer

Fortvita Biologics (USA) Inc.

Respiratory Tract Diseases

Poland, Denmark, Spain

27/04/2026

Phase IV

A randomized double-blind placebo-controlled study to demonstrate the efficacy of PMBL® sublingual tablets in reducing the incidence of respiratory tract infections in children aged 3-12 years (PIRTIK).

2025-524212-11-00Respiratory Tract Infections

Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz

Respiratory Tract Diseases

Poland

23/04/2026

Phase I

Phase I study of CDK8 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma; MEDWAY

2025-524031-39-00Medulloblastoma (recurrent or progressive)

DrugEverolimus

Instytut Pomnik Centrum Zdrowia Dziecka

Nervous System Diseases

Poland

23/04/2026

Phase II

A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants with Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)

2025-522076-85-00Rheumatoid arthritis

AstraZeneca AB

Immune System Diseases

Hungary, Spain, Bulgaria, Germany, Poland

22/04/2026

Phase II

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus.

2025-524514-28-00Type 2 Diabetes Mellitus

Corxel Pharmaceuticals Inc.

Nutritional and Metabolic Diseases

Poland

22/04/2026

Phase I/II

ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination with Ipilimumab in Participants with First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)

2025-523602-33-00Advanced or unresectable Hepatocellular Carcinoma (HCC)

DrugIpilimumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Poland, Spain, Germany, France, Italy

22/04/2026

Phase III

A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia

2025-524209-34-00Chemotherapy induced thrombocytopenia

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Not possible to specify

France, Romania, Poland, Spain, Bulgaria

21/04/2026

Phase II

Protocol Title: Efficacy and safety of once-weekly subcutaneous NNC0662-0419 in participants with type 2 diabetes – a dose-finding study

2025-523260-20-00type 2 diabetes

DrugSemaglutide

Novo Nordisk A/S

Hormonal diseases

Spain, Hungary, Portugal, Poland, Slovakia, Croatia

21/04/2026

Phase III

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia

2025-524366-21-00treatment-naive Chronic Lymphocytic Leukemia

BeOne Medicines I GmbH

Neoplasms

Netherlands, Poland, Italy, Germany, Spain, Romania, Czechia, France, Sweden

20/04/2026

Phase II

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)

2025-523793-16-00Homeostatic iron regulator gene-related hereditary hemochro…

CSL Behring LLC

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Austria, Poland, Spain, Germany, France, Ireland, Romania, Belgium, Italy, Czechia, Netherlands

20/04/2026

Phase II

A randomized phase II study comparing the safety and efficacy of mifamurtide and standard therapy containing sorafenib in pediatric and young adult patients with high-risk osteosarcoma

2026-525223-24-00Relapsed/refractory osteosarcoma, High-grade osteosarcoma

Instytut Matki I Dziecka

Neoplasms

Poland

20/04/2026

Phase III

A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) versus Adjuvant Placebo Plus MK-3475A in Participants with Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)

2024-517337-41-00Completely resected Stage IIA-IIIB (N2) KRAS G12C mutated N…

Merck Sharp & Dohme LLC

Neoplasms

Italy, Spain, Germany, Poland, Greece, France

20/04/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis

2025-524002-16-00Amyotrophic Lateral Sclerosis

Ferrer Internacional S.A., Prilenia Therapeutics B.V.

Nervous System Diseases

Belgium, Netherlands, Poland, France, Germany, Ireland, Italy, Sweden, Spain

20/04/2026

Phase III

J4G-MC-JZVD - FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined with Enfortumab Vedotin and Pembrolizumab in Adults with Untreated Locally Advanced or Metastatic Urothelial Carcinoma with an FGFR3 Genetic Alteration.

2025-522855-25-00Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Ne…

DrugsEnfortumab Vedotin·Pembrolizumab

Eli Lilly & Co.

Neoplasms

Italy, Poland, Denmark, Czechia, France, Hungary, Germany, Netherlands, Spain

20/04/2026

Phase III

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)

2025-522748-42-00Ovarian cancer

DrugsTopotecan·Doxorubicin·Gemcitabine·Paclitaxel

Incyte Corp.

Neoplasms

Ireland, Poland, France, Netherlands, Spain, Italy, Germany, Belgium

17/04/2026

Phase III

Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).

2025-523717-29-00HFpEF or HFmrEF and obesity

Novo Nordisk A/S

Cardiovascular Diseases

Denmark, Greece, Bulgaria, Italy, Netherlands, Spain, Poland, Czechia, Germany, France

17/04/2026

Phase III

A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

2025-523544-12-00Myelodysplastic neoplasms/syndromes (MDS)

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

France, Belgium, Germany, Italy, Bulgaria, Ireland, Lithuania, Norway, Romania, Hungary, Spain, Greece, Poland, Netherlands

17/04/2026

Phase III

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1 RA IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)

2025-523975-48-00Obesity

DrugBerobenatide

Metsera Inc.

Nutritional and Metabolic Diseases

Czechia, Bulgaria, Slovakia, Spain, Hungary, Germany, Romania, Poland

16/04/2026

Phase III

A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients with Suspected Vascular Disease

2024-518835-13-00Suspected Vascular Disease of supra-aortic (carotid/vertebr…

Guerbet, Bracco Imaging S.p.A.

Cardiovascular Diseases

Italy, France, Czechia, Hungary, Spain, Germany, Poland

15/04/2026

Phase III

A Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study with open-label extension to evaluate the efficacy and safety of fenfluramine hydrochloride in study participants with Rett syndrome

2025-523157-34-00Rett syndrome

UCB Biosciences Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Poland, France, Hungary, Belgium, Italy, Germany

15/04/2026

Phase II

Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group, Adaptive Proof-of-concept, Dose-selecting Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intranasal Cenegermin (recombinant human Nerve Growth Factor [rhNGF]) in Adult Participants with subacute moderate to severe Traumatic Brain Injury (TBI).

2025-522692-29-00Subacute Moderate to Severe Traumatic Brain Injury (TBI)

DrugCenegermin

Dompe' Farmaceutici S.p.A.

Nervous System Diseases

Italy, Denmark, Finland, France, Germany, Spain, Sweden, Poland

14/04/2026

Phase II

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer

2025-522107-18-00Locally advanced or metastatic Non-Small Cell Lung Cancer

DrugPegfilgrastim

Genmab A/S

Neoplasms

Germany, Hungary, Netherlands, France, Italy, Belgium, Spain, Poland

14/04/2026

Phase II

C6231002 - A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

2025-522965-31-00Atopic Dermatitis

Pfizer Inc.

Skin and Connective Tissue Diseases

Poland, Czechia, Germany, Bulgaria, France

14/04/2026

Phase II

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients with Primary Knee Osteoarthritis

2025-524668-39-00Knee Osteoarthritis

Enlivex Therapeutics Ltd.

Musculoskeletal Diseases

Denmark, Poland

13/04/2026

Phase III

A Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults with Focal Seizures

2025-524038-24-00Focal Epilepsy

Praxis Precision Medicines Inc.

Nervous System Diseases

Poland, Germany, Czechia, Italy, Spain

10/04/2026

Phase II

A Phase 2b, Randomized, Double blind, Placebo controlled, Parallel group, Multicenter, Dose ranging Study Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Adult Participants with Uncontrolled Moderate to Severe Eosinophilic Asthma

2025-523180-38-00Uncontrolled Moderate to Severe Eosinophilic Asthma

Kymera Therapeutics Inc.

Immune System Diseases

Spain, Romania, Slovakia, Poland, Germany, Italy, Belgium, Austria

10/04/2026

Phase I

Phase 1, Open-Label, single arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants from 2 to less than 12 years of age with a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis with Antibiotics

2025-522916-17-00Urinary Tract Infections

Glaxosmithkline Research & Development Limited

Bacterial Infections and Mycoses

Spain, Poland

09/04/2026

Phase II

A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults with Non-Small Cell Lung Cancer in Combination with Pembrolizumab.

2025-522867-13-00Non Small Cell Lung Cancer

Merus B.V.

Not possible to specify

Spain, Belgium, Netherlands, Poland, Italy, France

09/04/2026

Phase III

A multicenter, randomized, double-blind, parallel group, placebo-controlled study of the efficacy and safety of early depemokimab initiation as add-on treatment in COPD patients with type 2 inflammation.

2025-521108-23-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Germany, Belgium, Netherlands, Denmark, Spain, Greece, Poland, Hungary, France, Italy, Bulgaria, Romania

07/04/2026

Phase III

A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants with Diabetic Macular Edema (DME) (EYP-1901-303)

2025-523937-25-00Diabetic Macular Edema (DME)

Eyepoint Inc.

Eye Diseases

Germany, Poland, Slovakia

07/04/2026

Phase III

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 5)

2024-520444-42-00Overweight or obesity, and knee osteoarthritis

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Italy, Greece, Spain, Bulgaria, Denmark, Poland

07/04/2026

Phase III

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 6)

2024-520445-23-00Overweight or obesity, and knee osteoarthritis

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Greece, Poland, Spain, Bulgaria, Italy, Denmark

07/04/2026

Phase III

Multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis

2024-511593-70-00Polyarticular-course juvenile idiopathic arthritis

Alfasigma S.p.A.

Musculoskeletal Diseases

Spain, Bulgaria, France, Belgium, Germany, Greece, Italy, Poland, Hungary, Czechia

07/04/2026

Phase II

A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability via Autoinjector Device versus Syringe in Patients with Multiple Sclerosis

2025-523757-33-00multiple sclerosis

Tg Therapeutics Inc.

Nervous System Diseases

Poland

03/04/2026

Phase I

Evaluation of AG-181 in Subjects 18 to 69 Years of Age With Phenylketonuria

2025-522630-31-00Phenylketonuria

Agios Pharmaceuticals Inc.

Nutritional and Metabolic Diseases

Poland

03/04/2026

Phase II

Open-Label, Multi Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)

2025-522441-21-00Parkinson's Disease

Askbio Inc.

Nervous System Diseases

Poland

03/04/2026

Phase III

A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases

2025-523017-28-00Locoregional Recurrence of Squamous Cell Carcinoma of the H…

Rakuten Medical Inc.

Neoplasms

Poland

03/04/2026

Phase III

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1RA IN PEOPLE WITH OVERWEIGHT OR OBESITY: A PHASE 3, MULTI-CENTER RANDOMIZED, CONTROLLED TRIAL (VESPER-4)

2025-523974-18-00Obesity

DrugBerobenatide

Metsera Inc.

Nutritional and Metabolic Diseases

Germany, Hungary, Slovakia, Poland, Spain, Czechia, Romania, Bulgaria

02/04/2026

Phase III

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

2025-522567-15-00Plaque Psoriasis

Takeda Development Center Americas Inc.

Skin and Connective Tissue Diseases

Spain, Poland, Germany, Italy

01/04/2026

Phase III

Open Label Extension (OLE), multiple dose study to evaluate pharmacokinetics, safety, tolerability and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with juvenile idiopathic arthritis (JIA).

2025-523239-21-00Juvenile idiopathic arthritis

Alfasigma S.p.A.

Immune System Diseases

France, Germany, Poland, Belgium, Hungary, Greece

01/04/2026

Phase II

A Phase 2, randomized, placebo-controlled, double-blind clinical study to evaluate efficacy and safety of LAD328 in adult subjects with moderate to severe hidradenitis suppurativa

2025-521865-29-00moderate-to-severe hidradenitis suppurativa

Almirall S.A.

Skin and Connective Tissue Diseases

Bulgaria, Spain, France, Poland, Germany

01/04/2026

Phase II

A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Moderate to Severe Hidradenitis Suppurativa (COMPASS 2 - HS)

2025-522440-41-00Hidradenitis Suppurativa

Bluefin Biomedicine Inc.

Skin and Connective Tissue Diseases

Spain, Germany, Czechia, Poland, Bulgaria

31/03/2026

Phase I/II

A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (ALTAIR)

2024-519786-22-01metastatic non-small cell lung cancer (NSCLC)

DrugsRamucirumab·Rilvegostomig

AstraZeneca AB

Neoplasms

Germany, Spain, France, Poland, Belgium, Netherlands, Italy

30/03/2026

Phase IV

Identification of mitochondrial biomarkers reflecting omaveloxolone treatment (in FA patients)

2025-523881-26-00Friedreich's ataxia

Fakultni Nemocnice V Motole

Nervous System Diseases

Czechia, Poland

30/03/2026

Phase III

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder

2025-523618-10-00Major Depressive Disorder

Xenon Pharmaceuticals Inc.

Mental Disorders

Finland, Poland, Romania, Slovakia, Spain, Germany

30/03/2026

Phase III

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea not treated with positive airway pressure (AMAZE 3)

2024-520442-36-00Overweight or obesity, and obstructive sleep apnoea not tre…

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Denmark, Poland, Spain, Germany

30/03/2026

Phase I

A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants with Solid Tumours (IMFINZI-subQ)

2025-521639-34-00• Non-small cell lung cancer (Stage III, unresectable) • Sm…

AstraZeneca AB

Neoplasms

Poland

27/03/2026

Phase III

J3R-MC-YDAG - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes

2025-523657-34-00Obesity, Overweight

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Germany, Poland, Belgium

27/03/2026

Phase II

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients with Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)

2025-524006-14-00Chronic Spontaneous Urticaria

Yuhan Corp.

Skin and Connective Tissue Diseases

Bulgaria, Poland

27/03/2026

Phase III

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator’s Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

2024-519818-31-01Endometrial Cancer Advanced, Recurrent, Metastatic, or Prim…

DrugsDoxorubicin·Paclitaxel

Genmab A/S

Neoplasms

Poland, Denmark, Finland, Lithuania, France, Germany, Spain, Belgium, Greece, Norway, Italy

26/03/2026

Phase II

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants with Moderate-to-Severe Hidradenitis Suppurativa

2025-523557-33-00Moderate-to-Severe Hidradenitis Suppurativa

Navigator Medicines Inc.

Skin and Connective Tissue Diseases

Hungary, Poland, Germany, Bulgaria, Romania

25/03/2026

Phase III

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants with Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

2025-522583-32-00Cold-Induced Urticaria and Symptomatic Dermographism

Celldex Therapeutics Inc.

Skin and Connective Tissue Diseases

Germany, Lithuania, Spain, Poland

25/03/2026

Phase II

An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects with Advanced Non-small Cell Lung Cancer (NSCLC)

2025-523803-31-00Advanced non-small cell lung cancer (NSCLC)

Shanghai Henlius Biotech Inc.

Therapeutics

Italy, Romania, Poland, Spain, France

25/03/2026

Phase II

A Phase 2, randomized, placebo-controlled, double-blind clinical study to evaluate efficacy and safety of LAD603 in adult subjects with severe to very severe alopecia areata

2025-523342-27-00Alopecia areata

Almirall S.A.

Skin and Connective Tissue Diseases

Bulgaria, Romania, Poland, Germany, Spain

24/03/2026

Phase III

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure (AMAZE 4)

2024-520443-16-00Overweight or obesity, and obstructive sleep apnoea treated…

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Poland, Spain, Germany

24/03/2026

Phase III

J3R-MC-YDAF - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants with Obesity or Overweight, and Type 2 Diabetes

2025-523658-15-00Obesity, Overweight

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Germany, Spain, Poland, Czechia, Slovakia

24/03/2026

Phase III

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction

2025-522475-28-00Pulmonary Hypertension (PH) with Heart Failure with preserv…

Tenax Therapeutics Inc.

Cardiovascular Diseases

France, Italy, Germany, Czechia, Austria, Poland, Hungary, Bulgaria, Spain

24/03/2026

Phase III

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

2025-523461-17-01LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Pfizer Inc.

Neoplasms

France, Italy, Hungary, Greece, Czechia, Spain, Poland, Germany

24/03/2026

Phase I

A study to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in participants with B-cell driven ARD.

2025-522932-15-00Systemic Lupus Erythematosus

Glaxosmithkline Research & Development Limited

Immune System Diseases

Germany, France, Italy, Spain, Poland

23/03/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

2025-520902-37-00Non-small cell lung cancer stage IV

Merck Sharp & Dohme LLC

Neoplasms

Italy, Spain, Poland, France

23/03/2026

Phase III

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02).

2025-523085-24-00Biliary Tract Cancer

AstraZeneca AB

Neoplasms

Germany, Poland, Italy, Belgium, France, Netherlands, Spain

23/03/2026

Phase III

A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)

2025-522403-17-00Nummular Dermatitis

Almirall S.A.

Skin and Connective Tissue Diseases

Italy, Bulgaria, Spain, Germany, Poland, France

23/03/2026

Phase II

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8P Loss and Without a PIK3CA Mutation

2025-523013-28-00Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negativ…

F. Hoffmann-La Roche AG

Neoplasms

France, Italy, Poland, Germany, Spain

23/03/2026

Phase III

C6461003 - AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

2025-523521-18-00Metastatic Colorectal Cancer

DrugsPF-08634404·Calcium folinate·Fluorouracil·Oxaliplatin

Pfizer Inc.

Neoplasms

Spain, Belgium, France, Italy, Netherlands, Germany, Poland, Denmark

23/03/2026

Phase II

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults with Schizophrenia Who Warrant Inpatient Hospitalization

2025-521868-35-00Schizophrenia

Neurocrine Biosciences Inc.

Mental Disorders

Romania, Poland, Bulgaria, Croatia

23/03/2026

Phase II

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants with Active Psoriatic Arthritis

2025-523141-10-00Active Psoriatic Arthritis

Janssen Cilag International

Immune System Diseases

Spain, Poland, Czechia, Germany, Hungary

20/03/2026

Phase II

A Phase 2 Posology Study with Long-Term Extension in Participants with Well‑Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy from Standard Therapies

2025-523234-66-00Well-Controlled Recurrent Pericarditis

Kiniksa Pharmaceuticals GmbH

Therapeutics

Spain, Greece, Germany, France, Italy, Poland

19/03/2026

Phase II

SEZanne: A Phase 2 Randomized, Open label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination with Atezolizumab versus Standard of Care as First-Line Treatment in Subjects with Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

2024-517490-24-00Small Cell Lung Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Spain, Germany, Italy, Poland, Belgium

18/03/2026

Phase II

J6E-MC-KWAN: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis

2025-522338-30-00Ulcerative Colitis

Eli Lilly & Co.

Digestive System Diseases

Hungary, Spain, Denmark, Netherlands, Poland, Romania, Germany, Italy, Austria

18/03/2026

Phase II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults with Pulmonary Arterial Hypertension

2024-514754-79-00Pulmonary Arterial Hypertension (PAH)

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

Latvia, Belgium, France, Poland, Germany, Spain, Czechia

18/03/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-demand Treatment of Angioedema Attacks in Adults with Acquired Angioedema due to C1 Inhibitor Deficiency

2025-522051-26-00Acquired Angioedema due to C1 Inhibitor Deficiency

DrugDeucrictibant

Pharvaris Netherlands B.V.

Immune System Diseases

Hungary, Spain, Austria, Germany, Poland, Netherlands, France, Italy, Bulgaria

17/03/2026

Phase II

An open-label, uncontrolled, multicenter study to assess the effect of zigakibart treatment on histologic, circulating, and excreted markers of kidney disease and dysfunction in adult patients with IgA nephropathy

2024-519699-24-00IgA nephropathy

Novartis Pharma AG

Immune System Diseases

Czechia, Germany, Spain, Italy, Poland

17/03/2026

Phase I/II

A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Solid Tumors

2025-523742-27-00Advanced solid tumors

Medilink Therapeutics (Suzhou) Co. Ltd.

Neoplasms

Poland, Spain, France, Romania, Italy, Belgium, Hungary, Germany

17/03/2026

Phase III

A multicentre, randomised, double-blind, parallel group, placebo-controlled trial to assess the effects of oral TRPC6 inhibitor BI 764198 taken over a 104 week treatment period in adult and adolescent participants with primary focal segmental glomerulosclerosis (pFSGS) or genetic FSGS related to TRPC6 gene variants

2025-522191-86-00Focal segmental glomerulosclerosis

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Female Urogenital Diseases and Pregnancy Complications

Germany, Croatia, Poland, Sweden, Portugal, Netherlands, Italy, Denmark, Slovakia, Spain, Norway, Romania, Belgium, Greece, France

17/03/2026

Phase III

A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants with Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13 (EMBARQ-CSU LTE)

2025-522878-36-00Chronic Spontaneous Urticaria

DrugBarzolvolimab

Celldex Therapeutics Inc.

Skin and Connective Tissue Diseases

Croatia, France, Netherlands, Bulgaria, Portugal, Slovakia, Hungary, Italy, Greece, Germany, Czechia, Lithuania, Spain, Belgium, Denmark, Poland

16/03/2026

Phase I

A study to learn if bimekizumab given in different ways is safe and moves similarly throughout the body over time in adults

2025-522782-30-00CCI

UCB Biopharma

Immune System Diseases

Croatia, Poland, Germany, Czechia, Slovakia, Bulgaria

16/03/2026

Phase IV

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)

2025-522118-21-00Axial Spondyloarthritis, Acute Anterior Uveitis

DrugUpadacitinib

Care Arthritis Ltd.

Eye Diseases

Spain, Poland, Netherlands, France, Bulgaria, Germany

13/03/2026

Phase II

A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with Amyotrophic Lateral Sclerosis (ALS)

2025-522580-15-00Amyotrophic Lateral Sclerosis (ALS)

Zydus Therapeutics Inc.

Nervous System Diseases

Spain, Germany, Sweden, Ireland, Poland, Italy, Belgium, France, Netherlands

12/03/2026

Phase III

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (WHO Group 3)

2024-517943-29-00Pulmonary Hypertension associated with interstitial lung di…

DrugTreprostinil

Liquidia Technologies Inc.

Respiratory Tract Diseases

Latvia, Germany, Italy, Czechia, France, Belgium, Portugal, Poland, Austria, Spain

11/03/2026

Phase II

B7981119 A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 16-Week Study Evaluating the Safety and Efficacy of Ritlecitinib (PF-06651600) in Adults with Moderate to Severe Hidradenitis Suppurativa

2025-522705-37-00HIDRADENITIS SUPPURATIVA

Pfizer Inc.

Skin and Connective Tissue Diseases

Germany, Poland, Spain, Greece

11/03/2026

Phase II

A Phase II, multinational, multicentre, double-blind, randomised, active-controlled, 3-way cross-over study to evaluate the therapeutic equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in subjects with mild to moderate asthma. [TRECONY]

2025-521456-35-00Mild to moderate asthma

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

Slovakia, Czechia, Romania, Latvia, Germany, Hungary, Bulgaria, Poland

11/03/2026

Phase III

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy in Participants with Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

2025-523263-37-00Previously Untreated Advanced or Metastatic Gastric, Gastro…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Germany, Spain, Poland, France, Italy, Romania

10/03/2026

Phase III

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

2025-523224-45-00Untreated, Unresectable or Metastatic Colorectal Cancer

DrugsCalcium folinate·Fluorouracil·Irinotecan·Capecitabine

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Sweden, Czechia, Belgium, Romania, Netherlands, Italy, France, Spain, Germany, Poland, Austria

10/03/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

2025-522775-29-00Depressive episodes associated with Bipolar disorder I or I…

Xenon Pharmaceuticals Inc.

Mental Disorders

Germany, Bulgaria, Spain, Poland

10/03/2026

Phase II

A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis

2024-518013-25-00Idiopathic Pulmonary Fibrosis

AbbVie Deutschland GmbH & Co. KG

Respiratory Tract Diseases

Greece, Italy, Sweden, Germany, Portugal, Spain, France, Hungary, Poland, Bulgaria, Romania

10/03/2026

Phase III

REVEAL Study: Phase 3 Study of the Efficacy and Safety of ION582 in Children and Adults with Angelman Syndrome

2024-519711-33-01Angelman syndrome

Ionis Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Italy, Germany, Poland, Spain

09/03/2026

Phase III

PaTHway Adolescent - A Phase 3, Multicenter, Open-Label Single-Arm Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Palopegteriparatide Administered Subcutaneously Daily in the Adolescent Population (12 Years to Less Than 18 Years of Age) with Chronic Hypoparathyroidism

2025-523928-52-00Chronic hypoparathyroidism

Ascendis Pharma Bone Diseases A/S

Hormonal diseases

Germany, France, Romania, Poland

09/03/2026

Phase II

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF GALVOKIMIG IN ADULT STUDY PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

2025-522578-35-00Atopic Dermatitis

UCB Biopharma

Skin and Connective Tissue Diseases

Bulgaria, Czechia, Germany, Poland, Hungary

09/03/2026

Phase II

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa

2025-522831-33-00Hidradenitis Suppurativa

Takeda Development Center Americas Inc.

Skin and Connective Tissue Diseases

France, Poland, Netherlands, Germany

06/03/2026

Phase II

A multinational, multicenter extension study to investigate the long-term safety, tolerability and efficacy of balinatunfib in adults with Crohn’s disease or ulcerative colitis

2025-522511-42-00Colitis Ulcerative, Crohn's disease

DrugBalinatunfib

Sanofi-Aventis Recherche & Developpement

Digestive System Diseases

Belgium, Germany, Czechia, Netherlands, Spain, Austria, Italy, Greece, Croatia, Bulgaria, Poland, France, Romania, Hungary

06/03/2026

Phase III

A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD)

2025-522231-34-00Diabetic Macular Edema

Alvotech Swiss AG

Eye Diseases

Latvia, Slovakia, Czechia, Hungary, Poland, Bulgaria

06/03/2026

Phase III

A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease

2025-521884-12-00First line triple-negative breast cancer (TNBC)

DrugsEribulin·Gemcitabine·Paclitaxel·Carboplatin

BioNTech SE

Neoplasms

Czechia, Poland, Italy, France, Belgium, Netherlands, Germany, Spain

04/03/2026

Phase I/II

Protocol Title: KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

2024-512248-47-00Non-small Cell Lung Cancer (NSCLC)

DrugsCalderasib·Patritumab deruxtecan·Sacituzumab tirumotecan·Cetuximab

Merck Sharp & Dohme LLC

Neoplasms

Italy, Germany, Greece, Poland, Hungary, Spain

04/03/2026

Phase III

A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis

2025-521546-23-00Secondary progressive multiple sclerosis

Novartis Pharma AG

Nervous System Diseases

Denmark, Slovenia, Netherlands, Portugal, Ireland, Sweden, Croatia, Greece, Germany, Latvia, Czechia, Spain, Romania, Belgium, Austria, Lithuania, Slovakia, Poland, Estonia, Bulgaria, France, Italy, Hungary, Finland, Norway

03/03/2026

Phase II

An open label extension study to evaluate the long-term safety and efficacy of subcutaneous lunsekimig in adult participants with asthma who participated in study DRI16762 or ACT18301. AIRPHRODITE

2025-522896-27-00Asthma

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

Poland, Italy, Belgium, Sweden, Hungary, France, Germany, Spain, Denmark

02/03/2026

Phase II

C5041018 - A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

2025-523100-77-00Ulcerative Colitis

Pfizer Inc.

Digestive System Diseases

Finland, Poland, France, Germany, Italy, Slovakia

27/02/2026

Phase III

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

2024-520101-39-00TROP2 NMR-positive advanced or metastatic non-squamous non-…

AstraZeneca AB

Neoplasms

Spain, Poland, Hungary, Italy, Germany, France, Belgium, Austria

26/02/2026

Phase II

B7981118 - A Phase 2b Randomized, Double Blind, 12-Week Placebo Controlled Study With a 12-Week Double-Blind Extension Period to Evaluate the Efficacy, Safety and Tolerability of Ritlecitinib (PF 06651600) in Adult Participants with Chronic Spontaneous Urticaria

2025-522642-44-00CHRONIC SPONTANEOUS URTICARIA

Pfizer Inc.

Skin and Connective Tissue Diseases

Spain, Germany, Bulgaria, Poland

25/02/2026

Phase III

An Open-Label Study of Donidalorsen in Pediatric Patients Age 2 to Less than 12 Years Old with Hereditary Angioedema [Donidalorsen Treatment in Children with Hereditary Angioedema]

2025-523499-22-00Hereditary Angioedema (HAE)

Ionis Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Italy, Spain, Poland

25/02/2026

Phase III

A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)

2025-522471-28-00psoriatic arthritis (PsA)

DrugSonelokimab

MoonLake Immunotherapeutics AG

Musculoskeletal Diseases

Estonia, Croatia, Slovakia, Lithuania, Romania, Hungary, Germany, France, Latvia, Poland, Portugal, Greece, Czechia, Bulgaria, Finland, Spain

25/02/2026

Phase II

Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age with Immunoglobulin G4 related Disease (IgG4-RD)

2025-520988-41-00Immunoglobulin G4 related Disease (IgG4-RD)

DrugInebilizumab

Amgen Inc.

Immune System Diseases

Greece, Poland, Italy, Spain

25/02/2026

Phase I/II

A Phase Ib/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, pharmacokinetics, and recommended combination dose of BNT324 with BNT327 in participants with advanced lung cancer

2024-520238-31-01Advanced Lung Cancer

BioNTech SE

Neoplasms

Spain, France, Italy, Poland

24/02/2026

Phase II

A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults with Major Depressive Disorder

2025-522784-15-00Major Depressive Disorder

Draig Therapeutics Limited

Mental Disorders

Czechia, Bulgaria, Poland

24/02/2026

Phase III

J2A-MC-GZPW: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

2025-523123-22-00Atherosclerosis Cardiovascular Disease, Chronic Kidney Dise…

Eli Lilly & Co.

Cardiovascular Diseases

Germany, Czechia, Lithuania, Spain, Austria, France, Hungary, Greece, Estonia, Netherlands, Slovakia, Poland, Romania, Bulgaria, Italy, Belgium

24/02/2026

Phase II

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

2025-521939-36-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …

Merck Sharp & Dohme LLC

Neoplasms

Italy, Poland, Spain, Finland, Netherlands, Greece

24/02/2026

Phase III

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease

2025-521037-86-00Immune system diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Spain, Czechia, Lithuania, Hungary, Greece, Bulgaria, Poland, Belgium, France, Germany, Norway, Austria, Netherlands, Italy, Slovakia

24/02/2026

Phase III

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease

2025-521036-11-00Immune system disseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Slovakia, Netherlands, Poland, Greece, Czechia, Italy, Bulgaria, Belgium, Germany, Lithuania, Austria, Spain, Hungary, Norway, France

24/02/2026

Phase III

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

2025-521314-25-00NPM1-m and KMT2A-r Acute Myeloid Leukemia

DrugsZiftomenib·Cytarabine·Azacitidine·Venetoclax

Kura Oncology Inc.

Neoplasms

Belgium, Spain, Italy, Czechia, Hungary, Poland, France, Portugal, Germany, Greece

20/02/2026

Phase II

Master Protocol Full Title: A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 1 Full Title: An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod.

2025-522492-28-00AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthe…

Argenx

Immune System Diseases

Spain, Poland, Germany, Netherlands, Greece, Italy, Belgium

18/02/2026

Phase I/II

A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants with Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

2025-522406-20-00Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

Immunabs Inc.

Nervous System Diseases

Bulgaria, Poland, Spain, Italy

18/02/2026

Phase III

J2A-MC-GZPR: A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants with Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial

2025-523283-21-00Peripheral Arterial Disease

Eli Lilly & Co.

Cardiovascular Diseases

Slovakia, Poland, France, Netherlands

17/02/2026

Phase III

A phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer (OPERA-02)

2025-522873-12-00ER+, HER2- Advanced Breast Cancer

Olema Pharmaceuticals Inc.

Neoplasms

Hungary, Portugal, Italy, France, Poland, Czechia, Germany, Spain, Belgium, Austria, Romania, Greece, Netherlands

17/02/2026

Phase III

A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of early in hospital initiation of inclisiran treatment in patients with acute coronary syndromes: Victorion – RIDES

2025-521670-34-00Acute coronary syndrome (ST-elevation myocardial infarction…

Novartis Pharma AG

Cardiovascular Diseases

Germany, Hungary, Poland, France, Spain

16/02/2026

Phase II

Revumenib Treatment in Combination with FLA Chemotherapy in Paediatric Refractory/Relapsed KMT2A-r, NUP98-r or NPM1-mut Acute Myeloid Leukemia (AML)

2025-521390-14-00Acute Myeloid Leukemia

DrugsRevumenib·Cytarabine·Fludarabine

Pediatric Research International GmbH

Neoplasms

Denmark, Italy, Czechia, Sweden, Poland, Netherlands, Germany, Austria

16/02/2026

Phase I

A Phase 1 first-in-human study to evaluate SAR447754 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis.

2025-523826-41-00Dermatitis atopic

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Belgium, Czechia, France, Hungary, Poland, Spain, Bulgaria

16/02/2026

Phase I

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

2025-523142-28-00Chronic Obstructive Pulmonary Disease (COPD) Chronic Rhinos…

Bambusa Therapeutics Inc.

Respiratory Tract Diseases

Poland

16/02/2026

Phase III

Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab versus Placebo in Patients with Cancer-associated Cachexia

2025-523533-25-00Cancer-associated Cachexia

CatalYm GmbH

Nutritional and Metabolic Diseases

France, Czechia, Romania, Italy, Germany, Poland, Spain, Bulgaria, Norway, Ireland, Netherlands

13/02/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)

2025-522279-27-00Newly Diagnosed AML with an NPM1 mutation

Syndax Pharmaceuticals Inc.

Neoplasms

Greece, Poland, Spain, Austria, Italy, Romania, Belgium, France, Lithuania, Germany, Hungary, Czechia, Portugal

13/02/2026

Phase III

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)

2025-521587-35-00Metastatic colorectal cancer

Summit Therapeutics Inc.

Neoplasms

Belgium, Italy, Spain, Germany, France, Poland, Czechia, Hungary

12/02/2026

Phase I/II

A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)

2024-519005-35-00Type 2 Diabetes Mellitus

Alnylam Pharmaceuticals Inc.

Hormonal diseases

Germany, Poland

10/02/2026

Phase III

An Open-label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab plus Carfilzomib versus Standard of Care Combination Regimens in Patients with Relapsed/Refractory Multiple Myeloma

2024-519504-27-00Relapsed Refractory Multiple Myeloma

DrugsDiphenhydramine hydrochloride·Linvoseltamab·Paracetamol·Velcade

Regeneron Pharmaceuticals Inc.

Neoplasms

Greece, Spain, Poland, Italy, Austria, Czechia, Belgium, Germany, Netherlands, France

10/02/2026

Phase III

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-1)

2025-522703-14-00"Moderate to severe obstructive sleep apnea (OSA) in adults…

Amgen Inc.

Respiratory Tract Diseases

Poland, Germany, Czechia, Hungary, Spain, France

10/02/2026

Phase III

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

2025-520805-10-00Chronic inflammatory demyelinating polyneuropathy (CIDP)

DrugEmpasiprubart

Argenx

Nervous System Diseases

Czechia, Denmark, Poland, Slovenia, Netherlands, Austria, Estonia, Slovakia, Hungary, Finland, Bulgaria, France, Italy, Greece, Romania

10/02/2026

Phase II

A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to less than 18 Years of age With Generalized Myasthenia Gravis (gMG)

2025-520993-20-00Generalized Myasthenia Gravis

DrugInebilizumab

Amgen Inc.

Nervous System Diseases

Spain, Italy, Poland, France

09/02/2026

Phase IV

Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products

2025-521621-33-00Hepatocellular Carcinoma, Melanoma, Metastatic Melanoma, Ad…

Replimune Group Inc.

Neoplasms

Germany, Greece, France, Poland, Spain

09/02/2026

Phase III

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination with Osimertinib, Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713

2025-521124-29-00Non-Small Cell Lung Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Portugal, Italy, Spain, Poland, Netherlands, Germany, Belgium, Austria, France

09/02/2026

Phase III

A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE

2025-521142-22-00Hereditary Angioedema

Astria Therapeutics Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Netherlands, Spain, Poland, Germany, Czechia, Austria, Portugal, Hungary, France, Italy, Bulgaria

09/02/2026

Phase III

A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis

2025-521038-27-00Immune system diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Slovakia, Germany, Austria, Italy, Czechia, Netherlands, Poland, Belgium, Hungary, Lithuania, Greece, France, Bulgaria, Spain, Norway

09/02/2026

Phase III

2025-521035-37-00Immune system diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Austria, France, Norway, Hungary, Bulgaria, Netherlands, Czechia, Slovakia, Germany, Lithuania, Greece, Belgium, Italy, Spain, Poland

09/02/2026

Phase II

A Phase 2 randomized, double-blind, placebo-controlled study to investigate efficacy, safety, immunogenicity, and pharmacokinetics, of GSK3862995B in participants with bronchiectasis

2025-522892-27-00Bronchiectasis

GSK PLC

Respiratory Tract Diseases

Denmark, France, Spain, Italy, Germany, Poland

09/02/2026

Phase III

A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)

2025-522229-37-00Gastrointestinal Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

France, Romania, Spain, Netherlands, Norway, Belgium, Hungary, Italy, Poland, Germany

06/02/2026

Phase III

I4V-MC-JAJK: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

2025-522170-36-00Diabetes Mellitus, Type 1

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Finland, Germany, Italy, France, Sweden, Poland, Spain, Belgium, Czechia, Netherlands, Portugal, Norway

03/02/2026

Phase III

ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

2025-522960-34-00High cardiovascular risk, Hypertension, Established cardiov…

Alnylam Pharmaceuticals Inc.

Cardiovascular Diseases

Belgium, Hungary, Czechia, Austria, Germany, France, Greece, Spain, Romania, Netherlands, Italy, Poland, Slovakia, Sweden, Portugal, Denmark, Bulgaria

03/02/2026

Phase II

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D)

2025-521560-36-00Type 1 Diabetes

Sab Biotherapeutics Inc.

Nutritional and Metabolic Diseases

Austria, Germany, Poland, Italy, Denmark, Spain, Belgium, Finland, France, Lithuania, Slovenia

02/02/2026

Phase III

A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 followed by AZD0486 versus R-mini-CHOP x6 in Elderly or Unfit Participants with Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)

2025-522029-37-00Large B-cell Lymphoma

AstraZeneca AB

Neoplasms

Poland, Belgium

30/01/2026

Phase III

A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-DCM).

2025-522553-19-00Symptomatic genetic and familial dilated cardiomyopathy.

Kardigan Inc.

Cardiovascular Diseases

Spain, Denmark, Belgium, Hungary, Italy, Poland, France, Sweden, Netherlands

30/01/2026

Phase I

A study to find how safe different doses of LFD-200 are and how it works in both healthy people and people with moderate to severe rheumatoid arthritis

2025-523409-13-00Moderate to Severe Rheumatoid Arthritis

Lifordi Immunotherapeutics Inc.

Immune System Diseases

Poland

30/01/2026

Phase III

A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY OF NEOADJUVANT DAROVASERTIB IN SUBJECTS WITH PRIMARY NON-METASTATIC UVEAL MELANOMA (OptimUM-10)

2025-522387-32-00Uveal Melanoma

Ideaya Biosciences Inc.

Eye Diseases

France, Spain, Poland, Italy, Czechia, Belgium, Austria, Netherlands, Denmark, Germany, Slovenia

29/01/2026

Phase II

A Multi-Center, Double-Blind, Placebo-Controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, A Monoacylglycerol Lipase Inhibitor, as Add-On Therapy to Ocrelizumab, in Participants with Progressive Forms of Multiple Sclerosis

2025-521636-10-00Progressive Forms of Multiple Sclerosis (PMS)

F. Hoffmann-La Roche AG

Nervous System Diseases

Germany, Spain, France, Hungary, Italy, Poland, Portugal

28/01/2026

Phase III

A Phase 3 Randomized, Double-blind,Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-2)

2025-522699-94-00Moderate to severe obstructive sleep apnea (OSA) in adults …

Amgen Inc.

Respiratory Tract Diseases

Poland, Czechia, Germany, Hungary, France, Spain

27/01/2026

Phase III

An Open-label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients with Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/week and 120 mg/kg/week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)

2025-522792-29-00Alpha-1 Antitrypsin Deficiency

DrugIVIG

Grifols Therapeutics LLC

Respiratory Tract Diseases

Poland, Denmark, Netherlands, Ireland, Sweden, Spain, Portugal, Germany, France

27/01/2026

Phase III

N1T-MC-MALO: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD

2025-522674-36-00Metabolic Dysfunction-Associated Steatotic Liver Disease

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Czechia, France, Netherlands, Bulgaria, Norway, Austria, Poland, Spain, Italy, Hungary, Germany, Romania, Sweden, Portugal, Belgium

27/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallelgroup Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

2025-521558-40-00Pulmonary Hypertension Associated with Interstitial Lung Di…

DrugTreprostinil Palmitil

Insmed Inc.

Respiratory Tract Diseases

Portugal, Italy, Czechia, Poland, Denmark, Greece, Germany, Romania, Spain, France, Belgium, Austria

26/01/2026

Phase III

An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia

2024-519068-42-00Heterozygous Familial Hypercholesterolemia in pediatric p…

Merck Sharp & Dohme LLC

Cardiovascular Diseases

Germany, Spain, Belgium, Czechia, Norway, France, Poland, Netherlands, Italy, Finland

26/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

2025-523202-32-00Major Depressive Disorder

Xenon Pharmaceuticals Inc.

Mental Disorders

Spain, Czechia, Slovakia, Romania, Poland, Finland, Germany

26/01/2026

Phase IV

A multicenter, prospective clinical TRrial evaluating patient’s ability to make an independent and safe decision regarding the USe of the medicinal product Sildenafil Polpharma100 mg indicated in the Treatment of erectile dysfunction. TRUST Trial on Responsible Use and Self-assessed Treatment.

2025-522923-81-00Erectile dysfunction

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

Male Urogenital Diseases

Poland

26/01/2026

Phase I

A Phase 1, Randomized, Double-Blind, Two-Arm, Two-Way Crossover Study of Pharmacokinetics and Pharmacodynamics of QL0911

2025-523355-59-00Immune Thrombocytopenia, Hematopoietic Syndrome of Acute Ra…

Qilu Pharmaceutical Co. Ltd.

Hemic and Lymphatic Diseases

Poland

26/01/2026

Phase III

J2A-MC-GZPS: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared with Placebo in Female Participants with Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI) ; J2A-MC-GZS1: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight ; J2A-MC-GZS2: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight

2025-522514-23-00Urinary Incontinence, Stress

Eli Lilly & Co.

Female Urogenital Diseases and Pregnancy Complications

Romania, Czechia, Poland

26/01/2026

Phase II

A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of oral VH4524184 Coadministered with Emtricitabine and Tenofovir Alafenamide in Treatment Naïve Viremic Persons with HIV-1.( INNOVATE Study)

2025-521918-26-00HIV Infections

Viiv Healthcare UK Limited

Virus Diseases

Spain, Belgium, France, Germany, Italy, Portugal, Poland

23/01/2026

Phase II

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Dose Comparison and Exploratory Efficacy Study of Orally Administered SAT-3247 in Ambulatory DMD Patients

2025-522522-13-01Duchenne muscular dystrophy

Satellos Bioscience Inc.

Nervous System Diseases

Spain, Belgium, Poland

22/01/2026

Phase II

J2S-MC-GZMR: A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Uncontrolled Moderate to Severe Asthma

2025-522640-41-00Asthma

Eli Lilly & Co.

Respiratory Tract Diseases

Germany, Netherlands, France, Poland

21/01/2026

Phase III

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

2025-521908-22-00EGFR-mutated Non-small Cell Lung Cancer

DrugsPegfilgrastim·Iza-bren·Pemetrexed·Cisplatin

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Poland, Germany, Italy, Norway, Netherlands, Belgium, Romania, France, Greece, Spain

19/01/2026

Phase III

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

2023-503766-24-00Moderate to Severe Plaque Psoriasis

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

Romania, Bulgaria, Germany, Spain, Czechia, France, Hungary, Italy, Sweden, Poland, Denmark, Belgium

19/01/2026

Phase IV

International multicentre, open-label, phase IV clinical trial to evaluate the efficacy, safety and effect on quality of life of bilastine in children with allergic rhinoconjunctivitis

2024-519550-36-00Allergic rhinoconjunctivitis

Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Immune System Diseases

Poland, Spain, Italy

19/01/2026

Phase II

A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER 01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease

2025-523020-50-00Chronic Obstructive Pulmonary Disease

Aer Therapeutics Inc.

Respiratory Tract Diseases

Bulgaria, Poland, Spain

16/01/2026

Phase III

An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX

2025-521858-42-00Hemophilia

DrugFitusiran

Sanofi-Aventis Recherche & Developpement

Hemic and Lymphatic Diseases

Belgium, Italy, Romania, Germany, Hungary, Spain, Poland

15/01/2026

Phase II

A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions)

2025-523058-16-00Skin Toxicities Associated with Epidermal Growth Factor Rec…

Hoth Therapeutics Inc.

Skin and Connective Tissue Diseases

Spain, Hungary, Poland

15/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals with Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

2025-521845-26-00BP-I mania or mania with mixed features

DrugKarXT

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Romania, Poland, France, Italy, Denmark, Bulgaria

15/01/2026

Phase III

HOVON 181 AML: Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study

2025-522767-15-00Acute Myeloid Leukemia

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Neoplasms

Belgium, Netherlands, Germany, Austria, Denmark, Estonia, Finland, Ireland, Italy, Lithuania, Spain, Sweden, Norway, Poland

15/01/2026

Phase III

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

2025-521917-24-00Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous…

Janssen Cilag International

Neoplasms

Italy, Portugal, Spain, Romania, Hungary, France, Czechia, Germany, Netherlands, Austria, Poland, Belgium

14/01/2026

Phase II

A multicenter, randomized, participant- and investigator -blinded, placebo-controlled, phase 2a study to assess the efficacy, safety and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis

2025-521503-43-00Atopic dermatitis

Novartis Pharma AG

Skin and Connective Tissue Diseases

France, Germany, Poland, Czechia, Bulgaria

14/01/2026

Phase III

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

2025-521514-26-00Persistent, Recurrent, or Newly Diagnosed Metastatic Cervic…

Merck Sharp & Dohme LLC

Neoplasms

Greece, Ireland, France, Belgium, Czechia, Hungary, Austria, Spain, Sweden, Germany, Poland, Denmark, Italy

14/01/2026

Phase II

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study With an Open-label Period Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Participants with Moderate to Severe Atopic Dermatitis

2025-522370-36-00Moderate to Severe Atopic Dermatitis

Kymera Therapeutics Inc.

Skin and Connective Tissue Diseases

Czechia, Germany, Poland

13/01/2026

Phase III

A Phase 2/3, multicenter, randomized open-label study of zanzalintinib vs everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors

2025-521043-20-00Neuroendocrine tumors

Exelixis Inc.

Neoplasms

France, Poland, Netherlands, Belgium, Germany, Spain, Italy, Austria

09/01/2026

Phase III

A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination with Nivolumab versus Ipilimumab in Combination with Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients with Metastatic Uveal Melanoma

2023-508784-68-00metastatic uveal melanoma

DrugsRP2·Ipilimumab·Nivolumab

Replimune Inc.

Neoplasms

Germany, Italy, France, Spain, Poland

23/12/2025

Phase III

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early-Stage Parkinson’s Disease

2025-522683-32-00Early-Stage Parkinson’s Disease (PD)

F. Hoffmann-La Roche AG

Nervous System Diseases

France, Austria, Portugal, Netherlands, Poland, Germany, Spain, Denmark, Italy

23/12/2025

Phase I/II

Phase 1b/2 Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIde)

2025-523010-89-00Pulmonary arterial hypertension

35Pharma Inc.

Cardiovascular Diseases

Hungary, Spain, Poland, Germany, Czechia

23/12/2025

Phase III

I4V-MC-JAJJ: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years

2025-521797-34-00Diabetes Mellitus, Type 1

DrugBaricitinib

Eli Lilly & Co.

Immune System Diseases

Belgium, Spain, Norway, Germany, Sweden, Netherlands, France, Italy, Finland, Portugal, Poland

23/12/2025

Phase II

A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa

2025-522333-61-00Hidradenitis suppurativa

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Poland, Hungary, Netherlands, Germany, Czechia, Spain, France, Italy, Greece

22/12/2025

Phase III

A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)

2025-522046-42-00Colonic disease

Norgine Limited

Digestive System Diseases

Poland, Netherlands, Hungary, Spain, Italy, Belgium, Germany, Croatia, Portugal

22/12/2025

Phase III

A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer

2024-515765-34-00English First-line extensive-stage small-cell lung cancer (…

BioNTech SE

Neoplasms

Poland, Spain, France, Italy, Germany, Romania, Netherlands

22/12/2025

Phase III

C2321008: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)

2024-519369-24-00METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Pfizer Inc.

Not possible to specify

Belgium, Finland, France, Germany, Netherlands, Bulgaria, Spain, Slovakia, Italy, Czechia, Poland, Greece

22/12/2025

Phase III

Ublituximab in Pediatric Participants with Relapsing forms of Multiple Sclerosis (RMS)

2025-522257-19-00Relapsing Multiple Sclerosis

DrugsUblituximab·Fingolimod

Tg Therapeutics Inc.

Nervous System Diseases

Poland, Slovakia

22/12/2025

Phase IV

(ASK-PD0-CS002) Long-Term Safety and Efficacy Follow-up of AB-1005 Gene Transfer Study Participants with Parkinson’s Disease or Multiple System Atrophy

2025-522653-19-00Multiple System Atrophy, Parkinson's Disease

DrugPiflufolastat

Askbio Inc.

Nervous System Diseases

Poland

22/12/2025

Phase II

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants with Nonsegmental Vitiligo.

2025-522309-40-00Non-segmental vitiligo

Takeda Development Center Americas Inc.

Skin and Connective Tissue Diseases

Poland, Italy, Spain, France

19/12/2025

Phase II

A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications

2025-522632-14-00Non-small cell lung cancer (NSCLC)

Synthekine Inc.

Neoplasms

Ireland, Poland, Spain, Italy

19/12/2025

Phase II

A multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 2a trial to evaluate the efficacy and safety of BP1.4979 in adult participants with obsessive compulsive disorder

2025-522026-13-00Obsessive compulsive disorder

Bioprojet Pharma

Mental Disorders

Portugal, Spain, Italy, Poland

16/12/2025

Phase III

C3651021: A PHASE 2b/3, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PONSEGROMAB (PF-06946860) COMPARED WITH PLACEBO BOTH WITH BACKGROUND FIRST-LINE CHEMOTHERAPY IN ADULT PARTICIPANTS WITH CACHEXIA AND METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA

2025-522093-36-00Cancer cachexia

Pfizer Inc.

Nutritional and Metabolic Diseases

Slovakia, Italy, Belgium, Germany, Spain, France, Bulgaria, Poland

16/12/2025

Phase III

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants with Early Parkinson’s Disease

2025-521113-13-00Early Parkinson’s Disease

Biohaven Therapeutics Ltd.

Nervous System Diseases

Germany, France, Italy, Belgium, Czechia, Poland, Austria, Netherlands, Spain, Portugal

15/12/2025

Phase I

A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants with Parkinson’s Disease and Apathy

2025-523612-37-00Parkinson's Disease and Apathy

Integrative Research Laboratories Sweden AB

Nervous System Diseases

Bulgaria, Poland, Spain, Germany

12/12/2025

Phase I/II

A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer.

2024-520026-11-00Metastatic Prostate Cancer

AstraZeneca AB

Neoplasms

Italy, Spain, Poland

12/12/2025

Phase III

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)

2024-519444-33-00HER2-expressing endometrial cancer (IHC 3+/2+)

Daiichi Sankyo Inc.

Neoplasms

Germany, Poland, France, Greece, Spain, Portugal, Italy

11/12/2025

Phase III

A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants with Congenital Adrenal Hyperplasia Including a Long-Term Extension

2024-519578-38-00Classic congenital adrenal hyperplasia

Crinetics Pharmaceuticals Inc.

Hormonal diseases

Italy, Germany, France, Belgium, Netherlands, Poland

09/12/2025

Phase III

A 40-week study comparing the efficacy, safety and patient-reported outcomes of once weekly IcoSema and once or twice daily insulin degludec/insulin aspart 100 units/mL, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily pre-mixed insulin. COMBINE 5

2025-521150-42-00Type 2 diabetes

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Poland

09/12/2025

Phase II

A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults with Moderate to Severe Atopic Dermatitis

2025-522113-35-00Atopic dermatitis

Triveni Bio Inc.

Skin and Connective Tissue Diseases

Poland, Bulgaria, Czechia, Hungary

09/12/2025

Phase III

AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

2024-512804-20-00Metastatic Colorectal Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Germany, Poland, France, Italy, Netherlands, Spain

08/12/2025

Phase II

(22419) A randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome

2024-516471-33-00Alport Syndrome, Chronic kidney disease

Bayer AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Italy, Poland, Czechia, Germany, Portugal, France

05/12/2025

Phase II

A Phase II, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients with Multiple Sclerosis

2024-517980-22-00Multiple Sclerosis (MS)

F. Hoffmann-La Roche AG

Immune System Diseases

Poland, Italy, France, Spain, Germany

05/12/2025

Phase III

(21467) A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)

2024-519830-22-00Heart failure due to systemic left ventricular systolic dys…

DrugFinerenone

Bayer AG

Cardiovascular Diseases

Czechia, Germany, Greece, Italy, Finland, Bulgaria, Belgium, Poland, Austria, Portugal, Spain, Hungary, Sweden

05/12/2025

Phase III

(21466) A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK/ PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age, with heart failure (HF) and left ventricular systolic dysfunction (LVSD)

2024-519829-38-00Heart failure due to systemic left ventricular systolic dys…

Bayer AG

Cardiovascular Diseases

Czechia, Poland, Portugal, Austria, Finland, Greece, Bulgaria, Sweden, Spain, Italy, Belgium, Hungary, Germany

05/12/2025

Phase III

A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice-Weekly, Followed by a Long-Term, Open-Label Safety Evaluation in Patients with Short Bowel Syndrome–Intestinal Failure (SBS-IF)

2024-512486-14-00Short Bowel Syndrome

DrugGlepaglutide

Zealand Pharma A/S

Digestive System Diseases

Finland, France, Belgium, Germany, Hungary, Spain, Austria, Netherlands, Italy, Denmark, Czechia, Norway, Poland, Sweden, Estonia

04/12/2025

Phase II

A PHASE 2A, OPEN-LABEL SINGLE ARM MULTICENTER EXPLORATORY STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF ORAL DOSES OF ROC-101 IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE (ILD-PH)

2025-522074-37-00Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertensi…

Allrock Bio Inc.

Cardiovascular Diseases

Spain, Italy, Poland, France, Latvia, Germany

04/12/2025

Phase III

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia

2024-519579-24-00Classic Congenital Adrenal Hyperplasia

Crinetics Pharmaceuticals Inc.

Hormonal diseases

Sweden, Austria, Poland, Netherlands, Italy, France, Germany

02/12/2025

Phase I

First-in-Human Study of RO7812653

2025-522101-37-00Early Symptomatic Alzheimer’s Disease (eAD), (Mild Cognitiv…

F. Hoffmann-La Roche AG

Nervous System Diseases

Sweden, Poland, Spain, Netherlands

02/12/2025

Phase I/II

A Phase Ib/II, multi-site, open-label, dose finding trial to evaluate the safety, efficacy, and pharmacokinetics of BNT326 in combination with BNT327 in participants with advanced non-small cell lung cancer (NSCLC)

2024-519344-32-00Non-small Cell Lung Cancer

BioNTech SE

Neoplasms

Poland, Germany, Italy, Spain

02/12/2025

Phase III

A phase 3, randomized, double-blind, placebo-controlled, multicenter study with open-label extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis

2024-520337-80-00Palmoplantar Pustulosis

UCB Biopharma

Immune System Diseases

Czechia, Denmark, Spain, Poland, Germany, Hungary, Italy, France

02/12/2025

Phase III

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

2025-521382-27-00Moderately to Severely Active Crohn's Disease

Janssen Cilag International

Immune System Diseases

Netherlands, Italy, Portugal, Spain, Czechia, Romania, France, Sweden, Hungary, Belgium, Germany, Greece, Poland

01/12/2025

Phase III

A Phase III, randomized, open label, non-inferiority study comparing the efficacy and safety of furazidin vaginal tablets and clindamycin vaginal cream in the local treatment of bacterial vaginosis

2024-515332-80-00Bacterial vaginosis

Adamed Pharma S.A.

Bacterial Infections and Mycoses

Italy, Czechia, Poland, Slovakia

01/12/2025

Phase III

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

2025-521381-10-00Moderately to Severely Active Ulcerative Colitis

Janssen Cilag International

Digestive System Diseases

Netherlands, Romania, Italy, Spain, Sweden, Czechia, Greece, Hungary, France, Portugal, Belgium, Germany, Poland

01/12/2025

Phase I/II

TulmiSTAR-01: A two-part, Phase I dose escalation and expansion followed by a randomized, open-label multicenter, Phase II study to assess the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) vs standard of care in patients with progressive metastatic castrate resistant prostate cancer

2025-521880-10-00Metastatic castrate resistant prostate cancer (mCRPC)

Novartis Pharma AG

Neoplasms

Italy, Germany, Poland, France, Denmark, Spain

01/12/2025

Phase III

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

2025-521970-33-00Pulmonary Arterial Hypertension (PAH)

Merck Sharp & Dohme LLC

Cardiovascular Diseases

Czechia, Germany, Sweden, Greece, Croatia, Belgium, Poland, Spain, Portugal, Italy, Denmark, France, Netherlands

01/12/2025

Phase III

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

2024-520097-36-00Chronic inflammatory demyelinating polyneuropathy (CIDP)

DrugEmpasiprubart

Argenx

Nervous System Diseases

Czechia, Bulgaria, Netherlands, Hungary, Sweden, Slovakia, Slovenia, Greece, Norway, Poland, Italy, Spain, Estonia, Denmark, France, Romania, Portugal, Austria, Germany

01/12/2025

Phase III

A Randomized, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-Paclitaxel and Gemcitabine versus Placebo in Combination With Nab-Paclitaxel and Gemcitabine in Participants with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion

2025-522598-12-00Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Czechia, Austria, Belgium, Ireland, Spain, Germany, Romania, Netherlands, Slovakia, Greece, Poland, Italy, Denmark, France, Sweden

28/11/2025

Phase II

A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis

2024-519335-42-01Systemic Sclerosis

Zura Bio Inc.

Immune System Diseases

Hungary, Romania, Poland, Spain

27/11/2025

Phase II

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

2025-520730-28-00Common EGFR-Mutated Locally Advanced or Metastatic Non-Smal…

Janssen Cilag International

Neoplasms

Germany, Spain, Finland, Greece, Portugal, Italy, Belgium, Poland, France

27/11/2025

Phase III

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

2024-514500-14-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …

Merck Sharp & Dohme LLC

Neoplasms

Germany, Italy, France, Poland, Spain, Hungary, Romania, Greece, Austria, Netherlands, Belgium

27/11/2025

Phase III

A 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of Glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials

2025-520775-81-00Short Bowel Syndrome

Zealand Pharma A/S

Digestive System Diseases

Poland, France, Germany, Belgium

26/11/2025

Phase III

Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

2024-513911-28-00Acute Ischemic Stroke

Diamedica Therapeutics Inc.

Nervous System Diseases

Romania, Hungary, Belgium, Poland, Spain, France

25/11/2025

Phase I

A Phase 1b open label pilot study of CLN-978 for the treatment of moderate to severe systemic lupus erythematosus (SLE)

2024-518780-36-00Systemic Lupus Erythematosus

Cullinan Therapeutics Inc.

Musculoskeletal Diseases

Bulgaria, Romania, France, Germany, Spain, Poland

25/11/2025

Phase II

Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults with Moderately to Severely Active Rheumatologic Disease

2025-521791-63-00Moderately to Severely Active Rheumatologic Disease

Spyre Therapeutics Inc.

Immune System Diseases

Czechia, Poland, Spain, Bulgaria

25/11/2025

Phase III

Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

2024-515023-11-00Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear …

DrugsCasdatifan·Cabozantinib

Arcus Biosciences Inc.

Neoplasms

Italy, Spain, Romania, Germany, Netherlands, Poland, France, Czechia, Hungary

24/11/2025

Phase II

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity

2025-520831-18-00Primary Sjogren’s Disease

Immunovant Sciences GmbH

Immune System Diseases

Germany, Greece, Romania, Spain, Poland, Italy, Hungary

24/11/2025

Phase III

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation.

2024-520418-22-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Slovakia, Denmark, France, Sweden, Ireland, Belgium, Netherlands, Spain, Croatia, Germany, Poland, Hungary, Norway, Portugal

24/11/2025

Phase II

A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients with Moderate to Severe Rheumatoid Arthritis who have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors

2025-521034-28-00Moderate to Severe Rheumatoid Arthritis (RA)

DrugAfimkibart

F. Hoffmann-La Roche AG

Immune System Phenomena

Italy, Denmark, France, Poland, Germany, Spain, Belgium

23/11/2025

Phase II

A Phase 2, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of 2 doses of vipoglanstat in patients with moderate to severe endometriosis-related pain – the NOVA trial

2025-522452-16-00Endometriosis related pain

Gesynta Pharma AB

Female Urogenital Diseases and Pregnancy Complications

Italy, Hungary, Poland, Czechia, Bulgaria, Romania

21/11/2025

Phase III

Study of Oral MC-1 for the Treatment of Patients with PNPO Deficiency

2025-522346-46-00Seizures associated with Pyridox(am)ine 5’-Phosphate Oxidas…

Medicure International Inc.

Nervous System Diseases

Poland

21/11/2025

Phase I

BBT001 in Healthy Volunteers and in Adult Patients with Atopic Dermatitis

2025-522918-23-00Atopic Dermatitis

Bambusa Therapeutics Inc.

Skin and Connective Tissue Diseases

Poland

21/11/2025

Phase II

A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients with Symptomatic Non Obstructive Hypertrophic Cardiomyopathy – FORTITUDE-HCM

2024-515125-28-00Non-obstructive hypertrophic cardiomyopathy

Imbria Pharmaceuticals Inc.

Cardiovascular Diseases

Austria, Germany, Belgium, France, Portugal, Spain, Netherlands, Italy, Poland

20/11/2025

Phase I/II

Phase 1/2 Study of PYX-201 in Combination with Pembrolizumab in Advanced Solid Tumors

2025-521828-30-00Advanced Solid Tumors

Pyxis Oncology Inc.

Neoplasms

France, Spain, Poland

19/11/2025

Phase III

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

2025-522860-34-00Small lymphocytic lymphoma (SLL), Chronic lymphocytic leuke…

BeOne Medicines AG

Neoplasms

Sweden, Belgium, Spain, Germany, Austria, Netherlands, Italy, Romania, Poland, France

18/11/2025

Phase III

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of JNJ-78278343, a T-cell-redirecting Agent Targeting Human Kallikrein 2 Versus Placebo for Metastatic Castration-resistant Prostate Cancer

2025-520927-26-00Metastatic Castration-resistant Prostate Cancer (mCRPC)

Janssen Cilag International

Neoplasms

France, Belgium, Spain, Poland, Italy, Netherlands, Germany

18/11/2025

Phase II

A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of S-337395 in symptomatic nonhospitalized adults with respiratory syncytial virus who are at high risk of progression to severe disease

2025-523156-31-00Respiratory Syncytial Virus

Shionogi B.V.

Virus Diseases

Bulgaria, Poland

18/11/2025

Phase III

Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivo in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)

2025-521562-95-00Previously Untreated Advanced (Unresectable or Metastatic) …

DrugNivolumab

Mabxience Research S.L.

Musculoskeletal Diseases

Italy, Spain, Slovakia, Romania, Portugal, Greece, Poland

18/11/2025

Phase II

Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

2025-521706-17-00Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasc…

Alexion Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Spain, France, Italy, Germany, Poland

17/11/2025

Phase III

C5851005 - PADLINK-005: A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDL1V VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)

2025-521281-97-00Non-Small Cell Lung Cancer (NSCLC)

Pfizer Inc.

Neoplasms

Greece, Italy, Belgium, Slovakia, Czechia, Germany, France, Poland, Denmark, Spain, Netherlands, Sweden, Finland, Bulgaria

17/11/2025

Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 16 October 2026. https://priyalifescience.com/clinical-trials-europe/country/poland

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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,637 trial records at the last sync on 16 Oct 2026, 03:17 UTC; this register shows the 2,557 most recently authorised of them, a stated recency window rather than the full archive. The list can be downloaded as CSV or JSON.

This page shows the 609 of those trials with a site in Poland.

How many recently authorised EU trials have a site in Poland?

609 of the 2,557 most recently authorised trials in this register list a site in Poland; 346 of them are Phase III. Trials are counted by authorisation on CTIS, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Summary by phase

Trials by phase (Poland), 609 trials
Phase	Trials	Share
Phase III	346	56.8%
Phase II	179	29.4%
Phase I	38	6.2%
Phase I/II	32	5.3%
Phase IV	14	2.3%

Most active sponsors

Lead sponsors with the most trials (Poland)
Lead sponsor	Trials
AstraZeneca AB	35
Merck Sharp & Dohme LLC	24
F. Hoffmann-La Roche AG	23
Eli Lilly & Co.	21
Pfizer Inc.	21
Bristol-Myers Squibb Services Unlimited Company	19
Sanofi-Aventis Recherche & Developpement	18
Novo Nordisk A/S	15
Amgen Inc.	14
Janssen Cilag International	14

Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.