Clinical Trials in Czechia, 2026

Trials with a site in Czechia

Phase

Study

Lead sponsor

Area

Member states

Decision

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

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

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 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 I/II

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination with Ipilimumab or Cabozantinib in Participants with Advanced Renal Cell Carcinoma (RCC)

2026-527163-15-00Advanced Renal Cell Carcinoma

DrugsCabozantinib·Ipilimumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Ireland, Romania, Italy, Spain, Czechia, Finland, France, Germany

24/09/2026

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 III

A randomized, open-label, multicenter, Phase 3 study to investigate mocertatug rezetecan compared with standard of care in participants with platinum- resistant ovarian cancer.

2025-523361-25-00Ovarian Neoplasms

DrugsDoxorubicin·Gemcitabine·Paclitaxel·Bevacizumab

Glaxosmithkline Research & Development Limited

Neoplasms

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

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 III

A Multicentre, Parallel-Group, Observer-Blind, Randomised, Placebo-Controlled, Pivotal Trial Investigating the Safety and Immunogenicity of Group B Streptococcus Vaccine (GBS-NN/NN2) in Pregnant Women and Infants Born to Pregnant Women Vaccinated During Pregnancy

2026-525385-21-00Prevention of Group B streptoccoccus infection

Minervax ApS

Bacterial Infections and Mycoses

Czechia, Belgium, Denmark, Spain

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 Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions/Small Choroidal Melanomas)

2025-524405-33-00Choroidal Melanoma

Aura Biosciences Inc.

Neoplasms

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

17/09/2026

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, randomised, double-blind, placebo-controlled, multicentre trial comparing efficacy and safety of trilaciclib versus placebo in participants with limited-stage small cell lung cancer

2025-525026-35-00Limited-stage small cell lung cancer (LS-SCLC)

Pharmacosmos A/S

Neoplasms

Czechia, Greece, France, Belgium, Italy, Spain, Germany

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 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 II

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1065890 in Adult Participants With Tardive Dyskinesia

2025-524104-30-00Tardive Dyskinesia

Neurocrine Biosciences Inc.

Nervous System Diseases

Bulgaria, Croatia, Romania, Slovakia, Czechia

07/09/2026

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 II

A multicenter, prospective, randomized, placebo and non-surgical standard of care (NSSOC) controlled study, performed to evaluate the safety and efficacy of EscharEx and its placebo (gel vehicle) compared to NSSOC in participants with Venous Leg Ulcers (VLU)

2026-526070-16-00Venous Leg Ulcer (VLU)

DrugEscharEx

Mediwound Ltd.

Skin and Connective Tissue Diseases

Czechia, Slovakia

01/09/2026

Phase II

HOVON 168: Epcoritamab in Addition to R-Mini-CHOP Compared to R-Mini-CHOP in Elderly, Frail or Unfit Patients with Diffuse Large B-cell Lymphoma

2025-524230-25-00Diffuse large B-cell lymphoma (DLBCL)

DrugsEpcoritamab·Rituximab

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Hemic and Lymphatic Diseases

Czechia, Denmark, Croatia, Spain, Sweden, Finland, Portugal, Ireland, Netherlands, Belgium, Norway

31/08/2026

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 II

A Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Finding, Active-Controlled Study of Siplizumab (TCD601) Compared to Rabbit Anti-Thymocyte Globulin in Renal Transplant Recipients Requiring Induction Therapy and Receiving Standard of Care Immunosuppression with Tacrolimus, Mycophenolic Acid and Corticosteroids (MODERNIZE 1)

2026-525646-29-00Renal Transplantation

DrugSiplizumab

Nefro Avillion Clinical Development LLC

Immune system processes

Czechia, Spain, Portugal, Austria

25/08/2026

Phase I

The pivotal bioequivalence study comparing the test product to the reference product, which belongs to the group of medicines used for lowering levels of cholesterol in the blood.

2026-527468-34-00No medical condition

Adamed Pharma S.A.

Not possible to specify

Czechia

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 I

Bioavailability Comparison of Valsartan 320 mg Tablets (Test vs. Reference Product)

2026-527569-31-00Not applicable (submitted trial is a BE study in healthy pa…

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

Cardiovascular Diseases

Czechia

25/08/2026

Phase III

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Etifoxine Monotherapy in The Treatment of Adjustment Disorder with Anxiety (ADWA)

2025-524287-38-00Treatment of adjustment disorder with anxiety (ADWA).

Biocodex

Nervous System Diseases

Bulgaria, France, Romania, Czechia

24/08/2026

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 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 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 I

Bioequivalence of Estradiol 10 mcg Vaginal Tablets in Healthy Women Participants.

2026-526477-42-00Not applicable (submitted trial is a bioavailability trial …

Laboratorios Leon Farma S.A.

Female Urogenital Diseases and Pregnancy Complications

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 I

Bioavailability Comparison of Finerenone 20 mg Tablets (Test vs. Comparator Product).

2026-527382-30-00Comparative bioavailability study under fasting conditions.

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

Cardiovascular Diseases

Czechia

12/08/2026

Phase I

Bioequivalence study 3 to compare pharmacokinetics of Parkinson´s disease drugs in healthy volunteers

2026-525450-11-00Parkinson's desease

Orion Corporation

Nervous System Diseases

Czechia

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 I

An open label, randomized, single-dose, two-treatment, two-sequence, two-period, cross-over pilot comparative bioavailability study comparing Empagliflozin and Metformin f.c. tabs (12.5+1000) mg, VIANEX S.A., Greece versus Synjardy 12.5 mg/1,000 mg film-coated tablets, Boehringer Ingelheim International GmbH, Germany, in healthy male and female volunteers under fasting conditions.

2026-526397-17-00treatment of diabetes

Vianex S.A.

Hormonal diseases

Czechia

05/08/2026

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

DrugElecoglipron

AstraZeneca AB

Nutritional and Metabolic Diseases

Poland, Germany, Bulgaria, Czechia

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

Bioequivalence of Tramadol retard 200 mg Prolonged-Release Tablets in Healthy Participants Under Fasting Conditions

2026-525836-41-00Not applicable (submitted trial is a bioavailability trial …

Laboratorios Cinfa S.A.

Nervous System Diseases

Czechia

30/07/2026

Phase III

J3L-MC-EZEJ: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event

2025-524858-34-00Lipoprotein(a), Atherosclerosis, Cardiovascular Diseases

Eli Lilly & Co.

Cardiovascular Diseases

Hungary, Czechia, Spain, Netherlands

30/07/2026

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 …

DrugsElecoglipron·Dapagliflozin

AstraZeneca AB

Cardiovascular Diseases

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

29/07/2026

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, 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

A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia

2025-524282-24-00Classic Congenital Adrenal Hyperplasia (CAH)

DrugCrinecerfont

Neurocrine Biosciences Inc.

Hormonal diseases

Czechia, Germany, Sweden, Portugal, Romania, Bulgaria, Italy, Austria, Spain

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 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 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 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

The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.

2025-524463-20-00Asthma

DrugsDopamine·Depemokimab

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Ireland, Spain, Germany, Czechia, Bulgaria, France, Belgium, Romania, Italy

14/07/2026

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 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

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

DrugsCevostamab·Elotuzumab·Carfilzomib·Pomalidomide

F. Hoffmann-La Roche AG

Neoplasms

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

07/07/2026

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

2024-518213-25-00Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

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

06/07/2026

Phase I

Bioequivalence Study of Dapagliflozin 10 mg

2026-526840-10-00Not applicable (submitted trial is a BE study in healthy pa…

Vipharm S.A.

Cardiovascular Diseases

Czechia

02/07/2026

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)

Genmab A/S

Neoplasms

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

01/07/2026

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…

DrugEnpatoran

Merck Healthcare KGaA

Skin and Connective Tissue Diseases

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

29/06/2026

Phase III

A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants with Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer

2026-525531-16-00Non-Muscle Invasive Papillary Bladder Cancer

Hamlet BioPharma AB

Male Urogenital Diseases

Czechia

29/06/2026

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 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 I

A Phase 1 first-in-human study to evaluate SAR448272 in adult participants

2026-526014-87-00healthy volunteers, immunological diseases

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Germany, Czechia

19/06/2026

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 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of each of two dose levels of sarilumab in adults with early polymyalgia rheumatica

2024-511296-15-00Musculoskeletal diseases

Sanofi-Aventis Recherche & Developpement

Musculoskeletal Diseases

France, Netherlands, Germany, Czechia, Belgium, Austria, Hungary, Greece, Spain

15/06/2026

Phase IV

Real-World Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study (PRISMC3)

2025-524487-37-00C3 Glomerulopathy (C3G), Primary Immune Complex Membranopro…

DrugPegcetacoplan

Swedish Orphan Biovitrum AB (publ)

Immune System Diseases

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

15/06/2026

Phase I

Study to assess the relative bioavailability of Neludolat versus YAZ in healthy female subjects.

2025-524871-22-00Healthy subjects

Pevisal Group Farmaceutici S.r.l.

Reproductive and Urinary Physiological Phenomena

Czechia

12/06/2026

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 (UC),…

Eli Lilly & Co.

Digestive System Diseases

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

10/06/2026

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 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 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)

2025-524894-17-00Neovascular age-related macular degeneration (NVAMD)

Eyebiotech Limited

Eye Diseases

Austria, Slovakia, Portugal, Czechia, Hungary, Spain, France, Denmark, Italy, Croatia

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

Bioequivalence of Tramadol retard 200 mg Prolonged-Release Tablets in Healthy Subjects Under Fed Conditions

2026-525780-41-00Not applicable (submitted trial is a bioavailability trial …

Laboratorios Cinfa S.A.

Nervous System Diseases

Czechia

04/06/2026

Phase II

Prevention of radiation-induced salivary gland damage by botulinum toxin application in patients with head and neck cancers

2025-524720-22-00patients with head and neck squamous cell carcinoma (HNSCC)

DrugBotulinum toxin type A

Fakultni Nemocnice Kralovske Vinohrady

Otorhinolaryngologic Diseases

Czechia

02/06/2026

Phase I

Randomized, open-label, multiple dose, two-period, two-treatment, cross-over pharmacodynamic study in healthy male and female participants under fasting conditions.

2026-526556-31-00Pharmacodynamic study under fasting condition.

Adamed Pharma S.A.

Cardiovascular Diseases

Czechia

02/06/2026

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 I

An open label, randomized, multiple-dose, two-treatment, two-period, cross-over bioequivalence study comparing Pyridostigmine Bromide, P.R.Tab, 180 mg/tab, VIANEX S.A., Greece versus Mestinon® retard 180 mg/prolonged-release tablet, Viatris Healthcare GmbH, Germany, in healthy male and female volunteers under fasting conditions.

2025-524219-35-00treatment of myasthenia gravis

Vianex S.A.

Musculoskeletal Diseases

Czechia

02/06/2026

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 II

A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL

2024-516570-30-00Relapsed/refractory T-cell Acute Lymphoblastic Leukemia

DrugsAsparaginase Erwinia chrysanthemi·Tofacitinib·Everolimus·Azacitidine

Centre Hospitalier De Versailles

Hemic and Lymphatic Diseases

Germany, France, Czechia, Netherlands, Spain

29/05/2026

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

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX‑828/Deutivacaftor With and Without Tezacaftor in Subjects Aged 18 Years and Older With Cystic Fibrosis

2025-523400-72-00Cystic fibrosis

Vertex Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Sweden, Germany, Italy, Belgium, Czechia, Ireland, Portugal, Netherlands, France, Denmark

29/05/2026

Phase IV

Optimising the protocol of labour induction using misoprostol – randomised open-label clinical trial (OPTIMISO)

2026-525770-19-00Labour induction

Fakultni Nemocnice Brno

Female Urogenital Diseases and Pregnancy Complications

Czechia

28/05/2026

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 I/II

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

2025-522339-32-00Neoplasm malignant

DrugIfinatamab Deruxtecan

Merck Sharp & Dohme LLC

Neoplasms

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

26/05/2026

Phase I

A study comparing different dosage forms of midazolam and how they are taken up in the body.

2025-524999-37-00Bioavailability Study under Fasting Conditions

MIDAS Pharma GmbH

Anesthesia and Analgesia

Czechia

26/05/2026

Phase I

Bioequivalence study 1 to compare pharmacokinetics of Parkinson´s disease drugs in healthy volunteers

2026-525448-14-00Parkinson disease

Orion Corporation

Nervous System Diseases

Czechia

22/05/2026

Phase II

An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of KL1333 (napazimone) in patients with primary mitochondrial disease

2025-524367-20-00Adult patients with primary mitochondrial disease

Pharming Technologies B.V.

Metabolism

Belgium, Germany, Czechia, Spain, Denmark, Italy, France

21/05/2026

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)

DrugRemibrutinib

Novartis Pharma AG

Immune System Diseases

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

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 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 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 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 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 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 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 II

A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F

2026-525213-31-00Esophageal squamous cell carcinoma

DrugIfinatamab Deruxtecan

Merck Sharp & Dohme LLC

Neoplasms

Czechia, Germany, France, Norway

12/05/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma

2025-521950-41-00severe uncontrolled asthma

DrugGB-0895

Generate Biomedicines Inc.

Respiratory Tract Diseases

Latvia, Hungary, Bulgaria, Romania, Portugal, Netherlands, Croatia, Germany, Greece, Czechia

12/05/2026

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 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

Bioequivalence study comparing two temazepam 20 mg tablet formulations after fasted administration; an open, randomized, single centre, single dose study with crossover design in healthy subjects

2025-524376-36-00short-term treatment of insomnia

Orion Corporation

Nervous System Diseases

Czechia

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 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 III

A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy

2024-519638-22-00IgA nephropathy

Novartis Pharma AG

Immune System Diseases

Belgium, France, Czechia, Croatia, Greece, Germany, Italy, Spain

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 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 two-part, seamless, multicenter, RANDOMIZED, open-label, ADAPTIVE Phase ii/III STUDY OF THE BLOOD-BRAIN barrier PENETRANT RO7771950 versus Tucatinib, both in combination with trastuzumab and capecitabine, in patients with Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without central nervous system metastases

2025-524498-17-00Pretreated Unresectable Locally Advanced or Metastatic huma…

F. Hoffmann-La Roche AG

Neoplasms

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

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 I

Safety of stem cells in treatmemt of retinal diseases.

2023-503573-38-00Retinal degenerative diseases

Bioinova a.s.

Eye Diseases

Czechia

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 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 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

A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

2025-522019-40-00relapsed or refractory BCR::ABL1-positive (Philadelphia pos…

DrugsAsciminib·Hydrocortisone·Blinatumomab·Cytarabine

Novartis Pharma AG

Neoplasms

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

27/04/2026

Phase I

Multiple-dose, open-label, laboratory blinded, randomized, 2-period, 2-sequence, crossover, steady-state bioequivalence study comparing the Test Product Naproxen sodium 660 mg modified release tablets with the Reference Product Actromadol 660 mg Modified-Release tablets in healthy adult male and female subjects under fed conditions.

2026-526102-33-00No medical condition

Laboratorios Cinfa S.A.

Not possible to specify

Czechia

24/04/2026

Phase III

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

2025-523659-73-00Obesity, Overweight

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Spain, Romania, Belgium, Czechia

21/04/2026

Phase I

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants with Active Sjogren’s Disease or Idiopathic Inflammatory Myopathy

2025-524100-29-00Seropositive autoimmune disease: Sjogren’s disease or idiop…

Lakefront Biotherapeutics West LLC

Immune System Diseases

Czechia

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 I

A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).

2024-520125-36-00Relapsed or Refractory Acute Myeloid Leukemia; Acute Myelo…

DrugPivekimab Sunirine

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Spain, Hungary, Czechia, France, Italy, Belgium

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

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 I/II

An open-label, multi-center, phase I/II study of GVV858 as a single agent and in combination with endocrine therapy in patients with advanced hormone receptor positive, HER2-negative breast cancer and other advanced solid tumors

2025-521911-38-00Advanced HR+/HER- breast cancer

DrugsLeuprorelin Acetate·Goserelin·Letrozole·Fulvestrant

Novartis Pharma AG

Neoplasms

Italy, Germany, France, Czechia, Denmark, Spain

16/04/2026

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 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 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 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 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

J3R-MC-YDAN - A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants with Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4) J3R-MC-YOA1: Intervention-Specific Appendix 1 (ISA1) for Eloralintide in Participants with Osteoarthritis Knee Pain J3R-MC-YOA2: Intervention-Specific Appendix 2 (ISA2) for Eloralintide in Participants with Osteoarthritis Knee Pain

2025-523768-19-00Osteoarthritis, Overweight or Obesity

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Denmark, Belgium, Germany, Czechia

02/04/2026

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 III

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (RUBENS trial)

2025-521936-12-00Adults with Type 2 Diabetes and/or Metabolic Syndrome on g…

NewAmsterdam Pharma B.V.

Cardiovascular Diseases

Czechia, Slovakia, Netherlands

31/03/2026

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 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-1901-304)

2025-523938-10-00Diabetic Macular Edema (DME)

Eyepoint Inc.

Eye Diseases

Hungary, Czechia, Germany

30/03/2026

Phase I

Bioequivalence study 2 to compare pharmacokinetics of Parkinson´s disease drugs in healthy volunteers

2026-525449-57-00Parkinson desease

Orion Corporation

Nervous System Diseases

Czechia

27/03/2026

Phase III

Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator’s Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

2025-520466-22-00Advanced Platinum-resistant Epithelial Ovarian Cancer

AstraZeneca AB

Pathological Conditions, Signs and Symptoms

Ireland, Greece, Czechia, France, Sweden, Belgium, Denmark, Spain, Italy, Germany

27/03/2026

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 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

Low-dose versus standard-dose anticoagulation with argatroban or enoxaparin during extracorporeal membrane oxygenation controlled by anti-IIa or anti-Xa assay

2025-524553-13-00lung and/or heart failure

DrugEnoxaparin

Fakultni Nemocnice Ostrava

Cardiovascular Diseases

Czechia

19/03/2026

Phase IV

Efficacy and safety of pharmacological therapy of obesity in liver transplant candidates

2026-526044-12-00Obesity

DrugTirzepatide

Institute For Clinical And Experimental Medicine

Digestive System Diseases

Czechia

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 II

Effect of faecal microbiota transplant on the expression of autism spectrum disorder core symptoms in children – open-label phase II clinical trial (FMT-PAS)

2025-524673-16-00Autism spectrum disorder

DrugFaecal microbiota transplantation

Masarykova Univerzita

Nervous System Diseases

Czechia

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

Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE)

2024-516896-34-00progressive/relapsed/refractory pediatric low-grade glioma …

DrugTovorafenib

Universitaetsklinikum Heidelberg AöR

Nervous System Diseases

Denmark, Czechia, Austria, Sweden, Germany

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 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 I

Bioequivalence Study of Empagliflozin

2026-525434-33-00Not applicable (submitted trial is a BE study in healthy pa…

Tarchominskie Zaklady Farmaceutyczne Polfa S.A.

Nutritional and Metabolic Diseases

Czechia

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

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

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 I

Randomized, open-label, laboratory-blinded, balanced, single dose, 3-treatment, 6-sequence, 3-period crossover comparative bioavailability study comparing Finerenone, 20 mg, film-coated tablets (Prototype 1, Prototype 2) and Kerendia, 20 mg, film-coated tablets under fasting conditions in healthy participants.

2026-525256-29-00Comparative bioavailability study under fasting conditions

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

Cardiovascular Diseases

Czechia

04/03/2026

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 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 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

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 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

A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients

2025-521521-33-00Kidney transplant rejection

DrugsFrexalimab·Tacrolimus

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

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

23/02/2026

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 I

A bioequivalence study comparing Empagliflozin 25 mg film-coated tablets, VIANEX S.A., Greece versus Jardiance 25 mg film-coated tablets, Boehringer Ingelheim International GmbH, Germany, in healthy male and female volunteers under fasting conditions.

2025-524910-28-00none - healthy volunteers

Vianex S.A.

Cardiovascular Diseases

Czechia

18/02/2026

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 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 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 I

Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the relative bioavailability of Test Product Naproxen sodium 660 mg modified release tablets to Reference Product Actromadol 660 mg Modified-Release tablets in healthy adult male and female subjects under fed conditions.

2025-521732-11-00No medical condition

Laboratorios Cinfa S.A.

Not possible to specify

Czechia

12/02/2026

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 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 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 Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants with Late Isolated Microvascular Inflammation (MVI)- (299AR201-TRANSPIRE)

2025-521742-15-00Treatment of Late Isolated Microvascular Inflammation in Re…

Biogen Idec Research Limited

Immune System Diseases

Germany, Austria, Spain, Czechia, France

09/02/2026

Phase IV

Caffeine Administration for Preterms: Pharmacokinetics, Utilization and Correlation Inhibiting Nociception Outcome

2025-523475-33-00Primary apnea in preterms newborns

Masarykova Univerzita

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Czechia

09/02/2026

Phase III

Prospective, multi-center, randomized, double-blinded, placebo-controlled phase IIb clinical trial to evaluate safety and efficacy of DUOFAG® in bacterial infection treatment in patients with complicated wounds

2025-522752-45-00Complicated skin wounds (wounds healing per secundam via gr…

MB PHARMA s.r.o.

Bacterial Infections and Mycoses

Czechia

09/02/2026

Phase I

The pilot bioavailability study comparing the absorption of carbetocin (which is used as prevention of heavy bleeding after childbirth) in PABAL 100 μg/mL Solution for Injection when administered sublingually in the dose of 500 μg and intramuscularly in the dose of 100 μg.

2025-524768-39-00Not applicable (submitted trial is a bioavalability study i…

Oxytone Bioscience B.V.

Female Urogenital Diseases and Pregnancy Complications

Czechia

09/02/2026

Phase I

Study to compare drug availability in the bloodstream of two oral formulations of dexketoprofen in healthy volunteers under fasting conditions.

2025-524061-24-01Bioequivalence clinical trial in healthy volunteers under f…

Faes Farma S.A.

Not possible to specify

Czechia

06/02/2026

Phase III

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

2025-522015-42-00Chronic Hepatitis D Infection

Mirum Pharmaceuticals Inc.

Virus Diseases

Czechia, Austria, Spain, Romania, Germany, Italy, France

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

2025-522960-34-00Hypertension, Established cardiovascular disease, High card…

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 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

29/01/2026

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

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 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 III

Phase 3 Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent and Adult Subjects with Homozygous Familial Hypercholesterolemia (YOSEMITE)

2025-521792-31-01Homozygous Familial Hypercholesterolemia (HoFH)

DrugZodasiran

Arrowhead Pharmaceuticals Inc.

Cardiovascular Diseases

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

23/01/2026

Phase II

A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Mirvetuximab Soravtansine in Subjects with Ovarian Cancer (FLORENZA)

2025-521606-18-00Ovarian Cancer

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Spain, Czechia, France, Belgium, Denmark

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

DrugsUstekinumab·Deucravacitinib

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 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 IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury (SERENIA)

2025-522232-13-00Sepsis-associated acute kidney injury (AKI)

DrugAZD4144

AstraZeneca AB

Not possible to specify

Germany, France, Spain, Italy, Belgium, Czechia, Greece, Denmark, Hungary

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 I

To evaluate the pharmacokinetics and safety of nolasiban

2025-523706-32-00not applicable (submitted trial is a pharmacokinetic study …

ReproNovo ApS

Female Urogenital Diseases and Pregnancy Complications

Czechia

09/01/2026

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 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

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 I

An open label, randomized, single-dose, two-treatment, two-period, cross-over bioequivalence study comparing Pyridostigmine Bromide, P.R.Tab, 180 mg/tab, VIANEX S.A., Greece versus Mestinon® retard 180 mg/prolonged-release tablet, Viatris Healthcare GmbH, Germany, in healthy male and female volunteers under fed conditions.

2025-524218-27-00treatment of myasthenia gravis

Vianex S.A.

Musculoskeletal Diseases

Czechia

19/12/2025

Phase III

IZABRIGHT-BLADDER01: A Randomized, Open-label, Phase 2/3 trial of Izalontamab Brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment

2025-522400-24-00Metastatic urothelial cancer

Bristol-Myers Squibb Services Unlimited Company

Female Urogenital Diseases and Pregnancy Complications

Ireland, Belgium, Germany, Italy, Norway, Spain, Austria, Sweden, France, Romania, Czechia

19/12/2025

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 III

A Phase 2b/3 Adaptive, Randomized, Active controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy

2025-521661-27-00Primary Membranous Nephropathy

Vertex Pharmaceuticals Inc.

Immune System Diseases

Hungary, Ireland, Czechia, Italy, Spain, Germany, Netherlands

12/12/2025

Phase III

AALL2131/EsPhALL2022, An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitor with Blinatumomab in Patients with Newly Diagnosed Philadelphia Chromosome Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

2025-520982-39-00Philadelphia Chromosome Positive or ABL-class Philadelphia …

Universita Degli Studi Di Milano Bicocca

Neoplasms

France, Lithuania, Norway, Finland, Spain, Italy, Czechia, Germany, Hungary, Slovakia, Denmark, Austria, Netherlands

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 I

2025-524035-39-00Bioavailability study in healthy volunteers under fasting c…

Laboratorios Cinfa S.A.

Not possible to specify

Czechia

09/12/2025

Phase III

CLEOPATTRA: Effects of NNC6019-0001 versus placebo on cardiovascular outcomes in participants with transthyretin amyloid cardiomyopathy (ATTR-CM).

2024-518899-31-00Variant or wild-type transthyretin (TTR) amyloid cardiomyop…

Novo Nordisk A/S

Cardiovascular Diseases

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

09/12/2025

Phase III

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 - A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group - IntReALL BCP 2020

2023-509392-17-00Relapsed Acute Lymphoblastic Leukemia (ALL)

DrugsIdarubicin·Inotuzumab Ozogamicin·Pegaspargase·Mercaptopurine

Charite Universitaetsmedizin Berlin KöR

Hemic and Lymphatic Diseases

Netherlands, Czechia, Italy, Spain, Denmark, Austria, Norway, Sweden, Germany, France, Finland, Slovenia

09/12/2025

Phase II

Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)

2024-518231-11-00Immune thrombocytopenia (ITP) Warm autoimmune hemolytic an…

Novartis Pharma AG

Hemic and Lymphatic Diseases

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

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 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 III

A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

2024-512298-28-00Neovascular age-related macular degeneration

AbbVie Deutschland GmbH & Co. KG

Eye Diseases

Czechia, Portugal, Hungary, Spain, Belgium, Italy, Austria, France, Slovakia, Croatia, Germany, Bulgaria, Greece

02/12/2025

Phase II

C5001004 - A Phase 2, Open-Label Extension Study to Investigate the Safety and Efficacy of PF-07868489 Administered to Adult Participants With Pulmonary Arterial Hypertension

2025-521155-23-00Pulmonary Arterial Hypertension

Pfizer Inc.

Cardiovascular Diseases

Italy, Czechia, Germany, Greece, Spain, Belgium, France

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 I

2025-524217-89-00treatment of myasthenia gravis

Vianex S.A.

Musculoskeletal Diseases

Czechia

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 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

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 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

2024-520417-41-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Czechia, Greece, Latvia, Austria, Germany, Bulgaria, Romania, Italy

24/11/2025

Phase I

A Study of an IDH1m Inhibitor in Participants with IDH1-Mutated Malignancies and Hepatic or Renal Impairment

2024-517923-38-00Newly diagnosed and/or previously treated IDH1-mutated mali…

Institut De Recherches Internationales Servier IRIS

Neoplasms

Czechia, Spain

24/11/2025

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

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

Phase III

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)

2024-518777-34-00B7-H4-Selected Advanced/Metastatic Endometrial Cancer.

DrugsDoxorubicin·Paclitaxel

AstraZeneca AB

Neoplasms

Italy, Netherlands, Lithuania, Finland, Greece, Austria, Belgium, Hungary, Spain, Poland, Czechia, Germany, France, Denmark, Slovenia

17/11/2025

Phase III

Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.

2025-522052-13-00Framework for Optimizing, Refining, and Unifying Management…

DrugsTreosulfan·Thiotepa·Busulfan·Blinatumomab

Ospedale Pediatrico Bambino Gesu

Hemic and Lymphatic Diseases

Germany, Denmark, Finland, Norway, Austria, Italy, Poland, France, Czechia, Belgium, Croatia, Hungary, Lithuania, Sweden, Netherlands, Slovakia

17/11/2025

Phase III

A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor

2025-523083-21-00PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Gr…

Relay Therapeutics Inc.

Neoplasms

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

11/11/2025

Phase II

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

2025-521242-26-00Moderately to Severely Active Ulcerative Colitis

DrugsSPYPBO-101·SPY001·SPY002·SPY003

Spyre Therapeutics Inc.

Digestive System Diseases

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

10/11/2025

Phase III

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

2024-517136-21-00Renal Cell Carcinoma

Merck Sharp & Dohme LLC

Neoplasms

Greece, Germany, France, Italy, Croatia, Denmark, Czechia, Austria, Belgium, Ireland, Spain, Poland

10/11/2025

Phase III

A Phase 3, Multi-center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

2025-522862-58-00Locally advanced unresectable or metastatic gastric or gast…

BeOne Medicines AG

Neoplasms

Spain, France, Austria, Italy, Poland, Czechia

10/11/2025

Phase II

A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults with Major Depressive Disorder, With or Without Anxious Distress

2025-522347-18-00Major Depressive Disorder (MDD), with or without Anxious Di…

Seaport Therapeutics Inc.

Mental Disorders

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

06/11/2025

Phase III

A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults with Chronic Primary Immune Thrombocytopenia

2025-521692-31-00Chronic Primary Immune Thrombocytopenia

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

Bulgaria, Spain, Netherlands, Italy, Poland, Greece, Germany, France, Czechia, Croatia, Norway, Sweden

04/11/2025

Phase III

EORTC-2427-BTG: Vorasidenib as maintenance treatment after first-line chemoradiotherapy in IDH-mutant grade 2 or 3 astrocytoma: a placebo-controlled, triple-blind, randomized phase III study (VIGOR)

2024-519404-27-00IDH-mutant grade 2 or 3 astrocytoma

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Neoplasms

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

04/11/2025

Phase I/II

(22931) A first-in-human study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary clinical activity of BAY 3713372, a novel 2nd generation PRMT5 inhibitor, in participants with MTAP-deleted solid tumors.

2025-520623-24-00MTAP-deleted Solid Tumors

Bayer AG

Neoplasms

Belgium, Sweden, Denmark, Italy, Spain, Netherlands, Czechia

04/11/2025

Phase III

A Phase 3, Double-Blind, Randomized, Two-Period, Multicenter, Placebo-Controlled, Efficacy and Safety Study of JNT-517 for the Treatment of Participants with Phenylketonuria

2024-519554-37-00Phenylketonuria

Otsuka Pharmaceutical Development & Commercialization Inc.

Nervous System Diseases

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

03/11/2025

Phase III

A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

2025-521711-39-00Lewy body Dementia psychosis (LBDP)

Acadia Pharmaceuticals Inc.

Nervous System Diseases

Czechia, Italy, France, Bulgaria

03/11/2025

Phase I/II

A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP inhibitor (PARPi) niraparib in adult participants with solid tumors.

2024-520197-36-00Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

Estonia, Czechia, Spain, Romania, Italy, Denmark, Belgium, Greece

03/11/2025

Phase II

A Phase 2, Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Atopic Dermatitis (COMPASS 2-AD)

2025-521624-30-00Atopic dermatitis

Bluefin Biomedicine Inc.

Immune System Diseases

Poland, Bulgaria, Germany, Czechia, Spain

31/10/2025

Phase III

Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity and type 2 diabetes

2024-519531-41-00Overweight and obesity

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Czechia, Romania, Croatia, Slovakia, Hungary

29/10/2025

Phase II

A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults with Lewy Body Dementia Psychosis (LBDP)

2025-521710-25-00Lewy Body Dementia Psychosis (LBDP)

Acadia Pharmaceuticals Inc.

Nervous System Diseases

Bulgaria, Czechia, Italy, France

29/10/2025

Phase II

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

2024-519820-26-00Hallucinations and Delusions Associated with Alzheimer’s Di…

Maplight Therapeutics Inc.

Nervous System Diseases

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

27/10/2025

Phase III

A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2- expressing recurrent endometrial cancer

2023-507525-42-00Endometrial cancer

BioNTech SE

Female Urogenital Diseases and Pregnancy Complications

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

27/10/2025

Phase III

A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination with Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants with Homozygous MTAP Deletion.

2025-521511-40-00metastatic non-small cell lung cancer

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

24/10/2025

Phase III

STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

2025-521352-38-00Hereditary Angioedema

Adarx Pharmaceuticals Inc.

Immune System Diseases

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

22/10/2025

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-2)

2025-520612-34-00Agitation Associated with Alzheimer’s Disease

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Poland, Hungary, Italy, France, Czechia

22/10/2025

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia

2024-514401-54-00Chronic Primary Immune Thrombocytopenia

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

Poland, Spain, Bulgaria, Italy, Netherlands, Croatia, Germany, Sweden, Greece, Czechia, Norway, France

22/10/2025

Phase II

A Phase IIb Randomized, Double-blind, Placebo-controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1a (Cromolyn) as an Adjuvant Treatment in Subjects with Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)

2025-520688-42-00Amyotrophic Lateral Sclerosis (ALS)

Phenonet Inc.

Nervous System Diseases

Germany, Czechia, Poland, Spain

21/10/2025

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 1)

2025-520746-30-00Mild to moderate Alzheimer’s Disease

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Germany, Croatia, Italy, Poland, Romania, Czechia, Greece, Spain, France, Netherlands

21/10/2025

Phase II

A Phase 2, Multicenter, Randomized, Double blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants with Colorectal Cancer who have Cancer Cachexia (SAPPHIRE)

2025-521730-28-00Colorectal Cancer with Cancer Cachexia

Ngm Biopharmaceuticals Inc.

Nutritional and Metabolic Diseases

Czechia, Slovakia, Poland, Hungary, Bulgaria

21/10/2025

Phase III

CN012-0025: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)

2024-519994-20-00Agitation Associated with Alzheimer’s Disease

DrugsKarX-EC·KarXT

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Croatia, Romania, France, Spain, Italy, Greece, Czechia, Bulgaria, Poland, Portugal, Hungary

21/10/2025

Phase III

Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study

2024-518824-56-00Complete to incomplete (AIS A-C) sub-acute cervical or thor…

Fakultni Nemocnice V Motole

Musculoskeletal Diseases

Czechia

20/10/2025

Phase III

C4551002 - An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Adult Participants with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

2025-520566-22-00Hormone Receptor-Positive, HER2-Negative Advanced/Metastati…

Pfizer Inc.

Neoplasms

Hungary, Bulgaria, Czechia, Slovakia, Netherlands, Spain, Greece, Finland, Belgium, Sweden, Poland, Germany, France, Italy

20/10/2025

Phase II

A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD)

2025-522001-38-00Crohn’s Disease, Ulcerative Colitis

DrugMT-201

Mirador Therapeutics Inc.

Digestive System Diseases

Poland, Bulgaria, Croatia, Germany, Belgium, Slovakia, Czechia, Italy

20/10/2025

Phase III

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

2024-515979-35-00Generalized Myasthenia Gravis

Immunovant Sciences GmbH

Nervous System Diseases

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

20/10/2025

Phase II

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

2025-521920-31-00Graves’ Disease

Immunovant Sciences GmbH

Immune System Diseases

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

17/10/2025

Phase III

A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed During or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment. TROPION-Urothelial03 (TU03).

2024-516906-47-00Locally Advanced or Metastatic Urothelial Carcinoma

DrugsDato-DXd·Cisplatin·Carboplatin

Daiichi Sankyo Inc.

Neoplasms

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

15/10/2025

Phase III

B7981027 - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

2024-515438-33-00Alopecia areata

Pfizer Inc.

Immune System Diseases

Spain, France, Czechia, Italy, Poland

14/10/2025

Phase III

TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)

2024-519917-72-00Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloid…

Alnylam Pharmaceuticals Inc.

Cardiovascular Diseases

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

14/10/2025

Phase III

B7981028 - A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

2024-515439-31-00Alopecia areata

Pfizer Inc.

Immune System Diseases

Italy, France, Czechia, Poland, Spain

14/10/2025

Phase III

J2O-MC-EKBG: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event - MOVE-Lp(a)

2025-521067-13-00Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASC…

Eli Lilly & Co.

Cardiovascular Diseases

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

13/10/2025

Phase I

The pivotal bioequivalence study comparing the test product to the reference product, which belongs to the group of medicines used in treatment of schizophrenia in adults patients.

2025-523325-18-00Bioequivalence study under fasting conditions

Adamed Pharma S.A.

Mental Disorders

Czechia

13/10/2025

Phase I

Open-label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, study to assess the bioequivalence between the test product Betahistine dihydrochloride 24 mg tablets from Esperante Development BV and reference product Betaserc® 24 mg tablets.

2025-522971-27-00Bioequivalence study under fasting conditions

Esperante Development B.V.

Otorhinolaryngologic Diseases

Czechia

08/10/2025

Phase II

C4921003 - A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Oral Branched-Chain Ketoacid Dehydrogenase Kinase Inhibitor, PF-07328948 in Adults with Heart Failure (BRANCH-HF)

2024-518438-94-00Heart failure

Pfizer Inc.

Cardiovascular Diseases

France, Spain, Bulgaria, Poland, Hungary, Czechia

08/10/2025

Phase III

A multi-center, open-label, single-arm study to evaluate the efficacy and safety of oral rilzabrutinib in adults with immune thrombocytopenia (ITP) who failed first-line treatment

2025-522070-36-00immune thrombocytopenia (ITP)

DrugRilzabrutinib

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

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

07/10/2025

Phase III

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (FORTIFI-HN01).

2024-519654-37-00Recurrent or Metastatic Head and Neck Squamous Cell Carcino…

Bicara Therapeutics Inc.

Neoplasms

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

06/10/2025

Phase III

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impactof Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)

2024-516652-18-00Atherosclerotic cardiovascular disease (ASCVD) and obesity …

Amgen Inc.

Cardiovascular Diseases

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

06/10/2025

Phase II

A Phase 1b/2 Open-Label, Multicenter Study of Zoldonrasib (RMC-9805) with or without Daraxonrasib (RMC-6236), in Combination with Other Anticancer Agents, in Patients with RAS G12D-Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol C

2025-521147-21-00Lung Cancer

DrugsRMC-9805·Cetuximab·Pemetrexed·Cisplatin

Revolution Medicines Inc.

Respiratory Tract Diseases

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

06/10/2025

Phase II

A Phase IIb, Multicenter, Double-Blind, Placebo-Controlled Induction Study with an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients with Moderately to Severely Active Ulcerative Colitis

2025-520690-39-00Moderately to Severely Active Ulcerative Colitis (UC)

Genentech Inc.

Digestive System Diseases

France, Italy, Czechia, Poland, Germany

03/10/2025

Phase II

A Randomized Double-Blind Placebo-Controlled Cross-Over Trial of the Safety, Tolerability, and Efficacy of PN6047 HCl in Peripheral Neuropathic Pain Characterized by Mechanical Allodynia

2024-517304-12-00Mechanical allodynia

Pharmnovo AB

Nervous System Diseases

Spain, Czechia, Poland

30/09/2025

Phase II

A randomised, double-masked, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of oral BI 1815368 in participants with centre-involved diabetic macular edema for 48 weeks of treatment (THULITE)

2024-520384-14-00Centre-involved diabetic macular edema

Boehringer Ingelheim International GmbH

Eye Diseases

Germany, Slovakia, Poland, Hungary, Czechia

30/09/2025

Phase III

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

2024-517131-52-00Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymp…

BeOne Medicines AG

Neoplasms

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

26/09/2025

Phase III

EASi-PROTKT™ - A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease

2025-521188-11-00cardiovascular disease, hypertension, Type 2 diabetes

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

Cardiovascular Diseases

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

24/09/2025

Phase II

A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis

2024-520117-50-00Atopic Dermatitis

Inmagene LLC

Immune System Diseases

Czechia, Spain, Germany, Hungary, Poland

24/09/2025

Phase III

Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)

2024-518206-40-00Severe hypertriglyceridemia (SHTG)

Arrowhead Pharmaceuticals Inc.

Nutritional and Metabolic Diseases

Hungary, Bulgaria, Sweden, Austria, Norway, Belgium, Croatia, Czechia, Latvia, Lithuania, Spain, Slovakia

23/09/2025

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy (299IG301 / PREVAIL)

2024-519345-30-00IgA nephropathy

Biogen Idec Research Limited

Immune System Diseases

Greece, Portugal, Spain, Croatia, Czechia, Belgium, Bulgaria, Germany, Italy, Poland, France

23/09/2025

Phase II

A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis

2024-519081-49-00Moderate to severe atopic dermatitis

Novartis Pharma AG

Skin and Connective Tissue Diseases

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

22/09/2025

Phase II

A Phase 2, Open-Label, Multicenter Study of Zoldonrasib(RMC-9805) in Previously Treated Patients with RAS G12DMutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D

2025-521681-10-00Lung Cancer

Revolution Medicines Inc.

Respiratory Tract Diseases

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

22/09/2025

Phase III

A Double-blind, Randomized,Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)

2025-520554-11-00Cardiovascular Disease

Amgen Inc.

Cardiovascular Diseases

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

22/09/2025

Phase II

A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)

2024-520155-24-00Metastatic castration resistant prostate cancer (mCRPC)

Novartis Pharma AG

Neoplasms

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

17/09/2025

Phase III

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants with Primary IgA Nephropathy in Combination with Stable Background Therapy

2025-520825-19-00IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also k…

Takeda Development Center Americas Inc.

Immune System Diseases

Spain, Czechia, Austria, Hungary, Germany, Norway, Slovenia, France, Sweden, Netherlands, Poland, Italy

16/09/2025

Phase II

A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderately to Severely Active Rheumatoid Arthritis.

2025-520721-21-00Rheumatoid Arthritis

AbbVie Deutschland GmbH & Co. KG

Immune System Diseases

Germany, Czechia, Hungary, Spain, Poland, Slovakia

12/09/2025

Phase I

An open-label, randomized, single-dose, two-period, two-treatment, crossover bioequivalence study with GP-IMP-001 in healthy male volunteers under fasting conditions.

2025-522921-37-00inteneded for treatment of - active rheumatoid arthritis in…

Gebro Pharma GmbH

Skin and Connective Tissue Diseases

Czechia

11/09/2025

Phase I

Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the comparative bioavailability of Test Product Dapagliflozin/metformin hydrochloride 5 mg/1000 mg film-coated tablets to Reference Product Xigduo 5 mg/1000 mg film-coated tablets in healthy adult male and female subjects under fed conditions.

2025-522254-39-00Bioavailability study in healthy volunteers under fed condi…

Laboratorios Cinfa S.A.

Not possible to specify

Czechia

10/09/2025

Phase I

Single-center, single-dose, open-label, laboratory-blinded, randomized, two-treatment, two-period bioequivalence (BE) study comparing the Test Product Apixaban 5 mg film-coated tablets (MEDITOP) with the Reference Product Eliquis 5 mg film-coated tablets (Bristol-Myers Squibb/Pfizer) under fasting conditions.

2025-523137-25-00Comparative bioequivalence study in healthy volunteers unde…

MEDITOP Gyogyszeripari Kft.

Cardiovascular Diseases

Czechia

10/09/2025

Phase II

A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

2025-520488-42-00Moderate-to-Severe Chronic Obstructive Pulmonary Disease (C…

Upstream Bio Inc.

Respiratory Tract Diseases

Romania, Lithuania, Hungary, Spain, Bulgaria, Ireland, Germany, Latvia, Czechia, Poland, Slovakia

09/09/2025

Phase I

A randomised, open label, three periods, three-treatment crossover study to evaluate the pharmacokinetics of alendronic acid oral formulations after single dose administration in healthy volunteers under fasted conditions: a pilot study

2025-522606-20-00Pharmacokinetic study in healthy volunteers under fasted co…

Faes Farma S.A.

Musculoskeletal Diseases

Czechia

08/09/2025

Phase I

The pivotal bioequivalence study comparing the test product to the reference product, which belong to the group of medicines used in the treatment of type 2 diabetes mellitus when the condition cannot be adequately controlled by diet and exercise alone.

2025-522975-27-00Not applicable (submitted trial is a BE study in healthy su…

Adamed Pharma S.A.

Nutritional and Metabolic Diseases

Czechia

08/09/2025

Phase II

A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of three doses of orally administered BMS-986368, a FAAH/MAGL Inhibitor, for the treatment of Spasticity in Participants with Multiple Sclerosis (BALANCE-MSS-1)

2024-517745-14-00Multiple Sclerosis Spasticity

Celgene Corp.

Immune System Diseases

Germany, Czechia, Poland

08/09/2025

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease

2024-518296-56-00Crohn’s Disease

DrugTulisokibart

Merck Sharp & Dohme LLC

Digestive System Diseases

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

03/09/2025

Phase III

A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants with Major Depressive Disorder (EXTEND)

2024-516805-22-00Major Depressive Disorder

DrugCYB003

Cybin IRL Limited

Mental Disorders

Greece, Poland, Ireland, Germany, Czechia

02/09/2025

Phase III

A Randomized, Open-Label, Controlled Phase 3 Study Comparing Daratumumab, Lenalidomide and Dexamethasone Induction followed by Linvoseltamab Versus continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

2024-519827-16-00Newly Diagnosed Transplant Ineligible Multiple Myeloma Pati…

European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale

Neoplasms

Norway, Denmark, Spain, Sweden, Austria, Netherlands, Greece, Germany, Italy, Belgium, Portugal, Estonia, Croatia, Ireland, Czechia, Finland

01/09/2025

Phase III

A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial with extension period to evaluate the efficacy and safety of Xeomin® injections for the prevention of chronic migraine (MINT-C)

2024-515682-34-00Chronic migraine

Merz Therapeutics GmbH

Nervous System Diseases

Spain, Denmark, France, Germany, Slovakia, Austria, Italy, Poland, Czechia

01/09/2025

Phase III

A phase 3, randomised, multi-center, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with high-grade Bacillus Calmette-Guerin therapy (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC)

2024-512177-27-01High-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-m…

Ferring Pharmaceuticals A/S

Male Urogenital Diseases

Spain, Denmark, Poland, Czechia, France

01/09/2025

Phase III

2024-515715-22-00Episodic migraine

Merz Therapeutics GmbH

Nervous System Diseases

Italy, Austria, Poland, Germany, France, Spain, Slovakia, Denmark, Czechia

01/09/2025

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 moderate to severe hidradenitis suppurativa

2025-520564-17-00Hidradenitis suppurativa (HS)

MoonLake Immunotherapeutics AG

Skin and Connective Tissue Diseases

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

29/08/2025

Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 6 October 2026. https://priyalifescience.com/clinical-trials-europe/country/czechia

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Clinical Trials in Czechia, 2026

Trials with a site in Czechia

About this register

How many recently authorised EU trials have a site in Czechia?

Summary by phase

Most active sponsors

Phase	Trials	Share
Phase III	206	60.6%
Phase II	78	22.9%
Phase I	42	12.4%
Phase I/II	9	2.6%
Phase IV	5	1.5%