Clinical Trials in Hungary, 2026

Trials with a site in Hungary

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase III

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

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

DrugOlatorepatide

Regeneron Pharmaceuticals Inc.

Nutritional and Metabolic Diseases

Poland, Hungary, Germany, Spain

29/09/2026

Phase III

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

2026-525265-48-00Pulmonary Arterial Hypertension

DrugTreprostinil Palmitil

Insmed Inc.

Respiratory Tract Diseases

Germany, Hungary, Belgium, France, Italy, Sweden, Austria, Lithuania, Greece

29/09/2026

Phase III

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

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

DrugsCenvacibart·Apixaban

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

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

29/09/2026

Phase III

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

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

DrugsAmrecibart·Cenvacibart

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

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

29/09/2026

Phase II

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

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

Expedition Therapeutics Inc.

Respiratory Tract Diseases

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

29/09/2026

Phase III

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

2025-522954-37-00Peripheral Artery Disease

DrugsAmrecibart·Cenvacibart·Rivaroxaban

Regeneron Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

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

29/09/2026

Phase III

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

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

DrugDanicamtiv

Kardigan Inc.

Cardiovascular Diseases

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

28/09/2026

Phase III

A Phase 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 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 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, 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 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 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 III

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

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

DrugsSiltuximab·Tarlatamab

Amgen Inc.

Neoplasms

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

08/09/2026

Phase II

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

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

Argenx

Immune System Diseases

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

08/09/2026

Phase III

EFC18362 - A Phase 3, multicenter, multinational, randomized, open-label, active-comparator study to evaluate the efficacy and safety of venglustat compared with Cerezyme in pediatric participants 2 to 11 years of age with Gaucher disease type 3 who have reached therapeutic goals with enzyme replacement therapy

2026-525374-19-00Immune system diseases

DrugImiglucerase

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

Hungary, Italy, France, Finland, Germany, Spain

08/09/2026

Phase I

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

2026-526171-32-00Systemic Lupus Erythematosus

AstraZeneca AB

Immune System Diseases

Poland, Hungary

07/09/2026

Phase I

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

2026-525215-13-00Advanced Solid Tumors

F. Hoffmann-La Roche AG

Neoplasms

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

07/09/2026

Phase 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

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

2025-524748-37-00Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

DrugCenegermin

Dompe' Farmaceutici S.p.A.

Eye Diseases

Denmark, Italy, Germany, Hungary, Netherlands, Spain, Belgium, France, Portugal

01/09/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo‑controlled Study to Assess the Efficacy and Safety of Engasertib in Subjects With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)

2025-524490-17-00Hereditary Hemorrhagic Telangiectasia (HHT)

DrugEngasertib

Vaderis Therapeutics AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Hungary, Netherlands, Germany, Bulgaria, France, Italy, Lithuania, Spain, Belgium

31/08/2026

Phase III

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

2025-523857-32-00Spinal Muscular Atrophy

DrugSalanersen

Biogen Idec Research Limited

Nervous System Diseases

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

31/08/2026

Phase II

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

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

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Spain, Hungary, Romania, Slovakia, Poland, Germany

31/08/2026

Phase III

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

2025-524757-14-00Ocular Myasthenia Gravis

DrugRozanolixizumab

UCB Biopharma

Immune System Diseases

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

25/08/2026

Phase II

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

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

Apollo Therapeutics Limited

Skin and Connective Tissue Diseases

Hungary, Czechia, Germany, Bulgaria, Poland, Spain

25/08/2026

Phase II

Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

2025-524793-42-00Relapsed/Refractory Multiple Myeloma

Janssen Cilag International

Neoplasms

Sweden, Spain, Greece, Portugal, France, Hungary

25/08/2026

Phase II

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

2025-524905-34-00Solid tumor

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

25/08/2026

Phase III

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

2025-524669-25-00Polycythemia Vera

Deciphera Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

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

21/08/2026

Phase III

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

2025-524934-24-00Neoplasms, Gastrointestinal Stromal

DrugImatinib

Glaxosmithkline Research & Development Limited

Neoplasms

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

21/08/2026

Phase I/II

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

2025-525036-34-00Solid Tumours

DrugsImlunestrant·Fulvestrant

Terremoto Biosciences Inc.

Neoplasms

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

18/08/2026

Phase III

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

2025-524756-54-00Ocular Myasthenia Gravis

DrugRozanolixizumab

UCB Biopharma

Immune System Diseases

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

18/08/2026

Phase III

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

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

Amgen Inc.

Eye Diseases

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

17/08/2026

Phase III

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

2025-523447-35-02Pneumoccoccal Immunisation

DrugPF-07872412

Pfizer Inc.

Bacterial Infections and Mycoses

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

17/08/2026

Phase III

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

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

DrugsBNT324·Prednisone·Docetaxel

BioNTech SE

Male Urogenital Diseases

Belgium, Spain, Italy, Poland, Germany, Hungary

17/08/2026

Phase 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

A study to test how BI 3034701 is taken up and processed by the body in healthy men with normal weight or overweight

2026-525825-19-00Healthy

Boehringer Ingelheim International GmbH

Not possible to specify

Hungary

14/08/2026

Phase II

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

2023-509125-41-00Severe asthma

DrugSalbutamol

Kinaset Therapeutics Inc.

Respiratory Tract Diseases

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

14/08/2026

Phase III

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP)

2026-525454-11-00Diagnosis of primary ITP according to the 2019 Internationa…

DrugsRomiplostim·Prednisolone

Amgen Inc.

Hemic and Lymphatic Diseases

Spain, Hungary, Germany

14/08/2026

Phase II

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

2025-523807-31-00Atrial fibrillation

Bayer AG

Cardiovascular Diseases

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

06/08/2026

Phase II

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

2025-525016-41-00Idiopathic Pulmonary Fibrosis

AstraZeneca AB

Respiratory Tract Diseases

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

04/08/2026

Phase III

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron 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 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 IV

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

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

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

Mental Disorders

Bulgaria, Poland, Hungary

29/07/2026

Phase III

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

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

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

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

2025-523933-24-00type 2 diabetes mellitus

AstraZeneca AB

Nutritional and Metabolic Diseases

Poland, Hungary, Italy, Bulgaria, Germany

22/07/2026

Phase III

A placebo-controlled comparability study to compare two presentations of cagrilintide for weight management in participants with overweight or obesity

2025-524249-29-00Participants with overweight or obesity

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Sweden, Greece, Hungary, Portugal

20/07/2026

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 I

Bioequivalence study of Vitamin D3 Pharma Patent 20,000 IU and the Vigantol 20,000 IU oral drops solutions and assessment of bioavailability in healthy volunteers

2026-526224-48-02Healthy volunteers

Pharma Patent Kft.

Not possible to specify

Hungary

17/07/2026

Phase I

A Phase 1, Randomized, Placebo-Controlled, Multiple-Dose, Dose-Ranging Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTX611 in Healthy Adult Participants

2026-526708-56-00Thromboembolic disorders

CRISPR Therapeutics AG

Cardiovascular Diseases

Hungary

10/07/2026

Phase III

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

2024-518016-39-00Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

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

06/07/2026

Phase 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 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 III

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

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

DrugAdmilparant

Bristol-Myers Squibb Services Unlimited Company

Respiratory Tract Diseases

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

17/06/2026

Phase III

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

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

AstraZeneca AB

Neoplasms

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

16/06/2026

Phase III

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

2025-522643-18-00Stage I NSCLC

DrugsPembrolizumab Formulated with Berahyaluronidase Alfa·Intismeran autogene

Merck Sharp & Dohme LLC

Neoplasms

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

16/06/2026

Phase II

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

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

DrugsSPYPBO-101·SPY001·SPY002·SPY003

Spyre Therapeutics Inc.

Digestive System Diseases

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

16/06/2026

Phase III

A 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 II

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

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

DrugMirikizumab

Eli Lilly & Co.

Digestive System Diseases

Italy, Germany, Hungary, Poland, Belgium

11/06/2026

Phase II

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

2025-524404-29-00Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC),…

Eli Lilly & Co.

Digestive System Diseases

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

10/06/2026

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

2025-522434-32-00Hemophilia A Without Inhibitors

F. Hoffmann-La Roche AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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

01/06/2026

Phase III

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

2022-502365-26-00Asthma

DrugSalbutamol

Novartis Pharma AG

Respiratory Tract Diseases

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

01/06/2026

Phase III

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

2025-522435-33-00Hemophilia A

F. Hoffmann-La Roche AG

Hemic and Lymphatic Diseases

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

01/06/2026

Phase III

A 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 III

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

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

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

22/05/2026

Phase II

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

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

DrugPembrolizumab

Eikon Therapeutics Inc.

Neoplasms

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

21/05/2026

Phase 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 II

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

2025-521816-20-00Exocrine Pancreatic Insufficiency

DrugZenpep

Aimmune Nestle Health Science US R&D LLC

Nutritional and Metabolic Diseases

Poland, Hungary, Spain, Bulgaria, Italy

18/05/2026

Phase III

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

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

DrugOrelabrutinib

Zenas Biopharma (USA) LLC

Nervous System Diseases

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

18/05/2026

Phase II

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

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

Novartis Pharma AG

Neoplasms

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

18/05/2026

Phase 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

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

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

DrugSemaglutide

Novo Nordisk A/S

Nutritional and Metabolic Diseases

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

15/05/2026

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

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

F. Hoffmann-La Roche AG

Nutritional and Metabolic Diseases

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

13/05/2026

Phase III

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

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 II

A prospective, multinational, multicenter, randomized, sequential, double-blind, placebo-controlled, phase 2a clinical study to assess the safety and pharmacokinetics (PK) of OMN6 in hospital-acquired bacterial pneumonia (HABP) or ventilated-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

2025-524200-29-00Hospital-acquired bacterial pneumonia or ventilated-associa…

Omnix Medical Ltd.

Respiratory Tract Diseases

Italy, Hungary, Greece

06/05/2026

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

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

2024-520441-23-00Overweight or obesity, and type 2 diabetes

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Italy, Croatia, Hungary, Slovakia, Romania

04/05/2026

Phase II

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

2025-523488-39-00Systemic lupus erythematosus

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

Immune System Diseases

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

04/05/2026

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 III

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

2023-509176-42-00Obesity and T2D

DrugsCagrilintide·Semaglutide

Novo Nordisk A/S

Nutritional and Metabolic Diseases

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

28/04/2026

Phase III

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

2023-508047-40-00Ovarian cancer

Merck Sharp & Dohme LLC

Neoplasms

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

28/04/2026

Phase III

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

2025-522552-20-00Lennox-Gastaut Syndrome

Epygenix Therapeutics Inc.

Nervous System Diseases

Italy, Spain, Hungary, Romania, Czechia, Poland

28/04/2026

Phase II

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

2025-522076-85-00Rheumatoid arthritis

AstraZeneca AB

Immune System Diseases

Hungary, Spain, Bulgaria, Germany, Poland

22/04/2026

Phase II

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

2025-523260-20-00type 2 diabetes

DrugSemaglutide

Novo Nordisk A/S

Hormonal diseases

Spain, Hungary, Portugal, Poland, Slovakia, Croatia

21/04/2026

Phase 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

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

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

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

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

17/04/2026

Phase III

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

2025-523975-48-00Obesity

DrugBerobenatide

Metsera Inc.

Nutritional and Metabolic Diseases

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

16/04/2026

Phase III

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

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

Guerbet, Bracco Imaging S.p.A.

Cardiovascular Diseases

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

15/04/2026

Phase III

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

2025-523157-34-00Rett syndrome

UCB Biosciences Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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

15/04/2026

Phase I

A Single-Dose Pharmacokinetic Study of Eloralintide in Participants with Varying Degrees of Liver Impairment and Participants with Normal Liver Function

2025-523847-36-00Participants with Mild, Moderate, or Severe Hepatic Impairm…

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Hungary

14/04/2026

Phase II

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

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

DrugPegfilgrastim

Genmab A/S

Neoplasms

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

14/04/2026

Phase III

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

2025-521108-23-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

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

07/04/2026

Phase III

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

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

2025-523239-21-00Juvenile idiopathic arthritis

Alfasigma S.p.A.

Immune System Diseases

France, Germany, Poland, Belgium, Hungary

01/04/2026

Phase III

A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants with Diabetic Macular Edema (DME) (EYP-1901-304)

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

Eyepoint Inc.

Eye Diseases

Hungary, Czechia, Germany

30/03/2026

Phase II

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

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

Navigator Medicines Inc.

Skin and Connective Tissue Diseases

Hungary, Poland, Germany, Bulgaria, Romania

25/03/2026

Phase III

A Phase 3, 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

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

2025-522338-30-00Ulcerative Colitis

Eli Lilly & Co.

Digestive System Diseases

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

18/03/2026

Phase III

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

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

DrugDeucrictibant

Pharvaris Netherlands B.V.

Immune System Diseases

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

17/03/2026

Phase I/II

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

2025-523742-27-00Advanced solid tumors

Medilink Therapeutics (Suzhou) Co. Ltd.

Neoplasms

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

17/03/2026

Phase III

A 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 IV

The effect of Broncho-Vaxom on the COPD exacerbations in terms of lung function, lung mechanics, immune state, body composition, quality of life and physical activity.

2025-524501-32-02COPD exacerbation

Semmelweis University, University Of Pecs

Respiratory Tract Diseases

Hungary

13/03/2026

Phase III

An open label, pharmacokinetic and safety study of Combogesic® IV in pediatric patients with acute pain.

2025-524431-39-00Acute pain

Aft Pharmaceuticals Limited

Anesthesia and Analgesia

Hungary

12/03/2026

Phase III

TENACITY – A Phase III, prospective, randomized, open-label, blinded endpoint assessment (PROBE) to assess efficacy and safety of i.v. tenecteplase vs standard of care in patients with acute ischemic stroke (including wake-up stroke), last known well >4.5 h with imaging evidence of salvageable ischemic tissue

2025-522542-40-00Acute Ischemic Stroke

Boehringer Ingelheim International GmbH

Cardiovascular Diseases

Greece, Norway, Hungary, Romania, Spain, Bulgaria

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 II

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

2024-518013-25-00Idiopathic Pulmonary Fibrosis

AbbVie Deutschland GmbH & Co. KG

Respiratory Tract Diseases

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

10/03/2026

Phase 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/II

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

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

DrugsCalderasib·Patritumab deruxtecan·Sacituzumab tirumotecan·Cetuximab

Merck Sharp & Dohme LLC

Neoplasms

Italy, Germany, Greece, Poland, Hungary, Spain

04/03/2026

Phase III

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

2025-521546-23-00Secondary progressive multiple sclerosis

Novartis Pharma AG

Nervous System Diseases

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

03/03/2026

Phase II

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

2025-522896-27-00Asthma

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

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

02/03/2026

Phase II

A randomized, double-blind, placebo-controlled, Phase 2, dose-finding study to investigate the efficacy and safety of SAR445399 in participants with moderate to severe hidradenitis suppurativa

2025-522695-83-00Hidradenitis suppurativa

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

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

02/03/2026

Phase III

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

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

AstraZeneca AB

Neoplasms

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

26/02/2026

Phase 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 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

Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment with Romosozumab in Children and Adolescents with Osteogenesis Imperfecta

2023-503293-21-00Osteogenesis Imperfecta

DrugRomosozumab

Amgen Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Germany, Hungary, Italy, Belgium, Austria, Slovakia, Spain

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 II

Efficacy and safety of a combined therapy with Alpha-Lipoic Acid and Benfotiamine in the symptomatic treatment of diabetic sensorimotor polyneuropathy - a prospective, randomized, controlled, parallel group, double-blind, double-dummy 3-arm trial

2025-521985-82-00Diabetic sensorimotor polyneuropathy (DSPN)

Woerwag Pharma GmbH & Co. KG

Nutritional and Metabolic Diseases

Hungary

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 III

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

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

Novartis Pharma AG

Cardiovascular Diseases

Germany, Hungary, Poland, France, Spain

16/02/2026

Phase 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 II

A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above

2025-521416-19-00Recurrence of Clostridioides difficile Infection

AstraZeneca AB

Bacterial Infections and Mycoses

Greece, Spain, France, Germany, Italy, Hungary, Denmark, Sweden

16/02/2026

Phase III

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

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

Syndax Pharmaceuticals Inc.

Neoplasms

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

13/02/2026

Phase III

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

2025-521587-35-00Metastatic colorectal cancer

Summit Therapeutics Inc.

Neoplasms

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

12/02/2026

Phase 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 III

A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)

2025-522229-37-00Gastrointestinal Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

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

06/02/2026

Phase III

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 Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-DCM).

2025-522553-19-00Symptomatic genetic and familial dilated cardiomyopathy.

Kardigan Inc.

Cardiovascular Diseases

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

30/01/2026

Phase II

A Multi-Center, Double-Blind, Placebo-Controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, A Monoacylglycerol Lipase Inhibitor, as Add-On Therapy to Ocrelizumab, in Participants with Progressive Forms of Multiple Sclerosis

2025-521636-10-00Progressive Forms of Multiple Sclerosis (PMS)

F. Hoffmann-La Roche AG

Nervous System Diseases

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

28/01/2026

Phase III

A Phase 3 Randomized, Double-blind,Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-2)

2025-522699-94-00Moderate to severe obstructive sleep apnea (OSA) in adults …

Amgen Inc.

Respiratory Tract Diseases

Poland, Czechia, Germany, Hungary, France, Spain

27/01/2026

Phase III

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 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

An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX

2025-521858-42-00Hemophilia

DrugFitusiran

Sanofi-Aventis Recherche & Developpement

Hemic and Lymphatic Diseases

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

15/01/2026

Phase II

A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions)

2025-523058-16-00Skin Toxicities Associated with Epidermal Growth Factor Rec…

Hoth Therapeutics Inc.

Skin and Connective Tissue Diseases

Spain, Hungary, Poland

15/01/2026

Phase III

A Phase 3, Randomized, 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 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 IV

BudapestICIVasc: Cardiovascular side effects of immune checkpoint inhibitor oncological therapies and their monitoring in the context of onco-cardiology

2025-523620-44-02non small cell lung cancer (NSCLC), renal cell carcinoma, s…

Semmelweis University

Neoplasms

Hungary

14/01/2026

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

A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)

2025-522046-42-00Colonic disease

Norgine Limited

Digestive System Diseases

Poland, Netherlands, Hungary, Spain, Italy, Belgium, Germany, Croatia, Portugal

22/12/2025

Phase III

A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

2025-522105-38-00Chronic Hepatitis Delta Infection

Mirum Pharmaceuticals Inc.

Virus Diseases

Belgium, Hungary, Bulgaria

22/12/2025

Phase I/II

TulmiSTAR-02: A two-part Phase I dose escalation study of tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by open-label, randomized, Phase II dose expansion study to assess the safety and efficacy of tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer

2025-521873-15-00Metastatic hormone-sensitive prostate cancer

Novartis Pharma AG

Neoplasms

Hungary, Spain, Italy, Germany, France

18/12/2025

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 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 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 III

A phase 3, randomized, double-blind, placebo-controlled, multicenter study with open-label extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis

2024-520337-80-00Palmoplantar Pustulosis

UCB Biopharma

Immune System Diseases

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

02/12/2025

Phase III

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

2025-521382-27-00Moderately to Severely Active Crohn's Disease

Janssen Cilag International

Immune System Diseases

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

01/12/2025

Phase III

A Phase 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

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 II

A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis

2024-519335-42-01Systemic Sclerosis

Zura Bio Inc.

Immune System Diseases

Hungary, Romania, Poland, Spain

27/11/2025

Phase III

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

2024-514500-14-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …

Merck Sharp & Dohme LLC

Neoplasms

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

27/11/2025

Phase III

Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

2024-513911-28-00Acute Ischemic Stroke

Diamedica Therapeutics Inc.

Nervous System Diseases

Romania, Hungary, Belgium, Poland, Spain, France

25/11/2025

Phase III

Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

2024-515023-11-00Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear …

DrugsCasdatifan·Cabozantinib

Arcus Biosciences Inc.

Neoplasms

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

24/11/2025

Phase II

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity

2025-520831-18-00Primary Sjogren’s Disease

Immunovant Sciences GmbH

Immune System Diseases

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

24/11/2025

Phase III

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation.

2024-520418-22-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Slovakia, Denmark, France, Sweden, Ireland, Belgium, Netherlands, Spain, Croatia, Germany, Poland, Hungary, Norway, Portugal

24/11/2025

Phase II

A Phase 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

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)

2025-521349-25-00Macular neovascularization secondary to age-related macular…

4d Molecular Therapeutics Inc.

Eye Diseases

Germany, Italy, Hungary, Bulgaria, Lithuania, France, Spain, Latvia, Portugal

21/11/2025

Phase III

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults with Schizophrenia

2025-521216-19-00Schizophrenia, Schizophrenia

DrugNBI-1117568

Neurocrine Biosciences Inc.

Mental Disorders

Romania, Hungary, Bulgaria

21/11/2025

Phase III

A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior

2024-518615-19-00Major Depressive Disorder

DrugEsketamine

Janssen Cilag International

Mental Disorders

Italy, Hungary, Spain, Romania

19/11/2025

Phase I

Pharmacokinetics of NTRX-07 in fed and fasted participants

2025-523695-23-00Not applicable (trial is a pharmacokinetic study in healthy…

Neurotherapia Inc.

Nervous System Diseases

Hungary

19/11/2025

Phase III

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia

2025-521495-54-00Hyperlipidemia

Merck Sharp & Dohme LLC

Cardiovascular Diseases

Spain, Hungary

19/11/2025

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 Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)

2024-513586-39-00Prostate Cancer

AstraZeneca AB

Male Urogenital Diseases

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

12/11/2025

Phase II

A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization

2025-521325-33-00Chronic angina and left ventricular dysfunction due to coro…

Xylocor Therapeutics Inc.

Cardiovascular Diseases

Netherlands, Germany, Hungary, Poland

11/11/2025

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 Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults with Schizophrenia Who Warrant Inpatient Hospitalization

2025-521215-39-00Schizophrenia

Neurocrine Biosciences Inc.

Mental Disorders

Hungary, Romania, Bulgaria

07/11/2025

Phase III

A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY Kids)

2024-512577-27-00Chronic kidney disease in paediatric patients

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

Nutritional and Metabolic Diseases

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

06/11/2025

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 II

Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety (EXACT-2 Trial)

2024-514874-36-01Refractory angina due to obstructive coronary artery disease

Xylocor Therapeutics Inc.

Cardiovascular Diseases

Belgium, Poland, Hungary, Netherlands, Germany

04/11/2025

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 Phase 2b, Multi-center, Randomized, Double-blind, Placebo controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

2024-517614-14-00Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunovant Sciences GmbH

Immune System Diseases

Austria, Hungary, Slovenia, Greece, Denmark, Ireland, Finland, Estonia, Spain, Slovakia, Netherlands, Poland, Norway, Italy, Portugal, Belgium, Germany, Romania, Bulgaria

28/10/2025

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 IV

The Role of Beta-Blockade During Cardiac CT in Patients with Atrial Fibrillation

2025-523391-22-01Atrial fibrillation, Coronary artery disease

Semmelweis University

Cardiovascular Diseases

Hungary

22/10/2025

Phase IV

F-puff_SE_2024

2024-519131-42-02PAIN MANAGEMENT

DrugFentanyl

Semmelweis University

Not possible to specify

Hungary

22/10/2025

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 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

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB AND PEMBROLIZUMAB VERSUS PEMBROLIZUMAB AND PEMETREXED AND CARBOPLATIN OR CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED, KRAS G12C-MUTATED, ADVANCED OR METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

2024-518365-10-00Previously Untreated Advanced or Metastatic Non-Squamous No…

F. Hoffmann-La Roche AG

Neoplasms

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

21/10/2025

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 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

RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults with Focal Onset Seizures

2025-520587-18-00Focal Onset Seizures

DrugHuperzine A

Supernus Pharmaceuticals Inc.

Nervous System Diseases

Poland, Hungary, Bulgaria

20/10/2025

Phase I

A Study of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment

2025-521947-19-00Healthy, Hepatic Insufficiency

Eli Lilly & Co.

Digestive System Diseases

Slovakia, Hungary

17/10/2025

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

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 III

A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX).

2025-520478-20-00Thromboembolic disease

Regeneron Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Bulgaria, Lithuania, Poland, Hungary, Latvia, Romania

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 Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis

2023-506296-97-00Moderate to Severe Plaque Psoriasis

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

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

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 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 Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)

2025-521088-10-00Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL…

DrugBexobrutideg

Nurix Therapeutics Inc.

Neoplasms

France, Italy, Hungary, Poland

02/10/2025

Phase I

Phase 1b Study of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer (DeLLphi-310)

2024-515903-21-00Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Amgen Inc.

Neoplasms

France, Germany, Spain, Greece, Hungary, Italy

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 IV

A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease (AEOLUS)

2025-521268-37-00Respiratory tract diseases

DrugsSalbutamol·Dupilumab

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

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

29/09/2025

Phase III

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

2025-520582-51-00Hormone receptor positive breast cancer

Merck Sharp & Dohme LLC

Neoplasms

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

29/09/2025

Phase III

Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC)

2025-521627-78-00Neoplasms, Lung

Glaxosmithkline Research & Development Limited

Neoplasms

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

29/09/2025

Phase II

A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of SAR444336 in participants with microscopic colitis in clinical remission with budesonide.

2024-519495-83-00Digestive system diseases

Sanofi-Aventis Recherche & Developpement

Digestive System Diseases

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

29/09/2025

Phase II

A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination with Somatostatin Analogs in Adult Participants with Acromegaly

2025-521243-20-00Acromegaly

Alexion Pharmaceuticals Inc.

Hormonal diseases

Lithuania, Romania, Denmark, Italy, Hungary, Poland, Netherlands

29/09/2025

Phase II

Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.

2025-521377-14-00Atrial fibrillation

Acesion Pharma ApS

Cardiovascular Diseases

Hungary, Italy, Denmark, Bulgaria, Poland, Netherlands, Germany

29/09/2025

Phase II

A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis

2024-518821-13-00Non-cystic Fibrosis Bronchiectasis

CSL Behring LLC

Respiratory Tract Diseases

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

26/09/2025

Phase III

Changes in plaque characteristics after short-term statin therapy assessed with coronary CT

2025-522868-32-00Coronary Artery Disease, Cardiology, Statin Therapy, Corona…

Semmelweis University

Cardiovascular Diseases

Hungary

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 III

ARGX-113-2409: A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo- Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants from 12 Years to Less Than 18 Years of Age with Chronic ITP

2025-521055-23-00Chronic Idiopathic thrombocytopenic purpura

DrugEfgartigimod PH20

Argenx

Immune System Diseases

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

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 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 Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO).

2025-520473-40-00Moderate to Very Severe Chronic Obstructive Pulmonary Disea…

AstraZeneca AB

Respiratory Tract Diseases

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

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 III

INCB018424-316: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis

2024-518156-24-00Atopic Dermatitis

Incyte Corp.

Skin and Connective Tissue Diseases

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

18/09/2025

Phase III

A Multicenter, Open-label, Randomized Phase 3 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) vs Investigator Choice of Single-agent Chemotherapy as Third-line Treatment in Subjects with Advanced / Metastatic Non-Small Cell Lung Cancer (NSCLC)

2024-520164-33-00Non-Small Cell Lung Cancer

Maia Biotechnology Inc.

Neoplasms

Poland, Hungary, Romania, Spain, Portugal

18/09/2025

Phase III

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).

2024-517232-22-00KRAS G12C-mutant, Locally Advanced Unresectable or Metastat…

DrugsCalcium levofolinate·Calderasib·Calcium folinate·Fluorouracil

Merck Sharp & Dohme LLC

Neoplasms

Poland, Spain, Netherlands, Italy, Finland, Romania, France, Germany, Hungary

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 II

A phase 2, multi-center study consisting of a randomized, placebo-controlled period, followed by an open-label extension period to assess the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa

2024-519736-17-00Hidradenitis Suppurativa

Zura Bio Inc.

Immune System Diseases

Poland, Germany, Spain, Hungary

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 II

A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants with Type 2 Diabetes Mellitus

2024-520322-11-00Type 2 Diabetes Mellitus (T2D)

F. Hoffmann-La Roche AG

Nutritional and Metabolic Diseases

Poland, Spain, Hungary

05/09/2025

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 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

2024-520050-38-00Extensive stage small cell lung cancer (ES-SCLC). …

DrugsSiltuximab·Mycophenolate Mofetil·Tarlatamab·Infliximab

Amgen Inc.

Neoplasms

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

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/hungary

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Clinical Trials in Hungary, 2026

Trials with a site in Hungary

About this register

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

Summary by phase

Most active sponsors

Phase	Trials	Share
Phase III	173	64.6%
Phase II	72	26.9%
Phase I	11	4.1%
Phase I/II	6	2.2%
Phase IV	6	2.2%