Clinical Trials in Poland 2026 - 127 Recent EU Authorisations

Phase III Neoplasms Authorised 26/06/2026

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

Pancreatic Ductal Adenocarcinoma
Incyte Corp. · 205 participants

📍 Poland · Italy · Netherlands · Sweden · Denmark · Finland · Spain · France · Belgium · Norway · Austria

2025-525009-18-00 on CTIS ↗

Phase IV Hemic and Lymphatic Diseases Authorised 26/06/2026

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

Adult with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL)
Uniwersytet Medyczny W Lublinie · 36 participants

📍 Poland

2025-524795-35-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 24/06/2026

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

Multiple Sclerosis
F. Hoffmann-La Roche AG · 54 participants

📍 Spain · France · Poland · Italy

2025-523726-40-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 23/06/2026

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

Non-cystic fibrosis bronchiectasis
Sanofi-Aventis Recherche & Developpement · 41 participants

📍 Poland · Spain · France · Netherlands · Germany

2025-523403-29-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 23/06/2026

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

Small for gestational age (SGA) and idiopathic short stature (ISS)
Schneider Children's Medical Center Of Israel · 95 participants

📍 Greece · Poland · France · Czechia

2025-523832-38-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 23/06/2026

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

Relapsing-Remitting Multiple Sclerosis (RRMS)
F. Hoffmann-La Roche AG · 9 participants

📍 Poland · Germany · France

2025-524164-37-00 on CTIS ↗

Phase III Immune System Diseases Authorised 22/06/2026

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

Hereditary Angioedema
Adarx Pharmaceuticals Inc. · 45 participants

📍 Poland · Italy · Hungary · France · Austria · Czechia · Belgium · Spain · Bulgaria · Germany · Croatia

2025-521353-16-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 22/06/2026

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

Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC · 467 participants

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

2025-524322-18-00 on CTIS ↗

Phase II Neoplasms Authorised 22/06/2026

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

Muscle-invasive Bladder Cancer
Astellas Pharma Global Development Inc. · 88 participants

📍 Germany · France · Poland · Italy · Spain

2025-524488-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 22/06/2026

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

Colitis ulcerative
Merck Sharp & Dohme LLC · 44 participants

📍 Italy · Greece · Netherlands · Poland · Germany · France

2025-523479-49-00 on CTIS ↗

Phase I Skin and Connective Tissue Diseases Authorised 18/06/2026

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

Atopic Dermatitis
Pfizer Inc. · 19 participants

📍 Poland

2025-524150-34-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 17/06/2026

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

Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis
Bristol-Myers Squibb Services Unlimited Company · 318 participants

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

2025-522373-10-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 17/06/2026

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

Systemic sclerosis
Galderma S.A. · 56 participants

📍 Poland · Italy · Bulgaria · France · Greece · Spain · Croatia

2025-522294-11-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

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)

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer Expressing Claudin18.2
AstraZeneca AB · 516 participants

📍 France · Italy · Spain · Hungary · Poland · Belgium · Germany · Netherlands

2024-519787-40-00 on CTIS ↗

Phase I/II Neoplasms Authorised 16/06/2026

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

Metastatic Prostate Cancer
AstraZeneca AB · 45 participants

📍 Belgium · Spain · Poland · Italy · Netherlands

2025-520626-37-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

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)

Stage I NSCLC
Merck Sharp & Dohme LLC · 283 participants

📍 Greece · Poland · Italy · Hungary · Germany · Netherlands · France · Spain

2025-522643-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 16/06/2026

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

Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc. · 228 participants

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

2025-524640-35-00 on CTIS ↗

Phase III Neoplasms Authorised 12/06/2026

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

Locally advanced, unresected (unresectable or medically inoperable or refuse surgery) Stage II-III NSCLC with KRAS G12C mutation
Merck Sharp & Dohme LLC · 88 participants

📍 Italy · Netherlands · France · Germany · Spain · Poland · Greece

2025-522038-29-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 12/06/2026

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

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 210 participants

📍 Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria

2025-523674-16-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 11/06/2026

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

J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD01 - Crohn Disease
Eli Lilly & Co. · 37 participants

📍 Italy · Germany · Hungary · Poland · Belgium

2025-524112-11-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 10/06/2026

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)

Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC)
Eli Lilly & Co. · 104 participants

📍 Latvia · Portugal · Greece · France · Czechia · Italy · Poland · Slovakia · Hungary · Croatia · Lithuania

2025-524404-29-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 08/06/2026

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

Moderate Calcific Aortic Valve Stenosis (CAVS)
Kardigan Inc. · 496 participants

📍 Norway · Czechia · Portugal · Austria · Poland · France · Spain

2025-522176-86-01 on CTIS ↗

Phase II Immune System Diseases Authorised 08/06/2026

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

Alopecia Areata
Eli Lilly & Co. · 14 participants

📍 Poland · Netherlands

2025-524727-41-00 on CTIS ↗

Phase III Neoplasms Authorised 08/06/2026

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

Small Cell Lung Cancer (SCLC)
Zai Lab (US) LLC · 234 participants

📍 Belgium · Czechia · Germany · Denmark · Greece · Netherlands · Poland · Spain · Austria · Italy · France

2025-522818-23-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 08/06/2026

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)

MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Pfizer Inc. · 318 participants

📍 Spain · Germany · Poland · Czechia · Greece · Italy · Bulgaria · France · Hungary

2024-518587-12-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 08/06/2026

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

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 173 participants

📍 Belgium · Greece · Poland · France · Spain · Bulgaria · Italy · Germany · Austria · Netherlands

2025-523675-39-00 on CTIS ↗

Phase IV Nutritional and Metabolic Diseases Authorised 05/06/2026

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

Frailty with Iron Deficiency in Elderly Patients with Cardiovascular Disease
Wroclaw Medical University · 396 participants

📍 Poland

2025-521570-34-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 03/06/2026

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

Amyotrofic Lateral Sclerosis (ALS)
Nura Bio Inc. · 46 participants

📍 Poland · Netherlands · Italy · Spain

2025-523939-18-00 on CTIS ↗

Phase III Eye Diseases Authorised 03/06/2026

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)

Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 130 participants

📍 Spain · Poland · Estonia · Latvia · Germany

2025-524575-22-00 on CTIS ↗

Phase III Immune System Diseases Authorised 02/06/2026

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

Systemic lupus erythematosus
AstraZeneca AB · 97 participants

📍 Poland · Germany · Italy · France · Spain

2025-523670-17-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

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

Hemophilia A Without Inhibitors
F. Hoffmann-La Roche AG · 42 participants

📍 France · Austria · Poland · Netherlands · Spain · Denmark · Italy · Germany · Hungary

2025-522434-32-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 01/06/2026

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.

Asthma
Novartis Pharma AG · 68 participants

📍 Poland · France · Slovakia · Spain · Hungary · Germany · Romania

2022-502365-26-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

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

Hemophilia A
F. Hoffmann-La Roche AG · 124 participants

📍 Hungary · Spain · Ireland · Poland · Austria · Germany · Denmark · Belgium · Netherlands · Italy · France

2025-522435-33-00 on CTIS ↗

Phase III Neoplasms Authorised 01/06/2026

Use of DOTATOC labeled with V-Cu64 in PET-CT imaging of neuroendocrine tumors

Neoplasms
Voxel S.A. · 80 participants

📍 Poland

2025-524050-34-01 on CTIS ↗

Phase III Neoplasms Authorised 01/06/2026

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

Treatment-naїve mantle cell lymphoma (MCL)
Innocare Pharma Inc. · 102 participants

📍 Poland · France · Czechia · Spain · Romania

2025-524241-27-00 on CTIS ↗

Phase III Neoplasms Authorised 29/05/2026

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

Myelofibrosis
Novartis Pharma AG · 173 participants

📍 Belgium · Germany · Austria · Poland · Spain · Italy · Netherlands · Czechia · France

2025-523555-66-00 on CTIS ↗

Phase II Immune System Diseases Authorised 29/05/2026

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

Non-Segmental Vitiligo (NSV), Vitiligo
Eli Lilly & Co. · 14 participants

📍 Poland · Belgium

2025-524726-18-00 on CTIS ↗

Phase III Neoplasms Authorised 29/05/2026

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

Hodgkin lymphoma
Polska Grupa Badawcza Chloniakow · 370 participants

📍 Poland

2026-525263-41-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 29/05/2026

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

Generalized Myasthenia Gravis
Vertex Pharmaceuticals Inc. · 5 participants

📍 Poland

2025-523950-15-01 on CTIS ↗

Phase I Immune System Diseases Authorised 29/05/2026

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

Rheumatoid Arthritis
Neurocrine Biosciences Inc. · 15 participants

📍 Poland · Romania

2025-525113-22-00 on CTIS ↗

Phase I/II Hemic and Lymphatic Diseases Authorised 29/05/2026

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

Adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (PBL) with an indication to start treatment of relapsed disease according to IWCLL recommendations.
Uniwersytet Medyczny W Lublinie · 36 participants

📍 Poland

2024-513917-11-01 on CTIS ↗

Phase I/II Neoplasms Authorised 28/05/2026

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

Non-Hodgkin Lymphoma
Merck Sharp & Dohme LLC · 73 participants

📍 Poland · Italy · France · Germany · Spain

2025-523005-15-00 on CTIS ↗

Phase II Immune System Diseases Authorised 27/05/2026

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

moderate to severe rheumatoid arthritis (RA)
F. Hoffmann-La Roche AG · 46 participants

📍 Italy · Spain · Germany · France · Denmark · Poland · Belgium

2025-523579-47-00 on CTIS ↗

Phase III Immune System Diseases Authorised 27/05/2026

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

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 302 participants

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

2025-521590-13-00 on CTIS ↗

Phase II Mental Disorders Authorised 27/05/2026

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

Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Maplight Therapeutics Inc. · 85 participants

📍 Italy · Poland · Czechia · Portugal · Bulgaria · France · Slovakia · Romania · Hungary

2025-521757-16-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 25/05/2026

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

relapsed/refractory multiple myeloma
C4 Therapeutics Inc. · 43 participants

📍 Italy · France · Spain · Poland

2025-524181-26-00 on CTIS ↗

Phase III Neoplasms Authorised 22/05/2026

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

Unresectable Stage III non-small cell lung cancer without progression
Bristol-Myers Squibb Services Unlimited Company · 279 participants

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

2025-523576-23-00 on CTIS ↗

Phase II Eye Diseases Authorised 20/05/2026

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

Thyroid Eye Disease
Amgen Inc. · 5 participants

📍 Spain · Poland

2025-523280-38-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 20/05/2026

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

Chronic Spontaneous Urticaria
Novartis Pharma AG · 154 participants

📍 Germany · Spain · France · Poland · Bulgaria · Czechia

2025-524078-40-00 on CTIS ↗

Phase III Immune System Diseases Authorised 20/05/2026

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

Hidradenitis Suppurativa (HS)
Novartis Pharma AG · 307 participants

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

2025-523259-72-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 20/05/2026

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

Duchenne muscular dystrophy
Avidity Biosciences Inc. · 42 participants

📍 Italy · Germany · France · Spain · Belgium · Poland · Netherlands

2025-523087-20-00 on CTIS ↗

Phase II Immune System Diseases Authorised 19/05/2026

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)

Rheumatoid arthritis
Elevara Medicines Limited · 95 participants

📍 Czechia · Bulgaria · Hungary · Netherlands · Poland · Spain

2025-524005-32-00 on CTIS ↗

Phase I Digestive System Diseases Authorised 19/05/2026

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

Active Ulcerative Colitis (UC)
F. Hoffmann-La Roche AG · 19 participants

📍 Germany · Poland · Belgium

2025-524060-38-00 on CTIS ↗

Phase II Immune System Diseases Authorised 19/05/2026

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

Moderate to Severe Atopic Dermatitis
Janssen Cilag International · 14 participants

📍 Germany · Poland

2025-523464-20-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 19/05/2026

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)

Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding
VarmX B.V. · 443 participants

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

2025-521632-12-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 19/05/2026

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

Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 66 participants

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

2025-523425-17-00 on CTIS ↗

Phase III Neoplasms Authorised 19/05/2026

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

Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp. · 292 participants

📍 Poland · France · Denmark · Norway · Spain · Germany · Belgium · Netherlands · Austria · Italy

2025-523735-19-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 18/05/2026

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.

Exocrine Pancreatic Insufficiency
Aimmune Nestle Health Science US R&D LLC · 29 participants

📍 Poland · Hungary · Spain · Bulgaria · Italy

2025-521816-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 18/05/2026

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

Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants

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

2025-524316-11-00 on CTIS ↗

Phase II Neoplasms Authorised 18/05/2026

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

Philadelphia positive Chronic Myeloid leukemia in Chronic Phase with newly diagnosed and resistant/intolerant to previous TKIs, with or without the T315I mutation
Novartis Pharma AG · 14 participants

📍 Spain · France · Germany · Poland · Italy · Netherlands

2025-522138-29-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 18/05/2026

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

Asthma
Chiesi Farmaceutici S.p.A. · 606 participants

📍 Germany · Romania · Italy · Bulgaria · Poland · Slovakia · Spain · France

2025-524289-56-00 on CTIS ↗

Phase III Neoplasms Authorised 15/05/2026

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%

Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 265 participants

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

2025-523586-18-00 on CTIS ↗

Phase I/II Immune System Diseases Authorised 15/05/2026

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

Generalized Myasthenia Gravis
Aurinia Pharmaceuticals Inc. · 19 participants

📍 Poland

2025-525127-27-00 on CTIS ↗

Phase I/II Neoplasms Authorised 15/05/2026

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

Advanced Solid Tumors
Eikon Therapeutics Inc. · 49 participants

📍 France · Spain · Norway · Italy · Germany · Austria · Poland · Finland

2026-525248-13-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 15/05/2026

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)

Participants with overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 440 participants

📍 Germany · Croatia · Portugal · Hungary · Bulgaria · Romania · Poland

2024-520446-31-00 on CTIS ↗

Phase II Neoplasms Authorised 14/05/2026

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

Relapsed or Refractory Multiple Myeloma (RRMM)
Janssen Cilag International · 54 participants

📍 Poland · Italy

2025-521976-80-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 14/05/2026

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

Relapsed/refractory primary central nervous system lymphoma
Deciphera Pharmaceuticals Inc. · 74 participants

📍 Czechia · Germany · Italy · Belgium · Spain · Poland · Austria · France

2025-523389-26-00 on CTIS ↗

Phase III Neoplasms Authorised 13/05/2026

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

Acute Promyelocytic Leukemia
Quetzal Therapeutics LLC · 89 participants

📍 Germany · Poland · Spain · Romania · Italy · France

2025-524810-28-00 on CTIS ↗

Phase III Neoplasms Authorised 13/05/2026

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

advanced or metastatic extrapulmonary neuroendocrine carcinoma
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 144 participants

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

2025-523869-22-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 13/05/2026

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

Prurigo Nodularis
Innocare Pharma Inc. · 56 participants

📍 Belgium · Poland · Germany · France · Austria

2025-523404-74-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 13/05/2026

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

Obesity or Overweight and Type 2 Diabetes
F. Hoffmann-La Roche AG · 551 participants

📍 Germany · Romania · Czechia · Poland · Hungary · France · Spain · Italy

2025-523106-32-00 on CTIS ↗

Phase III Neoplasms Authorised 12/05/2026

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.

small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 295 participants

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

2025-520565-51-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 12/05/2026

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

Psoriatic Arthritis
Takeda Development Center Americas Inc. · 638 participants

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

2025-522586-30-00 on CTIS ↗

Phase II Neoplasms Authorised 12/05/2026

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

Non-small cell lung cancer (NSCLC), Cervical cancer (CC), Melanoma, Hepatocellular carcinoma (HCC), Ovarian cancer (OC), Squamous cell carcinoma of head and neck
Dualitybio Inc. · 102 participants

📍 Italy · Poland · France · Spain · Germany

2025-523895-22-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 11/05/2026

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

Huntington’s Disease Gene Expansion Carriers
F. Hoffmann-La Roche AG · 43 participants

📍 Italy · Poland · Denmark · Germany · Portugal · Spain

2025-520631-17-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 11/05/2026

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

Dyslipidemia at High to Very High Cardiovascular Risk
A. Menarini International Licensing S.A. · 338 participants

📍 Spain · Poland · Netherlands · Italy · Slovakia · Czechia · Germany

2025-524265-24-00 on CTIS ↗

Phase III Immune System Diseases Authorised 11/05/2026

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

Prevention of a Major infection in patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions receiving treatment with B-cell depletion therapy.
Octapharma Pharmazeutika Produktionsgesellschaft mbH · 215 participants

📍 Czechia · Lithuania · Greece · Poland · Germany · Latvia · Bulgaria · Italy

2025-522854-37-00 on CTIS ↗

Phase III Neoplasms Authorised 11/05/2026

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

Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Peritoneal Neoplasms
Eli Lilly & Co. · 486 participants

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

2025-522255-25-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 11/05/2026

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

Chronic rhinosinusitis with nasal polyps
Sanofi-Aventis Recherche & Developpement · 146 participants

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

2025-522983-33-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 07/05/2026

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 Without Type 2 Diabetes

Obesity or Overweight Without Type 2 Diabetes
F. Hoffmann-La Roche AG · 754 participants

📍 Poland · Hungary · France · Belgium · Italy · Netherlands · Czechia · Germany · Spain

2025-523104-71-00 on CTIS ↗

Phase I Not possible to specify Authorised 06/05/2026

PHARMACOKINETICS OF PETRELINTIDE FOLLOWING ADMINISTRATION TO PARTICIPANTS WITH IMPAIRED HEPATIC FUNCTION

Healthy / hepatic impaired volunteers only study to assess PK parameters
Zealand Pharma A/S · 36 participants

📍 Slovakia · Poland

2025-523641-10-00 on CTIS ↗

Phase I Neoplasms Authorised 05/05/2026

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

Small Cell Lung Cancer
Amgen Inc. · 53 participants

📍 Spain · Germany · Poland · Belgium · France

2025-522888-15-00 on CTIS ↗

Phase III Eye Diseases Authorised 05/05/2026

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)

Persistent Corneal Epithelial Defect (PCED)
Dompe' Farmaceutici S.p.A. · 91 participants

📍 Czechia · Italy · Netherlands · Poland · Germany · Spain · Hungary · France

2025-523443-35-00 on CTIS ↗

Phase II Immune System Diseases Authorised 05/05/2026

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

Graves’ Disease
Immunovant Sciences GmbH · 128 participants

📍 Italy · Greece · Germany · Hungary · Poland · Czechia · Netherlands · Spain · Belgium · Bulgaria · Latvia

2025-524001-33-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 05/05/2026

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

Obesity
Kailera Therapeutics Inc. · 612 participants

📍 Bulgaria · Hungary · Spain · Germany · Czechia · Poland

2025-523486-17-00 on CTIS ↗

Phase III Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 05/05/2026

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

Achondroplasia
Biomarin Pharmaceutical Inc. · 25 participants

📍 Poland · Italy · Romania

2025-523811-12-00 on CTIS ↗

Phase III Immune System Diseases Authorised 05/05/2026

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

Systemic Lupus Erythematosus
Janssen Cilag International · 271 participants

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

2025-523552-31-00 on CTIS ↗

Phase II Eye Diseases Authorised 04/05/2026

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

Geographic atrophy secondary to age-related macular degeneration
Novartis Pharma AG · 142 participants

📍 Bulgaria · Romania · Germany · Czechia · Spain · Poland · Italy · Hungary · France

2025-523704-77-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 04/05/2026

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

Obesity
Kailera Therapeutics Inc. · 626 participants

📍 Hungary · Poland · Bulgaria · Germany · Czechia · Spain

2025-523510-87-00 on CTIS ↗

Phase II Immune System Diseases Authorised 04/05/2026

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)

Systemic lupus erythematosus
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 106 participants

📍 Bulgaria · Romania · Germany · Spain · Hungary · Poland · Croatia

2025-523488-39-00 on CTIS ↗

Phase III Neoplasms Authorised 04/05/2026

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

Renal Cell Carcinoma
Merck Sharp & Dohme LLC · 311 participants

📍 Denmark · Spain · Netherlands · Germany · France · Czechia · Poland · Italy · Greece

2024-516993-31-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 30/04/2026

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

Psoriatic arthritis
Merck Sharp & Dohme LLC · 49 participants

📍 Poland · Germany · Spain

2025-520997-21-00 on CTIS ↗

Phase III Neoplasms Authorised 30/04/2026

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

Relapsed or Refractory Multiple Myeloma
AstraZeneca AB · 153 participants

📍 Norway · Poland · Spain · Germany · France · Italy

2025-523285-25-00 on CTIS ↗

Phase I/II Digestive System Diseases Authorised 29/04/2026

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

Ulcerative Colitis
Mage Biologics Inc. · 30 participants

📍 Poland

2025-524719-35-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 29/04/2026

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

Obesity
Kailera Therapeutics Inc. · 268 participants

📍 Poland · Bulgaria

2025-523511-11-00 on CTIS ↗

Phase I Skin and Connective Tissue Diseases Authorised 29/04/2026

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

Androgenetic alopecia
Bioresearch Pharma S.A. · 24 participants

📍 Poland

2025-522468-34-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 28/04/2026

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

Pulmonary Arterial Hypertension
Inhibikase Therapeutics Inc. · 94 participants

📍 Spain · Poland · Italy · Belgium · Latvia · Denmark · Czechia · Germany · France · Netherlands · Portugal · Ireland · Greece

2024-520218-23-00 on CTIS ↗

Phase III Neoplasms Authorised 28/04/2026

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)

Renal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dMMR colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, non-MSIH/dMMR endometrial cancer, esophageal squamous cell carcinoma, Advanced Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, von Hippel-Lindau (VHL)Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor, Advanced Solid Tumors With HIF-2α related Genetic Alterations
Merck Sharp & Dohme LLC · 37 participants

📍 Czechia · Spain · Poland · Belgium · Finland · Germany · France · Netherlands · Hungary · Denmark

2025-524160-38-00 on CTIS ↗

Phase III Neoplasms Authorised 28/04/2026

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

Pretreated Unresectable Locally Advanced or Metastatic human epidermal growth factor receptor 2 (HER2)-Positive Breast Cancer, with or without Central Nervous System (CNS) Metastases
F. Hoffmann-La Roche AG · 237 participants

📍 Belgium · France · Italy · Austria · Romania · Poland · Portugal · Czechia · Germany · Spain · Hungary

2025-524498-17-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 28/04/2026

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

Erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD)
Cinclus Pharma Holding AB (publ) · 96 participants

📍 Hungary · Germany · Romania · Bulgaria · Czechia · Poland

2025-522750-39-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 28/04/2026

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

Obesity and T2D
Novo Nordisk A/S · 157 participants

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

2023-509176-42-00 on CTIS ↗

Phase III Neoplasms Authorised 28/04/2026

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)

Ovarian cancer
Merck Sharp & Dohme LLC · 349 participants

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

2023-508047-40-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 28/04/2026

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

Lennox-Gastaut Syndrome
Epygenix Therapeutics Inc. · 98 participants

📍 Italy · Spain · Hungary · Romania · Czechia · Poland

2025-522552-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 28/04/2026

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

Agitation in Alzheimer's Disease Dementia
Exciva GmbH · 222 participants

📍 Italy · Slovakia · Spain · Poland · Czechia · Germany

2024-517388-22-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/04/2026

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

Classical Homocystinuria
Travere Therapeutics Inc. · 22 participants

📍 Belgium · Ireland · Spain · Italy · Germany · France · Portugal · Poland

2023-504135-40-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 27/04/2026

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

Cancer-Associated Thrombosis (CAT).
Regeneron Pharmaceuticals Inc. · 324 participants

📍 Belgium · Czechia · France · Romania · Germany · Poland · Bulgaria · Spain

2024-519298-21-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 27/04/2026

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

Idiopathic pulmonary fibrosis (IPF)
Chiesi Farmaceutici S.p.A. · 103 participants

📍 Belgium · Germany · Italy · Czechia · Bulgaria · Netherlands · France · Portugal · Poland · Spain · Romania

2024-514246-37-00 on CTIS ↗

Phase IV Immune System Diseases Authorised 27/04/2026

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

severely active ulcerative colitis (US) and CD (Crohn’s disease)
Eli Lilly & Co. · 16 participants

📍 Spain · Denmark · Germany · Italy · Poland

2025-522362-78-00 on CTIS ↗

Phase II Neoplasms Authorised 27/04/2026

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

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
AstraZeneca AB · 63 participants

📍 Italy · Austria · Spain · Ireland · Czechia · Poland

2024-518858-17-00 on CTIS ↗

Phase I/II Respiratory Tract Diseases Authorised 27/04/2026

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

Extensive-Stage Small Cell Lung Cancer
Fortvita Biologics (USA) Inc. · 30 participants

📍 Poland · Denmark · Spain

2025-523972-21-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 23/04/2026

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

Respiratory Tract Infections
Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz · 224 participants

📍 Poland

2025-524212-11-00 on CTIS ↗

Phase I Neoplasms Authorised 23/04/2026

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

Medulloblastoma (recurrent or progressive)
Instytut Pomnik Centrum Zdrowia Dziecka · 48 participants

📍 Poland

2025-524031-39-00 on CTIS ↗

Phase II Immune System Diseases Authorised 22/04/2026

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)

Rheumatoid arthritis
AstraZeneca AB · 97 participants

📍 Hungary · Spain · Bulgaria · Germany · Poland

2025-522076-85-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 22/04/2026

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

Type 2 Diabetes Mellitus
Corxel Pharmaceuticals Inc. · 121 participants

📍 Poland

2025-524514-28-00 on CTIS ↗

Phase I/II Neoplasms Authorised 22/04/2026

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

Advanced or unresectable Hepatocellular Carcinoma (HCC)
Bristol-Myers Squibb Services Unlimited Company · 47 participants

📍 Poland · Spain · Germany · France · Italy

2025-523602-33-00 on CTIS ↗

Phase III Not possible to specify Authorised 21/04/2026

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

Chemotherapy induced thrombocytopenia
Jiangsu Hengrui Pharmaceuticals Co. Ltd. · 58 participants

📍 France · Romania · Poland · Spain · Bulgaria

2025-524209-34-00 on CTIS ↗

Phase II Hormonal diseases Authorised 21/04/2026

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

type 2 diabetes
Novo Nordisk A/S · 145 participants

📍 Spain · Hungary · Portugal · Poland · Slovakia · Croatia

2025-523260-20-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

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

treatment-naive Chronic Lymphocytic Leukemia
BeOne Medicines I GmbH · 186 participants

📍 Netherlands · Poland · Italy · Germany · Spain · Romania · Czechia · France · Sweden

2025-524366-21-00 on CTIS ↗

Phase II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 20/04/2026

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

Homeostatic iron regulator gene-related hereditary hemochromatosis
CSL Behring LLC · 50 participants

📍 Austria · Poland · Spain · Germany · France · Ireland · Romania · Belgium · Italy · Czechia · Netherlands

2025-523793-16-00 on CTIS ↗

Phase II Neoplasms Authorised 20/04/2026

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

Relapsed/refractory osteosarcoma, High-grade osteosarcoma
Instytut Matki I Dziecka · 40 participants

📍 Poland

2026-525223-24-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 20/04/2026

A Multicenter, Open-Label, Dose Escalation Study of the Safety, Tolerability, and Efficacy of Budiodarone for the Treatment of Subjects with Non-permanent Atrial Fibrillation

Non-permanent Atrial Fibrillation
Xyra LLC · 100 participants

📍 Poland

2025-523860-19-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/04/2026

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

Amyotrophic Lateral Sclerosis
Ferrer Internacional S.A., Prilenia Therapeutics B.V. · 420 participants

📍 Belgium · Netherlands · Poland · France · Germany · Ireland · Italy · Sweden · Spain

2025-524002-16-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

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.

Urinary Bladder Neoplasms, Neoplasm Metastasis, Carcinoma, Transitional Cell
Eli Lilly & Co. · 197 participants

📍 Italy · Poland · Denmark · Czechia · France · Hungary · Germany · Netherlands · Spain

2025-522855-25-00 on CTIS ↗

Phase III Neoplasms Authorised 17/04/2026

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

Ovarian cancer
Incyte Corp. · 308 participants

📍 Ireland · Poland · France · Netherlands · Spain · Italy · Germany · Belgium

2025-522748-42-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 17/04/2026

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

HFpEF or HFmrEF and obesity
Novo Nordisk A/S · 1992 participants

📍 Denmark · Greece · Bulgaria · Italy · Netherlands · Spain · Poland · Czechia · Germany · France

2025-523717-29-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 17/04/2026

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

Myelodysplastic neoplasms/syndromes (MDS)
Takeda Development Center Americas Inc. · 114 participants

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

2025-523544-12-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 16/04/2026

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)

Obesity
Metsera Inc. · 919 participants

📍 Czechia · Bulgaria · Slovakia · Spain · Hungary · Germany · Romania · Poland

2025-523975-48-00 on CTIS ↗