Clinical Trials in Greece 2026 - 56 Recent EU Authorisations

📍 Denmark · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Estonia · Lithuania

2025-523884-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

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

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 194 participants

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

2026-525922-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

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

Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International · 302 participants

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

2026-525923-26-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/07/2026

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)

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.
AstraZeneca AB · 2343 participants

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

2026-526304-79-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

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

Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S · 1140 participants

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

2025-522488-14-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer
AbbVie Deutschland GmbH & Co. KG · 125 participants

📍 Italy · Greece · Spain · Belgium · France · Austria · Germany

2025-523819-11-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 24/07/2026

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)

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.
AstraZeneca AB · 1600 participants

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

2025-523994-41-00 on CTIS ↗

Phase II Immune System Diseases Authorised 21/07/2026

A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)

newly diagnosed amyloid light chain amyloidosis
Glaxosmithkline Research & Development Limited · 17 participants

📍 Italy · Greece · Spain

2025-522803-60-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 20/07/2026

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

Participants with overweight or obesity
Novo Nordisk A/S · 171 participants

📍 Sweden · Greece · Hungary · Portugal

2025-524249-29-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

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

Huntington’s Disease
Novartis Pharma AG · 368 participants

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

2025-522227-99-00 on CTIS ↗

Phase II Otorhinolaryngologic Diseases Authorised 16/07/2026

Randomized, observer-blind, placebo-controlled, four Parallel Group, Clinical Trial for exploring the Efficacy and Tolerability of two different strengths ketotifen nasal spray (Ketotifen 0.025 mcg/ml and 0.050 mcg/ml) vs sodium cromoglicate nasal spray 2% in Patients with Rhinitis

Rhinitis
Eudemus Pharmaceuticals Limited · 120 participants

📍 Greece

2026-525419-16-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 14/07/2026

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

Acute Ischemic Stroke
Takeda Development Center Americas Inc. · 67 participants

📍 Greece · Belgium · France · Germany

2025-522734-31-00 on CTIS ↗

Phase I/II Neoplasms Authorised 13/07/2026

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

Multiple Myeloma (MM), Multiple Myeloma (MM)
AbbVie Deutschland GmbH & Co. KG · 88 participants

📍 Germany · Poland · Czechia · Belgium · France · Greece · Sweden · Portugal · Italy

2025-525105-20-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/07/2026

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

AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
Argenx · 29 participants

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

2025-522939-33-00 on CTIS ↗

Phase III Eye Diseases Authorised 07/07/2026

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

Cataract
Ntc S.r.l. · 536 participants

📍 Spain · Poland · Greece · Sweden · Italy

2026-525594-39-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 07/07/2026

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

Fibrosing interstitial lung disease
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 20 participants

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

2025-523369-32-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

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

Multiple Myeloma
F. Hoffmann-La Roche AG · 133 participants

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

2025-524028-23-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

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

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement · 550 participants

📍 Germany · Romania · Greece · Norway · Netherlands · Poland · Lithuania · Czechia · Slovakia · Spain

2024-518213-25-00 on CTIS ↗

Phase III Mental Disorders Authorised 01/07/2026

AugmENtation witH cAnnabidiol iN first episode psyChosis: a doublE blind randomised controlled trial (STEP-ENHANCE Trial)

First Episode Psychosis (FEP)
University Of Oxford · 156 participants

📍 Netherlands · Greece · Germany · Italy · Austria · Spain

2025-521929-32-01 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

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

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International · 206 participants

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

2025-523815-12-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 30/06/2026

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

Pulmonary Hypertension Associated with Interstitial Lung Disease
Insmed Inc. · 165 participants

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

2025-521769-29-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 57 participants

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

2025-524855-30-00 on CTIS ↗

Phase III Immune System Diseases Authorised 29/06/2026

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 54 participants

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

2025-523871-44-00 on CTIS ↗

Phase III Neoplasms Authorised 29/06/2026

AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer

Colorectal Cancer
AbbVie Deutschland GmbH & Co. KG · 243 participants

📍 Greece · Portugal · Germany · Belgium · Spain

2025-521712-19-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/06/2026

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

Solid Tumors
Revolution Medicines Inc. · 252 participants

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

2025-524623-50-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 29/06/2026

CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL

Community- acquired pneumonia related sepsis with evidence of Sepsis Induced Immunoparalysis SII
Elliniko Institouto Meletis Tis Sipsis · 252 participants

📍 Greece

2025-525058-20-00 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 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 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 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 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 Musculoskeletal Diseases Authorised 15/06/2026

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

Musculoskeletal diseases
Sanofi-Aventis Recherche & Developpement · 177 participants

📍 France · Netherlands · Germany · Czechia · Belgium · Austria · Hungary · Greece · Spain

2024-511296-15-00 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 Neoplasms Authorised 12/06/2026

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Relapsed/refractory B-cell Acute Lymphoblastic Leukemia
Merck Sharp & Dohme LLC · 109 participants

📍 Greece · Netherlands · Sweden · France · Italy · Spain · Denmark

2025-522267-15-00 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 III Bacterial Infections and Mycoses Authorised 10/06/2026

A Phase 3 prospective, randomized, multicenter, active-controlled study to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B compared with colistin plus high-dose ampicillin/sulbactam in the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex

Hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex
Bioversys S.A.S. · 58 participants

📍 Greece · Croatia

2025-524092-23-00 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 Severe, Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Eli Lilly & Co. · 104 participants

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

2025-524404-29-00 on CTIS ↗

Phase III Neoplasms Authorised 09/06/2026

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

Follicular Lymphoma
Merck Sharp & Dohme LLC · 9 participants

📍 France · Spain · Greece

2025-522777-10-00 on CTIS ↗

Phase I/II Neoplasms Authorised 08/06/2026

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

Small cell lung cancer extensive stage
Merck Sharp & Dohme LLC · 79 participants

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

2025-521032-11-00 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 III Bacterial Infections and Mycoses Authorised 28/05/2026

A Randomized, Multicenter, Single-Blind, Parallel-Group Phase III Non-Inferiority Trial Comparing the Efficacy and Tolerability of a Fixed-Dose Combination of Metronidazole, Bismuth Oxide and Tetracycline HCl to Standard Concomitant Non-Bismuth Quadruple Therapy for First-Line Eradication of Helicobacter pylori in Adults.

Helicobacter Pylori Infection
Verisfield Single Member S.A. · 420 participants

📍 Greece

2026-525291-26-00 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 Neoplasms Authorised 21/05/2026

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).

Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)
Eikon Therapeutics Inc. · 115 participants

📍 Germany · Spain · Netherlands · Romania · Greece · Italy

2025-525013-23-00 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 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 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 · 15 participants

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

2025-522138-29-00 on CTIS ↗

Phase III Neoplasms Authorised 18/05/2026

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma 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
Janssen Cilag International · 157 participants

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

2025-522007-18-00 on CTIS ↗