Clinical Trials in Romania 2026 - 53 Recent EU Authorisations

Phase I Immune System Diseases Authorised 01/07/2026

An open label, balanced, randomized, single dose, two-treatment, two period, two-sequence, crossover, bioequivalence study comparing Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablet 180 mg/240 mg, Manufactured by: Sun Pharmaceutical Industries Limited, India with Allegra-D® 24 HR (Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablets 180 mg + 240 mg) tablets, Distributed by: Chattem Inc., a Sanofi Company Chattanooga, TN 37409-0219, USA, in healthy, adult, human participants under fed conditions.

Seasonal allergic rhinitis
Sun Pharmaceutical Industries Limited · 48 participants

📍 Romania

2026-525421-20-00 on CTIS ↗

Phase I Immune System Diseases Authorised 01/07/2026

An open label, balanced, randomized, single dose, two-treatment, four period, two-sequence, crossover, fully replicate, bioequivalence study comparing Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablet USP 180 mg/240 mg, Manufactured by: Sun Pharmaceutical Industries Limited, India with Allegra-D® 24 HR (Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablets 180 mg + 240 mg) tablets, Distributed by: Chattem Inc., a Sanofi Company Chattanooga, TN 37409-0219, USA, in healthy, adult, human participants under fasting conditions.

Seasonal allergic rhinitis
Sun Pharmaceutical Industries Limited · 48 participants

📍 Romania

2026-525420-22-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 26/06/2026

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants with Solid and Hematologic Cancers (ROXI-CAT-II)

Cancer Associated Thrombosis
Regeneron Pharmaceuticals Inc. · 164 participants

📍 Bulgaria · Romania

2024-519299-16-00 on CTIS ↗

Phase I Immune System Diseases Authorised 25/06/2026

Phase 1 Single Dose Study of JADE201 in Participants with Rheumatoid Arthritis

Rheumatoid Arthritis
Jade Biosciences Inc. · 24 participants

📍 Romania · Bulgaria · Germany

2025-524746-96-00 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 I Neoplasms Authorised 22/06/2026

Pharmacokinetics, safety, and immunogenicity comparison of Bmab1700 and Opdivo® as adjuvant monotherapy in patients with melanoma

Stage IIB/C, Stage III, or Stage IV Melanoma
Biocon Biologics UK PLC · 43 participants

📍 Spain · Romania

2025-525158-20-00 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 I/II Neoplasms Authorised 02/06/2026

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors.

Locally Advanced or Metastatic Solid Tumors
Crescent Biopharma Inc. · 180 participants

📍 Spain · Ireland · Italy · France · Romania

2025-523590-42-00 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 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 Nervous System Diseases Authorised 29/05/2026

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 years of age) with Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 years of age) with Irritability Associated with Autism Spectrum Disorder

Schizophrenia and Autism Spectrum Disorder (ASD)
Bristol-Myers Squibb Services Unlimited Company · 40 participants

📍 Romania

2025-524062-16-00 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 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 I Bacterial Infections and Mycoses Authorised 22/05/2026

A randomized, balanced, two-treatment, two-sequence, single oral dose, two stage crossover adaptative bioequivalence study of Rifaximin 200 mg film-coated tablets (Antibiotice SA) vs. Normix® 200 mg, film- coated tablets (Alfasigma S.P.A) in healthy subjects under fed conditions

healthy subjects
Antibiotice S.A. · 64 participants

📍 Romania

2025-525078-12-00 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 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 I/II Neoplasms Authorised 18/05/2026

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination with Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer

Relapsed/Refractory Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 21 participants

📍 Italy · Spain · Romania

2025-524090-16-00 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 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 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 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 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 Respiratory Tract Diseases Authorised 12/05/2026

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

severe uncontrolled asthma
Generate Biomedicines Inc. · 271 participants

📍 Latvia · Hungary · Bulgaria · Romania · Portugal · Netherlands · Croatia · Germany · Greece · Czechia

2025-521950-41-00 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 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 I Mental Disorders Authorised 05/05/2026

An open label, balanced, randomized, three treatment, three period, three sequence, single dose, crossover study to assess the effect of food and effect of apple sauce on bioavailability of the Test product (Bupropion Hydrochloride Extended Release Capsules 150 mg, manufactured by Sun Pharmaceutical Industries Limited, India) in healthy, adult, human subjects.

Seasonal affective disorder, Major depressive disorder
Sun Pharmaceutical Industries Limited · 72 participants

📍 Romania

2025-523411-11-00 on CTIS ↗

Phase I Mental Disorders Authorised 05/05/2026

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover, bioavailability study comparing Bupropion Hydrochloride Extended Release Capsules 150 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with WELLBUTRIN XL (Bupropion hydrochloride) extended release tablets 300 mg, Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA. Manufactured by: Bausch Health Companies, Inc. Steinbach, MB R5G 1Z7, Canada, in healthy, adult, human subjects under fasting condition.

Seasonal affective disorder, Major depressive disorder
Sun Pharmaceutical Industries Limited · 72 participants

📍 Romania

2025-523410-84-00 on CTIS ↗

Phase I Neoplasms Authorised 05/05/2026

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Imatinib Mesylate Tablets 400 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Glivec® (Imatinib mesylate) Coated tablets 400 mg, Produced by Novartis Pharma Produktions GmbH, Wehr, Germany or Novartis Pharmaceutical Manufacturing LLC, Ljubljana; Imported and Registered by Novartis Biosciences SA, Prof. Vicente Rao Avenue, 90, Sao Paulo – SP, CNPJ: 56.994.502/0001-30, Brazilian Industry, in healthy adult, human subjects under fed condition.

Acute Lymphoblastic Leukemia (Ph+ ALL), (Ph+) Chronic Myeloid Leukemia
Sun Pharmaceutical Industries Limited · 28 participants

📍 Romania

2025-524935-38-00 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

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

Overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 265 participants

📍 Italy · Croatia · Hungary · Slovakia · Romania

2024-520441-23-00 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 I Neoplasms Authorised 30/04/2026

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Trametinib tablets 2 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with MEKINIST® (Trametinib) tablets 2 mg, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA in healthy, adult, human subjects under fasting condition.

Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma (in combination with dabrafenib);, BRAF V600E mutation-positive unresectable or metastatic solid tumors;, BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC), in combination with dabrafenib;, BRAF V600E mutation-positive low-grade glioma (LGG)., BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC);, BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib;
Sun Pharmaceutical Industries Limited · 72 participants

📍 Romania

2025-524267-20-00 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 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 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 I Immune System Diseases Authorised 24/04/2026

Phase 1b study to assess the safety and tolerability of SR-878 in patients with rheumatoid arthritis

rheumatoid arthritis
SciRhom GmbH · 12 participants

📍 Romania

2025-523678-17-00 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 III Nutritional and Metabolic Diseases Authorised 21/04/2026

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

Obesity, Overweight
Eli Lilly & Co. · 286 participants

📍 Spain · Romania · Belgium · Czechia

2025-523659-73-00 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 III Mental Disorders Authorised 20/04/2026

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age)

Schizophrenia
Bristol-Myers Squibb Services Unlimited Company · 28 participants

📍 Romania

2025-523711-11-00 on CTIS ↗

Phase I Neoplasms Authorised 20/04/2026

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ponatinib Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Iclusig (Ponatinib hydrochloride) tablets 15 mg, Produced by: Patheon Inc. Mississauga, Canada or Takeda Ireland Limited Bray, Ireland, Imported and registered by: Pint Pharma Medical-Hospital and Pharmaceutical Products Ltd. Nelson Pontes Street, 125, Block 03, Jardim Margarida Zip Code 06739-024, Vargem Grande Paulista – SP CNPJ No. 21,896,000/0001-91, in healthy adult, human subjects under fasting condition.

chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia
Sun Pharmaceutical Industries Limited · 56 participants

📍 Romania

2025-524311-37-00 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 ↗