Clinical trial register · European Union · CTIS

Clinical Trials in Romania, 2026

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

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Source: EMA Clinical Trials Information System (CTIS). Showing the 2557 most recently authorised of 12637 total CTIS records — a stated recency window, not the full historical archive. Synced 16 Oct 2026, 03:17 UTC

2557

Shown in this register

most recently authorised

12,637

Total on CTIS

full historical archive

779

Phase III

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Spain 1071 France 924 Germany 907 Italy 776 Poland 609 Netherlands 560

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Phase

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All 28 states

Trials with a site in Romania

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase I

An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fed condition.

2026-525799-25-00Ulcerative colitis

Sun Pharmaceutical Industries Limited

Digestive System Diseases

Romania

12/10/2026

Phase I

An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fasting condition.

2026-525798-38-00Ulcerative colitis

Sun Pharmaceutical Industries Limited

Digestive System Diseases

Romania

12/10/2026

Phase III

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants with Active Primary Sjögren’s Disease

2026-525556-28-00Active Primary Sjögren’s Disease

DrugTelitacicept

Vor Biopharma Inc.

Immune System Diseases

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

06/10/2026

Phase III

A Phase 3b, open-label, multicenter, continued access study for participants transitioning from ViiV  Healthcare‑sponsored or ViiV  Healthcare‑collaborative parent studies for HIV treatment Appendix : Management of Participants from Parent Study BRIGHTE

2025-522910-21-00HIV infection

Viiv Healthcare UK Limited

Virus Diseases

Romania

05/10/2026

Phase III

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

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

DrugOlatorepatide

Regeneron Pharmaceuticals Inc.

Nutritional and Metabolic Diseases

Romania, Poland, Hungary, Germany, Spain

29/09/2026

Phase III

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

2026-525265-48-00Pulmonary Arterial Hypertension

DrugTreprostinil Palmitil

Insmed Inc.

Cardiovascular Diseases

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

29/09/2026

Phase III

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

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

DrugsCenvacibart·Apixaban

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

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

29/09/2026

Phase III

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

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

DrugsAmrecibart·Cenvacibart

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

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

29/09/2026

Phase II

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

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

Expedition Therapeutics Inc.

Respiratory Tract Diseases

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

29/09/2026

Phase III

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

2025-522954-37-00Peripheral Artery Disease

DrugsAmrecibart·Cenvacibart·Rivaroxaban

Regeneron Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

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

29/09/2026

Phase I/II

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

2026-527163-15-00Advanced Renal Cell Carcinoma

DrugsCabozantinib·Ipilimumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

24/09/2026

Phase III

LUMIOS - A Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to assess the efficacy, safety and tolerability of cenerimod in adult patients with systemic lupus erythematosus and active lupus nephritis in combination with background therapy

2025-522984-14-00Systemic lupus erythematosus and active lupus nephritis

DrugCenerimod

Viatris Innovation GmbH

Immune System Diseases

Germany, Spain, Poland, Bulgaria, Romania

23/09/2026

Phase III

A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults with Idiopathic Pulmonary Fibrosis (SURPASS-IPF)

2025-524493-42-00Idiopathic Pulmonary Fibrosis

DrugsDeupirfenidone·Pirfenidone

Puretech Lyt 100 Inc.

Respiratory Tract Diseases

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

18/09/2026

Phase III

A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination with the Modified Gemcitabine and nab-Paclitaxel Regimen Versus the Standard Gemcitabine and nab-Paclitaxel Regimen for the Treatment of Patients with Metastatic Pancreatic Ductal Adenocarcinoma Cancer (MAPKeeper 301)

2026-525617-31-00Metastatic Pancreatic Ductal Adenocarcinoma

DrugsGemcitabine·Paclitaxel

Immuneering Corp.

Neoplasms

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

17/09/2026

Phase II

J2S-MC-GZMV: A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

2026-525480-41-00Pulmonary Disease, Chronic Obstructive

DrugBrenipatide

Eli Lilly & Co.

Respiratory Tract Diseases

Denmark, France, Romania, Czechia, Poland, Hungary, Germany, Austria

15/09/2026

Phase IV

A Rollover Study to Follow the Long-term Durability of Response to UGN-103 in Participants From Study BL013

2026-526359-75-00Non-Muscle Invasive Bladder Cancer

DrugMitomycin C

Urogen Pharma Ltd.

Neoplasms

Estonia, Romania, Spain, Bulgaria, Latvia

11/09/2026

Phase II

A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

2026-526241-98-00Uncontrolled Moderate to Severe Eosinophilic Asthma

DrugKT-621

Kymera Therapeutics Inc.

Immune System Diseases

Austria, Germany, Belgium, Romania, Italy, Slovakia, Poland, Spain

09/09/2026

Phase III

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

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

DrugsSiltuximab·Tarlatamab

Amgen Inc.

Neoplasms

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

08/09/2026

Phase IV

A double-blind, randomised, 30-week placebo-controlled phase IV study to assess the efficacy and safety of osilodrostat in patients with hypertension caused by hypercortisolaemia due to Cushing’s Syndrome

2025-524649-28-00Cushing's syndrome

DrugOsilodrostat

Recordati AG

Hormonal diseases

Germany, Bulgaria, France, Romania, Italy, Poland, Spain

08/09/2026

Phase II

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

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

Argenx

Immune System Diseases

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

08/09/2026

Phase II

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as First-line Treatment for Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

2026-525170-19-00Locally Advanced or Metastatic Non-Small Cell Lung Cancer (…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Italy, Spain, Romania, Germany, France

07/09/2026

Phase I

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

2026-525215-13-00Advanced Solid Tumors

F. Hoffmann-La Roche AG

Neoplasms

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

07/09/2026

Phase II

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

2025-524104-30-00Tardive Dyskinesia

Neurocrine Biosciences Inc.

Nervous System Diseases

Bulgaria, Croatia, Romania, Slovakia, Czechia

07/09/2026

Phase II

Randomized, Double blind, Phase II Trial of Vortosiran to Evaluate Safety, Tolerability, and Pharmacodynamic Efficacy in Participants with Prior Venous Thromboembolism After Completion of Initial Anticoagulant Therapy (Cohort A) and in Cancer Patients at High Risk of Venous Thromboembolism (Cohort B)

2026-525479-15-00Venous Thromboembolism

DrugRBD4059

Ribocure Pharmaceuticals AB

Cardiovascular Diseases

Poland, Romania, France, Bulgaria

04/09/2026

Phase III

A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy

2026-525913-30-00Immune system diseases

DrugsBelumosudil·Ixazomib·Imatinib·Sirolimus

Sanofi-Aventis Recherche & Developpement

Immune System Diseases

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

02/09/2026

Phase II

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

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

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Spain, Hungary, Romania, Slovakia, Poland, Germany

31/08/2026

Phase II

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

2025-524905-34-00Solid tumor

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

25/08/2026

Phase III

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

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

Biocodex

Nervous System Diseases

Bulgaria, France, Romania, Czechia

24/08/2026

Phase III

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (both in Combination with the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women with HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3)

2025-524846-85-00HR-positive, HER2-negative, inoperable locally advanced o…

DrugsRibociclib·Letrozole

Laboratorios Farmaceuticos Rovi S.A.

Neoplasms

Romania, Spain, Bulgaria, Czechia, Latvia, Poland, Croatia, Slovakia

21/08/2026

Phase III

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

2025-524934-24-00Neoplasms, Gastrointestinal Stromal

Glaxosmithkline Research & Development Limited

Neoplasms

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

21/08/2026

Phase III

A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants with Stage IIB/C-III Melanoma Following Complete Resection

2025-525093-11-00Stage IIB/C-III Melanoma

Alvotech Swiss AG

Neoplasms

Romania, Spain

21/08/2026

Phase I/II

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

2025-525036-34-00Solid Tumours

DrugsImlunestrant·Fulvestrant

Terremoto Biosciences Inc.

Neoplasms

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

18/08/2026

Phase II

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

2023-509125-41-00Severe asthma

DrugSalbutamol

Kinaset Therapeutics Inc.

Respiratory Tract Diseases

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

14/08/2026

Phase III

A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects with Schizophrenia, Followed by a 40-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications

2026-525925-19-00Schizophrenia with negative symptoms

DrugsAripiprazole·Risperidone·Olanzapine

Minerva Neurosciences Inc.

Mental Disorders

Bulgaria, Romania

10/08/2026

Phase III

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs

2025-523333-26-00Graves' Disease (GD)

Argenx

Hormonal diseases

Italy, Czechia, Spain, Denmark, Belgium, Romania, Latvia, France, Germany, Greece, Sweden, Poland, Lithuania, Bulgaria

07/08/2026

Phase I

A study of enzomenib investigating potential drug-drug interactions and the effect of liver impairment in adult patients with advanced cancer

2025-524652-63-00Advanced Cancer

Sumitomo Pharma America Inc.

Neoplasms

Spain, Bulgaria, Poland, Romania

04/08/2026

Phase III

A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

2025-523884-39-00Systemic sclerosis

DrugNerandomilast

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

Skin and Connective Tissue Diseases

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

03/08/2026

Phase III

A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease

2026-525922-39-00Moderately to Severely Active Crohn’s Disease

Janssen Cilag International

Immune System Diseases

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

03/08/2026

Phase III

A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis

2026-525923-26-00Moderately to Severely Active Ulcerative Colitis

DrugsJNJ-78934804·Guselkumab

Janssen Cilag International

Immune System Diseases

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

03/08/2026

Phase III

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

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

AstraZeneca AB

Cardiovascular Diseases

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

29/07/2026

Phase III

A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

2025-522488-14-00Participants with obesity with or without type 2 diabetes

Novo Nordisk A/S

Nutritional and Metabolic Diseases

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

27/07/2026

Phase III

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

2025-523994-41-00Chronic kidney disease (CKD) in adults, with specified rang…

DrugsElecoglipron·Dapagliflozin

AstraZeneca AB

Cardiovascular Diseases

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

24/07/2026

Phase III

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

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

DrugCrinecerfont

Neurocrine Biosciences Inc.

Hormonal diseases

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

23/07/2026

Phase III

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

2026-525727-24-00No medical condition

Chemo Research S.L.

Not possible to specify

Sweden, Czechia, Spain, Hungary, Poland, Finland, Romania

23/07/2026

Phase III

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

2026-525242-29-00Primary Sclerosing Cholangitis

DrugElafibranor

Ipsen Bioscience Inc.

Digestive System Diseases

Spain, Sweden, Germany, Romania, Finland, Portugal, Austria, Italy, Denmark, Czechia, France, Netherlands, Poland, Belgium, Norway

21/07/2026

Phase III

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

2025-522227-99-00Huntington’s Disease

DrugVotoplam

Novartis Pharma AG

Nervous System Diseases

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

20/07/2026

Phase II

An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension due to Interstitial Lung Disease

2026-525810-80-00Pulmonary hypertension secondary to interstitial lung disea…

Tectonic Operating Company Inc.

Cardiovascular Diseases

Poland, Romania, Spain

17/07/2026

Phase III

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

2025-524463-20-00Asthma

DrugsDopamine·Depemokimab

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

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

14/07/2026

Phase III

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Xembify versus Gamunex-C in Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

2025-522165-30-00Chronic inflammatory demyelinating polyradiculoneuropathy (…

Grifols Therapeutics LLC

Nervous System Diseases

Romania, Czechia, Poland

07/07/2026

Phase II

A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MTX-474 in the Treatment of Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

2025-523288-39-00Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Mediar Therapeutics Inc.

Immune System Diseases

Netherlands, Romania, Poland, France, Italy, Spain

06/07/2026

Phase III

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

2024-518213-25-00Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

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

06/07/2026

Phase I

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.

2026-525421-20-00Seasonal allergic rhinitis

Sun Pharmaceutical Industries Limited

Immune System Diseases

Romania

01/07/2026

Phase I

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.

2026-525420-22-00Seasonal allergic rhinitis

Sun Pharmaceutical Industries Limited

Immune System Diseases

Romania

01/07/2026

Phase III

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

2025-521769-29-00Pulmonary Hypertension Associated with Interstitial Lung Di…

DrugTreprostinil Palmitil

Insmed Inc.

Respiratory Tract Diseases

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

30/06/2026

Phase III

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

2025-524855-30-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…

Merck Healthcare KGaA

Skin and Connective Tissue Diseases

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

29/06/2026

Phase III

2025-523871-44-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…

DrugEnpatoran

Merck Healthcare KGaA

Immune System Diseases

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

29/06/2026

Phase III

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)

2024-519299-16-00Cancer Associated Thrombosis

Regeneron Pharmaceuticals Inc.

Cardiovascular Diseases

Bulgaria, Romania

26/06/2026

Phase I

A Phase 1 Study of LBL-051 in Patients with Refractory Autoimmune Disease

2026-525621-20-00B-cell–mediated autoimmune diseases

Oblenio Bio Inc.

Immune system processes

Germany, Romania, Poland

25/06/2026

Phase I

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

2025-524746-96-00Rheumatoid Arthritis

Jade Biosciences Inc.

Immune System Diseases

Romania, Bulgaria, Germany

25/06/2026

Phase III

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

2025-524322-18-00Non-active Secondary Progressive Multiple Sclerosis (SPMS)

DrugOrelabrutinib

Zenas Biopharma (USA) LLC

Nervous System Diseases

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

22/06/2026

Phase I

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

2025-525158-20-00Stage IIB/C, Stage III, or Stage IV Melanoma

Biocon Biologics UK PLC

Neoplasms

Spain, Romania

22/06/2026

Phase II

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

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

DrugsSPYPBO-101·SPY001·SPY002·SPY003

Spyre Therapeutics Inc.

Digestive System Diseases

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

16/06/2026

Phase I/II

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.

2025-523590-42-00Locally Advanced or Metastatic Solid Tumors

Crescent Biopharma Inc.

Neoplasms

Spain, Ireland, Italy, France, Romania

02/06/2026

Phase III

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

2022-502365-26-00Asthma

DrugSalbutamol

Novartis Pharma AG

Respiratory Tract Diseases

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

01/06/2026

Phase III

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

2025-524241-27-00Treatment-naїve mantle cell lymphoma (MCL)

DrugsOrelabrutinib·Bendamustine·Rituximab

Innocare Pharma Inc.

Neoplasms

Poland, France, Czechia, Spain, Romania

01/06/2026

Phase III

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

2025-524062-16-00Schizophrenia and Autism Spectrum Disorder (ASD)

Bristol-Myers Squibb Services Unlimited Company

Nervous System Diseases

Romania

29/05/2026

Phase I

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

2025-525113-22-00Rheumatoid Arthritis

Neurocrine Biosciences Inc.

Immune System Diseases

Poland, Romania

29/05/2026

Phase II

An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

2025-521757-16-00Hallucinations and Delusions Associated with Alzheimer’s Di…

Maplight Therapeutics Inc.

Mental Disorders

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

27/05/2026

Phase I

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

2025-525078-12-00healthy subjects

Antibiotice S.A.

Bacterial Infections and Mycoses

Romania

22/05/2026

Phase III

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

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

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

22/05/2026

Phase II

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

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

DrugPembrolizumab

Eikon Therapeutics Inc.

Neoplasms

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

21/05/2026

Phase III

A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)

2025-521632-12-00Patients on Factor Xa inhibitor treatment needing an urgent…

VarmX B.V.

Hemic and Lymphatic Diseases

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

19/05/2026

Phase II

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

2025-523425-17-00Proteinuric kidney diseases

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

Nutritional and Metabolic Diseases

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

19/05/2026

Phase I/II

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

2025-524090-16-00Relapsed/Refractory Small Cell Lung Cancer

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Italy, Spain, Romania

18/05/2026

Phase III

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

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

DrugOrelabrutinib

Zenas Biopharma (USA) LLC

Nervous System Diseases

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

18/05/2026

Phase IV

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.

2025-524289-56-00Asthma

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

Germany, Romania, Italy, Bulgaria, Poland, Slovakia, Spain, France

18/05/2026

Phase III

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%

2025-523586-18-00Non-Small Cell Lung Cancer

DrugPembrolizumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

15/05/2026

Phase III

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

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

DrugSemaglutide

Novo Nordisk A/S

Nutritional and Metabolic Diseases

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

15/05/2026

Phase III

A 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

2025-524810-28-00Acute Promyelocytic Leukemia

DrugArsenic Trioxide

Quetzal Therapeutics LLC

Neoplasms

Germany, Poland, Spain, Romania, Italy, France

13/05/2026

Phase III

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

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

F. Hoffmann-La Roche AG

Nutritional and Metabolic Diseases

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

13/05/2026

Phase III

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

2025-521950-41-00severe uncontrolled asthma

DrugGB-0895

Generate Biomedicines Inc.

Respiratory Tract Diseases

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

12/05/2026

Phase III

DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.

2025-520565-51-00small cell lung cancer

DrugsObrixtamig·Tocilizumab·Atezolizumab·Carboplatin

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

Neoplasms

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

12/05/2026

Phase III

J5E-MC-JZXB - FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer

2025-522255-25-00Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neop…

Eli Lilly & Co.

Neoplasms

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

11/05/2026

Phase III

A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies

2025-522983-33-00Chronic rhinosinusitis with nasal polyps

DrugItepekimab

Sanofi-Aventis Recherche & Developpement

Respiratory Tract Diseases

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

11/05/2026

Phase I

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.

2025-523411-11-00Seasonal affective disorder, Major depressive disorder

Sun Pharmaceutical Industries Limited

Mental Disorders

Romania

05/05/2026

Phase I

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.

2025-523410-84-00Seasonal affective disorder, Major depressive disorder

Sun Pharmaceutical Industries Limited

Mental Disorders

Romania

05/05/2026

Phase I

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.

2025-524935-38-00(Ph+) Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemi…

Sun Pharmaceutical Industries Limited

Neoplasms

Romania

05/05/2026

Phase III

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

2025-523811-12-00Achondroplasia

DrugVosoritide

Biomarin Pharmaceutical Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Poland, Italy, Romania, France, Norway

05/05/2026

Phase III

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

2025-523552-31-00Systemic Lupus Erythematosus

Janssen Cilag International

Immune System Diseases

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

05/05/2026

Phase II

A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration

2025-523704-77-00Geographic atrophy secondary to age-related macular degener…

Novartis Pharma AG

Eye Diseases

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

04/05/2026

Phase III

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

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

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Italy, Croatia, Hungary, Slovakia, Romania

04/05/2026

Phase II

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

2025-523488-39-00Systemic lupus erythematosus

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

Immune System Diseases

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

04/05/2026

Phase I

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.

2025-524267-20-00Adjuvant treatment of BRAF V600E or V600K mutation-positive…

Sun Pharmaceutical Industries Limited

Neoplasms

Romania

30/04/2026

Phase III

A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter clinical trial to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole in maintenance of healing in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D

2025-522750-39-00Erosive esophagitis (EE) due to gastroesophageal reflux dis…

Cinclus Pharma Holding AB (publ)

Digestive System Diseases

Hungary, Germany, Romania, Bulgaria, Czechia, Poland

28/04/2026

Phase III

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

2023-509176-42-00Obesity and T2D

DrugsCagrilintide·Semaglutide

Novo Nordisk A/S

Nutritional and Metabolic Diseases

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

28/04/2026

Phase III

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

2025-522552-20-00Lennox-Gastaut Syndrome

Epygenix Therapeutics Inc.

Nervous System Diseases

Italy, Spain, Hungary, Romania, Czechia, Poland

28/04/2026

Phase II

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

2024-514246-37-00Idiopathic pulmonary fibrosis (IPF)

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

Belgium, Germany, Italy, Czechia, Bulgaria, Netherlands, France, Portugal, Poland, Spain, Romania

27/04/2026

Phase III

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

2024-519298-21-00Cancer-Associated Thrombosis (CAT).

DrugCenvacibart

Regeneron Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

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

27/04/2026

Phase I

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

2025-523678-17-00rheumatoid arthritis

SciRhom GmbH

Immune System Diseases

Romania

24/04/2026

Phase III

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

2025-524209-34-00Chemotherapy induced thrombocytopenia

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Not possible to specify

France, Romania, Poland, Spain, Bulgaria

21/04/2026

Phase III

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

2025-523659-73-00Overweight, Obesity

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Spain, Romania, Belgium, Czechia

21/04/2026

Phase III

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

2025-524366-21-00treatment-naive Chronic Lymphocytic Leukemia

BeOne Medicines I GmbH

Neoplasms

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

20/04/2026

Phase II

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

2025-523793-16-00Homeostatic iron regulator gene-related hereditary hemochro…

CSL Behring LLC

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Austria, Poland, Spain, Germany, France, Ireland, Romania, Belgium, Italy, Czechia, Netherlands

20/04/2026

Phase III

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)

2025-523711-11-00Schizophrenia

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Romania

20/04/2026

Phase I

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.

2025-524311-37-00chronic myeloid leukemia, Philadelphia chromosome-positive …

Sun Pharmaceutical Industries Limited

Neoplasms

Romania

20/04/2026

Phase III

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

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

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

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

17/04/2026

Phase III

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

2025-523975-48-00Obesity

DrugBerobenatide

Metsera Inc.

Nutritional and Metabolic Diseases

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

16/04/2026

Phase II

A Phase 2b, Randomized, Double blind, Placebo controlled, Parallel group, Multicenter, Dose ranging Study Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Adult Participants with Uncontrolled Moderate to Severe Eosinophilic Asthma

2025-523180-38-00Uncontrolled Moderate to Severe Eosinophilic Asthma

Kymera Therapeutics Inc.

Immune System Diseases

Spain, Romania, Slovakia, Poland, Germany, Italy, Belgium, Austria

10/04/2026

Phase I

A first in human study of people with chronic hepatitis B, where all participants will receive the new drug PBGENE-HBV. This study will use increasing dose amounts of the drug to see how safe and bearable it is. The study will also test how well PBGENE-HBV works and how it is processed by the body.

2025-524157-13-00Chronic Hepatitis B

Precision Biosciences Inc.

Virus Diseases

Romania, France

08/04/2026

Phase III

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

2025-521108-23-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

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

07/04/2026

Phase III

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1RA IN PEOPLE WITH OVERWEIGHT OR OBESITY: A PHASE 3, MULTI-CENTER RANDOMIZED, CONTROLLED TRIAL (VESPER-4)

2025-523974-18-00Obesity

DrugBerobenatide

Metsera Inc.

Nutritional and Metabolic Diseases

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

02/04/2026

Phase III

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder

2025-523618-10-00Major Depressive Disorder

Xenon Pharmaceuticals Inc.

Mental Disorders

Finland, Poland, Romania, Slovakia, Spain, Germany

30/03/2026

Phase II

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

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

Navigator Medicines Inc.

Skin and Connective Tissue Diseases

Hungary, Poland, Germany, Bulgaria, Romania

25/03/2026

Phase II

An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects with Advanced Non-small Cell Lung Cancer (NSCLC)

2025-523803-31-00Advanced non-small cell lung cancer (NSCLC)

Shanghai Henlius Biotech Inc.

Therapeutics

Italy, Romania, Poland, Spain, France

25/03/2026

Phase II

A Phase 2, randomized, placebo-controlled, double-blind clinical study to evaluate efficacy and safety of LAD603 in adult subjects with severe to very severe alopecia areata

2025-523342-27-00Alopecia areata

Almirall S.A.

Skin and Connective Tissue Diseases

Bulgaria, Romania, Poland, Germany, Spain

24/03/2026

Phase I

Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants

2025-521758-40-00Geographic Atrophy

Regeneron Pharmaceuticals Inc.

Eye Diseases

Romania

23/03/2026

Phase II

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults with Schizophrenia Who Warrant Inpatient Hospitalization

2025-521868-35-00Schizophrenia

Neurocrine Biosciences Inc.

Mental Disorders

Romania, Poland, Bulgaria, Croatia

23/03/2026

Phase II

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

2025-522338-30-00Ulcerative Colitis

Eli Lilly & Co.

Digestive System Diseases

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

18/03/2026

Phase I/II

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

2025-523742-27-00Advanced solid tumors

Medilink Therapeutics (Suzhou) Co. Ltd.

Neoplasms

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

17/03/2026

Phase III

A multicentre, randomised, double-blind, parallel group, placebo-controlled trial to assess the effects of oral TRPC6 inhibitor BI 764198 taken over a 104 week treatment period in adult and adolescent participants with primary focal segmental glomerulosclerosis (pFSGS) or genetic FSGS related to TRPC6 gene variants

2025-522191-86-00Focal segmental glomerulosclerosis

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

Female Urogenital Diseases and Pregnancy Complications

Germany, Croatia, Poland, Sweden, Portugal, Netherlands, Italy, Denmark, Slovakia, Spain, Norway, Romania, Belgium, Greece, France

17/03/2026

Phase III

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

2025-522542-40-00Acute Ischemic Stroke

Boehringer Ingelheim International GmbH

Cardiovascular Diseases

Greece, Norway, Hungary, Romania, Spain, Bulgaria

11/03/2026

Phase II

A Phase II, multinational, multicentre, double-blind, randomised, active-controlled, 3-way cross-over study to evaluate the therapeutic equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in subjects with mild to moderate asthma. [TRECONY]

2025-521456-35-00Mild to moderate asthma

Chiesi Farmaceutici S.p.A.

Respiratory Tract Diseases

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

11/03/2026

Phase III

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy in Participants with Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

2025-523263-37-00Previously Untreated Advanced or Metastatic Gastric, Gastro…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Germany, Spain, Poland, France, Italy, Romania

10/03/2026

Phase III

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

2025-523224-45-00Untreated, Unresectable or Metastatic Colorectal Cancer

DrugsCalcium folinate·Fluorouracil·Irinotecan·Capecitabine

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Sweden, Czechia, Belgium, Romania, Netherlands, Italy, France, Spain, Germany, Poland, Austria

10/03/2026

Phase II

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

2024-518013-25-00Idiopathic Pulmonary Fibrosis

AbbVie Deutschland GmbH & Co. KG

Respiratory Tract Diseases

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

10/03/2026

Phase III

PaTHway Adolescent - A Phase 3, Multicenter, Open-Label Single-Arm Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Palopegteriparatide Administered Subcutaneously Daily in the Adolescent Population (12 Years to Less Than 18 Years of Age) with Chronic Hypoparathyroidism

2025-523928-52-00Chronic hypoparathyroidism

Ascendis Pharma Bone Diseases A/S

Hormonal diseases

Germany, France, Romania, Poland

09/03/2026

Phase II

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

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

DrugBalinatunfib

Sanofi-Aventis Recherche & Developpement

Digestive System Diseases

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

06/03/2026

Phase III

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

2025-521546-23-00Secondary progressive multiple sclerosis

Novartis Pharma AG

Nervous System Diseases

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

03/03/2026

Phase III

HighLiGHts - A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents with Growth Failure or Short Stature due to Growth Hormone Sufficient Disorders – Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature

2025-523079-44-00Turner Syndrome (TS), idiopathic short stature (ISS), short…

Ascendis Pharma Endocrinology Division A/S

Musculoskeletal Diseases

Germany, Spain, Italy, France, Romania

27/02/2026

Phase III

A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)

2025-522471-28-00psoriatic arthritis (PsA)

DrugSonelokimab

MoonLake Immunotherapeutics AG

Musculoskeletal Diseases

Estonia, Croatia, Slovakia, Lithuania, Romania, Hungary, Germany, France, Latvia, Poland, Portugal, Greece, Czechia, Bulgaria, Finland, Spain

25/02/2026

Phase III

J2A-MC-GZPW: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

2025-523123-22-00Atherosclerosis Cardiovascular Disease, Chronic Kidney Dise…

Eli Lilly & Co.

Cardiovascular Diseases

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

24/02/2026

Phase II

J2R-MC-YAAD: A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease

2025-522204-24-00Neoplasms, Vomiting, Drug-Related Side Effects and Adverse …

Eli Lilly & Co.

Neoplasms

Romania, Spain, France, Italy

23/02/2026

Phase I

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fasting condition.

2025-523838-13-00plaque psoriasis

Sun Pharmaceutical Industries Limited

Immune System Diseases

Romania

19/02/2026

Phase I

2025-523839-18-00plaque psoriasis

Sun Pharmaceutical Industries Limited

Immune System Diseases

Romania

19/02/2026

Phase III

A phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer (OPERA-02)

2025-522873-12-00ER+, HER2- Advanced Breast Cancer

Olema Pharmaceuticals Inc.

Neoplasms

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

17/02/2026

Phase III

Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab versus Placebo in Patients with Cancer-associated Cachexia

2025-523533-25-00Cancer-associated Cachexia

CatalYm GmbH

Nutritional and Metabolic Diseases

France, Czechia, Romania, Italy, Germany, Poland, Spain, Bulgaria, Norway, Ireland, Netherlands

13/02/2026

Phase III

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

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

Syndax Pharmaceuticals Inc.

Neoplasms

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

13/02/2026

Phase I

A Participant- and Investigator--Blinded, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants with Chronic Kidney Disease

2025-520978-18-00Chronic Kidney Disease

Novartis Pharma AG

Female Urogenital Diseases and Pregnancy Complications

Germany, Romania

10/02/2026

Phase III

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

2025-520805-10-00Chronic inflammatory demyelinating polyneuropathy (CIDP)

DrugEmpasiprubart

Argenx

Nervous System Diseases

Czechia, Denmark, Poland, Slovenia, Netherlands, Austria, Estonia, Slovakia, Hungary, Finland, Bulgaria, France, Italy, Greece, Romania

10/02/2026

Phase I/II

Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta.

2025-522729-36-00Chronic Hepatitis Delta.

Gilead Sciences Inc.

Virus Diseases

Italy, Romania, Germany, Bulgaria

09/02/2026

Phase III

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

2025-522229-37-00Gastrointestinal Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

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

06/02/2026

Phase III

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

2025-522015-42-00Chronic Hepatitis D Infection

Mirum Pharmaceuticals Inc.

Virus Diseases

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

03/02/2026

Phase III

ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

2025-522960-34-00High cardiovascular risk, Hypertension, Established cardiov…

Alnylam Pharmaceuticals Inc.

Cardiovascular Diseases

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

03/02/2026

Phase III

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

2025-523347-35-00Atopic Dermatitis

AbbVie Deutschland GmbH & Co. KG

Immune System Diseases

Spain, Italy, Romania

02/02/2026

Phase I

A clinical study of MK-1045 in people with lupus or rheumatoid arthritis (MK-1045-004)

2025-523412-36-00Systemic lupus erythematosus, Rheumatoid arthritis

Merck Sharp & Dohme LLC

Immune System Diseases

Italy, Belgium, Romania, Spain

02/02/2026

Phase I

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Maribavir Tablets 200 mg, manufactured by Sun Pharmaceutical Industries Limited, India with LIVTENCITY® (Maribavir) Coated Tablets 200 mg, manufactured by: Catalent CTS, LLC Kansas City, United States of America, packed by: Takeda Ireland Limited Bray, Ireland, imported by: Takeda Pharma Ltda. Highway SP 340 S/N, km 133.5 Jaguariúna Administrative Building -SP CNPJ 60.397.775/0001-74 SAC: 0800 - 7710345, in healthy adult, human subjects under fasting condition.

2025-523487-21-00cytomegalovirus (CMV) infection and/or disease that is refr…

Sun Pharmaceutical Industries Limited

Virus Diseases

Romania

02/02/2026

Phase III

N1T-MC-MALO: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD

2025-522674-36-00Metabolic Dysfunction-Associated Steatotic Liver Disease

Eli Lilly & Co.

Nutritional and Metabolic Diseases

Czechia, France, Netherlands, Bulgaria, Norway, Austria, Poland, Spain, Italy, Hungary, Germany, Romania, Sweden, Portugal, Belgium

27/01/2026

Phase I

A PK study to compare JPB898 (proposed nivolumab biosimilar) and US-licensed Opdivo® in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting

2025-521919-39-00Resected stage IIB, IIC, or III melanoma requiring adjuvant…

H e x a l AG

Neoplasms

Spain, Romania, Italy, Greece

27/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallelgroup Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

2025-521558-40-00Pulmonary Hypertension Associated with Interstitial Lung Di…

DrugTreprostinil Palmitil

Insmed Inc.

Respiratory Tract Diseases

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

26/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

2025-523202-32-00Major Depressive Disorder

Xenon Pharmaceuticals Inc.

Mental Disorders

Spain, Czechia, Slovakia, Romania, Poland, Finland, Germany

26/01/2026

Phase III

J2A-MC-GZPS: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared with Placebo in Female Participants with Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI) ; J2A-MC-GZS1: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight ; J2A-MC-GZS2: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight

2025-522514-23-00Urinary Incontinence, Stress

Eli Lilly & Co.

Female Urogenital Diseases and Pregnancy Complications

Romania, Czechia, Poland

26/01/2026

Phase III

Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations

2025-521284-12-00Non-small cell lung cancer

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

Neoplasms

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

19/01/2026

Phase III

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

2025-521908-22-00EGFR-mutated Non-small Cell Lung Cancer

DrugsPegfilgrastim·Iza-bren·Pemetrexed·Cisplatin

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

19/01/2026

Phase III

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

2023-503766-24-00Moderate to Severe Plaque Psoriasis

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

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

19/01/2026

Phase III

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

2025-521858-42-00Hemophilia

DrugFitusiran

Sanofi-Aventis Recherche & Developpement

Hemic and Lymphatic Diseases

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

15/01/2026

Phase III

A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals with Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

2025-521845-26-00BP-I mania or mania with mixed features

DrugKarXT

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Romania, Poland, France, Italy, Denmark, Bulgaria

15/01/2026

Phase III

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

2025-521917-24-00Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous…

Janssen Cilag International

Neoplasms

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

14/01/2026

Phase II

A multicenter, double-blind, randomized, placebo-controlled, parallel-group, twelve-week treatment proof-of-concept trial to explore the efficacy and safety of IDOR-1117-2520 in adults with moderate to severe chronic plaque psoriasis with or without psoriatic arthritis.

2025-523051-64-00Moderate to severe chronic plaque psoriasis

Idorsia Pharmaceuticals Ltd.

Immune System Diseases

Romania, Bulgaria

07/01/2026

Phase III

A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer

2024-515765-34-00English First-line extensive-stage small-cell lung cancer (…

BioNTech SE

Neoplasms

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

22/12/2025

Phase III

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

2025-522400-24-00Metastatic urothelial cancer

Bristol-Myers Squibb Services Unlimited Company

Male Urogenital Diseases

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

19/12/2025

Phase I

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of CND261 in Patients with Seropositive Rheumatoid Arthritis

2025-523265-15-00Seropositive Rheumatoid Arthritis

Candid Therapeutics Inc.

Immune System Diseases

Romania

16/12/2025

Phase II

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

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

Novartis Pharma AG

Hemic and Lymphatic Diseases

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

08/12/2025

Phase I

A Study to Evaluate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Xdivane versus Opdivo® in Patients with Resected Melanoma

2025-522307-14-00Melanoma

Intas Pharmaceuticals Limited

Neoplasms

Spain, Romania

08/12/2025

Phase III

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

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

Janssen Cilag International

Immune System Diseases

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

01/12/2025

Phase III

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

2025-521381-10-00Moderately to Severely Active Ulcerative Colitis

Janssen Cilag International

Digestive System Diseases

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

01/12/2025

Phase III

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

2024-520097-36-00Chronic inflammatory demyelinating polyneuropathy (CIDP)

DrugEmpasiprubart

Argenx

Nervous System Diseases

Czechia, Bulgaria, Netherlands, Hungary, Sweden, Slovakia, Slovenia, Greece, Norway, Poland, Italy, Spain, Estonia, Denmark, France, Romania, Portugal, Austria, Germany

01/12/2025

Phase III

A Randomized, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-Paclitaxel and Gemcitabine versus Placebo in Combination With Nab-Paclitaxel and Gemcitabine in Participants with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion

2025-522598-12-00Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

28/11/2025

Phase II

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

2024-519335-42-01Systemic Sclerosis

Zura Bio Inc.

Immune System Diseases

Hungary, Romania, Poland, Spain

27/11/2025

Phase III

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

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

Merck Sharp & Dohme LLC

Neoplasms

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

27/11/2025

Phase III

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

2024-513911-28-00Acute Ischemic Stroke

Diamedica Therapeutics Inc.

Nervous System Diseases

Romania, Hungary, Belgium, Poland, Spain, France

25/11/2025

Phase I

A Phase 1b open label pilot study of CLN-978 for the treatment of moderate to severe systemic lupus erythematosus (SLE)

2024-518780-36-00Systemic Lupus Erythematosus

Cullinan Therapeutics Inc.

Musculoskeletal Diseases

Bulgaria, Romania, France, Germany, Spain, Poland

25/11/2025

Phase III

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

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

DrugsCasdatifan·Cabozantinib

Arcus Biosciences Inc.

Neoplasms

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

24/11/2025

Phase II

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

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

Immunovant Sciences GmbH

Immune System Diseases

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

24/11/2025

Phase III

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

2024-520417-41-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

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

24/11/2025

Phase II

A Phase 2, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of 2 doses of vipoglanstat in patients with moderate to severe endometriosis-related pain – the NOVA trial

2025-522452-16-00Endometriosis related pain

Gesynta Pharma AB

Female Urogenital Diseases and Pregnancy Complications

Italy, Hungary, Poland, Czechia, Bulgaria, Romania

21/11/2025

Phase III

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

2025-521216-19-00Schizophrenia, Schizophrenia

Neurocrine Biosciences Inc.

Mental Disorders

Romania, Hungary, Bulgaria

21/11/2025

Phase III

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

2024-518615-19-00Major Depressive Disorder

Janssen Cilag International

Mental Disorders

Italy, Hungary, Spain, Romania

19/11/2025

Phase III

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

2025-522860-34-00Small lymphocytic lymphoma (SLL), Chronic lymphocytic leuke…

BeOne Medicines AG

Neoplasms

Sweden, Belgium, Spain, Germany, Austria, Netherlands, Italy, Romania, Poland, France

18/11/2025

Phase III

Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivo in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)

2025-521562-95-00Previously Untreated Advanced (Unresectable or Metastatic) …

DrugNivolumab

Mabxience Research S.L.

Musculoskeletal Diseases

Italy, Spain, Slovakia, Romania, Portugal, Greece, Poland

18/11/2025

Phase III

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

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

Relay Therapeutics Inc.

Neoplasms

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

11/11/2025

Phase II

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

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

DrugsSPYPBO-101·SPY001·SPY002·SPY003

Spyre Therapeutics Inc.

Digestive System Diseases

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

10/11/2025

Phase III

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

2025-521215-39-00Schizophrenia

Neurocrine Biosciences Inc.

Mental Disorders

Hungary, Romania, Bulgaria

07/11/2025

Phase II

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

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

Seaport Therapeutics Inc.

Mental Disorders

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

06/11/2025

Phase I/II

A Multicenter First-in-human Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of the 5T4 Antibody-Drug Conjugate TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01)

2025-522517-35-00Patients with advanced/metastatic tumors with head and neck…

Gilead Sciences Inc.

Neoplasms

France, Spain, Romania

03/11/2025

Phase I/II

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

2024-520197-36-00Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

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

03/11/2025

Phase I

A study to find how well budoprutug (TNT119) works and how safe it is in participants with Systemic Lupus Erythematosus

2024-520385-57-01Systemic Lupus Erythematosus

Climb Bio Inc.

Immune System Diseases

Romania, Bulgaria, Greece, Spain

31/10/2025

Phase III

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

2024-519531-41-00Overweight and obesity

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Czechia, Romania, Croatia, Slovakia, Hungary

29/10/2025

Phase II

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

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

Immunovant Sciences GmbH

Immune System Diseases

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

28/10/2025

Phase II

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

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

Maplight Therapeutics Inc.

Nervous System Diseases

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

27/10/2025

Phase I

A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Bupropion Hydrochloride Sustained-Release Tablets 150 mg, manufactured for Sun Pharmaceutical Industries Limited, India with PrOdan Bupropion SR (Bupropion Hydrochloride Sustained-Release Tablets 150 mg), product of Odan Laboratories Ltd., 325 Stillview Avenue, Pointe Claire, Quebec, H9R 2Y6, in healthy adult, human subjects under fasting condition.

2024-516034-35-00major depressive illness

Sun Pharmaceutical Industries Limited

Mental Disorders

Romania

27/10/2025

Phase I

2024-516035-27-00major depressive illness

Sun Pharmaceutical Industries Limited

Mental Disorders

Romania

27/10/2025

Phase I

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTIPLE RISING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF DEURUXOLITINIB IN HEALTHY ADULTS

2025-522097-36-00alopecia areata

Sun Pharmaceutical Industries Inc.

Immune System Diseases

Romania

27/10/2025

Phase III

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

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

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

24/10/2025

Phase III

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

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

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

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

21/10/2025

Phase III

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

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

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

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

21/10/2025

Phase III

2025-520747-32-00Mild to moderate Alzheimer’s Disease

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Germany, Netherlands, Portugal, France, Spain, Poland, Greece, Romania, Italy, Finland

21/10/2025

Phase III

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

2024-515979-35-00Generalized Myasthenia Gravis

Immunovant Sciences GmbH

Nervous System Diseases

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

20/10/2025

Phase III

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

2025-520613-31-00Agitation Associated with Alzheimer’s Disease

Bristol-Myers Squibb Services Unlimited Company

Mental Disorders

Portugal, Croatia, Bulgaria, Greece, Spain, Romania

20/10/2025

Phase III

IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC who are Ineligible for Anti-PD1/PD-L1 Treatment

2024-519871-24-00Breast cancer, Triple-negative breast cancer

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

France, Portugal, Romania, Greece, Italy, Spain, Sweden, Austria, Poland, Germany

17/10/2025

Phase III

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

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

Alnylam Pharmaceuticals Inc.

Cardiovascular Diseases

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

14/10/2025

Phase III

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

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

Eli Lilly & Co.

Cardiovascular Diseases

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

13/10/2025

Phase III

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

2025-520478-20-00Thromboembolic disease

Regeneron Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Bulgaria, Lithuania, Poland, Hungary, Latvia, Romania

08/10/2025

Phase III

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

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

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

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

08/10/2025

Phase III

A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

2025-521775-31-00Stage IB-IIIA NSCLC Patients with uncommon EGFR Mutations

DrugsZipalertinib·Cisplatin·Carboplatin

Taiho Oncology Inc.

Neoplasms

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

06/10/2025

Phase II

A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab plus Nivolumab with or without Docetaxel versus Docetaxel Monotherapy in Second-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-02)

2024-516794-70-00Metastatic non-squamous non-small cell lung cancer

CatalYm GmbH

Neoplasms

Spain, Italy, Germany, Poland, Romania

06/10/2025

Phase III

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2-overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer. (DESTINY-Lung06)

2024-515658-26-00Unresectable or Metastatic HER2 overexpressing and PD-L1 TP…

Daiichi Sankyo Inc.

Neoplasms

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

06/10/2025

Phase III

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

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

Amgen Inc.

Cardiovascular Diseases

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

06/10/2025

Phase III

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

2025-521627-78-00Neoplasms, Lung

Glaxosmithkline Research & Development Limited

Neoplasms

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

29/09/2025

Phase III

A Phase 3b Extension Study to Evaluate the Long-Term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease

2023-508804-39-00Ulcerative Colitis or Crohn’s Disease

Takeda Development Center Americas Inc.

Digestive System Diseases

Spain, Ireland, Portugal, Poland, Belgium, Netherlands, Bulgaria, Romania, Italy, Denmark

29/09/2025

Phase II

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

2025-521243-20-00Acromegaly

Alexion Pharmaceuticals Inc.

Hormonal diseases

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

29/09/2025

Phase II

A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects with Chronic Hepatitis B Virus Infection (B-SUPREME)

2025-521178-33-00Chronic Hepatitis B Virus Infection

Aligos Therapeutics Inc.

Virus Diseases

Spain, Italy, Bulgaria, Romania, France

24/09/2025

Phase III

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

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

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

Cardiovascular Diseases

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

24/09/2025

Phase III

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

2025-521055-23-00Chronic Idiopathic thrombocytopenic purpura

DrugEfgartigimod PH20

Argenx

Immune System Diseases

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

24/09/2025

Phase III

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

2025-520554-11-00Cardiovascular Disease

Amgen Inc.

Cardiovascular Diseases

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

22/09/2025

Phase III

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

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

Maia Biotechnology Inc.

Neoplasms

Poland, Hungary, Romania, Spain, Portugal

18/09/2025

Phase III

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

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

DrugsCalcium levofolinate·Calderasib·Calcium folinate·Fluorouracil

Merck Sharp & Dohme LLC

Neoplasms

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

17/09/2025

Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 16 October 2026. https://priyalifescience.com/clinical-trials-europe/country/romania

Query this register directly

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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,637 trial records at the last sync on 16 Oct 2026, 03:17 UTC; this register shows the 2,557 most recently authorised of them, a stated recency window rather than the full archive. The list can be downloaded as CSV or JSON.

This page shows the 216 of those trials with a site in Romania.

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

216 of the 2,557 most recently authorised trials in this register list a site in Romania; 131 of them are Phase III. Trials are counted by authorisation on CTIS, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Summary by phase

Trials by phase (Romania), 216 trials
Phase	Trials	Share
Phase III	131	60.6%
Phase II	42	19.4%
Phase I	32	14.8%
Phase I/II	8	3.7%
Phase IV	3	1.4%

Most active sponsors

Lead sponsors with the most trials (Romania)
Lead sponsor	Trials
Bristol-Myers Squibb Services Unlimited Company	22
Sun Pharmaceutical Industries Limited	14
Eli Lilly & Co.	9
Regeneron Pharmaceuticals Inc.	8
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.	7
Glaxosmithkline Research & Development Limited	7
Janssen Cilag International	7
Neurocrine Biosciences Inc.	6
Novartis Pharma AG	6
Novo Nordisk A/S	6

Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.