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Trackers› Clinical trials› Romania
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 12561 total CTIS records — a stated recency window, not the full historical archive. Synced 06 Oct 2026, 03:17 UTC
2557
Shown in this register
most recently authorised
12,561
Total on CTIS
full historical archive
776
Phase III
within the shown window
Top member states
Spain 1059 France 917 Germany 897 Italy 756 Poland 605 Netherlands 555
Narrow the registerReset
Phase
Phase I 573 Phase I/II 216 Phase II 728 Phase III 776 Phase IV 264
Lead sponsor
AstraZeneca AB 66 Merck Sharp & Dohme LLC 50 Pfizer Inc. 48 Assistance Publique Hopitaux De Paris 48 Novartis Pharma AG 43
Member state
Spain 1059 France 917 Germany 897 Italy 756 Poland 605 Netherlands 555 Belgium 451 Czechia 340
All 28 states

Trials with a site in Romania

217 of 2557 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants with Atrial Fibrillation (ROXI-EVEREST)
2025-521617-97-00Atrial Fibrillation (AF)
DrugsCenvacibart·Apixaban
Regeneron Pharmaceuticals Inc.
Cardiovascular Diseases
Germany, Italy, Czechia, Austria, Spain, Belgium, Netherlands, Poland, Sweden, Greece, Latvia, Hungary, Bulgaria, Romania
29/09/2026
Phase III
A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, versus Placebo in Participants with Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)
2025-521618-25-00Atrial Fibrillation (AF)
DrugsAmrecibart·Cenvacibart
Regeneron Pharmaceuticals Inc.
Cardiovascular Diseases
Spain, Bulgaria, Hungary, Poland, Romania, Sweden, Germany, Italy, Latvia, Netherlands, Portugal
29/09/2026
Phase II
A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants with COPD
2026-525216-34-00Chronic Obstructive Pulmonary Disease (COPD) exacerbations
Expedition Therapeutics Inc.
Respiratory Tract Diseases
Italy, Germany, Spain, Poland, Czechia, Romania, Hungary, Denmark, Bulgaria
29/09/2026
Phase III
A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants with Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)
2025-522954-37-00Peripheral Artery Disease
DrugsAmrecibart·Cenvacibart·Rivaroxaban
Regeneron Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Spain, Slovakia, Hungary, Czechia, Romania, Estonia, Austria, France, Belgium, Sweden, Italy, Latvia, Poland, Bulgaria, Greece, Germany, Denmark, Lithuania, Netherlands
29/09/2026
Phase 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 (…
DrugsVedolizumab·Infliximab·Pemetrexed·Paclitaxel
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)
2025-524846-85-00​​HR-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
DrugImatinib
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
DrugPembrolizumab
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 …
DrugsElecoglipron·Dapagliflozin
AstraZeneca AB
Cardiovascular Diseases
Spain, Hungary, Germany, Poland, Italy, Bulgaria, Netherlands, Austria, Romania, Sweden, France, Greece, Slovakia, Czechia
29/07/2026
Phase III
A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes
2025-522488-14-00Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Greece, Portugal, France, Slovakia, Bulgaria, Netherlands, Romania, Italy, Austria, Poland, Hungary, Spain, Czechia, Belgium
27/07/2026
Phase III
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)
2025-523994-41-00Chronic kidney disease (CKD) in adults, with specified rang…
DrugsElecoglipron·Dapagliflozin
AstraZeneca AB
Cardiovascular Diseases
Czechia, Italy, Hungary, Romania, Bulgaria, Sweden, Denmark, Poland, Spain, Norway, Finland, Greece, France, Germany
24/07/2026
Phase III
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 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…
DrugEnpatoran
Merck Healthcare KGaA
Skin and Connective Tissue Diseases
Germany, Romania, France, Bulgaria, Belgium, Spain, Poland, Greece, Italy, Czechia
29/06/2026
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
2025-523871-44-00Cutaneous 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 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
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
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
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 two-part, seamless, multicenter, RANDOMIZED, open-label, ADAPTIVE Phase ii/III STUDY OF THE BLOOD-BRAIN barrier PENETRANT RO7771950 versus Tucatinib, both in combination with trastuzumab and capecitabine, in patients with Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without central nervous system metastases
2025-524498-17-00Pretreated Unresectable Locally Advanced or Metastatic huma…
F. Hoffmann-La Roche AG
Neoplasms
Belgium, France, Italy, Austria, Romania, Poland, Portugal, Czechia, Germany, Spain, Hungary
28/04/2026
Phase III
A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter clinical trial to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole in maintenance of healing in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D
2025-522750-39-00Erosive esophagitis (EE) due to gastroesophageal reflux dis…
Cinclus Pharma Holding AB (publ)
Digestive System Diseases
Hungary, Germany, Romania, Bulgaria, Czechia, Poland
28/04/2026
Phase III
Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity
2023-509176-42-00Obesity and T2D
DrugsCagrilintide·Semaglutide
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Slovakia, Austria, Spain, Romania, Portugal, Italy, Denmark, Belgium, Sweden, Poland, Netherlands, Croatia, Hungary, Bulgaria
28/04/2026
Phase III
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
2025-523659-73-00Obesity, Overweight
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
2025-522511-42-00Crohn's disease, Colitis Ulcerative
DrugBalinatunfib
Sanofi-Aventis Recherche & Developpement
Digestive System Diseases
Belgium, Germany, Czechia, Netherlands, Spain, Austria, Italy, Greece, Croatia, Bulgaria, Poland, France, Romania, Hungary
06/03/2026
Phase III
A randomized, double-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
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 fed condition
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
2025-522960-34-00Hypertension, Established cardiovascular disease, High card…
Alnylam Pharmaceuticals Inc.
Cardiovascular Diseases
Belgium, Hungary, Czechia, Austria, Germany, France, Greece, Spain, Romania, Netherlands, Italy, Poland, Slovakia, Sweden, Portugal, Denmark, Bulgaria
03/02/2026
Phase III
A Phase 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
DrugsUstekinumab·Deucravacitinib
Bristol-Myers Squibb Services Unlimited Company
Immune System Diseases
Romania, Bulgaria, Germany, Spain, Czechia, France, Hungary, Italy, Sweden, Poland, Denmark, Belgium
19/01/2026
Phase III
An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX
2025-521858-42-00Hemophilia
DrugFitusiran
Sanofi-Aventis Recherche & Developpement
Hemic and Lymphatic Diseases
Belgium, Italy, Romania, Germany, Hungary, Spain, Poland
15/01/2026
Phase 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
Female Urogenital Diseases and Pregnancy Complications
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
DrugNBI-1117568
Neurocrine Biosciences Inc.
Mental Disorders
Romania, Hungary, Bulgaria
21/11/2025
Phase III
A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior
2024-518615-19-00Major Depressive Disorder
DrugEsketamine
Janssen Cilag International
Mental Disorders
Italy, Hungary, Spain, Romania
19/11/2025
Phase 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
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 fed condition.
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
DrugsKarX-EC·KarXT
Bristol-Myers Squibb Services Unlimited Company
Mental Disorders
Croatia, Romania, France, Spain, Italy, Greece, Czechia, Bulgaria, Poland, Portugal, Hungary
21/10/2025
Phase III
A Phase 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 2)
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
Phase II
A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
2025-520488-42-00Moderate-to-Severe Chronic Obstructive Pulmonary Disease (C…
Upstream Bio Inc.
Respiratory Tract Diseases
Romania, Lithuania, Hungary, Spain, Bulgaria, Ireland, Germany, Latvia, Czechia, Poland, Slovakia
09/09/2025
Phase III
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
2025-521096-31-00Chronic Hepatitis C Virus (HCV) Infection
Atea Pharmaceuticals Inc.
Virus Diseases
Romania, France, Germany, Greece, Poland, Spain
08/09/2025
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
2024-518296-56-00Crohn’s Disease
DrugTulisokibart
Merck Sharp & Dohme LLC
Digestive System Diseases
Spain, Austria, Lithuania, France, Belgium, Germany, Sweden, Czechia, Finland, Croatia, Latvia, Portugal, Netherlands, Italy, Denmark, Slovakia, Romania, Poland, Ireland, Hungary, Greece
03/09/2025
Phase III
A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
2024-520050-38-00Extensive stage small cell lung cancer (ES-SCLC). …
DrugsSiltuximab·Mycophenolate Mofetil·Tarlatamab·Infliximab
Amgen Inc.
Neoplasms
Portugal, Germany, Spain, Italy, Denmark, Netherlands, France, Austria, Greece, Belgium, Hungary, Poland, Romania
01/09/2025
Phase I
A double blinded, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine Delayed Release Tablets USP 1.2 g manufactured by Sun Pharmaceutical Industries Limited, India with Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g product of Takeda Canada Inc., in healthy, adult, human subjects under fasting condition.
2025-522106-20-00ulcerative colitis
Sun Pharmaceutical Industries Limited
Digestive System Diseases
Romania
01/09/2025
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
2024-520195-94-00BP-I mania or mania with mixed features
Bristol-Myers Squibb Services Unlimited Company
Mental Disorders
Slovakia, Spain, Croatia, Sweden, Romania
28/08/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 6 October 2026. https://priyalifescience.com/clinical-trials-europe/country/romania

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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 12,561 trial records at the last sync on 06 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 217 of those trials with a site in Romania.

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

217 of the 2,557 most recently authorised trials in this register list a site in Romania; 132 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), 217 trials
PhaseTrialsShare
Phase III13260.8%
Phase II4319.8%
Phase I3114.3%
Phase I/II83.7%
Phase IV31.4%

Most active sponsors

Lead sponsors with the most trials (Romania)
Lead sponsorTrials
Bristol-Myers Squibb Services Unlimited Company23
Sun Pharmaceutical Industries Limited13
Eli Lilly & Co.9
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.7
Glaxosmithkline Research & Development Limited7
Janssen Cilag International7
Regeneron Pharmaceuticals Inc.7
Neurocrine Biosciences Inc.6
Novartis Pharma AG6
Novo Nordisk A/S6
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.