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Trackers› Clinical trials› Bulgaria
Clinical trial register · European Union · CTIS

Clinical Trials in Bulgaria, 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 12568 total CTIS records — a stated recency window, not the full historical archive. Synced 07 Oct 2026, 03:16 UTC
2557
Shown in this register
most recently authorised
12,568
Total on CTIS
full historical archive
778
Phase III
within the shown window
Top member states
Spain 1060 France 917 Germany 902 Italy 762 Poland 604 Netherlands 554
Narrow the registerReset
Phase
Phase I 570 Phase I/II 216 Phase II 729 Phase III 778 Phase IV 264
Lead sponsor
AstraZeneca AB 67 Merck Sharp & Dohme LLC 50 Pfizer Inc. 48 Assistance Publique Hopitaux De Paris 48 Novartis Pharma AG 44
Member state
Spain 1060 France 917 Germany 902 Italy 762 Poland 604 Netherlands 554 Belgium 452 Czechia 343
All 28 states

Trials with a site in Bulgaria

211 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
Portugal, Germany, Italy, Czechia, Austria, Spain, Belgium, Netherlands, Poland, Sweden, Greece, Latvia, Hungary, Bulgaria, Romania
29/09/2026
Phase III
A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, versus Placebo in Participants with Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)
2025-521618-25-00Atrial Fibrillation (AF)
DrugsAmrecibart·Cenvacibart
Regeneron Pharmaceuticals Inc.
Cardiovascular Diseases
Spain, Bulgaria, Hungary, Poland, Romania, Sweden, Germany, Italy, Latvia, Netherlands, Portugal
29/09/2026
Phase II
A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants with COPD
2026-525216-34-00Chronic Obstructive Pulmonary Disease (COPD) exacerbations
Expedition Therapeutics Inc.
Respiratory Tract Diseases
Italy, Germany, Spain, Poland, Czechia, Romania, Hungary, Denmark, Bulgaria
29/09/2026
Phase III
A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants with Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)
2025-522954-37-00Peripheral Artery Disease
DrugsAmrecibart·Cenvacibart·Rivaroxaban
Regeneron Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Spain, Slovakia, Hungary, Czechia, Romania, Estonia, Austria, France, Belgium, Sweden, Italy, Latvia, Poland, Bulgaria, Greece, Germany, Denmark, Lithuania, Netherlands
29/09/2026
Phase III
A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients with Generalized Myasthenia Gravis (EMERGE)
2026-525298-38-00generalized Myasthenia gravis
DrugClaseprubart
Dianthus Therapeutics Inc.
Immune System Diseases
Czechia, Portugal, Austria, Bulgaria, Germany, France, Latvia, Poland, Italy, Spain, Denmark
28/09/2026
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 Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants with Obesity or Overweight with Type 2 Diabetes Mellitus
2025-524788-19-00Chronic Weight Management
DrugMaridebart cafraglutide
Amgen Inc.
Nutritional and Metabolic Diseases
Germany, Hungary, Czechia, Italy, Poland, Bulgaria
21/09/2026
Phase II
Randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of 2 dose levels of the oral ghrelin receptor agonist AC01 over 12 weeks in patients with chronic advanced heart failure with reduced ejection fraction (HFrEF)
2025-524469-25-00chronic advanced heart failure with reduced ejection fracti…
AnaCardio AB
Cardiovascular Diseases
Czechia, Slovakia, Spain, Bulgaria, Netherlands, Italy, Poland, Germany, Sweden, Hungary
21/09/2026
Phase II
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)
2025-524384-20-00Atopic dermatitis (AD)
DrugSoquelitinib
Corvus Pharmaceuticals Inc.
Skin and Connective Tissue Diseases
Italy, Czechia, Germany, Poland, Spain, Bulgaria
18/09/2026
Phase III
Zenagamtide use for the reduction of risk of major adverse cardiovascular events in people with established atherosclerotic cardiovascular disease and either overweight or obesity (AMBIENCE)
2026-525182-53-00Atherosclerotic cardiovascular disease and either overweigh…
Novo Nordisk A/S
Cardiovascular Diseases
Denmark, Czechia, Greece, France, Italy, Germany, Spain, Poland, Netherlands, Bulgaria
16/09/2026
Phase III
A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study Of Inebilizumab In Participants With Autoimmune Hepatitis
2025-522393-37-00Autoimmune Hepatitis (AIH)
DrugInebilizumab
Amgen Inc.
Digestive System Diseases
Belgium, Germany, Hungary, Czechia, Bulgaria, France, Netherlands, Italy, Poland, Greece, Portugal, Spain
16/09/2026
Phase I
Comparative bioavailability study of Colistin Cyclops® administered as 3 different doses
2025-524657-14-00No therapeutic indication in the current bioavailability tr…
CCDRD Cooperative Clinical Drug Research and Development AG, PureIMS B.V.
Respiratory Tract Diseases
Bulgaria
14/09/2026
Phase II
A multicenter, randomized, double-blind, placebo- controlled Phase 2 study to investigate the efficacy, safety and tolerability of remibrutinib (LOU064) in adult patients with Papulopustular Rosacea (PPR)
2025-524496-23-00Papulopustular Rosacea (PPR)
DrugRemibrutinib
Novartis Pharma AG
Skin and Connective Tissue Diseases
Bulgaria, Spain, France, Italy, Germany
14/09/2026
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 I
Evaluation of the bioequivalence of two intravaginal gel preparations containing 90 mg progesterone
2025-520498-38-00No therapeutic indication in the current trial with healthy…
CCDRD Cooperative Clinical Drug Research and Development AG, Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
Physiological processes
Bulgaria
10/09/2026
Phase II
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants with Moderate-to-Severe Atopic Dermatitis
2026-526184-38-00Atopic Dermatitis
DrugENV-294
Enveda Therapeutics Inc.
Skin and Connective Tissue Diseases
Germany, Czechia, Bulgaria, Poland, Spain
10/09/2026
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, 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 III
A Phase 3, Randomized, Double-blind, Placebo‑controlled Study to Assess the Efficacy and Safety of Engasertib in Subjects With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)
2025-524490-17-00Hereditary Hemorrhagic Telangiectasia (HHT)
DrugEngasertib
Vaderis Therapeutics AG
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Hungary, Netherlands, Germany, Bulgaria, France, Italy, Lithuania, Spain, Belgium
31/08/2026
Phase II
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults with Moderate-to-Severe Atopic Dermatitis
2026-525673-39-00Atopic Dermatitis (AD)
Apollo Therapeutics Limited
Skin and Connective Tissue Diseases
Hungary, Czechia, Germany, Bulgaria, Poland, Spain
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 I
A Two-part study to learn the amount of polymyxin E1 in the body over time formed after a single inhaled dose of colistimethate sodium (CMS) in healthy adults (Part 1) and after single inhaled and vein-infused doses of CMS in adults with non‑cystic fibrosis bronchiectasis (NCFB) (Part 2)
2025-524324-22-00Non-cystic fibrosis bronchiectasis
Zambon S.p.A.
Respiratory Tract Diseases
Belgium, Poland, Bulgaria
17/08/2026
Phase II
A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)
2025-525033-31-00heart failure
DrugCRD-4730
Cardurion Pharmaceuticals Inc.
Cardiovascular Diseases
Latvia, Slovakia, Lithuania, Hungary, Italy, Netherlands, Spain, Poland, Bulgaria, Czechia
14/08/2026
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
Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity
2025-524626-18-00Overweight and obesity
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Netherlands, Belgium, Greece, Poland, Spain, Denmark, France, Bulgaria, Sweden
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 II
[22961] A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.
2025-523807-31-00Atrial fibrillation
Bayer AG
Cardiovascular Diseases
Belgium, Netherlands, Germany, Poland, Italy, Hungary, Bulgaria
06/08/2026
Phase II
A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)
2025-525016-41-00Idiopathic Pulmonary Fibrosis
AstraZeneca AB
Respiratory Tract Diseases
Poland, Hungary, Netherlands, Germany, Spain, Greece, Bulgaria, Italy, France, Denmark
04/08/2026
Phase III
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Placebo in Adults with Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)
2025-523935-20-00type 2 diabetes mellitus
DrugElecoglipron
AstraZeneca AB
Nutritional and Metabolic Diseases
Poland, Germany, Bulgaria, Czechia
04/08/2026
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 Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron compared with Placebo in Adults with Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)
2025-523940-12-00type 2 diabetes mellitus
AstraZeneca AB
Nutritional and Metabolic Diseases
Germany, Bulgaria, Spain, Denmark
03/08/2026
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 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 IV
Effectiveness of Trazodone on Emotional Blunting in Patients with Major Depressive: a Phase IV, Open-label, clinical study
2025-523267-38-00Major depressive disorder (MDD)
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Mental Disorders
Bulgaria, Poland, Hungary
29/07/2026
Phase III
A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)
2026-526304-79-00Heart failure with preserved ejection fraction (HFpEF) and …
AstraZeneca AB
Cardiovascular Diseases
Spain, Hungary, Germany, Poland, Italy, Bulgaria, Netherlands, Austria, Romania, Sweden, France, Greece, Slovakia, Czechia
29/07/2026
Phase III
A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes
2025-522488-14-00Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Greece, Portugal, France, Slovakia, Bulgaria, Netherlands, Romania, Italy, Austria, Poland, Hungary, Spain, Czechia, Belgium
27/07/2026
Phase III
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)
2025-523994-41-00Chronic kidney disease (CKD) in adults, with specified rang…
DrugsElecoglipron·Dapagliflozin
AstraZeneca AB
Cardiovascular Diseases
Czechia, Italy, Hungary, Romania, Bulgaria, Sweden, Denmark, Poland, Spain, Norway, Finland, Greece, France, Germany
24/07/2026
Phase III
A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia
2025-524282-24-00Classic Congenital Adrenal Hyperplasia (CAH)
DrugCrinecerfont
Neurocrine Biosciences Inc.
Hormonal diseases
Czechia, Germany, Sweden, Portugal, Romania, Bulgaria, Italy, Austria, Spain
23/07/2026
Phase III
A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Oral Semaglutide in Adults with Type 2 Diabetes Mellitus (Eluminate-2)
2025-523933-24-00type 2 diabetes mellitus
AstraZeneca AB
Nutritional and Metabolic Diseases
Poland, Hungary, Italy, Bulgaria, Germany
22/07/2026
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 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 I
Evaluation of bioequivalence of two products containing estradiol: Estradiol/INTERMED gel 0.1% w/w (Test) vs. ESTREVA 0.1% gel (Comparator). An open, randomized, single-dose, four-period, full-replicative trial in healthy postmenopausal women
2025-524775-23-00No therapeutic indication in the current trial with healthy…
CCDRD Cooperative Clinical Drug Research and Development AG, Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
Physiological processes
Bulgaria
30/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
2025-524855-30-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…
Merck Healthcare KGaA
Skin and Connective Tissue Diseases
Germany, Romania, France, Bulgaria, Belgium, Spain, Poland, Greece, Italy, Czechia
29/06/2026
Phase III
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 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
Skin irritation and sensitization trial
2026-525269-34-00The intended indication is for the treatment of major depre…
CCDRD Cooperative Clinical Drug Research and Development AG, Corium Innovations Inc.
Mental Disorders
Bulgaria
26/06/2026
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 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
2025-521353-16-00Hereditary Angioedema
DrugDopamine
Adarx Pharmaceuticals Inc.
Immune System Diseases
Poland, Italy, Hungary, France, Austria, Czechia, Belgium, Spain, Bulgaria, Germany, Croatia
22/06/2026
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 II
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis, including a 52-Week Main Treatment Period and a 156-Week Extension Treatment Period
2025-522294-11-00Systemic sclerosis
Galderma S.A.
Skin and Connective Tissue Diseases
Poland, Italy, Bulgaria, France, Greece, Spain, Croatia
17/06/2026
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 III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
2025-523674-16-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited
Nutritional and Metabolic Diseases
Greece, Germany, Belgium, Netherlands, Poland, Italy, France, Spain, Bulgaria, Austria
12/06/2026
Phase II
C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
2024-518587-12-00MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (C…
DrugTilrekimig
Pfizer Inc.
Respiratory Tract Diseases
Spain, Germany, Poland, Czechia, Greece, Italy, Bulgaria, France, Hungary
08/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)
2025-523675-39-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited
Nutritional and Metabolic Diseases
Belgium, Greece, Poland, France, Spain, Bulgaria, Italy, Germany, Austria, Netherlands
08/06/2026
Phase II
A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)
2025-523539-20-00Low Grade Upper Tract Urothelial Carcinoma
Tyra Biosciences Inc.
Neoplasms
Bulgaria, France, Spain
28/05/2026
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 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
An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib
2025-524078-40-00Chronic Spontaneous Urticaria
Novartis Pharma AG
Skin and Connective Tissue Diseases
Germany, Spain, France, Poland, Bulgaria, Czechia
20/05/2026
Phase III
A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa
2025-523259-72-00Hidradenitis Suppurativa (HS)
DrugRemibrutinib
Novartis Pharma AG
Immune System Diseases
Portugal, Greece, Germany, Hungary, France, Spain, Bulgaria, Slovakia, Poland, Czechia, Belgium, Italy
20/05/2026
Phase II
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
2025-524005-32-00Rheumatoid arthritis
Elevara Medicines Limited
Immune System Diseases
Czechia, Bulgaria, Hungary, Netherlands, Poland, Spain
19/05/2026
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
A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency.
2025-521816-20-00​​Exocrine Pancreatic Insufficiency​
DrugZenpep
Aimmune Nestle Health Science US R&D LLC
Nutritional and Metabolic Diseases
Poland, Hungary, Spain, Bulgaria, Italy
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 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
A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs
2025-522586-30-00Psoriatic Arthritis
DrugZasocitinib
Takeda Development Center Americas Inc.
Musculoskeletal Diseases
Germany, Belgium, Spain, Czechia, Croatia, Portugal, Poland, Latvia, Bulgaria, France, Estonia, Hungary, Italy
12/05/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infections in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy ("PROTECT")
2025-522854-37-00Prevention of a Major infection in patients with Hypogammag…
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Immune System Diseases
Czechia, Lithuania, Greece, Poland, Germany, Latvia, Bulgaria, Italy
11/05/2026
Phase II
A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease
2025-524001-33-00Graves’ Disease
Immunovant Sciences GmbH
Immune System Diseases
Italy, Greece, Germany, Hungary, Poland, Czechia, Netherlands, Spain, Belgium, Bulgaria, Latvia
05/05/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight with Weight-Related Comorbidities Who Do Not Have Diabetes
2025-523486-17-00Obesity
DrugRibupatide
Kailera Therapeutics Inc.
Nutritional and Metabolic Diseases
Bulgaria, Hungary, Spain, Germany, Czechia, Poland
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
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight and Diabetes
2025-523510-87-00Obesity
DrugRibupatide
Kailera Therapeutics Inc.
Nutritional and Metabolic Diseases
Hungary, Poland, Bulgaria, Germany, Czechia, Spain
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 III
A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living with Obesity Who Do Not Have Diabetes
2025-523511-11-00Obesity
Kailera Therapeutics Inc.
Nutritional and Metabolic Diseases
Poland, Bulgaria
29/04/2026
Phase II
A Phase 2a, Randomized, Participant- and Investigator blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with DSM-5 Schizophrenia (STAR-1)
2025-524058-32-00Schizophrenia
Novartis Pharma AG
Mental Disorders
Bulgaria
29/04/2026
Phase III
A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression
2025-522872-10-00Depressive episodes associated with Bipolar disorder I or I…
Xenon Pharmaceuticals Inc.
Mental Disorders
Bulgaria, Germany, France, Spain
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 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
Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12).
2025-523804-62-00Obesity
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Belgium, Germany, Bulgaria, France, Spain, Denmark, Italy, Netherlands
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 II
A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants with Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)
2025-522076-85-00Rheumatoid arthritis
AstraZeneca AB
Immune System Diseases
Hungary, Spain, Bulgaria, Germany, Poland
22/04/2026
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
Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).
2025-523717-29-00HFpEF or HFmrEF and obesity
Novo Nordisk A/S
Cardiovascular Diseases
Denmark, Greece, Bulgaria, Italy, Netherlands, Spain, Poland, Czechia, Germany, France
17/04/2026
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
C6231002 - A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
2025-522965-31-00Atopic Dermatitis
Pfizer Inc.
Skin and Connective Tissue Diseases
Poland, Czechia, Germany, Bulgaria, France
14/04/2026
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
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 5)
2024-520444-42-00Overweight or obesity, and knee osteoarthritis
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Italy, Greece, Spain, Bulgaria, Denmark, Poland
07/04/2026
Phase III
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 6)
2024-520445-23-00Overweight or obesity, and knee osteoarthritis
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Greece, Poland, Spain, Bulgaria, Italy, Denmark
07/04/2026
Phase III
Multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis
2024-511593-70-00Polyarticular-course juvenile idiopathic arthritis
Alfasigma S.p.A.
Musculoskeletal Diseases
Spain, Bulgaria, France, Belgium, Germany, Greece, Italy, Poland, Hungary, Czechia
07/04/2026
Phase II
Randomized, Double-blind, Placebo-controlled, Proof-of-concept Phase II Trial Investigating the Effect of Valproic Acid in Women with Adenomyosis.
2025-523076-23-00Adenomyosis
CCDRD Cooperative Clinical Drug Research and Development AG, Nadezhda Reproductive Science OOD
Female Urogenital Diseases and Pregnancy Complications
Bulgaria
03/04/2026
Phase I
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed by the Body in Men With Prostate Cancer
2024-520286-31-00Hot Flush
Astellas Pharma Global Development Inc.
Male Urogenital Diseases
Bulgaria
03/04/2026
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 II
A Phase 2, randomized, placebo-controlled, double-blind clinical study to evaluate efficacy and safety of LAD328 in adult subjects with moderate to severe hidradenitis suppurativa
2025-521865-29-00moderate-to-severe hidradenitis suppurativa
Almirall S.A.
Skin and Connective Tissue Diseases
Bulgaria, Spain, France, Poland, Germany
01/04/2026
Phase II
A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Moderate to Severe Hidradenitis Suppurativa (COMPASS 2 - HS)
2025-522440-41-00Hidradenitis Suppurativa
Bluefin Biomedicine Inc.
Skin and Connective Tissue Diseases
Spain, Germany, Czechia, Poland, Bulgaria
31/03/2026
Phase II
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients with Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)
2025-524006-14-00Chronic Spontaneous Urticaria
Yuhan Corp.
Skin and Connective Tissue Diseases
Bulgaria, Poland
27/03/2026
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
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 III
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
2025-522475-28-00Pulmonary Hypertension (PH) with Heart Failure with preserv…
Tenax Therapeutics Inc.
Cardiovascular Diseases
France, Italy, Germany, Czechia, Austria, Poland, Hungary, Bulgaria, Spain
24/03/2026
Phase III
A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)
2025-522403-17-00Nummular Dermatitis
Almirall S.A.
Skin and Connective Tissue Diseases
Italy, Bulgaria, Spain, Germany, Poland, France
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 III
A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-demand Treatment of Angioedema Attacks in Adults with Acquired Angioedema due to C1 Inhibitor Deficiency
2025-522051-26-00Acquired Angioedema due to C1 Inhibitor Deficiency
DrugDeucrictibant
Pharvaris Netherlands B.V.
Immune System Diseases
Hungary, Spain, Austria, Germany, Poland, Netherlands, France, Italy, Bulgaria
17/03/2026
Phase III
A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants with Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13 (EMBARQ-CSU LTE)
2025-522878-36-00Chronic Spontaneous Urticaria
DrugBarzolvolimab
Celldex Therapeutics Inc.
Skin and Connective Tissue Diseases
Croatia, France, Netherlands, Bulgaria, Portugal, Slovakia, Hungary, Italy, Greece, Germany, Czechia, Lithuania, Spain, Belgium, Denmark, Poland
16/03/2026
Phase I
A study to learn if bimekizumab given in different ways is safe and moves similarly throughout the body over time in adults
2025-522782-30-00CCI
UCB Biopharma
Immune System Diseases
Croatia, Poland, Germany, Czechia, Slovakia, Bulgaria
16/03/2026
Phase IV
Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)
2025-522118-21-00Axial Spondyloarthritis, Acute Anterior Uveitis
DrugUpadacitinib
Care Arthritis Ltd.
Eye Diseases
Spain, Poland, Netherlands, France, Bulgaria, Germany
13/03/2026
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
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
2025-522775-29-00Depressive episodes associated with Bipolar disorder I or I…
Xenon Pharmaceuticals Inc.
Mental Disorders
Germany, Bulgaria, Spain, Poland
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 II
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF GALVOKIMIG IN ADULT STUDY PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
2025-522578-35-00Atopic Dermatitis
UCB Biopharma
Skin and Connective Tissue Diseases
Bulgaria, Czechia, Germany, Poland, Hungary
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-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD)
2025-522231-34-00Diabetic Macular Edema
Alvotech Swiss AG
Eye Diseases
Latvia, Slovakia, Czechia, Hungary, Poland, Bulgaria
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 II
B7981118 - A Phase 2b Randomized, Double Blind, 12-Week Placebo Controlled Study With a 12-Week Double-Blind Extension Period to Evaluate the Efficacy, Safety and Tolerability of Ritlecitinib (PF 06651600) in Adult Participants with Chronic Spontaneous Urticaria
2025-522642-44-00CHRONIC SPONTANEOUS URTICARIA
Pfizer Inc.
Skin and Connective Tissue Diseases
Spain, Germany, Bulgaria, Poland
25/02/2026
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 II
A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults with Major Depressive Disorder
2025-522784-15-00Major Depressive Disorder
Draig Therapeutics Limited
Mental Disorders
Czechia, Bulgaria, Poland
24/02/2026
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 III
A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease
2025-521037-86-00Immune system diseases
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Spain, Czechia, Lithuania, Hungary, Greece, Bulgaria, Poland, Belgium, France, Germany, Norway, Austria, Netherlands, Italy, Slovakia
24/02/2026
Phase III
A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease
2025-521036-11-00Immune system disseases
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Slovakia, Netherlands, Poland, Greece, Czechia, Italy, Bulgaria, Belgium, Germany, Lithuania, Austria, Spain, Hungary, Norway, France
24/02/2026
Phase I/II
A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants with Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
2025-522406-20-00Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Immunabs Inc.
Nervous System Diseases
Bulgaria, Poland, Spain, Italy
18/02/2026
Phase I
A Phase 1 first-in-human study to evaluate SAR447754 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis.
2025-523826-41-00Dermatitis atopic
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Belgium, Czechia, France, Hungary, Poland, Spain, Bulgaria
16/02/2026
Phase II
A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Baxdrostat on Albuminuria in Participants with Chronic Kidney Disease and High Blood Pressure
2025-522407-23-00Chronic kidney disease (CKD) and hypertension.
DrugsBaxdrostat·Dapagliflozin
AstraZeneca AB
Cardiovascular Diseases
Spain, Bulgaria
16/02/2026
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 I
Bioavailability study with naloxone hydrochloride in healthy volunteers
2024-517838-17-00No therapeutic indication in the current trial with healthy…
CCDRD Cooperative Clinical Drug Research and Development AG, Vaccpower Limited
Behavior and Behavior Mechanisms
Bulgaria
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 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE
2025-521142-22-00Hereditary Angioedema
Astria Therapeutics Inc.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Netherlands, Spain, Poland, Germany, Czechia, Austria, Portugal, Hungary, France, Italy, Bulgaria
09/02/2026
Phase III
A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis
2025-521038-27-00Immune system diseases
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Slovakia, Germany, Austria, Italy, Czechia, Netherlands, Poland, Belgium, Hungary, Lithuania, Greece, France, Bulgaria, Spain, Norway
09/02/2026
Phase III
A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis.
2025-521035-37-00Immune system diseases
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Austria, France, Norway, Hungary, Bulgaria, Netherlands, Czechia, Slovakia, Germany, Lithuania, Greece, Belgium, Italy, Spain, Poland
09/02/2026
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
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
(22597) A study to learn about how safe nitroglycerin is and how it affects the body when taken along with nurandociguat in people with coronary artery disease.
2025-522335-34-00Chronic kidney disease, Coronary artery disease
Bayer AG
Cardiovascular Diseases
Germany, Bulgaria
22/01/2026
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 II
A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER 01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
2025-523020-50-00Chronic Obstructive Pulmonary Disease
Aer Therapeutics Inc.
Respiratory Tract Diseases
Bulgaria, Poland, Spain
16/01/2026
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 II
A multicenter, randomized, participant- and investigator -blinded, placebo-controlled, phase 2a study to assess the efficacy, safety and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis
2025-521503-43-00Atopic dermatitis
Novartis Pharma AG
Skin and Connective Tissue Diseases
France, Germany, Poland, Czechia, Bulgaria
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 Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
2025-522105-38-00Chronic Hepatitis Delta Infection
Mirum Pharmaceuticals Inc.
Virus Diseases
Belgium, Hungary, Bulgaria
22/12/2025
Phase III
C2321008: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
2024-519369-24-00METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
Pfizer Inc.
Not possible to specify
Belgium, Finland, France, Germany, Netherlands, Bulgaria, Spain, Slovakia, Italy, Czechia, Poland, Greece
22/12/2025
Phase III
C3651021: A PHASE 2b/3, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PONSEGROMAB (PF-06946860) COMPARED WITH PLACEBO BOTH WITH BACKGROUND FIRST-LINE CHEMOTHERAPY IN ADULT PARTICIPANTS WITH CACHEXIA AND METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
2025-522093-36-00Cancer cachexia
Pfizer Inc.
Nutritional and Metabolic Diseases
Slovakia, Italy, Belgium, Germany, Spain, France, Bulgaria, Poland
16/12/2025
Phase I
A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants with Parkinson’s Disease and Apathy
2025-523612-37-00Parkinson's Disease and Apathy
Integrative Research Laboratories Sweden AB
Nervous System Diseases
Bulgaria, Poland, Spain, Germany
12/12/2025
Phase II
A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults with Moderate to Severe Atopic Dermatitis
2025-522113-35-00Atopic dermatitis
Triveni Bio Inc.
Skin and Connective Tissue Diseases
Poland, Bulgaria, Czechia, Hungary
09/12/2025
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 III
(21467) A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)
2024-519830-22-00Heart failure due to systemic left ventricular systolic dys…
DrugFinerenone
Bayer AG
Cardiovascular Diseases
Czechia, Germany, Greece, Italy, Finland, Bulgaria, Belgium, Poland, Austria, Portugal, Spain, Hungary, Sweden
05/12/2025
Phase III
(21466) A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK/ PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age, with heart failure (HF) and left ventricular systolic dysfunction (LVSD)
2024-519829-38-00Heart failure due to systemic left ventricular systolic dys…
Bayer AG
Cardiovascular Diseases
Czechia, Poland, Portugal, Austria, Finland, Greece, Bulgaria, Sweden, Spain, Italy, Belgium, Hungary, Germany
05/12/2025
Phase III
A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)
2024-512298-28-00Neovascular age-related macular degeneration
AbbVie Deutschland GmbH & Co. KG
Eye Diseases
Czechia, Portugal, Hungary, Spain, Belgium, Italy, Austria, France, Slovakia, Croatia, Germany, Bulgaria, Greece
02/12/2025
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 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 II
Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults with Moderately to Severely Active Rheumatologic Disease
2025-521791-63-00Moderately to Severely Active Rheumatologic Disease
Spyre Therapeutics Inc.
Immune System Diseases
Czechia, Poland, Spain, Bulgaria
25/11/2025
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 Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)
2025-521349-25-00Macular neovascularization secondary to age-related macular…
4d Molecular Therapeutics Inc.
Eye Diseases
Germany, Italy, Hungary, Bulgaria, Lithuania, France, Spain, Latvia, Portugal
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 II
A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of S-337395 in symptomatic nonhospitalized adults with respiratory syncytial virus who are at high risk of progression to severe disease
2025-523156-31-00Respiratory Syncytial Virus
Shionogi B.V.
Virus Diseases
Bulgaria, Poland
18/11/2025
Phase I
Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of intravenous single ascending doses of IM-250 in healthy volunteers.
2025-523146-27-00Herpes simplex virus encephalitis
Fuics Development Limited
Not possible to specify
Bulgaria
18/11/2025
Phase III
C5851005 - PADLINK-005: A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDL1V VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)
2025-521281-97-00Non-Small Cell Lung Cancer (NSCLC)
Pfizer Inc.
Neoplasms
Greece, Italy, Belgium, Slovakia, Czechia, Germany, France, Poland, Denmark, Spain, Netherlands, Sweden, Finland, Bulgaria
17/11/2025
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 II
A Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants with Moderate or Severe Asthma (the POLARIS trial)
2025-521391-58-00Asthma
Windward Bio AG
Respiratory Tract Diseases
Germany, France, Sweden, Bulgaria, Spain
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 III
A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults with Chronic Primary Immune Thrombocytopenia
2025-521692-31-00Chronic Primary Immune Thrombocytopenia
Takeda Development Center Americas Inc.
Hemic and Lymphatic Diseases
Bulgaria, Spain, Netherlands, Italy, Poland, Greece, Germany, France, Czechia, Croatia, Norway, Sweden
04/11/2025
Phase II
Efficacy and safety assessment of T1695 ophthalmic suspension, versus Ciclosporin ophthalmic emulsion, in participants with moderate to severe Vernal Keratoconjunctivitis (VKC)
2025-521567-12-00Vernal Keratoconjunctivitis (VKC)
DrugCiclosporin
Laboratoires Thea
Eye Diseases
Spain, Italy, Bulgaria, France, Greece
04/11/2025
Phase I/II
A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects with Immune Thrombocytopenia (ITP)
2024-519745-30-01Immune Thrombocytopenia (ITP)
Climb Bio Inc.
Hemic and Lymphatic Diseases
Greece, Spain, Bulgaria
03/11/2025
Phase III
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
2025-521711-39-00Lewy body Dementia psychosis (LBDP)
Acadia Pharmaceuticals Inc.
Nervous System Diseases
Czechia, Italy, France, Bulgaria
03/11/2025
Phase II
A Phase 2, Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Atopic Dermatitis (COMPASS 2-AD)
2025-521624-30-00Atopic dermatitis
Bluefin Biomedicine Inc.
Immune System Diseases
Poland, Bulgaria, Germany, Czechia, Spain
31/10/2025
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 II
A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults with Lewy Body Dementia Psychosis (LBDP)
2025-521710-25-00Lewy Body Dementia Psychosis (LBDP)
Acadia Pharmaceuticals Inc.
Nervous System Diseases
Bulgaria, Czechia, Italy, France
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 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
STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
2025-521352-38-00Hereditary Angioedema
Adarx Pharmaceuticals Inc.
Immune System Diseases
Belgium, Poland, Italy, Czechia, Hungary, Spain, Germany, Croatia, France, Bulgaria, Austria
22/10/2025
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia
2024-514401-54-00Chronic Primary Immune Thrombocytopenia
Takeda Development Center Americas Inc.
Hemic and Lymphatic Diseases
Poland, Spain, Bulgaria, Italy, Netherlands, Croatia, Germany, Sweden, Greece, Czechia, Norway, France
22/10/2025
Phase II
A Phase 2, Multicenter, Randomized, Double blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants with Colorectal Cancer who have Cancer Cachexia (SAPPHIRE)
2025-521730-28-00Colorectal Cancer with Cancer Cachexia
Ngm Biopharmaceuticals Inc.
Nutritional and Metabolic Diseases
Czechia, Slovakia, Poland, Hungary, Bulgaria
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
C4551002 - An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Adult Participants with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy
2025-520566-22-00Hormone Receptor-Positive, HER2-Negative Advanced/Metastati…
Pfizer Inc.
Neoplasms
Hungary, Bulgaria, Czechia, Slovakia, Netherlands, Spain, Greece, Finland, Belgium, Sweden, Poland, Germany, France, Italy
20/10/2025
Phase II
A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD)
2025-522001-38-00Crohn’s Disease, Ulcerative Colitis
DrugMT-201
Mirador Therapeutics Inc.
Digestive System Diseases
Poland, Bulgaria, Croatia, Germany, Belgium, Slovakia, Czechia, Italy
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 II
RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults with Focal Onset Seizures
2025-520587-18-00Focal Onset Seizures
DrugHuperzine A
Supernus Pharmaceuticals Inc.
Nervous System Diseases
Poland, Hungary, Bulgaria
20/10/2025
Phase II
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease
2025-521920-31-00Graves’ Disease
Immunovant Sciences GmbH
Immune System Diseases
Italy, Poland, Greece, Germany, Netherlands, Czechia, Spain, Latvia, Bulgaria
17/10/2025
Phase I
Clinical research trial for evaluating different properties, such as safety, tolerability and body interaction, of a new drug called ALY688ER, administered as subcutaneous injection in healthy overweight or obese people.
2024-512905-18-00NASH
Allysta Pharmaceuticals Inc.
Nutritional and Metabolic Diseases
Bulgaria
10/10/2025
Phase I
A multi-part, adaptive, Phase 1, first time in human study in healthy participants and participants with atopic dermatitis (AD) to assess the safety, tolerability, pharmacokinetics (PK) of single ascending (SAD), multiple ascending doses (MAD) and selected dose of SYX-5219 (AD Participants)
2025-522216-17-00Atopic Dermatitis
Sitryx Therapeutics Limited
Skin and Connective Tissue Diseases
Germany, Bulgaria, Ireland, Denmark
09/10/2025
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 II
C4921003 - A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Oral Branched-Chain Ketoacid Dehydrogenase Kinase Inhibitor, PF-07328948 in Adults with Heart Failure (BRANCH-HF)
2024-518438-94-00Heart failure
Pfizer Inc.
Cardiovascular Diseases
France, Spain, Bulgaria, Poland, Hungary, Czechia
08/10/2025
Phase I
Single dose oral bioequivalence study of Cladribine 10 mg Tablets and Mavenclad® 10 mg tablets (Cladribine) in healthy adult human subjects under fed conditions
2025-522252-74-00No therapeutic indication in the current trial with healthy…
PharOS Pharmaceutical Oriented Servises Ltd., CCDRD Cooperative Clinical Drug Research and Development AG
Not possible to specify
Bulgaria
08/10/2025
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 I
A first-in-human, dose finding study to evaluate the safety, tolerability and pharmacokinetics of EGL-003 in healthy volunteers followed by adults with autoimmune disease.
2025-521658-40-00Atopic dermatitis
Egle Therapeutics
Skin and Connective Tissue Diseases
Germany, Bulgaria, Poland
01/10/2025
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
Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
2025-521377-14-00Atrial fibrillation
Acesion Pharma ApS
Cardiovascular Diseases
Hungary, Italy, Denmark, Bulgaria, Poland, Netherlands, Germany
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
Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)
2024-518206-40-00Severe hypertriglyceridemia (SHTG)
Arrowhead Pharmaceuticals Inc.
Nutritional and Metabolic Diseases
Hungary, Bulgaria, Sweden, Austria, Norway, Belgium, Croatia, Czechia, Latvia, Lithuania, Spain, Slovakia
23/09/2025
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy (299IG301 / PREVAIL)
2024-519345-30-00IgA nephropathy
Biogen Idec Research Limited
Immune System Diseases
Greece, Portugal, Spain, Croatia, Czechia, Belgium, Bulgaria, Germany, Italy, Poland, France
23/09/2025
Phase II
A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO).
2025-520473-40-00Moderate to Very Severe Chronic Obstructive Pulmonary Disea…
AstraZeneca AB
Respiratory Tract Diseases
Spain, Greece, Bulgaria, Germany, Denmark, Hungary, Italy, Poland
22/09/2025
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
ADVANCE: A Phase III Multi-Centre, Randomised, Double-Blind, Double-Dummy Clinical Trial Comparing Essentiale® Liquid vs. Capsules for MASLD/MASH, Alcoholic Liver Disease, and Chronic Viral Hepatitis B
2025-521678-32-00Chronic Viral Hepatitis B, Alcoholic Liver Disease, MASLD (…
Opella Healthcare Group S.A.S.
Digestive System Diseases
Bulgaria, Germany, Poland
22/09/2025
Phase I
A Trial to Determine if Quabodepistat is Processed Differently in Adults with Reduced Liver Function Compared to Adults with Normal Liver Function
2025-521502-18-00Tuberculosis
Otsuka Pharmaceutical Development & Commercialization Inc.
Respiratory Tract Diseases
Bulgaria
19/09/2025
Phase III
NBI-1065845-MDD3027: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI 1065845 as an Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)
2025-520541-72-00Major Depressive Disorder
Neurocrine Biosciences Inc.
Mental Disorders
Bulgaria, Estonia, Poland, Italy, Spain
16/09/2025
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
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
2025-520564-17-00Hidradenitis suppurativa (HS)
MoonLake Immunotherapeutics AG
Skin and Connective Tissue Diseases
Norway, Hungary, Spain, France, Germany, Poland, Czechia, Slovakia, Bulgaria, Netherlands, Italy, Portugal, Belgium
29/08/2025
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Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 7 October 2026. https://priyalifescience.com/clinical-trials-europe/country/bulgaria

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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 12,568 trial records at the last sync on 07 Oct 2026, 03:16 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 211 of those trials with a site in Bulgaria.

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

211 of the 2,557 most recently authorised trials in this register list a site in Bulgaria; 115 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 (Bulgaria), 211 trials
PhaseTrialsShare
Phase III11554.5%
Phase II6731.8%
Phase I2110%
Phase IV52.4%
Phase I/II31.4%

Most active sponsors

Lead sponsors with the most trials (Bulgaria)
Lead sponsorTrials
AstraZeneca AB9
Novartis Pharma AG9
Novo Nordisk A/S9
Pfizer Inc.8
Bristol-Myers Squibb Services Unlimited Company7
Sanofi-Aventis Recherche & Developpement7
Glaxosmithkline Research & Development Limited6
Neurocrine Biosciences Inc.6
Regeneron Pharmaceuticals Inc.6
Takeda Development Center Americas Inc.5
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.