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Updated 06 Jul 2026 · EMA CTIS official data

Clinical Trials in Bulgaria

← All EU trials

The most recently authorised clinical trials across the European Union - drawn live from the European Medicines Agency's Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation. Searchable by country, phase, sponsor and condition.

48
Recent authorisations
31
Phase III trials
Bulgaria
Selected country
Phase I Physiological processes Authorised 30/06/2026
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
No therapeutic indication in the current trial with healthy volunteers.
CCDRD Cooperative Clinical Drug Research and Development AG, Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. · 140 participants
📍 Bulgaria
2025-524775-23-00 on CTIS ↗
Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 40 participants
📍 Germany · Bulgaria · Belgium · Spain · Greece · Italy · Czechia
2025-524855-30-00 on CTIS ↗
Phase III Immune System Diseases Authorised 29/06/2026
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 46 participants
📍 Spain · Belgium · France · Germany · Slovakia · Bulgaria · Italy · Greece
2025-523871-44-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 26/06/2026
A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants with Solid and Hematologic Cancers (ROXI-CAT-II)
Cancer Associated Thrombosis
Regeneron Pharmaceuticals Inc. · 164 participants
📍 Bulgaria · Romania
2024-519299-16-00 on CTIS ↗
Phase I Mental Disorders Authorised 26/06/2026
Skin irritation and sensitization trial
The intended indication is for the treatment of major depressive disorder.
CCDRD Cooperative Clinical Drug Research and Development AG, Corium Innovations Inc. · 230 participants
📍 Bulgaria
2026-525269-34-00 on CTIS ↗
Phase I Immune System Diseases Authorised 25/06/2026
Phase 1 Single Dose Study of JADE201 in Participants with Rheumatoid Arthritis
Rheumatoid Arthritis
Jade Biosciences Inc. · 24 participants
📍 Romania · Bulgaria · Germany
2025-524746-96-00 on CTIS ↗
Phase III Immune System Diseases Authorised 22/06/2026
A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
Hereditary Angioedema
Adarx Pharmaceuticals Inc. · 45 participants
📍 Poland · Italy · Hungary · France · Austria · Czechia · Belgium · Spain · Bulgaria · Germany · Croatia
2025-521353-16-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 22/06/2026
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC · 467 participants
📍 Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece
2025-524322-18-00 on CTIS ↗
Phase II Skin and Connective Tissue Diseases Authorised 17/06/2026
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis, including a 52-Week Main Treatment Period and a 156-Week Extension Treatment Period
Systemic sclerosis
Galderma S.A. · 56 participants
📍 Poland · Italy · Bulgaria · France · Greece · Spain · Croatia
2025-522294-11-00 on CTIS ↗
Phase II Digestive System Diseases Authorised 16/06/2026
A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants with Inflammatory Bowel Disease
Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc. · 228 participants
📍 Croatia · Poland · Austria · Czechia · Italy · Slovakia · Bulgaria · Greece · Belgium · Spain · Hungary · Germany · Lithuania · France · Romania
2025-524640-35-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 12/06/2026
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 210 participants
📍 Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria
2025-523674-16-00 on CTIS ↗
Phase II Respiratory Tract Diseases Authorised 08/06/2026
C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Pfizer Inc. · 318 participants
📍 Spain · Germany · Poland · Czechia · Greece · Italy · Bulgaria · France · Hungary
2024-518587-12-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 08/06/2026
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 173 participants
📍 Belgium · Greece · Poland · France · Spain · Bulgaria · Italy · Germany · Austria · Netherlands
2025-523675-39-00 on CTIS ↗
Phase II Neoplasms Authorised 28/05/2026
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)
Low Grade Upper Tract Urothelial Carcinoma
Tyra Biosciences Inc. · 34 participants
📍 Bulgaria · France · Spain
2025-523539-20-00 on CTIS ↗
Phase II Mental Disorders Authorised 27/05/2026
An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Maplight Therapeutics Inc. · 85 participants
📍 Italy · Poland · Czechia · Portugal · Bulgaria · France · Slovakia · Romania · Hungary
2025-521757-16-00 on CTIS ↗
Phase III Neoplasms Authorised 22/05/2026
ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy
Unresectable Stage III non-small cell lung cancer without progression
Bristol-Myers Squibb Services Unlimited Company · 279 participants
📍 France · Ireland · Germany · Greece · Bulgaria · Spain · Netherlands · Italy · Sweden · Romania · Hungary · Belgium · Austria · Poland
2025-523576-23-00 on CTIS ↗
Phase III Skin and Connective Tissue Diseases Authorised 20/05/2026
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
Chronic Spontaneous Urticaria
Novartis Pharma AG · 154 participants
📍 Germany · Spain · France · Poland · Bulgaria · Czechia
2025-524078-40-00 on CTIS ↗
Phase III Immune System Diseases Authorised 20/05/2026
A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa
Hidradenitis Suppurativa (HS)
Novartis Pharma AG · 307 participants
📍 Portugal · Greece · Germany · Hungary · France · Spain · Bulgaria · Slovakia · Poland · Czechia · Belgium · Italy
2025-523259-72-00 on CTIS ↗
Phase II Immune System Diseases Authorised 19/05/2026
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)
Rheumatoid arthritis
Elevara Medicines Limited · 95 participants
📍 Czechia · Bulgaria · Hungary · Netherlands · Poland · Spain
2025-524005-32-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 19/05/2026
A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)
Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding
VarmX B.V. · 443 participants
📍 Belgium · Germany · Italy · France · Czechia · Bulgaria · Hungary · Spain · Netherlands · Poland · Austria · Estonia · Romania · Portugal · Lithuania
2025-521632-12-00 on CTIS ↗
Phase II Nutritional and Metabolic Diseases Authorised 18/05/2026
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.
​​Exocrine Pancreatic Insufficiency​
Aimmune Nestle Health Science US R&D LLC · 29 participants
📍 Poland · Hungary · Spain · Bulgaria · Italy
2025-521816-20-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 18/05/2026
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants
📍 Italy · Finland · Bulgaria · Greece · Belgium · Estonia · Portugal · Spain · Germany · France · Czechia · Slovakia · Romania · Croatia · Poland · Austria · Netherlands · Denmark · Sweden · Hungary
2025-524316-11-00 on CTIS ↗
Phase IV Respiratory Tract Diseases Authorised 18/05/2026
A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.
Asthma
Chiesi Farmaceutici S.p.A. · 606 participants
📍 Germany · Romania · Italy · Bulgaria · Poland · Slovakia · Spain · France
2025-524289-56-00 on CTIS ↗
Phase III Neoplasms Authorised 15/05/2026
ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%
Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 265 participants
📍 Portugal · Norway · Sweden · Bulgaria · France · Belgium · Austria · Germany · Finland · Poland · Romania · Netherlands · Spain · Italy · Hungary · Czechia
2025-523586-18-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 15/05/2026
Efficacy and safety of NNC0487-0111 s.c. once-weekly compared to semaglutide s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 8)
Participants with overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 440 participants
📍 Germany · Croatia · Portugal · Hungary · Bulgaria · Romania · Poland
2024-520446-31-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 12/05/2026
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma
severe uncontrolled asthma
Generate Biomedicines Inc. · 271 participants
📍 Latvia · Hungary · Bulgaria · Romania · Portugal · Netherlands · Croatia · Germany · Greece · Czechia
2025-521950-41-00 on CTIS ↗
Phase III Neoplasms Authorised 12/05/2026
DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.
small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 295 participants
📍 Czechia · Sweden · Poland · Netherlands · Greece · Latvia · Finland · Norway · Belgium · Austria · Portugal · Romania · Italy · Estonia · France · Ireland · Germany · Spain · Bulgaria · Hungary
2025-520565-51-00 on CTIS ↗
Phase III Musculoskeletal Diseases Authorised 12/05/2026
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
Psoriatic Arthritis
Takeda Development Center Americas Inc. · 638 participants
📍 Germany · Belgium · Spain · Czechia · Croatia · Portugal · Poland · Latvia · Bulgaria · France · Estonia · Hungary · Italy
2025-522586-30-00 on CTIS ↗
Phase III Immune System Diseases Authorised 11/05/2026
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")
Prevention of a Major infection in patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions receiving treatment with B-cell depletion therapy.
Octapharma Pharmazeutika Produktionsgesellschaft mbH · 215 participants
📍 Czechia · Lithuania · Greece · Poland · Germany · Latvia · Bulgaria · Italy
2025-522854-37-00 on CTIS ↗
Phase II Immune System Diseases Authorised 05/05/2026
A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease
Graves’ Disease
Immunovant Sciences GmbH · 128 participants
📍 Italy · Greece · Germany · Hungary · Poland · Czechia · Netherlands · Spain · Belgium · Bulgaria · Latvia
2025-524001-33-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 05/05/2026
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
Obesity
Kailera Therapeutics Inc. · 612 participants
📍 Bulgaria · Hungary · Spain · Germany · Czechia · Poland
2025-523486-17-00 on CTIS ↗
Phase III Immune System Diseases Authorised 05/05/2026
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Janssen Cilag International · 271 participants
📍 Denmark · Hungary · Portugal · Italy · Norway · Greece · Slovakia · Czechia · France · Poland · Bulgaria · Germany · Spain · Romania · Finland
2025-523552-31-00 on CTIS ↗
Phase II Eye Diseases Authorised 04/05/2026
A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration
Geographic atrophy secondary to age-related macular degeneration
Novartis Pharma AG · 142 participants
📍 Bulgaria · Romania · Germany · Czechia · Spain · Poland · Italy · Hungary · France
2025-523704-77-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 04/05/2026
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
Obesity
Kailera Therapeutics Inc. · 626 participants
📍 Hungary · Poland · Bulgaria · Germany · Czechia · Spain
2025-523510-87-00 on CTIS ↗
Phase II Immune System Diseases Authorised 04/05/2026
Randomised, placebo-controlled, double-blind, parallel-group Phase II study to evaluate the efficacy and safety of oral BI 3000202 in patients with moderate to severe systemic lupus erythematosus (SLE)
Systemic lupus erythematosus
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 106 participants
📍 Bulgaria · Romania · Germany · Spain · Hungary · Poland · Croatia
2025-523488-39-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 29/04/2026
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
Obesity
Kailera Therapeutics Inc. · 268 participants
📍 Poland · Bulgaria
2025-523511-11-00 on CTIS ↗
Phase II Mental Disorders Authorised 29/04/2026
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)
Schizophrenia
Novartis Pharma AG · 42 participants
📍 Bulgaria
2025-524058-32-00 on CTIS ↗
Phase III Mental Disorders Authorised 28/04/2026
A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression
Depressive episodes associated with Bipolar disorder I or II (Bipolar Depression)
Xenon Pharmaceuticals Inc. · 70 participants
📍 Bulgaria · Germany · France · Spain
2025-522872-10-00 on CTIS ↗
Phase III Digestive System Diseases Authorised 28/04/2026
A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter clinical trial to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole in maintenance of healing in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D
Erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD)
Cinclus Pharma Holding AB (publ) · 96 participants
📍 Hungary · Germany · Romania · Bulgaria · Czechia · Poland
2025-522750-39-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 28/04/2026
Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity
Obesity and T2D
Novo Nordisk A/S · 157 participants
📍 Slovakia · Austria · Spain · Romania · Portugal · Italy · Denmark · Belgium · Sweden · Poland · Netherlands · Croatia · Hungary · Bulgaria
2023-509176-42-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 27/04/2026
Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12).
Obesity
Novo Nordisk A/S · 325 participants
📍 Belgium · Germany · Bulgaria · France · Spain · Denmark · Italy · Netherlands
2025-523804-62-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 27/04/2026
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants with Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)
Cancer-Associated Thrombosis (CAT).
Regeneron Pharmaceuticals Inc. · 324 participants
📍 Belgium · Czechia · France · Romania · Germany · Poland · Bulgaria · Spain
2024-519298-21-00 on CTIS ↗
Phase II Respiratory Tract Diseases Authorised 27/04/2026
A Phase IIb, multicentre, randomised, doubleblind, placebocontrolled, three-arm parallel-group study to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab), with an optional 24-week doubleblind, placebocontrolled extension phase in participants with idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF)
Chiesi Farmaceutici S.p.A. · 103 participants
📍 Belgium · Germany · Italy · Czechia · Bulgaria · Netherlands · France · Portugal · Poland · Spain · Romania
2024-514246-37-00 on CTIS ↗
Phase II Immune System Diseases Authorised 22/04/2026
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)
Rheumatoid arthritis
AstraZeneca AB · 97 participants
📍 Hungary · Spain · Bulgaria · Germany · Poland
2025-522076-85-00 on CTIS ↗
Phase III Not possible to specify Authorised 21/04/2026
A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia
Chemotherapy induced thrombocytopenia
Jiangsu Hengrui Pharmaceuticals Co. Ltd. · 58 participants
📍 France · Romania · Poland · Spain · Bulgaria
2025-524209-34-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 17/04/2026
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).
HFpEF or HFmrEF and obesity
Novo Nordisk A/S · 1992 participants
📍 Denmark · Greece · Bulgaria · Italy · Netherlands · Spain · Poland · Czechia · Germany · France
2025-523717-29-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 17/04/2026
A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions
Myelodysplastic neoplasms/syndromes (MDS)
Takeda Development Center Americas Inc. · 114 participants
📍 France · Belgium · Germany · Italy · Bulgaria · Ireland · Lithuania · Norway · Romania · Hungary · Spain · Greece · Poland · Netherlands
2025-523544-12-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 16/04/2026
EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1 RA IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)
Obesity
Metsera Inc. · 919 participants
📍 Czechia · Bulgaria · Slovakia · Spain · Hungary · Germany · Romania · Poland
2025-523975-48-00 on CTIS ↗
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Cite this page

Priya Life Science (2026). EU Clinical Trials Tracker. Available at: https://priyalifescience.com/clinical-trials-europe/country/bulgaria (Accessed: 6 July 2026).

Source: Clinical Trials Information System (CTIS), European Medicines Agency - trials authorised under the EU Clinical Trials Regulation (Regulation 536/2014), showing the most recent EU authorisation decisions, refreshed daily. Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See our Ireland Clinical Trials Tracker. For approved medicines, see the EMA Approvals Tracker.