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Updated 13 Sep 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.

40
Recent authorisations
24
Phase III trials
Bulgaria
Selected country
Showing 40 trials
Phase I Physiological processes Authorised 10/09/2026

Evaluation of the bioequivalence of two intravaginal gel preparations containing 90 mg progesterone

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.
48 participants planned
Bulgaria
2025-520498-38-00 on CTIS ↗
Phase II Nervous System Diseases Authorised 07/09/2026

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

Tardive Dyskinesia
Neurocrine Biosciences Inc.
15 participants planned
Bulgaria · Slovakia · Czechia
2025-524104-30-00 on CTIS ↗
Phase II Cardiovascular Diseases Authorised 04/09/2026

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)

Venous Thromboembolism
Ribocure Pharmaceuticals AB
150 participants planned
Poland · Romania · France · Bulgaria
2026-525479-15-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 04/09/2026

Efficacy and safety of zenagamtide s.c. once weekly compared to insulin glargine s.c. once daily in participants with type 2 diabetes and increased cardiovascular risk inadequately controlled on 1–3 oral glucose-lowering medications (AMBITION 7)

Type 2 diabetes (T2D) and increased cardiovascular (CV) risk not in adequate glycaemic control on 1–3 marketed oral glucose lowering medications.
Novo Nordisk A/S
477 participants planned
Greece · Germany · Italy · Czechia · Poland · Bulgaria · Spain
2026-525209-11-00 on CTIS ↗
Phase III Immune System Diseases Authorised 02/09/2026

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

Immune system diseases
Sanofi-Aventis Recherche & Developpement
338 participants planned
Belgium · Czechia · Hungary · Sweden · Lithuania · Croatia · Netherlands · Slovakia · Poland · Austria · Norway · France · Italy · Bulgaria · Spain · Germany · Romania · Slovenia · Estonia · Portugal · Greece · Denmark
2026-525913-30-00 on CTIS ↗
Phase III Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 31/08/2026

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)

Hereditary Hemorrhagic Telangiectasia (HHT)
Vaderis Therapeutics AG
130 participants planned
Hungary · Netherlands · Germany · Bulgaria · France · Italy · Lithuania · Spain · Belgium
2025-524490-17-00 on CTIS ↗
Phase II Skin and Connective Tissue Diseases Authorised 25/08/2026

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

Atopic Dermatitis (AD)
Apollo Therapeutics Limited
138 participants planned
Hungary · Czechia · Germany · Bulgaria · Poland · Spain
2026-525673-39-00 on CTIS ↗
Phase III Neoplasms Authorised 21/08/2026

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)

​​HR-positive, HER2-negative, inoperable locally advanced or metastatic breast cancer​
Laboratorios Farmaceuticos Rovi S.A.
97 participants planned
Romania · Spain · Bulgaria · Czechia · Latvia · Poland · Croatia · Slovakia
2025-524846-85-00 on CTIS ↗
Phase I Respiratory Tract Diseases Authorised 17/08/2026

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)

Non-cystic fibrosis bronchiectasis
Zambon S.p.A.
55 participants planned
Belgium · Poland · Bulgaria
2025-524324-22-00 on CTIS ↗
Phase II Cardiovascular Diseases Authorised 14/08/2026

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)

heart failure
Cardurion Pharmaceuticals Inc.
369 participants planned
Latvia · Slovakia · Lithuania · Hungary · Italy · Netherlands · Spain · Poland · Bulgaria · Czechia
2025-525033-31-00 on CTIS ↗
Phase II Respiratory Tract Diseases Authorised 14/08/2026

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)

Severe asthma
Kinaset Therapeutics Inc.
350 participants planned
Czechia · Bulgaria · Romania · Hungary · Germany · Poland · Greece
2023-509125-41-00 on CTIS ↗
Phase III Mental Disorders Authorised 10/08/2026

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

Schizophrenia with negative symptoms
Minerva Neurosciences Inc.
120 participants planned
Bulgaria · Romania
2026-525925-19-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 10/08/2026

Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity

Overweight and obesity
Novo Nordisk A/S
315 participants planned
Netherlands · Belgium · Greece · Poland · Spain · Denmark · France · Bulgaria · Sweden
2025-524626-18-00 on CTIS ↗
Phase III Hormonal diseases Authorised 07/08/2026

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

Graves' Disease (GD)
Argenx
145 participants planned
Italy · Czechia · Spain · Denmark · Belgium · Romania · Latvia · France · Germany · Greece · Sweden · Poland · Lithuania · Bulgaria
2025-523333-26-00 on CTIS ↗
Phase II Cardiovascular Diseases Authorised 06/08/2026

[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.

Atrial fibrillation
Bayer AG
105 participants planned
Belgium · Netherlands · Germany · Poland · Italy · Hungary · Bulgaria
2025-523807-31-00 on CTIS ↗
Phase II Respiratory Tract Diseases Authorised 04/08/2026

A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)

Idiopathic Pulmonary Fibrosis
AstraZeneca AB
139 participants planned
Poland · Hungary · Netherlands · Germany · Spain · Greece · Bulgaria · Italy · France · Denmark
2025-525016-41-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 04/08/2026

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)

type 2 diabetes mellitus
AstraZeneca AB
200 participants planned
Poland · Germany · Bulgaria · Czechia
2025-523935-20-00 on CTIS ↗
Phase I Neoplasms Authorised 04/08/2026

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

Advanced Cancer
Sumitomo Pharma America Inc.
43 participants planned
Spain · Bulgaria · Poland · Romania
2025-524652-63-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 03/08/2026

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)

type 2 diabetes mellitus
AstraZeneca AB
183 participants planned
Germany · Bulgaria · Spain · Denmark
2025-523940-12-00 on CTIS ↗
Phase III Skin and Connective Tissue Diseases Authorised 03/08/2026

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

Systemic sclerosis
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
179 participants planned
Denmark · Hungary · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Austria · Romania · Croatia · Poland · Estonia · Italy · Lithuania
2025-523884-39-00 on CTIS ↗
Phase III Immune System Diseases Authorised 03/08/2026

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

Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International
302 participants planned
France · Bulgaria · Romania · Slovakia · Norway · Denmark · Greece · Italy · Austria · Poland · Netherlands · Czechia · Germany · Belgium · Spain · Hungary · Portugal
2026-525923-26-00 on CTIS ↗
Phase IV Mental Disorders Authorised 29/07/2026

Effectiveness of Trazodone on Emotional Blunting in Patients with Major Depressive: a Phase IV, Open-label, clinical study

Major 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.
120 participants planned
Bulgaria · Poland · Hungary
2025-523267-38-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 29/07/2026

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)

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.
AstraZeneca AB
2343 participants planned
Spain · Hungary · Germany · Poland · Italy · Bulgaria · Netherlands · Austria · Romania · Sweden · France · Greece · Slovakia · Czechia
2026-526304-79-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

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

Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S
1140 participants planned
Greece · Portugal · France · Slovakia · Bulgaria · Netherlands · Romania · Italy · Austria · Poland · Hungary · Spain · Czechia · Belgium
2025-522488-14-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 24/07/2026

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)

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.
AstraZeneca AB
1600 participants planned
Czechia · Italy · Hungary · Romania · Bulgaria · Sweden · Denmark · Poland · Spain · Norway · Finland · Greece · France · Germany
2025-523994-41-00 on CTIS ↗
Phase III Hormonal diseases Authorised 23/07/2026

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

Classic Congenital Adrenal Hyperplasia (CAH)
Neurocrine Biosciences Inc.
71 participants planned
Czechia · Germany · Sweden · Portugal · Romania · Bulgaria · Italy · Austria · Spain
2025-524282-24-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 22/07/2026

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)

type 2 diabetes mellitus
AstraZeneca AB
335 participants planned
Poland · Hungary · Italy · Bulgaria · Germany
2025-523933-24-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 20/07/2026

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

Huntington’s Disease
Novartis Pharma AG
368 participants planned
Norway · Poland · Spain · Sweden · Bulgaria · Netherlands · Finland · Portugal · Austria · Italy · Greece · Ireland · Czechia · France · Romania · Belgium · Germany · Denmark · Slovakia · Hungary
2025-522227-99-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 14/07/2026

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.

Asthma
Glaxosmithkline Research & Development Limited
229 participants planned
Ireland · Spain · Germany · Czechia · Bulgaria · France · Belgium · Romania · Italy
2025-524463-20-00 on CTIS ↗
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 planned
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
57 participants planned
Germany · Romania · France · Bulgaria · Belgium · Spain · Poland · 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
54 participants planned
Spain · Belgium · France · Germany · Slovakia · Romania · Bulgaria · Italy · Poland · 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 planned
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 planned
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 planned
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 planned
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
486 participants planned
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 planned
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 planned
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 planned
Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria
2025-523674-16-00 on CTIS ↗
No trials match your search.
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Priya Life Science (2026). EU Clinical Trials Tracker. Available at: https://priyalifescience.com/clinical-trials-europe/country/bulgaria (Accessed: 13 September 2026).

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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. See who's running these trials in our Company Directory, or compare pay across these markets in the EU Salary Guide.