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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

67 of 2557 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 II
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults with Schizophrenia Who Warrant Inpatient Hospitalization
2025-521868-35-00Schizophrenia
Neurocrine Biosciences Inc.
Mental Disorders
Romania, Poland, Bulgaria, Croatia
23/03/2026
Phase II
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
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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

Query this register directly
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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,568 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 67 of those trials with a site in Bulgaria that also match the filters currently applied.

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

67 of the 2,557 most recently authorised trials in this register list a site in Bulgaria and match the filters applied; 0 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), 67 trials
PhaseTrialsShare
Phase II67100%

Most active sponsors

Lead sponsors with the most trials (Bulgaria)
Lead sponsorTrials
Novartis Pharma AG5
AstraZeneca AB4
Pfizer Inc.4
Immunovant Sciences GmbH3
Spyre Therapeutics Inc.3
Almirall S.A.2
Bluefin Biomedicine Inc.2
Chiesi Farmaceutici S.p.A.2
Maplight Therapeutics Inc.2
Neurocrine Biosciences Inc.2
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.