Clinical Trials in Hungary 2026 - 53 Recent EU Authorisations

Phase III Neoplasms Authorised 08/09/2026

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants with Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line chemotherapy (DeLLphi-315)

Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line chemotherapy

Amgen Inc.

100 participants planned

Netherlands · Hungary · Portugal · France · Belgium · Italy · Spain

2026-525489-23-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/09/2026

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

Sjogren’s Disease-Associated Sensorimotor Polyneuropathy (SMPN) or Sensory Polyneuropathy (SPN)

Argenx

34 participants planned

Germany · Lithuania · Portugal · Slovakia · Hungary · Spain · Belgium · France

2026-526218-10-00 on CTIS ↗

Phase III Immune System Diseases Authorised 08/09/2026

EFC18362 - A Phase 3, multicenter, multinational, randomized, open-label, active-comparator study to evaluate the efficacy and safety of venglustat compared with Cerezyme in pediatric participants 2 to 11 years of age with Gaucher disease type 3 who have reached therapeutic goals with enzyme replacement therapy

Immune system diseases

Sanofi-Aventis Recherche & Developpement

9 participants planned

Hungary · Italy · France · Finland · Germany

2026-525374-19-00 on CTIS ↗

Phase I Immune System Diseases Authorised 07/09/2026

A trial to learn how safe anifrolumab is, how it moves throughout the body over time, and how it affects the body of adults with systemic lupus erythematosus

Systemic Lupus Erythematosus

AstraZeneca AB

1 participants planned

Hungary

2026-526171-32-00 on CTIS ↗

Phase I Neoplasms Authorised 07/09/2026

A Study of RO7806767 as Single Agent and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Advanced Solid Tumors

F. Hoffmann-La Roche AG

99 participants planned

Spain · Hungary · Italy · Belgium · Denmark · France

2026-525215-13-00 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 II Eye Diseases Authorised 01/09/2026

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Dompe' Farmaceutici S.p.A.

171 participants planned

Denmark · Italy · Germany · Hungary · Netherlands · Spain · Belgium · France · Portugal

2025-524748-37-00 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 III Nervous System Diseases Authorised 31/08/2026

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants with Genetically Diagnosed Spinal Muscular Atrophy

Spinal Muscular Atrophy

Biogen Idec Research Limited

24 participants planned

Portugal · Italy · Belgium · Croatia · Hungary · Germany · Ireland · France · Norway · Poland

2025-523857-32-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 31/08/2026

Efficacy and safety of once-weekly subcutaneous UBT251 in participants with type 2 diabetes – a dose-finding study

Type 2 diabetes (T2D)

Novo Nordisk A/S

175 participants planned

Spain · Hungary · Romania · Slovakia · Poland · Germany

2026-525465-42-00 on CTIS ↗

Phase III Immune System Diseases Authorised 25/08/2026

A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis

Ocular Myasthenia Gravis

UCB Biopharma

46 participants planned

Hungary · France · Greece · Poland · Spain · Italy · Germany

2025-524757-14-00 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 II Neoplasms Authorised 25/08/2026

Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

Janssen Cilag International

123 participants planned

Sweden · Spain · Greece · Portugal · France · Hungary

2025-524793-42-00 on CTIS ↗

Phase II Neoplasms Authorised 25/08/2026

Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)

Solid tumor

Bristol-Myers Squibb Services Unlimited Company

116 participants planned

Greece · Hungary · Poland · Belgium · Spain · Netherlands · Germany · France · Portugal · Italy · Romania

2025-524905-34-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 21/08/2026

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Polycythemia Vera

Deciphera Pharmaceuticals Inc.

106 participants planned

Austria · Czechia · Italy · Portugal · Germany · France · Hungary · Spain · Poland

2025-524669-25-00 on CTIS ↗

Phase III Neoplasms Authorised 21/08/2026

A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

Neoplasms, Gastrointestinal Stromal

Glaxosmithkline Research & Development Limited

302 participants planned

Italy · Portugal · Germany · Sweden · Poland · Romania · Finland · Greece · Norway · Spain · Netherlands · France · Hungary

2025-524934-24-00 on CTIS ↗

Phase I/II Neoplasms Authorised 18/08/2026

A Phase 1/2 Trial of TER-2013 in Patients with Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

Solid Tumours

Terremoto Biosciences Inc.

228 participants planned

Spain · Ireland · Hungary · Romania · France · Portugal · Belgium · Poland

2025-525036-34-00 on CTIS ↗

Phase III Immune System Diseases Authorised 18/08/2026

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis

Ocular Myasthenia Gravis

UCB Biopharma

46 participants planned

Hungary · Greece · Italy · Spain · Germany · Poland · France

2025-524756-54-00 on CTIS ↗

Phase III Eye Diseases Authorised 17/08/2026

A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered via Intravitreal Injection in Participants with Neovascular Age-related Macular Degeneration

Neovascular Age-related Macular Degeneration (nAMD)

Amgen Inc.

255 participants planned

Slovakia · Latvia · Czechia · Poland · Spain · Hungary · Lithuania

2025-523500-72-00 on CTIS ↗

Phase III Bacterial Infections and Mycoses Authorised 17/08/2026

C4931007 - A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Pneumoccoccal Immunisation

Pfizer Inc.

1345 participants planned

Spain · Finland · Poland · Germany · Greece · Hungary · Italy

2025-523447-35-02 on CTIS ↗

Phase III Male Urogenital Diseases Authorised 17/08/2026

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

Metastatic castration-resistant prostate cancer (mCRPC)

BioNTech SE

183 participants planned

Belgium · Spain · Italy · Poland · Germany · Hungary

2025-524445-27-00 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 I Not possible to specify Authorised 14/08/2026

A study to test how BI 3034701 is taken up and processed by the body in healthy men with normal weight or overweight

Healthy

Boehringer Ingelheim International GmbH

8 participants planned

Hungary

2026-525825-19-00 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 Hemic and Lymphatic Diseases Authorised 14/08/2026

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP)

Diagnosis of primary ITP according to the 2019 International Consensus Report that is previously untreated and requires treatment

Amgen Inc.

42 participants planned

Spain · Hungary · Germany

2026-525454-11-00 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 03/08/2026

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared with Elecoglipron Alone and Dapagliflozin Alone, in Adults with Type 2 Diabetes Mellitus (Eluminate-5)

type 2 diabetes mellitus

AstraZeneca AB

360 participants planned

Slovakia · Poland · Czechia · Germany · Hungary · Greece · Denmark

2025-523941-81-00 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 Crohn’s Disease

Moderately to Severely Active Crohn’s Disease

Janssen Cilag International

194 participants planned

Norway · Romania · Austria · Italy · Slovakia · Germany · Hungary · Netherlands · Belgium · France · Portugal · Czechia · Poland · Spain · Greece

2026-525922-39-00 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 III Cardiovascular Diseases Authorised 30/07/2026

J3L-MC-EZEJ: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event

Lipoprotein(a), Atherosclerosis, Cardiovascular Diseases

Eli Lilly & Co.

145 participants planned

Hungary · Czechia · Spain · Netherlands

2025-524858-34-00 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 Not possible to specify Authorised 23/07/2026

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

No medical condition

Chemo Research S.L.

1550 participants planned

Sweden · Czechia · Spain · Hungary · Poland · Finland · Romania

2026-525727-24-00 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 Nutritional and Metabolic Diseases Authorised 20/07/2026

A placebo-controlled comparability study to compare two presentations of cagrilintide for weight management in participants with overweight or obesity

Participants with overweight or obesity

Novo Nordisk A/S

171 participants planned

Sweden · Greece · Hungary · Portugal

2025-524249-29-00 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 I Not possible to specify Authorised 17/07/2026

Bioequivalence study of Vitamin D3 Pharma Patent 20,000 IU and the Vigantol 20,000 IU oral drops solutions and assessment of bioavailability in healthy volunteers

Healthy volunteers

Pharma Patent Kft.

36 participants planned

Hungary

2026-526224-48-02 on CTIS ↗

Phase I Cardiovascular Diseases Authorised 10/07/2026

A Phase 1, Randomized, Placebo-Controlled, Multiple-Dose, Dose-Ranging Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTX611 in Healthy Adult Participants

Thromboembolic disorders

CRISPR Therapeutics AG

48 participants planned

Hungary

2026-526708-56-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

613 participants planned

Denmark · Sweden · Poland · Estonia · Portugal · Latvia · Spain · Hungary · Germany · Finland · Italy · Belgium · France

2024-518016-39-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 01/07/2026

A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose‑ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) versus Placebo in Participants of 4 to Less than 12 Years of Age with Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF) (FAROS)

Asthma

AstraZeneca AB

35 participants planned

Czechia · Poland · Hungary

2025-524914-26-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)

Genmab A/S

257 participants planned

Finland · Belgium · Hungary · France · Denmark · Austria · Germany · Italy · Spain · Czechia · Norway · Poland

2025-522167-15-00 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 III Respiratory Tract Diseases Authorised 17/06/2026