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Updated 13 Sep 2026 · EMA CTIS official data

Clinical Trials in Croatia

← 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.

9
Recent authorisations
6
Phase III trials
Croatia
Selected country
Showing 9 trials
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 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 Hemic and Lymphatic Diseases Authorised 31/08/2026

HOVON 168: Epcoritamab in Addition to R-Mini-CHOP Compared to R-Mini-CHOP in Elderly, Frail or Unfit Patients with Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL)
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
276 participants planned
Czechia · Denmark · Croatia · Spain · Sweden · Finland · Portugal · Ireland · Netherlands · Belgium · Norway
2025-524230-25-00 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 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 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 ↗
No trials match your search.
Cite this page

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