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Clinical trial register · European Union · CTIS

Clinical Trials in Belgium

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 2500 most recently authorised of 12445 total CTIS records — a stated recency window, not the full historical archive. Synced 21 Sep 2026, 03:16 UTC
2500
Shown in this register
most recently authorised
12,445
Total on CTIS
full historical archive
745
Phase III
within the shown window
Top member states
Spain 1023 France 890 Germany 861 Italy 742 Poland 587 Netherlands 524
Narrow the registerReset
Phase
Phase I 558 Phase I/II 214 Phase II 726 Phase III 745 Phase IV 257
Lead sponsor
AstraZeneca AB 60 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 48 Pfizer Inc. 45 Novo Nordisk A/S 42
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 587 Netherlands 524 Belgium 426 Czechia 327
All 28 states
426 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants with Atopic Dermatitis
2025-524205-32-00Atopic Dermatits
Regeneron Pharmaceuticals Inc.
Skin and Connective Tissue Diseases
Belgium, Czechia, Germany, Poland
30/04/2026
Phase I
Study to Learn How Safe EV25 is and the Amount of EV25 in the Body Over a Period of Time, When Given as a Single Dose to Adult Healthy People [CCI]
2026-525176-26-00Influenza
Eradivir Inc.
Virus Diseases
Belgium
30/04/2026
Phase III
An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial on the Effects of EA-230 on the Length of Hospital Stay Following On-Pump Coronary Artery Bypass Grafting Surgery
2025-525053-39-00Coronary artery disease
EBI Anti Sepsis B.V.
Cardiovascular Diseases
Belgium, Netherlands
29/04/2026
Phase I
​​AMG 436 as monotherapy and combination therapy in participants with Microsatellite Instability-High/Mismatch Repair Deficient Solid Tumors ​
2025-524056-63-00microsatellite instability high/mismatch repair deficient (…
Amgen Inc.
Neoplasms
Spain, France, Belgium
28/04/2026
Phase III
An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.
2024-520218-23-00Pulmonary Arterial Hypertension
Inhibikase Therapeutics Inc.
Cardiovascular Diseases
Spain, Poland, Italy, Belgium, Latvia, Denmark, Czechia, Germany, France, Netherlands, Portugal, Ireland, Austria, Greece, Lithuania
28/04/2026
Phase III
A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long‑term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)
2025-524160-38-00Renal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dM…
Merck Sharp & Dohme LLC
Neoplasms
Czechia, Spain, Poland, Belgium, Finland, Germany, France, Netherlands, Hungary, Denmark
28/04/2026
Phase II
Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease
2025-521154-42-00Sickle Cell Disease
CSL Behring LLC
Hemic and Lymphatic Diseases
Belgium, Netherlands, France, Italy
28/04/2026
Phase III
A two-part, seamless, multicenter, RANDOMIZED, open-label, ADAPTIVE Phase ii/III STUDY OF THE BLOOD-BRAIN barrier PENETRANT RO7771950 versus Tucatinib, both in combination with trastuzumab and capecitabine, in patients with Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without central nervous system metastases
2025-524498-17-00Pretreated Unresectable Locally Advanced or Metastatic huma…
F. Hoffmann-La Roche AG
Neoplasms
Belgium, France, Italy, Austria, Romania, Poland, Portugal, Czechia, Germany, Spain, Hungary
28/04/2026
Phase I
A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults
2025-525125-12-00Migraine with or without aura
Pfizer Inc.
Nervous System Diseases
Belgium
28/04/2026
Phase III
A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants with Myotonic Dystrophy Type 1
2025-522957-20-00Myotonic Dystrophy Type 1
Dyne Therapeutics Inc.
Musculoskeletal Diseases
Netherlands, Spain, Italy, Denmark, Germany, Belgium, France
28/04/2026
Phase III
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
2023-509176-42-00Obesity and T2D
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Slovakia, Austria, Spain, Romania, Portugal, Italy, Denmark, Belgium, Sweden, Poland, Netherlands, Croatia, Hungary, Bulgaria
28/04/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/ GOG-3102)
2023-508047-40-00Ovarian cancer
Merck Sharp & Dohme LLC
Neoplasms
Norway, Ireland, Spain, Greece, France, Poland, Denmark, Austria, Hungary, Belgium, Czechia, Finland, Germany, Italy, Sweden
28/04/2026
Phase III
A Phase 3, Parallel-group Treatment, Blinded, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Pegtibatinase Administered Subcutaneously in Addition to Standard of Care in Participants with Classical Homocystinuria due to Cystathionine Beta Synthase Deficiency (HARMONY)
2023-504135-40-00Classical Homocystinuria
Travere Therapeutics Inc.
Nutritional and Metabolic Diseases
Belgium, Ireland, Spain, Italy, Germany, France, Portugal, Poland
27/04/2026
Phase III
Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12).
2025-523804-62-00Obesity
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Belgium, Germany, Bulgaria, France, Spain, Denmark, Italy, Netherlands
27/04/2026
Phase III
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)
2024-519298-21-00Cancer-Associated Thrombosis (CAT).
Regeneron Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Belgium, Czechia, France, Romania, Germany, Poland, Bulgaria, Spain
27/04/2026
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), with an optional 24-week doubleblind, placebocontrolled extension phase 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 I
Relative bioavailability and effect of food study with GLPG3667 in healthy subjects
2026-525706-35-00inflammatory and autoimmune diseases
Galapagos
Immune System Diseases
Belgium
27/04/2026
Phase II
A phase II trial evaluating treatment intensification with Ezabenlimab in patients with PD-L1–expressing, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) with minimal residual disease (MRD) as detected by circulating tumor DNA (ctDNA) after curative-intent chemoradiation
2025-523575-36-00Locally advanced head and neck squamous cell carcinoma (LA-…
Cliniques Universitaires Saint-Luc
Neoplasms
Belgium
22/04/2026
Phase III
A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension
2025-523481-24-00Participants with Progressive Supranuclear Palsy Richardson…
Novartis Pharma AG
Nervous System Diseases
Netherlands, Germany, Spain, Italy, France, Belgium
21/04/2026
Phase III
J3R-MC-YDAL - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes
2025-523659-73-00Obesity, Overweight
Eli Lilly & Co.
Nutritional and Metabolic Diseases
Spain, Romania, Belgium, Czechia
21/04/2026
Phase II
A single center study to evaluate the safety and tolerability of oral Azathioprine in patients with ADPKD
2025-524313-86-00Autosomal dominant polycystic kidney and liver disease
UZ Leuven
Not possible to specify
Belgium
21/04/2026
Phase II
A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)
2025-523793-16-00Homeostatic iron regulator gene-related hereditary hemochro…
CSL Behring LLC
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Austria, Poland, Spain, Germany, France, Ireland, Romania, Belgium, Italy, Czechia, Netherlands
20/04/2026
Phase I
A study to test how well different doses of BI 3820768 are tolerated by people with advanced cancer (solid tumours)
2025-522913-45-00Advanced relapsed or refractory ovarian cancer, Advanced re…
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Neoplasms
Spain, France, Belgium, Germany
20/04/2026
Phase I
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).
2024-520125-36-00Relapsed or Refractory Acute Myeloid Leukemia; Acute Myelo…
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Spain, Hungary, Czechia, France, Italy, Belgium
20/04/2026
Phase III
A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator’s Choice of Non-platinum Chemotherapy in Participants with Pretreated Locally Advanced/Metastatic Urothelial Carcinoma
2024-520014-22-00Locally advanced/metastatic urothelial carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Netherlands, Greece, Italy, Germany, Spain, Belgium, Sweden, France
20/04/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 21 September 2026. https://priyalifescience.com/clinical-trials-europe/country/belgium

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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.