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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 20 Sep 2026, 03:17 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 581 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 581 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 III
Colchicine for the Reduction of Dependency and Vascular Events after an Acute Intracerebral Hemorrhage (CoVasc-ICH2)
2025-523435-18-00Major cardiovascular events (MACE), spontaneous intracerebr…
Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International
Cardiovascular Diseases
Spain, Belgium
22/07/2026
Phase III
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis
2026-525242-29-00Primary Sclerosing Cholangitis
Ipsen Bioscience Inc.
Digestive System Diseases
Spain, Sweden, Germany, Romania, Finland, Portugal, Austria, Italy, Denmark, Czechia, France, Netherlands, Poland, Belgium, Norway
21/07/2026
Phase II
J2J-MC-JZLL - preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women with Estrogen Receptor-Positive, HER2-Negative Breast Cancer.
2025-523258-15-00Breast Neoplasms
Eli Lilly & Co.
Neoplasms
Belgium, France, Italy, Germany
21/07/2026
Phase III
A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease
2025-522227-99-00Huntington’s Disease
Novartis Pharma AG
Nervous System Diseases
Norway, Poland, Spain, Sweden, Bulgaria, Netherlands, Finland, Portugal, Austria, Italy, Greece, Ireland, Czechia, France, Romania, Belgium, Germany, Denmark, Slovakia, Hungary
20/07/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
2025-524711-36-00Narcolepsy Type 1
Alkermes Inc.
Nervous System Diseases
Sweden, Finland, Belgium, Spain, Austria, Netherlands, France, Norway, Germany, Italy, Poland
20/07/2026
Phase III
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.
2025-524463-20-00Asthma
Glaxosmithkline Research & Development Limited
Respiratory Tract Diseases
Ireland, Spain, Germany, Czechia, Bulgaria, France, Belgium, Romania, Italy
14/07/2026
Phase II
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke
2025-522734-31-00Acute Ischemic Stroke
Takeda Development Center Americas Inc.
Nervous System Diseases
Greece, Belgium, France, Germany
14/07/2026
Phase III
A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
2025-524648-37-00Metastatic colorectal cancer
Merck Healthcare KGaA
Neoplasms
Belgium, Germany, France, Denmark, Poland, Spain, Netherlands, Italy, Austria
14/07/2026
Phase III
RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma
2025-525088-34-00Metastatic Pancreatic Adenocarcinoma
Revolution Medicines Inc.
Digestive System Diseases
Poland, Belgium, Norway, Sweden, Austria, Germany, Denmark, Netherlands, France, Italy, Spain
14/07/2026
Phase II
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease
2025-524139-38-00Antibody-mediated Kidney Disease
AstraZeneca AB
Immune System Diseases
France, Germany, Italy, Belgium, Poland, Spain
13/07/2026
Phase I/II
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma
2025-525105-20-00Multiple Myeloma (MM), Multiple Myeloma (MM)
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Germany, Poland, Czechia, Belgium, France, Greece, Sweden, Portugal, Italy
13/07/2026
Phase I
A Phase 1 Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
2026-525234-39-00Relapsed or Refractory acute myeloid leukemia, Relapsed or …
Janssen Cilag International
Neoplasms
France, Spain, Germany, Denmark, Belgium
13/07/2026
Phase II
Prospective trial of [18F]AlF-FAPI-74 for PET imaging of fibroblast activation protein in patients with endometriosis
2026-525272-25-00endometriosis
UZ Leuven
Female Urogenital Diseases and Pregnancy Complications
Belgium
10/07/2026
Phase II
Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
2025-522939-33-00AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthe…
Argenx
Immune System Diseases
Greece, Italy, Germany, Belgium, Netherlands, Spain, Poland
08/07/2026
Phase II
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy
2025-523503-30-00Narcolepsy
Eisai Limited
Nervous System Diseases
Belgium, Italy, Spain, Germany
08/07/2026
Phase I
A Trial to Evaluate the Safety and Drug Levels of Single and Multiple Oral Doses of AT-587 in Healthy Adults
2026-526237-26-00Chronic hepatitis E virus (HEV) infection
Atea Pharmaceuticals Inc.
Virus Diseases
Belgium
07/07/2026
Phase II
A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion
2025-524285-18-00Advanced and/or Metastatic Solid Tumors with Homozygous MTA…
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Belgium, Ireland, Germany, Norway, Italy, France, Spain
07/07/2026
Phase III
A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)
2025-523369-32-00Fibrosing interstitial lung disease
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Respiratory Tract Diseases
Belgium, Greece, Germany, France, Finland, Spain, Czechia, Poland, Italy, Netherlands, Denmark, Portugal
07/07/2026
Phase IV
Oral versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomised Non-Inferiority Trial (TRANSCAB Study)
2026-526581-24-01Coronary artery disease requiring off-pump coronary artery …
Sante et Prevoyance
Cardiovascular Diseases
Belgium
06/07/2026
Phase III
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
2024-518016-39-00Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement
Respiratory Tract Diseases
Denmark, Sweden, Poland, Estonia, Portugal, Latvia, Spain, Hungary, Germany, Finland, Italy, Belgium, France
06/07/2026
Phase I
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants with End-Stage Kidney Disease on Hemodialysis
2026-525844-14-00End-Stage Kidney Disease (ESKD)
Regeneron Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Belgium
03/07/2026
Phase I
A Study to Evaluate Targeted Therapies for Patients with Rheumatoid Arthritis
2025-523127-21-00Rheumatoid Arthritis
AbbVie Deutschland GmbH & Co. KG
Immune System Diseases
Belgium, Netherlands, Spain, Germany, Italy
01/07/2026
Phase III
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)
2025-522167-15-00Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)
Genmab A/S
Neoplasms
Finland, Belgium, Hungary, France, Denmark, Austria, Germany, Italy, Spain, Czechia, Norway, Poland
01/07/2026
Phase I
C6501003 - A Phase 1, Open-Label, Randomized, Single Dose, Parallel Group Study to Assess Relative Bioavailability of PF-08653945 When Administered Across Different Injection Sites in Adults With Overweight or Obesity
2026-526334-67-00chronic weight management and other weight-related co-morbi…
Pfizer Inc.
Nutritional and Metabolic Diseases
Belgium
01/07/2026
Phase III
A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection
2025-521971-29-00Non Small Cell Lung Cancer (NSCLC)
Nuvation Bio Inc.
Respiratory Tract Diseases
Spain, Belgium, France, Italy, Germany
30/06/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 20 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.