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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
218 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
An Open-label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of 12-month Treatment with Migalastat in Pediatric Subjects (aged 2 to < 12 years) with Fabry Disease and Amenable GLA Variants
2025-521244-38-00Fabry disease
Amicus Therapeutics Inc.
Nutritional and Metabolic Diseases
Spain, Germany, Belgium
17/12/2025
Phase III
C3651021: A PHASE 2b/3, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PONSEGROMAB (PF-06946860) COMPARED WITH PLACEBO BOTH WITH BACKGROUND FIRST-LINE CHEMOTHERAPY IN ADULT PARTICIPANTS WITH CACHEXIA AND METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
2025-522093-36-00Cancer cachexia
Pfizer Inc.
Nutritional and Metabolic Diseases
Slovakia, Italy, Belgium, Germany, Spain, France, Bulgaria, Poland
16/12/2025
Phase III
A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants with Early Parkinson’s Disease
2025-521113-13-00Early Parkinson’s Disease
Biohaven Therapeutics Ltd.
Nervous System Diseases
Germany, France, Italy, Belgium, Czechia, Poland, Austria, Netherlands, Spain, Portugal
15/12/2025
Phase III
A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants with Congenital Adrenal Hyperplasia Including a Long-Term Extension
2024-519578-38-00Classic congenital adrenal hyperplasia
Crinetics Pharmaceuticals Inc.
Hormonal diseases
Italy, Germany, France, Belgium, Netherlands, Poland
09/12/2025
Phase III
CLEOPATTRA: Effects of NNC6019-0001 versus placebo on cardiovascular outcomes in participants with transthyretin amyloid cardiomyopathy (ATTR-CM).
2024-518899-31-00Variant or wild-type transthyretin (TTR) amyloid cardiomyop…
Novo Nordisk A/S
Cardiovascular Diseases
Germany, France, Belgium, Italy, Denmark, Netherlands, Spain, Czechia
09/12/2025
Phase III
(21467) A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)
2024-519830-22-00Heart failure due to systemic left ventricular systolic dys…
Bayer AG
Cardiovascular Diseases
Czechia, Germany, Greece, Italy, Finland, Bulgaria, Belgium, Poland, Austria, Portugal, Spain, Hungary, Sweden
05/12/2025
Phase III
(21466) A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK/ PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age, with heart failure (HF) and left ventricular systolic dysfunction (LVSD)
2024-519829-38-00Heart failure due to systemic left ventricular systolic dys…
Bayer AG
Cardiovascular Diseases
Czechia, Poland, Portugal, Austria, Finland, Greece, Bulgaria, Sweden, Spain, Italy, Belgium, Hungary, Germany
05/12/2025
Phase III
A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice-Weekly, Followed by a Long-Term, Open-Label Safety Evaluation in Patients with Short Bowel Syndrome–Intestinal Failure (SBS-IF)
2024-512486-14-00Short Bowel Syndrome
Zealand Pharma A/S
Digestive System Diseases
Finland, France, Belgium, Germany, Hungary, Spain, Austria, Netherlands, Italy, Denmark, Czechia, Norway, Poland, Sweden, Estonia
04/12/2025
Phase III
A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)
2024-512298-28-00Neovascular age-related macular degeneration
AbbVie Deutschland GmbH & Co. KG
Eye Diseases
Czechia, Portugal, Hungary, Spain, Belgium, Italy, Austria, France, Slovakia, Croatia, Germany, Bulgaria, Greece
02/12/2025
Phase III
A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
2025-521382-27-00Moderately to Severely Active Crohn's Disease
Janssen Cilag International
Immune System Diseases
Netherlands, Italy, Portugal, Spain, Czechia, Romania, France, Sweden, Hungary, Belgium, Germany, Greece, Poland
01/12/2025
Phase III
A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
2025-521381-10-00Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International
Digestive System Diseases
Netherlands, Romania, Italy, Spain, Sweden, Czechia, Greece, Hungary, France, Portugal, Belgium, Germany, Poland
01/12/2025
Phase III
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
2025-521970-33-00​​Pulmonary Arterial Hypertension (PAH)
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Czechia, Germany, Sweden, Greece, Croatia, Belgium, Poland, Spain, Portugal, Italy, Denmark, France, Netherlands
01/12/2025
Phase III
A Randomized, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-Paclitaxel and Gemcitabine versus Placebo in Combination With Nab-Paclitaxel and Gemcitabine in Participants with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion
2025-522598-12-00Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Czechia, Austria, Belgium, Ireland, Spain, Germany, Romania, Netherlands, Slovakia, Greece, Poland, Italy, Denmark, France, Sweden
28/11/2025
Phase III
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
2024-514500-14-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …
Merck Sharp & Dohme LLC
Neoplasms
Germany, Italy, France, Poland, Spain, Hungary, Romania, Greece, Austria, Netherlands, Belgium
27/11/2025
Phase III
Hysteroscopic resection versus medical management of early pregnancy loss (HyME): a randomized controlled trial
2024-520166-63-00Early pregnancy loss (< 10 weeks of gestation)
UZ Brussel
Female Urogenital Diseases and Pregnancy Complications
Belgium
26/11/2025
Phase III
A 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of Glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials
2025-520775-81-00Short Bowel Syndrome
Zealand Pharma A/S
Digestive System Diseases
Poland, France, Germany, Belgium
26/11/2025
Phase III
Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
2024-513911-28-00Acute Ischemic Stroke
Diamedica Therapeutics Inc.
Nervous System Diseases
Romania, Hungary, Belgium, Poland, Spain, France
25/11/2025
Phase III
A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation.
2024-520418-22-00Chronic Obstructive Pulmonary Disease
Glaxosmithkline Research & Development Limited
Respiratory Tract Diseases
Slovakia, Denmark, France, Sweden, Ireland, Belgium, Netherlands, Spain, Croatia, Germany, Poland, Hungary, Norway, Portugal
24/11/2025
Phase III
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2025-522860-34-00Small lymphocytic lymphoma (SLL), Chronic lymphocytic leuke…
BeOne Medicines AG
Neoplasms
Sweden, Belgium, Spain, Germany, Austria, Netherlands, Italy, Romania, Poland, France
18/11/2025
Phase III
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of JNJ-78278343, a T-cell-redirecting Agent Targeting Human Kallikrein 2 Versus Placebo for Metastatic Castration-resistant Prostate Cancer
2025-520927-26-00Metastatic Castration-resistant Prostate Cancer (mCRPC)
Janssen Cilag International
Neoplasms
France, Belgium, Spain, Poland, Italy, Netherlands, Germany
18/11/2025
Phase III
C5851005 - PADLINK-005: A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDL1V VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)
2025-521281-97-00Non-Small Cell Lung Cancer (NSCLC)
Pfizer Inc.
Neoplasms
Greece, Italy, Belgium, Slovakia, Czechia, Germany, France, Poland, Denmark, Spain, Netherlands, Sweden, Finland, Bulgaria
17/11/2025
Phase III
A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)
2024-518777-34-00B7-H4-Selected Advanced/Metastatic Endometrial Cancer.
AstraZeneca AB
Neoplasms
Italy, Netherlands, Lithuania, Finland, Greece, Austria, Belgium, Hungary, Spain, Poland, Czechia, Germany, France, Denmark, Slovenia
17/11/2025
Phase III
Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.
2025-522052-13-00Framework for Optimizing, Refining, and Unifying Management…
Ospedale Pediatrico Bambino Gesu
Hemic and Lymphatic Diseases
Germany, Denmark, Finland, Norway, Austria, Italy, Poland, France, Czechia, Belgium, Croatia, Hungary, Lithuania, Sweden, Netherlands, Slovakia
17/11/2025
Phase III
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)
2024-513586-39-00Prostate Cancer
AstraZeneca AB
Male Urogenital Diseases
Austria, Sweden, Spain, France, Netherlands, Germany, Belgium, Finland, Hungary, Poland, Italy
12/11/2025
Phase III
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor
2025-523083-21-00PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Gr…
Relay Therapeutics Inc.
Neoplasms
Hungary, Spain, Italy, Belgium, Netherlands, Austria, Germany, Greece, Czechia, Denmark, Poland, Bulgaria, Portugal, France, Ireland, Romania
11/11/2025
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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.