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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
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
2025-521769-29-00Pulmonary Hypertension Associated with Interstitial Lung Di…
Insmed Inc.
Respiratory Tract Diseases
Greece, France, Italy, Belgium, Denmark, Germany, Poland, Czechia, Portugal, Austria, Spain, Romania
30/06/2026
Phase I/II
Phase 1-2, Open-Label, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION337 in Patients with Dravet Syndrome
2025-523835-20-00Dravet Syndrome
Ionis Pharmaceuticals Inc.
Nervous System Diseases
Spain, France, Belgium, Portugal, Germany
30/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
2025-524855-30-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…
Merck Healthcare KGaA
Skin and Connective Tissue Diseases
Germany, Romania, France, Bulgaria, Belgium, Spain, Poland, Greece, Italy, Czechia
29/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
2025-523871-44-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…
Merck Healthcare KGaA
Immune System Diseases
Spain, Belgium, France, Germany, Slovakia, Romania, Bulgaria, Italy, Poland, Greece
29/06/2026
Phase III
AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer
2025-521712-19-00Colorectal Cancer
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Greece, Portugal, Germany, Belgium, Spain
29/06/2026
Phase I/II
A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) inhibitors in Combination with Ivonescimab with or without Other Anti-Cancer Agents in Patients with Solid Tumors
2025-524623-50-00Solid Tumors
Revolution Medicines Inc.
Neoplasms
France, Poland, Ireland, Spain, Greece, Germany, Italy, Sweden, Belgium
29/06/2026
Phase III
A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
2025-525009-18-00Pancreatic Ductal Adenocarcinoma
Incyte Corp.
Neoplasms
Poland, Italy, Netherlands, Sweden, Denmark, Finland, Spain, France, Germany, Belgium, Norway, Austria
26/06/2026
Phase IV
Randomized Evaluation of fleCAinide safety vs. STandard of care in patients with coronary artery disease and Atrial Fibrillation (ReCAST AF).
2025-525121-13-00Coronary artery disease, Atrial fibrillation
UZ Leuven
Cardiovascular Diseases
Belgium
26/06/2026
Phase III
A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
2025-521353-16-00Hereditary Angioedema
Adarx Pharmaceuticals Inc.
Immune System Diseases
Poland, Italy, Hungary, France, Austria, Czechia, Belgium, Spain, Bulgaria, Germany, Croatia
22/06/2026
Phase III
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis
2025-524322-18-00Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC
Nervous System Diseases
Germany, Bulgaria, Netherlands, Sweden, Portugal, Croatia, Italy, Austria, Spain, Poland, France, Denmark, Hungary, Romania, Estonia, Slovakia, Belgium, Czechia, Norway, Lithuania, Greece, Slovenia
22/06/2026
Phase I
Safety and Tolerability of REGN17235 in Adult Participants with Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome with SF3B1 Mutation
2026-525464-18-00Clonal Cytopenia of Undetermined Significance with SF3B1 mu…
Regeneron Pharmaceuticals Inc.
Neoplasms
Belgium
22/06/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)
2025-524337-11-00Systemic Sclerosis
Celgene Corp.
Immune System Diseases
Spain, Germany, France, Italy, Belgium
19/06/2026
Phase I
A first study in healthy volunteers to examine the safety and tolerability of convalescent plasma given through the nose,  as well as the duration of its presence in the nose
2025-525085-29-00Healthy volunteers
Rode Kruis-Vlaanderen
Respiratory Tract Diseases
Belgium
18/06/2026
Phase I
A Study to Learn About How Different Forms of Study Medicine Prifetrastat are Taken Up Into the Blood in Healthy Adults
2026-526038-26-00Locally advanced or metastatic ER+/HER2- breast cancer
Pfizer Inc.
Neoplasms
Belgium
17/06/2026
Phase III
IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis
2025-522373-10-00Progressive pulmonary fibrosis and Idiopathic pulmonary fib…
Bristol-Myers Squibb Services Unlimited Company
Respiratory Tract Diseases
Finland, Portugal, Hungary, Ireland, Poland, Greece, France, Belgium, Denmark, Italy, Spain, Netherlands, Austria, Germany
17/06/2026
Phase II
A Phase 2, Open-Label Long-Term Extension Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon Skipping to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Efficacy of Endosomal Escape Vehicle Phosphorodiamidate Morpholino Oligomer Platform Products (ELEVATE-LTE)
2025-525124-10-00Duchenne Muscular Dystrophy
Entrada Therapeutics Inc.
Musculoskeletal Diseases
Belgium, Italy, Netherlands, Spain
16/06/2026
Phase I
A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
2025-523130-11-00Hematological malignancies, Advanced solid tumors
Incyte Corp.
Neoplasms
Italy, Belgium, Denmark
16/06/2026
Phase III
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
2024-519787-40-00Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, E…
AstraZeneca AB
Neoplasms
France, Italy, Spain, Hungary, Poland, Belgium, Germany, Netherlands
16/06/2026
Phase I/II
A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)
2025-520626-37-00Metastatic Prostate Cancer
AstraZeneca AB
Neoplasms
Belgium, Spain, Poland, Italy, Netherlands
16/06/2026
Phase II
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
2025-524640-35-00Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc.
Digestive System Diseases
Croatia, Poland, Austria, Czechia, Italy, Slovakia, Bulgaria, Greece, Belgium, Spain, Hungary, Germany, Lithuania, France, Romania
16/06/2026
Phase III
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of each of two dose levels of sarilumab in adults with early polymyalgia rheumatica
2024-511296-15-00Musculoskeletal diseases
Sanofi-Aventis Recherche & Developpement
Musculoskeletal Diseases
France, Netherlands, Germany, Czechia, Belgium, Austria, Hungary, Greece, Spain
15/06/2026
Phase IV
Real-World Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study (PRISMC3)
2025-524487-37-00C3 Glomerulopathy (C3G), Primary Immune Complex Membranopro…
Swedish Orphan Biovitrum AB (publ)
Immune System Diseases
France, Italy, Spain, Germany, Belgium
15/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
2025-523674-16-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited
Nutritional and Metabolic Diseases
Greece, Germany, Belgium, Netherlands, Poland, Italy, France, Spain, Bulgaria, Austria
12/06/2026
Phase II
J6Z-MC-IIBD - A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease J6Z-MC-CD01 - A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared with Mirikizumab in Adults with Moderately to Severely Active Crohn’s Disease
2025-524112-11-00J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD…
Eli Lilly & Co.
Digestive System Diseases
Italy, Germany, Hungary, Poland, Belgium
11/06/2026
Phase I
A trial in healthy participants to find out how long JNJ-101556143 stays in and acts on the body when administered as different formulations and under different food conditions
2026-526263-38-00Prostate Cancer
Janssen Cilag International
Neoplasms
Belgium
09/06/2026
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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.