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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 Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)
2025-521632-12-00Patients on Factor Xa inhibitor treatment needing an urgent…
VarmX B.V.
Hemic and Lymphatic Diseases
Belgium, Germany, Italy, France, Czechia, Bulgaria, Hungary, Spain, Netherlands, Poland, Austria, Estonia, Romania, Portugal, Lithuania
19/05/2026
Phase II
PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases
2025-523425-17-00Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Nutritional and Metabolic Diseases
Portugal, Greece, Italy, Poland, Estonia, Slovakia, Sweden, Denmark, Belgium, Norway, Romania, France, Spain, Germany, Netherlands, Croatia
19/05/2026
Phase III
A multicentre, open-label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming. "BAZOOKA_221"
2025-524765-24-00Rabies infection/prophylaxis
Institute Of Tropical Medicine
Virus Diseases
Belgium
19/05/2026
Phase III
A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
2025-523735-19-00Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp.
Neoplasms
Poland, France, Denmark, Norway, Spain, Germany, Belgium, Netherlands, Austria, Italy
19/05/2026
Phase III
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
2025-524316-11-00Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC
Nervous System Diseases
Italy, Finland, Bulgaria, Greece, Belgium, Estonia, Portugal, Spain, Germany, France, Czechia, Slovakia, Romania, Croatia, Poland, Austria, Netherlands, Denmark, Sweden, Hungary
18/05/2026
Phase IV
The effect of beta-blockers on how you feel and recover after a heart attack when your heart is still pumping well
2026-525475-96-00Myocardial infarction without reduced ejection fraction
UZ Leuven
Cardiovascular Diseases
Belgium
18/05/2026
Phase III
ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%
2025-523586-18-00Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Portugal, Norway, Sweden, Bulgaria, France, Belgium, Austria, Germany, Finland, Poland, Romania, Netherlands, Spain, Italy, Hungary, Czechia
15/05/2026
Phase I/II
A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors
2026-525248-13-00Advanced Solid Tumors
Eikon Therapeutics Inc.
Neoplasms
France, Spain, Norway, Italy, Germany, Austria, Poland, Finland, Belgium, Denmark, Portugal
15/05/2026
Phase III
A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants with Relapsed/Refractory Primary Central Nervous System Lymphoma
2025-523389-26-00Relapsed/refractory primary central nervous system lymphoma
Deciphera Pharmaceuticals Inc.
Nervous System Diseases
Czechia, Germany, Italy, Belgium, Spain, Poland, Austria, France, Hungary
14/05/2026
Phase IV
Reproductive outcomes with letrozole co-treatment during ovarian stimulation in women with endometriosis undergoing IVF/ICSI: a randomised, multicentre, parallel group pragmatic trial
2025-524995-53-00Women with endometriosis undergoing IVF/ICSI
UZ Brussel
Reproductive and Urinary Physiological Phenomena
Belgium
13/05/2026
Phase III
A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.
2025-523869-22-00advanced or metastatic extrapulmonary neuroendocrine carcin…
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Neoplasms
Portugal, Spain, Poland, Sweden, Italy, Czechia, France, Netherlands, Finland, Denmark, Austria, Germany, Belgium, Norway
13/05/2026
Phase II
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants with Prurigo Nodularis
2025-523404-74-00Prurigo Nodularis
Innocare Pharma Inc.
Skin and Connective Tissue Diseases
Belgium, Poland, Germany, France, Austria
13/05/2026
Phase I
A clinical trial of MK-1824 in healthy participants (MK-1824-001)
2026-525748-14-00Heart failure with preserved ejection fraction
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Belgium
12/05/2026
Phase III
DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.
2025-520565-51-00small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Neoplasms
Czechia, Sweden, Poland, Netherlands, Greece, Latvia, Finland, Norway, Belgium, Austria, Portugal, Romania, Italy, Estonia, France, Ireland, Germany, Spain, Bulgaria, Hungary
12/05/2026
Phase III
A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs
2025-522586-30-00Psoriatic Arthritis
Takeda Development Center Americas Inc.
Musculoskeletal Diseases
Germany, Belgium, Spain, Czechia, Croatia, Portugal, Poland, Latvia, Bulgaria, France, Estonia, Hungary, Italy
12/05/2026
Phase III
A randomized controlled non-inferiority trial comparing 7 versus 14 days of ciprofloxacin for male urinary tract infections with systemic involvement.
2025-524703-76-00Urinary tract infection with systemic involvement (UTI: def…
UZ Brussel
Bacterial Infections and Mycoses
Belgium
11/05/2026
Phase I
A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a single dose of REGN22044 in Healthy Adults
2025-523562-24-00Heathy volunteer trial
Regeneron Pharmaceuticals Inc.
Not possible to specify
Belgium
11/05/2026
Phase III
J5E-MC-JZXB - FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer
2025-522255-25-00Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neop…
Eli Lilly & Co.
Neoplasms
Netherlands, Hungary, France, Austria, Poland, Italy, Denmark, Romania, Greece, Norway, Czechia, Belgium, Spain, Ireland, Germany
11/05/2026
Phase III
A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies
2025-522983-33-00Chronic rhinosinusitis with nasal polyps
Sanofi-Aventis Recherche & Developpement
Respiratory Tract Diseases
Germany, Netherlands, Portugal, Denmark, Sweden, Finland, France, Spain, Austria, Italy, Hungary, Romania, Belgium, Czechia, Poland
11/05/2026
Phase III
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes
2025-523104-71-00Obesity or Overweight Without Type 2 Diabetes
F. Hoffmann-La Roche AG
Nutritional and Metabolic Diseases
Poland, Hungary, France, Belgium, Italy, Netherlands, Czechia, Germany, Spain
07/05/2026
Phase I
A clinical trial of MK-4605 in healthy participants (MK-4605-001)
2026-525627-24-00Dementia
Merck Sharp & Dohme LLC
Nervous System Diseases
Belgium
06/05/2026
Phase I
Phase 1b Study of Tarlatamab + ZL-1310 +/- Anti-PD-L1 in Small Cell Lung Cancer
2025-522888-15-00Small Cell Lung Cancer
Amgen Inc.
Neoplasms
Spain, Germany, Poland, Belgium, France
05/05/2026
Phase II
A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease
2025-524001-33-00Graves’ Disease
Immunovant Sciences GmbH
Immune System Diseases
Italy, Greece, Germany, Hungary, Poland, Czechia, Netherlands, Spain, Belgium, Bulgaria, Latvia
05/05/2026
Phase III
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)
2024-520440-42-00Obesity
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Denmark, France, Germany, Belgium
04/05/2026
Phase III
A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy
2024-519638-22-00IgA nephropathy
Novartis Pharma AG
Immune System Diseases
Belgium, France, Czechia, Croatia, Greece, Germany, Italy, Spain
04/05/2026
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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.