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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
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)
2025-522229-37-00Gastrointestinal Neoplasms
Glaxosmithkline Research & Development Limited
Neoplasms
France, Romania, Spain, Netherlands, Norway, Belgium, Hungary, Italy, Poland, Germany
06/02/2026
Phase III
J2S-MC-GZME: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
2025-522313-38-00Alcohol Use Disorder
Eli Lilly & Co.
Behavioral Disciplines and Activities
Belgium, Germany
05/02/2026
Phase III
ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
2025-522960-34-00Hypertension, Established cardiovascular disease, High card…
Alnylam Pharmaceuticals Inc.
Cardiovascular Diseases
Belgium, Hungary, Czechia, Austria, Germany, France, Greece, Spain, Romania, Netherlands, Italy, Poland, Slovakia, Sweden, Portugal, Denmark, Bulgaria
03/02/2026
Phase III
A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 followed by AZD0486 versus R-mini-CHOP x6 in Elderly or Unfit Participants with Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
2025-522029-37-00Large B-cell Lymphoma
AstraZeneca AB
Neoplasms
Poland, Belgium
30/01/2026
Phase III
A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-DCM).
2025-522553-19-00Symptomatic genetic and familial dilated cardiomyopathy.
Kardigan Inc.
Cardiovascular Diseases
Spain, Denmark, Belgium, Hungary, Italy, Poland, France, Sweden, Netherlands
30/01/2026
Phase III
J2S-MC-GZMP: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)
2025-522312-16-00Alcohol Use Disorder
Eli Lilly & Co.
Behavioral Disciplines and Activities
Germany, Belgium
29/01/2026
Phase III
A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY OF NEOADJUVANT DAROVASERTIB IN SUBJECTS WITH PRIMARY NON-METASTATIC UVEAL MELANOMA (OptimUM-10)
2025-522387-32-00Uveal Melanoma
Ideaya Biosciences Inc.
Eye Diseases
France, Spain, Poland, Italy, Czechia, Belgium, Austria, Netherlands, Denmark, Germany
29/01/2026
Phase III
N1T-MC-MALO: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD
2025-522674-36-00Metabolic Dysfunction-Associated Steatotic Liver Disease
Eli Lilly & Co.
Nutritional and Metabolic Diseases
Czechia, France, Netherlands, Bulgaria, Norway, Austria, Poland, Spain, Italy, Hungary, Germany, Romania, Sweden, Portugal, Belgium
27/01/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallelgroup Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
2025-521558-40-00Pulmonary Hypertension Associated with Interstitial Lung Di…
Insmed Inc.
Respiratory Tract Diseases
Portugal, Italy, Czechia, Poland, Denmark, Greece, Germany, Romania, Spain, France, Belgium, Austria
26/01/2026
Phase III
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia
2024-519068-42-00​Heterozygous Familial Hypercholesterolemia​ in pediatric p…
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Germany, Spain, Belgium, Czechia, Norway, France, Poland, Netherlands, Italy, Finland
26/01/2026
Phase III
Phase 3 Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent and Adult Subjects with Homozygous Familial Hypercholesterolemia (YOSEMITE)
2025-521792-31-01Homozygous Familial Hypercholesterolemia (HoFH)
Arrowhead Pharmaceuticals Inc.
Cardiovascular Diseases
Greece, France, Belgium, Germany, Netherlands, Austria, Sweden, Spain, Czechia, Italy
23/01/2026
Phase III
Evaluation of a New Pain Management Regime for Oocyte Pick-Up During Fertility Treatment
2025-523018-10-00Acute procedural pain associated with oocyte pick-up (oocyt…
UZ Brussel
Anesthesia and Analgesia
Belgium
22/01/2026
Phase III
Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
2025-521284-12-00Non-small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Neoplasms
Austria, Portugal, Netherlands, Greece, Belgium, Spain, Germany, France, Romania, Sweden, Italy, Denmark
19/01/2026
Phase III
IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
2025-521908-22-00EGFR-mutated Non-small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Poland, Germany, Italy, Norway, Netherlands, Belgium, Romania, France, Greece, Spain
19/01/2026
Phase III
A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)
2023-503766-24-00Moderate to Severe Plaque Psoriasis
Bristol-Myers Squibb Services Unlimited Company
Immune System Diseases
Romania, Bulgaria, Germany, Spain, Czechia, France, Hungary, Italy, Sweden, Poland, Denmark, Belgium
19/01/2026
Phase III
An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX
2025-521858-42-00Hemophilia
Sanofi-Aventis Recherche & Developpement
Hemic and Lymphatic Diseases
Belgium, Italy, Romania, Germany, Hungary, Spain, Poland
15/01/2026
Phase III
HOVON 181 AML: Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study
2025-522767-15-00Acute Myeloid Leukemia
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Neoplasms
Belgium, Netherlands, Germany, Austria, Denmark, Estonia, Finland, Ireland, Italy, Lithuania, Spain, Sweden, Norway, Poland
15/01/2026
Phase III
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
2025-521917-24-00Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous…
Janssen Cilag International
Neoplasms
Italy, Portugal, Spain, Romania, Hungary, France, Czechia, Germany, Netherlands, Austria, Poland, Belgium
14/01/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
2025-521514-26-00Persistent, Recurrent, or Newly Diagnosed Metastatic Cervic…
Merck Sharp & Dohme LLC
Neoplasms
Greece, Ireland, France, Belgium, Czechia, Hungary, Austria, Spain, Sweden, Germany, Poland, Denmark, Italy
14/01/2026
Phase III
A Phase 2/3, multicenter, randomized open-label study of zanzalintinib vs everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors
2025-521043-20-00Neuroendocrine tumors
Exelixis Inc.
Neoplasms
France, Poland, Netherlands, Belgium, Germany, Spain, Italy, Austria
09/01/2026
Phase III
A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)
2025-522046-42-00Colonic disease
Norgine Limited
Digestive System Diseases
Poland, Netherlands, Hungary, Spain, Italy, Belgium, Germany, Croatia, Portugal
22/12/2025
Phase III
A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
2025-522105-38-00Chronic Hepatitis Delta Infection
Mirum Pharmaceuticals Inc.
Virus Diseases
Belgium, Hungary, Bulgaria
22/12/2025
Phase III
C2321008: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
2024-519369-24-00METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
Pfizer Inc.
Not possible to specify
Belgium, Finland, France, Germany, Netherlands, Bulgaria, Spain, Slovakia, Italy, Czechia, Poland, Greece
22/12/2025
Phase III
IZABRIGHT-BLADDER01: A Randomized, Open-label, Phase 2/3 trial of Izalontamab Brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment
2025-522400-24-00Metastatic urothelial cancer
Bristol-Myers Squibb Services Unlimited Company
Female Urogenital Diseases and Pregnancy Complications
Ireland, Belgium, Germany, Italy, Norway, Spain, Austria, Sweden, France, Romania, Czechia
19/12/2025
Phase III
A randomized, open-label, multicenter, Phase 3 trial of ivonescimab alone or ivonescimab with ligufalimab versus pembrolizumab for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma(HNSCC)
2025-522996-27-00recurrent and/or metastatic squamous cell carcinoma of the …
Groupe Oncologie Radiotherapie Tete Cou
Neoplasms
France, Spain, Belgium
18/12/2025
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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.