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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 12467 total CTIS records — a stated recency window, not the full historical archive. Synced 22 Sep 2026, 03:17 UTC
2500
Shown in this register
most recently authorised
12,467
Total on CTIS
full historical archive
744
Phase III
within the shown window
Top member states
Spain 1018 France 887 Germany 856 Italy 735 Poland 580 Netherlands 527
Narrow the registerReset
Phase
Phase I 557 Phase I/II 211 Phase II 727 Phase III 744 Phase IV 261
Lead sponsor
AstraZeneca AB 62 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 47 Pfizer Inc. 44 Novo Nordisk A/S 43
Member state
Spain 1018 France 887 Germany 856 Italy 735 Poland 580 Netherlands 527 Belgium 424 Czechia 329
All 28 states
424 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
2024-517131-52-00Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymp…
BeOne Medicines AG
Neoplasms
France, Sweden, Czechia, Austria, Belgium, Germany, Denmark, Spain, Netherlands, Italy, Ireland, Poland
26/09/2025
Phase II
PK/PD of Cefadroxil in Staphylococcus Aureus Bacteremia, a preliminary study
2025-522547-17-00staphylococcus aureus bacteremia
UZ Brussel
Bacterial Infections and Mycoses
Belgium
24/09/2025
Phase III
EASi-PROTKT™ - A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease
2025-521188-11-00hypertension, cardiovascular disease, Type 2 diabetes
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Cardiovascular Diseases
Lithuania, Netherlands, Ireland, Romania, France, Hungary, Finland, Latvia, Austria, Germany, Greece, Italy, Sweden, Denmark, Czechia, Belgium, Slovakia, Croatia, Spain, Norway, Bulgaria, Poland, Portugal
24/09/2025
Phase III
Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)
2024-518206-40-00Severe hypertriglyceridemia (SHTG)
Arrowhead Pharmaceuticals Inc.
Nutritional and Metabolic Diseases
Hungary, Bulgaria, Sweden, Austria, Norway, Belgium, Croatia, Czechia, Latvia, Lithuania, Spain, Slovakia
23/09/2025
Phase III
OPTIMA YOUNG : Optimal Personalized Treatment of early breast cancer using Multi-parameter Analysis : focus on YOUNGer women
2024-519655-28-00Premenopausal patients with high-risk HR-positive/HER2-nega…
Unicancer
Neoplasms
Poland, France, Italy, Greece, Spain, Ireland, Belgium
23/09/2025
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy (299IG301 / PREVAIL)
2024-519345-30-00IgA nephropathy
Biogen Idec Research Limited
Immune System Diseases
Greece, Portugal, Spain, Croatia, Czechia, Belgium, Bulgaria, Germany, Italy, Poland, France
23/09/2025
Phase I
A research study looking at how different doses of study medicine (Inno8) work in the body of people with haemophilia A
2025-520490-38-00Haemophilia A with or without inhibitors. Proposed indicati…
Novo Nordisk A/S
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Poland, Spain, Austria, Italy, Germany, Belgium, France, Portugal, Sweden
22/09/2025
Phase I
A Study to assess the Safety, Tolerability and effect of RO7673396 when used alone as well as with other cancer medications in participants with Advanced Solid Tumors
2024-519622-20-00Advanced Solid Tumors Harboring RAS Mutation(S)
F. Hoffmann-La Roche AG
Neoplasms
Germany, Netherlands, Spain, Denmark, France, Belgium
22/09/2025
Phase I
An exploratory study to investigate the impact on the viral reservoir of adding a broadly neutralizing antibody with or without an attachment inhibitor to an integrase inhibitor-based antiretroviral therapy regimen in adults living with HIV (ENTRANCE)
2025-520629-19-00HIV Infections
Viiv Healthcare UK Limited
Virus Diseases
Netherlands, Spain, Belgium, Denmark
22/09/2025
Phase III
A Double-blind, Randomized,Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)
2025-520554-11-00Cardiovascular Disease
Amgen Inc.
Cardiovascular Diseases
Spain, Hungary, Portugal, Greece, Germany, Italy, Austria, Ireland, Romania, Slovakia, Netherlands, Czechia, Bulgaria, Denmark, France, Poland, Belgium
22/09/2025
Phase III
INCB018424-316: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis
2024-518156-24-00Atopic Dermatitis
Incyte Corp.
Skin and Connective Tissue Diseases
France, Germany, Spain, Belgium, Italy, Hungary, Poland
18/09/2025
Phase II
Phase II RAINSPOT: a multicentric open label trial of Zolbetuximab-Paclitaxel-Ramucirumab in second line setting for CLDN18.2 positive gastro-esophageal adenocarcinoma
2025-521358-41-00CLDN18.2 positive gastro-esophageal adenocarcinoma
UZ Leuven
Neoplasms
Belgium
17/09/2025
Phase IV
A Single-arm, Open-label Phase 4 Study of Nirogacestat in Adult Premenopausal Females with Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
2024-515215-21-00DESMOID TUMOURS/AGGRESSIVE FIBROMATOSIS (DT/AF)
Springworks Therapeutics Inc.
Skin and Connective Tissue Diseases
Netherlands, Italy, Spain, Belgium, Germany
15/09/2025
Phase I
A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations
2025-521480-12-00Advanced solid tumors, Breast Cancer
Atavistik Bio Inc.
Neoplasms
Belgium, Italy, Spain, France
15/09/2025
Phase I
A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144
2025-522331-34-00locally advanced or metastatic ER+/HER2- breast cancer
Pfizer Inc.
Neoplasms
Belgium
09/09/2025
Phase II
A Phase 2a randomized, observer-blind, study to evaluate the immunogenicity and safety of mRNA-based multivalent seasonal influenza vaccine candidates in adults 18 years of age and older.
2025-522278-35-00Influenza, Human
GlaxoSmithKline Biologicals
Virus Diseases
Belgium
09/09/2025
Phase III
A Phase 3 Randomized, Controlled Study to Assess the Efficacy and Safety of NVD003 compared with Iliac Crest Bone Graft in Pediatric Participants Treated Surgically for Congenital Pseudarthrosis of the Tibia
2025-520998-39-00Congenital pseudarthrosis of the tibia
Novadip Biosciences
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
France, Spain, Belgium
08/09/2025
Phase II
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
2024-518465-10-00Multiple Autoimmune Glomerular Diseases
Vera Therapeutics Inc.
Pathological Conditions, Signs and Symptoms
Germany, France, Italy, Spain, Poland, Belgium
08/09/2025
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
2024-518296-56-00Crohn’s Disease
Merck Sharp & Dohme LLC
Digestive System Diseases
Spain, Austria, Lithuania, France, Belgium, Germany, Sweden, Czechia, Finland, Croatia, Latvia, Portugal, Netherlands, Italy, Denmark, Slovakia, Romania, Poland, Ireland, Hungary, Greece
03/09/2025
Phase I
Multiple Ascending Dose Study of LY4256984 in Participants with Sporadic Amyotrophic Lateral Sclerosis
2025-521295-60-00Sporadic Amyotrophic Lateral Sclerosis
Eli Lilly & Co.
Nervous System Diseases
Belgium, Spain, Netherlands, Germany
02/09/2025
Phase III
A Randomized, Open-Label, Controlled Phase 3 Study Comparing Daratumumab, Lenalidomide and Dexamethasone Induction followed by Linvoseltamab Versus continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
2024-519827-16-00Newly Diagnosed Transplant Ineligible Multiple Myeloma Pati…
European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
Neoplasms
Norway, Denmark, Spain, Sweden, Austria, Netherlands, Greece, Germany, Italy, Belgium, Portugal, Estonia, Croatia, Ireland, Czechia, Finland
01/09/2025
Phase III
A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
2024-520050-38-00Extensive stage small cell lung cancer (ES-SCLC). …
Amgen Inc.
Neoplasms
Portugal, Germany, Spain, Italy, Denmark, Netherlands, France, Austria, Greece, Belgium, Hungary, Poland, Romania
01/09/2025
Phase III
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
2025-520564-17-00Hidradenitis suppurativa (HS)
MoonLake Immunotherapeutics AG
Skin and Connective Tissue Diseases
Norway, Hungary, Spain, France, Germany, Poland, Czechia, Slovakia, Bulgaria, Netherlands, Italy, Portugal, Belgium
29/08/2025
Phase III
A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Ulcerative Colitis
2024-514695-41-00Ulcerative Colitis
AbbVie Deutschland GmbH & Co. KG
Digestive System Diseases
Sweden, Greece, Germany, Italy, Belgium, Spain
29/08/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 22 September 2026. https://priyalifescience.com/clinical-trials-europe/country/belgium?page=5

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