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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 I/II
A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors
2025-523432-39-01Advanced KRAS G12D-Mutant Solid Tumors
Verastem Inc.
Neoplasms
Italy, France, Germany, Belgium, Spain, Netherlands
09/06/2026
Phase IV
A neuropsychobiological approach to optimize patient selection for GLP-1-based pharmacotherapy for weight management across the binge eating spectrum
2026-526016-36-00obesity
UZ Leuven
Nutritional and Metabolic Diseases
Belgium
08/06/2026
Phase III
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer
2025-522818-23-00Small Cell Lung Cancer (SCLC)
Zai Lab (US) LLC
Neoplasms
Belgium, Czechia, Germany, Denmark, Greece, Netherlands, Poland, Spain, Austria, Italy, France
08/06/2026
Phase I
A study to learn more about how safe BAY 3771249 is and how well it works in people with advanced or metastatic colorectal cancer that has a KRAS G12D mutation
2025-523648-11-00adenocarcinoma of the colon or rectum
Bayer Consumer Care AG
Neoplasms
Finland, Spain, Sweden, Italy, Denmark, Netherlands, Belgium
08/06/2026
Phase I/II
KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments
2025-523537-26-00Locally advanced or metastatic KRAS G12C-mutated non-small …
Novartis Pharma AG
Neoplasms
Spain, Italy, France, Denmark, Belgium
08/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)
2025-523675-39-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited
Nutritional and Metabolic Diseases
Belgium, Greece, Poland, France, Spain, Bulgaria, Italy, Germany, Austria, Netherlands
08/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
2025-523912-35-00Narcolepsy Type 2
Alkermes Inc.
Nervous System Diseases
Spain, Netherlands, Belgium, Italy, France, Austria, Czechia, Germany, Sweden, Poland
04/06/2026
Phase I/II
A study on the safety of and immune response to different doses of RSV/hMPV combination and hMPV vaccines in adults
2025-524456-58-00Respiratory Syncytial Virus Infections+Metapneumovirus
GlaxoSmithKline Biologicals
Respiratory Tract Diseases
Belgium
04/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
2025-523911-13-00Narcolepsy Type 1
Alkermes Inc.
Nervous System Diseases
Italy, France, Netherlands, Spain, Belgium, Austria, Czechia, Finland, Germany, Sweden, Norway, Poland
02/06/2026
Phase III
A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A
2025-522435-33-00Hemophilia A
F. Hoffmann-La Roche AG
Hemic and Lymphatic Diseases
Hungary, Spain, Ireland, Poland, Austria, Germany, Denmark, Belgium, Netherlands, Italy, France
01/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive
2025-523555-66-00Myelofibrosis
Novartis Pharma AG
Neoplasms
Belgium, Germany, Austria, Poland, Spain, Italy, Netherlands, Czechia, France
29/05/2026
Phase II
J5D-MC-FPAD: A Phase 2a, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants with Non-Segmental Vitiligo
2025-524726-18-00Non-Segmental Vitiligo (NSV), Vitiligo
Eli Lilly & Co.
Immune System Diseases
Poland, Belgium
29/05/2026
Phase II
A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX‑828/Deutivacaftor With and Without Tezacaftor in Subjects Aged 18 Years and Older With Cystic Fibrosis
2025-523400-72-00Cystic fibrosis
Vertex Pharmaceuticals Inc.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Spain, Sweden, Germany, Italy, Belgium, Czechia, Ireland, Portugal, Netherlands, France, Denmark
29/05/2026
Phase II
An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous Afimkibart Clinical Trials
2025-523579-47-00moderate to severe rheumatoid arthritis (RA)
F. Hoffmann-La Roche AG
Immune System Diseases
Italy, Spain, Germany, France, Denmark, Poland, Belgium
27/05/2026
Phase III
A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease
2025-521590-13-00Moderately to Severely Active Crohn’s Disease
Janssen Cilag International
Immune System Diseases
Slovakia, Germany, Denmark, France, Spain, Italy, Netherlands, Belgium, Poland, Sweden, Austria, Czechia, Hungary
27/05/2026
Phase III
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of a Single Intravenous Dose of SGT-003 in Ambulant Males With Duchenne Muscular Dystrophy
2025-522949-22-00Duchenne muscular dystrophy
Solid Biosciences Inc.
Musculoskeletal Diseases
Spain, Netherlands, France, Italy, Belgium, Germany
26/05/2026
Phase I/II
LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
2025-522339-32-00Neoplasm malignant
Merck Sharp & Dohme LLC
Neoplasms
France, Spain, Sweden, Germany, Italy, Belgium, Denmark, Czechia, Hungary, Netherlands, Slovakia
26/05/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma
2025-524040-35-00Severe uncontrolled asthma
Generate Biomedicines Inc.
Respiratory Tract Diseases
Italy, Slovakia, Spain, Ireland, Belgium, France, Estonia
26/05/2026
Phase I
A PET Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
2025-524564-38-00Neuropsychiatric indications and potentially other conditio…
Bristol-Myers Squibb Services Unlimited Company
Behavior and Behavior Mechanisms
Belgium
22/05/2026
Phase III
ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy
2025-523576-23-00Unresectable Stage III non-small cell lung cancer without p…
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
France, Ireland, Germany, Greece, Bulgaria, Spain, Netherlands, Italy, Sweden, Romania, Hungary, Belgium, Austria, Poland
22/05/2026
Phase II
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
2025-525013-23-00Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)
Eikon Therapeutics Inc.
Neoplasms
Germany, Spain, Netherlands, Romania, Greece, Italy, Austria, Belgium, Bulgaria, France, Hungary, Poland
21/05/2026
Phase II
An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of KL1333 (napazimone) in patients with primary mitochondrial disease
2025-524367-20-00Adult patients with primary mitochondrial disease
Pharming Technologies B.V.
Metabolism
Belgium, Germany, Czechia, Spain, Denmark, Italy, France
21/05/2026
Phase III
A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa
2025-523259-72-00Hidradenitis Suppurativa (HS)
Novartis Pharma AG
Immune System Diseases
Portugal, Greece, Germany, Hungary, France, Spain, Bulgaria, Slovakia, Poland, Czechia, Belgium, Italy
20/05/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (delpacibart zotadirsen) for the Treatment of DMD with Gene Mutations Amenable to Exon 44 Skipping
2025-523087-20-00Duchenne muscular dystrophy
Avidity Biosciences Inc.
Musculoskeletal Diseases
Italy, Germany, France, Spain, Belgium, Poland, Netherlands
20/05/2026
Phase I
An Early-Stage Study in Multiple Clinics of how Afimkibart May Affect the Body’s Processing of Medicines that Rely on Cytochrome P450 Enzymes in Patients with Ulcerative Colitis
2025-524060-38-00Active Ulcerative Colitis (UC)
F. Hoffmann-La Roche AG
Digestive System Diseases
Germany, Poland, Belgium
19/05/2026
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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.