Clinical Trials in Belgium 2026 - 94 Recent EU Authorisations

Phase II Neoplasms Authorised 09/09/2026

Pilot study with Low-dose nivolumab in Advanced Neoplasms that are TMB-high

TMB-high advanced neoplasms

UZ Brussel

40 participants planned

Belgium

2026-525445-73-00 on CTIS ↗

Phase III Neoplasms Authorised 08/09/2026

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants with Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line chemotherapy (DeLLphi-315)

Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line chemotherapy

Amgen Inc.

100 participants planned

Netherlands · Hungary · Portugal · France · Belgium · Italy · Spain

2026-525489-23-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/09/2026

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants with Sjogren’s Disease-Associated Sensorimotor or Sensory Polyneuropathy

Sjogren’s Disease-Associated Sensorimotor Polyneuropathy (SMPN) or Sensory Polyneuropathy (SPN)

Argenx

37 participants planned

Germany · Lithuania · Portugal · Slovakia · Hungary · Spain · Austria · Belgium · France

2026-526218-10-00 on CTIS ↗

Phase I Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 07/09/2026

A Study to Learn How Different Manufactured Products of the Study Medicine Called Osivelotor (PF-07940367) Taste and Are Taken Up Into the Blood When Mixed With Soft Foods or Liquids Given on an Empty Stomach or Given With Food or an Acid Reducing Agent in Healthy Adults

Sickle Cell Disease

Pfizer Inc.

52 participants planned

Belgium

2024-511410-20-01 on CTIS ↗

Phase I Neoplasms Authorised 07/09/2026

A Study of RO7806767 as Single Agent and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Advanced Solid Tumors

F. Hoffmann-La Roche AG

99 participants planned

Spain · Hungary · Italy · Belgium · Denmark · France

2026-525215-13-00 on CTIS ↗

Phase I/II Virus Diseases Authorised 04/09/2026

Phase 1/2, first-in-human, randomized, double-blind, reference-controlled study to evaluate the safety and immunogenicity of an extemporaneously mixed Combo Inactivated Influenza Vaccine (Green Cross [GC]-IIV; 15µg of each hemagglutinin [HA])/OVX836 (480µg), in comparison to GC-IIV (15µg of each HA) concomitantly administered with OVX836 (480µg), GC-IIV alone (15 µg each HA), OVX836 alone (480µg), and a licensed reference trivalent IIV (Vaxigrip®; 15µg of each HA), administered intramuscularly (IM) in healthy participants

Influenza disease

Osivax

250 participants planned

Belgium

2026-526939-19-00 on CTIS ↗

Phase III Immune System Diseases Authorised 02/09/2026

A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy

Immune system diseases

Sanofi-Aventis Recherche & Developpement

338 participants planned

Belgium · Czechia · Hungary · Sweden · Lithuania · Croatia · Netherlands · Slovakia · Poland · Austria · Norway · France · Italy · Bulgaria · Spain · Germany · Romania · Slovenia · Estonia · Portugal · Greece · Denmark

2026-525913-30-00 on CTIS ↗

Phase II Eye Diseases Authorised 01/09/2026

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Dompe' Farmaceutici S.p.A.

171 participants planned

Denmark · Italy · Germany · Hungary · Netherlands · Spain · Belgium · France · Portugal

2025-524748-37-00 on CTIS ↗

Phase III Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 31/08/2026

A Phase 3, Randomized, Double-blind, Placebo‑controlled Study to Assess the Efficacy and Safety of Engasertib in Subjects With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)

Hereditary Hemorrhagic Telangiectasia (HHT)

Vaderis Therapeutics AG

130 participants planned

Hungary · Netherlands · Germany · Bulgaria · France · Italy · Lithuania · Spain · Belgium

2025-524490-17-00 on CTIS ↗

Phase II Neoplasms Authorised 31/08/2026

Clinical Study of Local and Systemic biological Impact of GLP1/GIP-Receptor Agonists in patients with Breast Cancer: The CLARA trial

Hormone Receptor positive postmenopausal breast cancer

UZ Leuven

168 participants planned

Belgium

2026-525820-76-00 on CTIS ↗

Phase I/II Neoplasms Authorised 31/08/2026

Perioperative zanidatamab combined with chemotherapy in HER2-positive locally advanced operable gastroesophageal adenocarcinoma (GEA): a Phase 1b/2a single-arm trial

Gastroesophageal adenocarcinoma (GEA)

UZ Leuven

29 participants planned

Belgium

2025-523483-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 31/08/2026

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants with Genetically Diagnosed Spinal Muscular Atrophy

Spinal Muscular Atrophy

Biogen Idec Research Limited

24 participants planned

Portugal · Italy · Belgium · Croatia · Hungary · Germany · Ireland · France · Norway · Poland

2025-523857-32-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 31/08/2026

HOVON 168: Epcoritamab in Addition to R-Mini-CHOP Compared to R-Mini-CHOP in Elderly, Frail or Unfit Patients with Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL)

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

276 participants planned

Czechia · Denmark · Croatia · Spain · Sweden · Finland · Portugal · Ireland · Netherlands · Belgium · Norway

2025-524230-25-00 on CTIS ↗

Phase I Hemic and Lymphatic Diseases Authorised 31/08/2026

REGN9220 in Combination with Odronextamab in Adult Participants with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphomas (BCNHLs)

B-cell Non-Hodgkins Lymphoma (B-NHL)

Regeneron Pharmaceuticals Inc.

10 participants planned

Belgium

2025-524780-20-00 on CTIS ↗

Phase III Neoplasms Authorised 28/08/2026

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB COMPARED WITH INVESTIGATOR’S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER

Resected Stage II-III Kirsten rat sarcoma virus oncogene homolog glycine 12 to Cysteine (KRAS G12C) -Positive Non-Small Cell Lung Cancer

F. Hoffmann-La Roche AG

198 participants planned

France · Spain · Austria · Greece · Portugal · Ireland · Belgium · Italy · Germany · Netherlands

2025-524263-21-01 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 26/08/2026

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE-791 in Subjects with Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF)

Contineum Therapeutics Inc.

156 participants planned

Italy · Belgium · Denmark · Austria · Greece · Germany · France · Netherlands · Portugal · Poland · Spain

2025-521901-42-00 on CTIS ↗

Phase II Neoplasms Authorised 26/08/2026

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers

Gastrointestinal Cancers

Genmab A/S

67 participants planned

Italy · Belgium · France · Spain · Denmark · Netherlands · Germany

2025-524130-26-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 25/08/2026

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension

narcolepsy

Harmony Biosciences Management Inc.

92 participants planned

Belgium · Italy · Germany · France · Spain · Poland

2025-523821-17-00 on CTIS ↗

Phase I Digestive System Diseases Authorised 25/08/2026

A Phase 1 Trial to Evaluate the Safety, PK, and PD of AX-0811 in Healthy Participants

Cholestatic disease

ProQR Therapeutics VIII B.V.

44 participants planned

Belgium

2026-526764-21-00 on CTIS ↗

Phase II Neoplasms Authorised 25/08/2026

Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)

Solid tumor

Bristol-Myers Squibb Services Unlimited Company

116 participants planned

Greece · Hungary · Poland · Belgium · Spain · Netherlands · Germany · France · Portugal · Italy · Romania

2025-524905-34-00 on CTIS ↗

Phase III Neoplasms Authorised 24/08/2026

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)

Pancreatic Adenocarcinoma

Revolution Medicines Inc.

281 participants planned

Sweden · Spain · France · Poland · Italy · Norway · Belgium · Germany · Czechia · Austria · Netherlands · Denmark

2025-524928-21-00 on CTIS ↗

Phase III Neoplasms Authorised 21/08/2026

A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

K-Group Beta Inc.

197 participants planned

Germany · Spain · Italy · Belgium · Poland · France · Ireland

2025-524641-27-00 on CTIS ↗

Phase III Eye Diseases Authorised 20/08/2026

A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK-001) on the Progression of Stargardt Disease (STGD) - NORTHSTAR

Stargardt Disease (STGD1)

Alkeus Pharmaceuticals Inc.

64 participants planned

Belgium · France · Spain · Italy · Germany

2026-525296-60-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 20/08/2026

J2S-MC-GZMS: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants with IBS-D

Irritable Bowel Syndrome Diarrhea

Eli Lilly & Co.

186 participants planned

Germany · Poland · Spain · Belgium

2025-524973-17-00 on CTIS ↗

Phase I Virus Diseases Authorised 19/08/2026

A clinical trial of MK-8210 in healthy participants (MK-8210-001)

HIV-1 (Human Immunodeficiency Virus Type 1)

Merck Sharp & Dohme LLC

88 participants planned

Belgium

2026-527022-13-00 on CTIS ↗

Phase I/II Neoplasms Authorised 18/08/2026

A Phase 1/2 Trial of TER-2013 in Patients with Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

Solid Tumours

Terremoto Biosciences Inc.

228 participants planned

Spain · Ireland · Hungary · Romania · France · Portugal · Belgium · Poland

2025-525036-34-00 on CTIS ↗

Phase III Male Urogenital Diseases Authorised 17/08/2026

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

Metastatic castration-resistant prostate cancer (mCRPC)

BioNTech SE

183 participants planned

Belgium · Spain · Italy · Poland · Germany · Hungary

2025-524445-27-00 on CTIS ↗

Phase I Respiratory Tract Diseases Authorised 17/08/2026

A Two-part study to learn the amount of polymyxin E1 in the body over time formed after a single inhaled dose of colistimethate sodium (CMS) in healthy adults (Part 1) and after single inhaled and vein-infused doses of CMS in adults with non‑cystic fibrosis bronchiectasis (NCFB) (Part 2)

Non-cystic fibrosis bronchiectasis

Zambon S.p.A.

55 participants planned

Belgium · Poland · Bulgaria

2025-524324-22-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 13/08/2026

A randomized, double blind, placebo-controlled study comparing the efficacy of dupilumab to standard of care (SOC) treatment following hospitalization for a COPD exacerbation

Chronic obstructive pulmonary disease (COPD)

Regeneron Pharmaceuticals Inc.

190 participants planned

Belgium · Italy · Spain

2025-524392-23-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 11/08/2026

J2S-MC-GZMT: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants with IBS-C

Irritable Bowel Syndrome - Constipation

Eli Lilly & Co.

70 participants planned

Belgium · Spain

2025-524974-41-00 on CTIS ↗

Phase I Neoplasms Authorised 10/08/2026

A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms

Incyte Corp.

60 participants planned

Italy · Belgium · Germany · France · Spain

2026-525217-31-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 10/08/2026

Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity

Overweight and obesity

Novo Nordisk A/S

315 participants planned

Netherlands · Belgium · Greece · Poland · Spain · Denmark · France · Bulgaria · Sweden

2025-524626-18-00 on CTIS ↗

Phase III Hormonal diseases Authorised 07/08/2026

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs

Graves' Disease (GD)

Argenx

145 participants planned

Italy · Czechia · Spain · Denmark · Belgium · Romania · Latvia · France · Germany · Greece · Sweden · Poland · Lithuania · Bulgaria

2025-523333-26-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 06/08/2026

[22961] A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.

Atrial fibrillation

Bayer AG

105 participants planned

Belgium · Netherlands · Germany · Poland · Italy · Hungary · Bulgaria

2025-523807-31-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 06/08/2026

Spironolactone and SGLT2 inhibitor to Address Fontan circulatory failure and Enhance Resilience: The SAFER-Fontan trial

Fontan circulation

UZ Leuven

30 participants planned

Belgium

2025-524783-38-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 04/08/2026

ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study with Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit from Continued Treatment

Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES), Asthma

AstraZeneca AB

94 participants planned

Denmark · Belgium · France · Italy · Netherlands · Austria · Poland

2025-523307-29-00 on CTIS ↗

Phase I Neoplasms Authorised 03/08/2026

A First-in-Human Study of INCA035784 in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms

Incyte Corp.

40 participants planned

Italy · Belgium · Germany

2026-525360-18-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 03/08/2026

A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

Systemic sclerosis

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

179 participants planned

Denmark · Hungary · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Austria · Romania · Croatia · Poland · Estonia · Italy · Lithuania

2025-523884-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease

Janssen Cilag International

194 participants planned

Norway · Romania · Austria · Italy · Slovakia · Germany · Hungary · Netherlands · Belgium · France · Portugal · Czechia · Poland · Spain · Greece

2026-525922-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

Janssen Cilag International

302 participants planned

France · Bulgaria · Romania · Slovakia · Norway · Denmark · Greece · Italy · Austria · Poland · Netherlands · Czechia · Germany · Belgium · Spain · Hungary · Portugal

2026-525923-26-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 31/07/2026

A Randomised, Placebo‑Controlled Trial to Assess Effect of IMU‑838 on QT/QTc

Multiple sclerosis

Immunic AG

20 participants planned

Belgium

2026-526859-54-00 on CTIS ↗

Phase III Anesthesia and Analgesia Authorised 31/07/2026

Perioperative Intravenous Metamizole in Laparoscopic Cholecystectomy: A rondomized, double blind, clinical trial.

Post operative pain relief in Patients undergoing laparoscopic cystectomy in day-surgery clinic

UZ Leuven

76 participants planned

Belgium

2026-526531-18-00 on CTIS ↗

Phase I Nutritional and Metabolic Diseases Authorised 27/07/2026

A first-in-human, randomized, double-blind, placebo-controlled, 3-part study assessing the safety, tolerability, pharmacodynamics and pharmacokinetics of GL0071 after single and repeated ascending subcutaneous doses in healthy normal weight, overweight and obese participants, as well as a 12-week treatment randomized, double blind, placebo-controlled exploratory Proof-of-Concept study in overweight and obese participants.

Type 2 diabetes mellitus, Overweight

Sun Pharmaceutical Industries Limited

124 participants planned

Belgium

2025-524233-45-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

Participants with obesity with or without type 2 diabetes

Novo Nordisk A/S

1140 participants planned

Greece · Portugal · France · Slovakia · Bulgaria · Netherlands · Romania · Italy · Austria · Poland · Hungary · Spain · Czechia · Belgium

2025-522488-14-00 on CTIS ↗

Phase I Parasitic Diseases Authorised 27/07/2026

A clinical trial of MK-3868 in healthy participants (MK-3868-001)

Malaria

Merck Sharp & Dohme LLC

16 participants planned

Belgium

2026-526674-17-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer

AbbVie Deutschland GmbH & Co. KG

125 participants planned

Italy · Greece · Spain · Belgium · France · Austria · Germany

2025-523819-11-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 22/07/2026

Colchicine for the Reduction of Dependency and Vascular Events after an Acute Intracerebral Hemorrhage (CoVasc-ICH2)

Major cardiovascular events (MACE), spontaneous intracerebral hemorrhage

Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International

312 participants planned

Spain · Belgium

2025-523435-18-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 21/07/2026

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis

Ipsen Bioscience Inc.

127 participants planned

Spain · Sweden · Germany · Romania · Finland · Portugal · Austria · Italy · Denmark · Czechia · France · Netherlands · Poland · Belgium · Norway

2026-525242-29-00 on CTIS ↗

Phase II Neoplasms Authorised 21/07/2026

J2J-MC-JZLL - preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women with Estrogen Receptor-Positive, HER2-Negative Breast Cancer.

Breast Neoplasms

Eli Lilly & Co.

361 participants planned

Belgium · France · Italy · Germany

2025-523258-15-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

Huntington’s Disease

Novartis Pharma AG

368 participants planned

Norway · Poland · Spain · Sweden · Bulgaria · Netherlands · Finland · Portugal · Austria · Italy · Greece · Ireland · Czechia · France · Romania · Belgium · Germany · Denmark · Slovakia · Hungary

2025-522227-99-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Narcolepsy Type 1

Alkermes Inc.

116 participants planned

Sweden · Finland · Belgium · Spain · Austria · Netherlands · France · Norway · Germany · Italy · Poland

2025-524711-36-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 14/07/2026

The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.

Asthma

Glaxosmithkline Research & Development Limited

229 participants planned

Ireland · Spain · Germany · Czechia · Bulgaria · France · Belgium · Romania · Italy

2025-524463-20-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 14/07/2026

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

Acute Ischemic Stroke

Takeda Development Center Americas Inc.

67 participants planned

Greece · Belgium · France · Germany

2025-522734-31-00 on CTIS ↗

Phase III Neoplasms Authorised 14/07/2026

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Metastatic colorectal cancer

Merck Healthcare KGaA

323 participants planned

Belgium · Germany · France · Denmark · Poland · Spain · Netherlands · Italy · Austria

2025-524648-37-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 14/07/2026

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma

Revolution Medicines Inc.

337 participants planned

Poland · Belgium · Norway · Sweden · Austria · Germany · Denmark · Netherlands · France · Italy · Spain

2025-525088-34-00 on CTIS ↗

Phase II Immune System Diseases Authorised 13/07/2026

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease

Antibody-mediated Kidney Disease

AstraZeneca AB

17 participants planned

France · Germany · Italy · Belgium · Poland · Spain

2025-524139-38-00 on CTIS ↗

Phase I/II Neoplasms Authorised 13/07/2026

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

Multiple Myeloma (MM), Multiple Myeloma (MM)

AbbVie Deutschland GmbH & Co. KG

88 participants planned

Germany · Poland · Czechia · Belgium · France · Greece · Sweden · Portugal · Italy

2025-525105-20-00 on CTIS ↗

Phase I Neoplasms Authorised 13/07/2026

A Phase 1 Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Relapsed or Refractory acute myeloid leukemia, Relapsed or Refractory chronic lymphocytic leukemia, Relapsed or Refractory higher-risk myelodysplastic syndromes, Relapsed or Refractory small lymphocytic lymphoma

Janssen Cilag International

175 participants planned

France · Spain · Germany · Denmark · Belgium

2026-525234-39-00 on CTIS ↗

Phase II Female Urogenital Diseases and Pregnancy Complications Authorised 10/07/2026

Prospective trial of [18F]AlF-FAPI-74 for PET imaging of fibroblast activation protein in patients with endometriosis

endometriosis

UZ Leuven

64 participants planned

Belgium

2026-525272-25-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/07/2026

Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG

Argenx

29 participants planned

Greece · Italy · Germany · Belgium · Netherlands · Spain · Poland

2025-522939-33-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 08/07/2026

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy

Narcolepsy

Eisai Limited

51 participants planned

Belgium · Italy · Spain · Germany

2025-523503-30-00 on CTIS ↗

Phase I Virus Diseases Authorised 07/07/2026

A Trial to Evaluate the Safety and Drug Levels of Single and Multiple Oral Doses of AT-587 in Healthy Adults

Chronic hepatitis E virus (HEV) infection

Atea Pharmaceuticals Inc.

62 participants planned

Belgium

2026-526237-26-00 on CTIS ↗

Phase II Neoplasms Authorised 07/07/2026

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

Bristol-Myers Squibb Services Unlimited Company

123 participants planned

Belgium · Ireland · Germany · Norway · Italy · France · Spain

2025-524285-18-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 07/07/2026

A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)

Fibrosing interstitial lung disease

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

20 participants planned

Belgium · Greece · Germany · France · Finland · Spain · Czechia · Poland · Italy · Netherlands · Denmark · Portugal

2025-523369-32-00 on CTIS ↗

Phase IV Cardiovascular Diseases Authorised 06/07/2026

Oral versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomised Non-Inferiority Trial (TRANSCAB Study)

Coronary artery disease requiring off-pump coronary artery bypass surgery (OPCAB)

Sante et Prevoyance

160 participants planned

Belgium

2026-526581-24-01 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

613 participants planned

Denmark · Sweden · Poland · Estonia · Portugal · Latvia · Spain · Hungary · Germany · Finland · Italy · Belgium · France

2024-518016-39-00 on CTIS ↗

Phase I Hemic and Lymphatic Diseases Authorised 03/07/2026

Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants with End-Stage Kidney Disease on Hemodialysis

End-Stage Kidney Disease (ESKD)

Regeneron Pharmaceuticals Inc.

36 participants planned

Belgium

2026-525844-14-00 on CTIS ↗

Phase I Immune System Diseases Authorised 01/07/2026

A Study to Evaluate Targeted Therapies for Patients with Rheumatoid Arthritis

Rheumatoid Arthritis

AbbVie Deutschland GmbH & Co. KG

19 participants planned

Belgium · Netherlands · Spain · Germany · Italy

2025-523127-21-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)

Genmab A/S

257 participants planned

Finland · Belgium · Hungary · France · Denmark · Austria · Germany · Italy · Spain · Czechia · Norway · Poland

2025-522167-15-00 on CTIS ↗

Phase I Nutritional and Metabolic Diseases Authorised 01/07/2026

C6501003 - A Phase 1, Open-Label, Randomized, Single Dose, Parallel Group Study to Assess Relative Bioavailability of PF-08653945 When Administered Across Different Injection Sites in Adults With Overweight or Obesity

chronic weight management and other weight-related co-morbidities

Pfizer Inc.

57 participants planned

Belgium

2026-526334-67-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 30/06/2026

A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection

Non Small Cell Lung Cancer (NSCLC)

Nuvation Bio Inc.

45 participants planned

Spain · Belgium · France · Italy · Germany

2025-521971-29-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 30/06/2026

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

Pulmonary Hypertension Associated with Interstitial Lung Disease

Insmed Inc.

165 participants planned

Greece · France · Italy · Belgium · Denmark · Germany · Poland · Czechia · Portugal · Austria · Spain · Romania

2025-521769-29-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 30/06/2026

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

Dravet Syndrome

Ionis Pharmaceuticals Inc.

11 participants planned

Spain · France · Belgium · Portugal · Germany

2025-523835-20-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease

Merck Healthcare KGaA

57 participants planned

Germany · Romania · France · Bulgaria · Belgium · Spain · Poland · Greece · Italy · Czechia

2025-524855-30-00 on CTIS ↗

Phase III Immune System Diseases Authorised 29/06/2026

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

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease

Merck Healthcare KGaA

54 participants planned

Spain · Belgium · France · Germany · Slovakia · Romania · Bulgaria · Italy · Poland · Greece

2025-523871-44-00 on CTIS ↗

Phase III Neoplasms Authorised 29/06/2026

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

Colorectal Cancer

AbbVie Deutschland GmbH & Co. KG

243 participants planned

Greece · Portugal · Germany · Belgium · Spain

2025-521712-19-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/06/2026

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

Solid Tumors

Revolution Medicines Inc.

252 participants planned

France · Poland · Ireland · Spain · Greece · Germany · Italy · Sweden · Belgium

2025-524623-50-00 on CTIS ↗

Phase IV Cardiovascular Diseases Authorised 26/06/2026

Randomized Evaluation of fleCAinide safety vs. STandard of care in patients with coronary artery disease and Atrial Fibrillation (ReCAST AF).

Coronary artery disease, Atrial fibrillation

UZ Leuven

988 participants planned

Belgium

2025-525121-13-00 on CTIS ↗

Phase III Immune System Diseases Authorised 22/06/2026

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Hereditary Angioedema

Adarx Pharmaceuticals Inc.

45 participants planned

Poland · Italy · Hungary · France · Austria · Czechia · Belgium · Spain · Bulgaria · Germany · Croatia

2025-521353-16-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 22/06/2026

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis

Non-active Secondary Progressive Multiple Sclerosis (SPMS)

Zenas Biopharma (USA) LLC

486 participants planned

Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece

2025-524322-18-00 on CTIS ↗

Phase I Neoplasms Authorised 22/06/2026

Safety and Tolerability of REGN17235 in Adult Participants with Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome with SF3B1 Mutation

Clonal Cytopenia of Undetermined Significance with SF3B1 mutation, Low-Risk Myelodysplastic Syndrome with SF3B1 mutation

Regeneron Pharmaceuticals Inc.

15 participants planned

Belgium

2026-525464-18-00 on CTIS ↗

Phase III Immune System Diseases Authorised 19/06/2026

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)

Systemic Sclerosis

Celgene Corp.

37 participants planned

Spain · Germany · France · Italy · Belgium

2025-524337-11-00 on CTIS ↗

Phase I Respiratory Tract Diseases Authorised 18/06/2026

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

Healthy volunteers

Rode Kruis-Vlaanderen

104 participants planned

Belgium

2025-525085-29-00 on CTIS ↗

Phase I Neoplasms Authorised 17/06/2026

A Study to Learn About How Different Forms of Study Medicine Prifetrastat are Taken Up Into the Blood in Healthy Adults

Locally advanced or metastatic ER+/HER2- breast cancer

Pfizer Inc.

32 participants planned

Belgium

2026-526038-26-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 17/06/2026

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

Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis

Bristol-Myers Squibb Services Unlimited Company

318 participants planned

Finland · Portugal · Hungary · Ireland · Poland · Greece · France · Belgium · Denmark · Italy · Spain · Netherlands · Austria · Germany

2025-522373-10-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 16/06/2026

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)

Duchenne Muscular Dystrophy

Entrada Therapeutics Inc.

56 participants planned

Belgium · Italy · Netherlands · Spain

2025-525124-10-00 on CTIS ↗

Phase I Neoplasms Authorised 16/06/2026

A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies

Hematological malignancies, Advanced solid tumors

Incyte Corp.

150 participants planned

Italy · Belgium · Denmark

2025-523130-11-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

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)

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer Expressing Claudin18.2

AstraZeneca AB

516 participants planned

France · Italy · Spain · Hungary · Poland · Belgium · Germany · Netherlands

2024-519787-40-00 on CTIS ↗

Phase I/II Neoplasms Authorised 16/06/2026

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)

Metastatic Prostate Cancer

AstraZeneca AB

45 participants planned

Belgium · Spain · Poland · Italy · Netherlands

2025-520626-37-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 16/06/2026

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

Ulcerative colitis (Inflammatory Bowel Disease)

Spyre Therapeutics Inc.

228 participants planned

Croatia · Poland · Austria · Czechia · Italy · Slovakia · Bulgaria · Greece · Belgium · Spain · Hungary · Germany · Lithuania · France · Romania

2025-524640-35-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 15/06/2026

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

Musculoskeletal diseases

Sanofi-Aventis Recherche & Developpement

177 participants planned

France · Netherlands · Germany · Czechia · Belgium · Austria · Hungary · Greece · Spain

2024-511296-15-00 on CTIS ↗

Phase IV Immune System Diseases Authorised 15/06/2026

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)

C3 Glomerulopathy (C3G), Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Swedish Orphan Biovitrum AB (publ)

82 participants planned

France · Italy · Spain · Germany · Belgium

2025-524487-37-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 12/06/2026

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)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Glaxosmithkline Research & Development Limited

210 participants planned

Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria

2025-523674-16-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 11/06/2026

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

J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD01 - Crohn Disease

Eli Lilly & Co.

37 participants planned

Italy · Germany · Hungary · Poland · Belgium

2025-524112-11-00 on CTIS ↗