Phase III Immune System Diseases Authorised 22/06/2026
Hereditary Angioedema
Adarx Pharmaceuticals Inc. · 45 participants
📍 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
Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC · 467 participants
📍 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 II Skin and Connective Tissue Diseases Authorised 17/06/2026
Systemic sclerosis
Galderma S.A. · 56 participants
📍 Poland · Italy · Bulgaria · France · Greece · Spain · Croatia
2025-522294-11-00 on CTIS ↗
Phase II Digestive System Diseases Authorised 16/06/2026
Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc. · 228 participants
📍 Croatia · Poland · Austria · Czechia · Italy · Slovakia · Bulgaria · Greece · Belgium · Spain · Hungary · Germany · Lithuania · France · Romania
2025-524640-35-00 on CTIS ↗
Phase III Bacterial Infections and Mycoses Authorised 10/06/2026
Hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex
Bioversys S.A.S. · 58 participants
📍 Greece · Croatia
2025-524092-23-00 on CTIS ↗
Phase II Digestive System Diseases Authorised 10/06/2026
Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC)
Eli Lilly & Co. · 104 participants
📍 Latvia · Portugal · Greece · France · Czechia · Italy · Poland · Slovakia · Hungary · Croatia · Lithuania
2025-524404-29-00 on CTIS ↗
Phase III Eye Diseases Authorised 05/06/2026
Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 250 participants
📍 Austria · Slovakia · Portugal · Czechia · Hungary · Spain · France · Denmark · Italy · Croatia
2025-524894-17-00 on CTIS ↗
Phase II Nutritional and Metabolic Diseases Authorised 19/05/2026
Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 66 participants
📍 Portugal · Greece · Italy · Poland · Estonia · Slovakia · Sweden · Denmark · Belgium · Norway · Romania · France · Spain · Germany · Netherlands · Croatia
2025-523425-17-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 18/05/2026
Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants
📍 Italy · Finland · Bulgaria · Greece · Belgium · Estonia · Portugal · Spain · Germany · France · Czechia · Slovakia · Romania · Croatia · Poland · Austria · Netherlands · Denmark · Sweden · Hungary
2025-524316-11-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 15/05/2026
Participants with overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 440 participants
📍 Germany · Croatia · Portugal · Hungary · Bulgaria · Romania · Poland
2024-520446-31-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 12/05/2026
severe uncontrolled asthma
Generate Biomedicines Inc. · 271 participants
📍 Latvia · Hungary · Bulgaria · Romania · Portugal · Netherlands · Croatia · Germany · Greece · Czechia
2025-521950-41-00 on CTIS ↗
Phase III Musculoskeletal Diseases Authorised 12/05/2026
Psoriatic Arthritis
Takeda Development Center Americas Inc. · 638 participants
📍 Germany · Belgium · Spain · Czechia · Croatia · Portugal · Poland · Latvia · Bulgaria · France · Estonia · Hungary · Italy
2025-522586-30-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 04/05/2026
Overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 265 participants
📍 Italy · Croatia · Hungary · Slovakia · Romania
2024-520441-23-00 on CTIS ↗
Phase II Immune System Diseases Authorised 04/05/2026
Systemic lupus erythematosus
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 106 participants
📍 Bulgaria · Romania · Germany · Spain · Hungary · Poland · Croatia
2025-523488-39-00 on CTIS ↗
Phase III Immune System Diseases Authorised 04/05/2026
IgA nephropathy
Novartis Pharma AG · 69 participants
📍 Belgium · France · Czechia · Croatia · Greece · Germany · Italy · Spain
2024-519638-22-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 28/04/2026
Obesity and T2D
Novo Nordisk A/S · 157 participants
📍 Slovakia · Austria · Spain · Romania · Portugal · Italy · Denmark · Belgium · Sweden · Poland · Netherlands · Croatia · Hungary · Bulgaria
2023-509176-42-00 on CTIS ↗
Phase II Hormonal diseases Authorised 21/04/2026
type 2 diabetes
Novo Nordisk A/S · 145 participants
📍 Spain · Hungary · Portugal · Poland · Slovakia · Croatia
2025-523260-20-00 on CTIS ↗
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