Product Description
Mechanisms of Action: MAPK Inhibitor,Immunomodulator
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Muscular Dystrophies|Muscular Dystrophy, FacioscapulohumeralOrphan Drug - Muscular Dystrophies|Muscular Dystrophy, Facioscapulohumeral *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Muscular Dystrophy, Facioscapulohumeral
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
1821-FSH-301 | P3 |
Unknown Status |
Muscular Dystrophy, Facioscapulohumeral |
2027-05-31 |
|
FIS-002-2019 OLE | P2 |
Active, not recruiting |
Muscular Dystrophy, Facioscapulohumeral |
2025-10-01 |
24% |
FSHD | P2 |
Active, not recruiting |
Muscular Dystrophy, Facioscapulohumeral |
2025-10-01 |
24% |
REACH | P3 |
Active, not recruiting |
Muscular Dystrophy, Facioscapulohumeral |
2024-10-01 |
42% |