Product Description
Garetosmab is a VelocImmune-derived fully-human monoclonal antibody that binds and neutralizes Activin A, which is involved in the development of heterotopic bone in people with FOP. Garetosmab is currently being studied in adults with FOP. (Sourced from: https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-encouraging-garetosmab-phase-2-results#:~:text=Garetosmab%20is%20a%20VelocImmune%2Dderived,studied%20in%20adults%20with%20FOP.)
Mechanisms of Action: TGFb Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Regeneron
Company Location: Eastern America
Company Founding Year: 1988
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Canada, Chile, China, Colombia, Finland, France, Hong Kong, Italy, Japan, Korea, Malaysia, Netherlands, Poland, Puerto Rico, South Africa, Spain, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Regeneron presented P2 Obesity results on 2025-06-02 for Garetosmab
Highest Development Phases
Phase 3: Fibrodysplasia Ossificans Progressiva|Myositis Ossificans
Phase 2: Obesity
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06299098 |
COURAGE | P2 |
Active, not recruiting |
Obesity |
2026-05-18 |
50% |
2025-12-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
jRCT2041220096 |
jRCT2041220096 | P3 |
Recruiting |
Fibrodysplasia Ossificans Progressiva |
2026-03-31 |
|||
NCT05394116 |
OPTIMA | P3 |
Active, not recruiting |
Myositis Ossificans|Fibrodysplasia Ossificans Progressiva |
2025-07-17 |
20% |
2025-08-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
jRCT2031250302 |
jRCT2031250302 | P3 |
Not yet recruiting |
Fibrodysplasia Ossificans Progressiva |
2031-03-25 |
|||
2023-508350-26-00 |
R2477-FOP-2175 | P3 |
Active, not recruiting |
Fibrodysplasia Ossificans Progressiva |
2026-09-29 |
20% |
2025-05-02 |
Treatments |
2022-000880-40 |
OPTIMA | P3 |
Active, not recruiting |
Fibrodysplasia Ossificans Progressiva |
2026-04-26 |
20% |
2025-05-06 |
Treatments |