Garetosmab is a fully human monoclonal antibody drug candidate from Regeneron being developed for fibrodysplasia ossificans progressiva (FOP). It binds and neutralizes Activin A and remains in clinical/regulatory development. As of the cited source, it is not FDA approved.
The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.
The FDA has accepted Regeneron's biologics license application for garetosmab with priority review, targeting fibrodysplasia ossificans progressiva. A decision is expected by August 2026 based on Phase 3 trial data showing significant reductions in new bone lesions.
Regeneron said the FDA accepted its garetosmab BLA for FOP and granted Priority Review, with a decision expected by August 2026. Phase 3 OPTIMA data reported major lesion reductions versus placebo.
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07559513 |
A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07301450 |
An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP) |
TEMPORARILY_NOT_AVAILABLE | |
| NCT06970405 |
Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women |
WITHDRAWN | PHASE1 |
| NCT06299098 |
A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05394116 |
A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04577820 |
Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP) |
WITHDRAWN | PHASE3 |
