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Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva

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Trial Profile

Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Mar 2026

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At a glance

  • Drugs Garetosmab (Primary)
  • Indications Fibrodysplasia ossificans progressiva
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms OPTIMA
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 19 Feb 2026 According to Regeneron Pharmaceuticals, Inc. media release, based on results from this trial the, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva (FOP). The target action date for the FDA decision is August 2026.
  • 17 Sep 2025 According to Regeneron Pharmaceuticals, Inc. media release, Based on these data and the safety profile, the Independent Data Monitoring Committee (IDMC) recommended those receiving placebo be transitioned to garetosmab as soon as possible; U.S. regulatory submission of garetosmab in adults planned for year-end 2025.with global regulatory submissions slated for 2026. These data are also planned for future presentation and publication.
  • 17 Sep 2025 Results presented at Regeneron Pharmaceuticals media release.

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