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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: 25 Aug 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 Aug 2026 According to Regeneron Pharmaceuticals, Inc. media release, company announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru (garetosmab-grts) to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
  • 04 Jun 2026 According to Regeneron Pharmaceuticals, Inc. media release, data from this trial will be presented at he Endocrine Society Annual Meeting (ENDO 2026), June 13-16 in Chicago.
  • 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.

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