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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARgamma-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)

Trial Profile

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARgamma-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Oct 2019

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At a glance

  • Drugs Palovarotene (Primary)
  • Indications Fibrodysplasia ossificans progressiva
  • Focus Registrational; Therapeutic Use
  • Sponsors Clementia Pharmaceuticals
  • Most Recent Events

    • 24 Oct 2019 According to an Ipsen media release, the Palovarotene regulatory submission to the FDA for the episodic treatment of FOP now expected in Q1 2020 as a result of the processing of additional supportive data.
    • 15 Feb 2019 Argentina was a planned location for this trial.
    • 11 Feb 2019 According to a Clementia Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP), based on the completed Phase II program.
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