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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety and Efficacy of Subcutaneous Injections of Elamipretide in Subjects With Genetically Confirmed Barth Syndrome Followed by Open-Label Treatment

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Trial Profile

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety and Efficacy of Subcutaneous Injections of Elamipretide in Subjects With Genetically Confirmed Barth Syndrome Followed by Open-Label Treatment

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 10 May 2024

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At a glance

  • Drugs Elamipretide (Primary)
  • Indications Barth syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms TAZPOWER
  • Sponsors Stealth BioTherapeutics
  • Most Recent Events

    • 07 May 2024 According to a Stealth BioTherapeutics media release, the U.S. Food and Drug Administration has now determined that its New Drug Application for elamipretide for the treatment of Barth syndrome is entitled to a Priority Review designation. Per FDA policy, the user fee goal date of January 29, 2025 is unchanged.
    • 08 Apr 2024 According to a Stealth BioTherapeutics media release, company announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for elamipretide for the treatment of Barth syndrome. The NDA is supported by the positive data from the SPIBA-001 Phase 3 Natural History Control Study and additional supporting efficacy and safety data from the TAZPOWER Part 2 baseline-controlled trial.
    • 09 Mar 2023 Results presented in a Stealth BioTherapeutics media release.
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