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A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects With Primary Mitochondrial Disease Resulting From Pathogenic Nuclear DNA Mutations (nPMD) - NuPower Study

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Trial Profile

A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects With Primary Mitochondrial Disease Resulting From Pathogenic Nuclear DNA Mutations (nPMD) - NuPower Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2024

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At a glance

  • Drugs Elamipretide (Primary)
  • Indications Mitochondrial myopathies
  • Focus Registrational; Therapeutic Use
  • Acronyms NuPOWER
  • Sponsors Stealth BioTherapeutics

Most Recent Events

  • 29 Jul 2024 According to a Stealth BioTherapeutics media release, Elamipretide is in Phase 3 development for primary mitochondrial myopathy, with pivotal data expected in late 2024
  • 11 Oct 2023 Status changed from recruiting to active, no longer recruiting.
  • 11 Sep 2023 According to a Stealth BioTherapeutics media release, the study achieved target enrollment and the study will continue to enroll through month-end to allow for participation of additional interested patients. Topline data from this trial expected next year.

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