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A Phase 3 Randomized Withdrawal Trial of Elamipretide in patients with Barth syndrome

Trial Profile

A Phase 3 Randomized Withdrawal Trial of Elamipretide in patients with Barth syndrome

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 24 May 2021

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At a glance

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

    • 24 May 2021 New trial record
    • 18 May 2021 According to a Stealth BioTherapeutics media release, the Food and Drug Administration (FDA) and the Division of Cardiology and Nephrology (DCN) recommended to conduct another phase 3 study in a meeting requested by the FDA held in April 2021. The Company expects initiate the trial during the third quarter of this year and data expected in the first quarter of 2022 subject to the timing of requisite clinical events.
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