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A post-approval randomized, double-blind, placebo-controlled trial of Forzinity

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Trial Profile

A post-approval randomized, double-blind, placebo-controlled trial of Forzinity

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Jan 2026

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At a glance

  • Drugs Elamipretide (Primary)
  • Indications Barth syndrome
  • Focus Therapeutic Use

Most Recent Events

  • 06 Jan 2026 According to Stealth BioTherapeutics media release, the Company is on track to initiate its FDA-required post-marketing trial to confirm clinical benefit during 1H 2026.
  • 10 Nov 2025 New trial record
  • 19 Sep 2025 According to a Food and Drug Administration media release, as a condition of accelerated approval, FDA is requiring the manufacturer of Forzinity to conduct a post-approval randomized, double-blind, placebo-controlled trial to confirm that the changes seen on knee muscle strength translate into patient benefit.

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