Trial Profile

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

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 10 Nov 2025

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At a glance

Drugs Elamipretide (Primary)
Indications Barth syndrome
Focus Therapeutic Use

Most Recent Events

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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