Superseded · version 3: Elamipretide^↗

Related names recorded in this version: SS-31, MTP-131, Forzinity^↗↗

FDA granted Forzinity (elamipretide) accelerated approval to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg.^↗

This is preserved historical wording.
It is no longer the current profile. Read the canonical profile and its correction notice.

Correction · September 15, 2026

The previous profile described elamipretide only as investigational. We added FDA's September 19, 2025 accelerated approval of Forzinity for the specified Barth syndrome population. This correction does not extend that approval to other uses or formulations. ²

What this version reported

FDA's September 19, 2025 approval letter requires a confirmatory trial to verify clinical benefit. The approval concerns this product and specified use; a recruiting trial record does not describe its full regulatory status.^↗

Organizations named in cited records:

Stealth BioTherapeutics Inc.^↗

Trial records: NCT07531251

Sources for this version

1
4TAZPower: Elamipretide in Participants With Barth Syndrome · record history version 4 · last update posted 2026-07-13 ↗
ClinicalTrials.gov · Official source · Source checked July 22, 2026
2
Forzinity (elamipretide): NDA 215244 accelerated approval letter, September 19, 2025 ↗
U.S. Food and Drug Administration · Official source · Source checked September 15, 2026