U.S. Food and Drug Administration (FDA)
Is Elamipretide (SS-31) legal in United States?
Approved, restrictedFDA-approved under accelerated approval on 19 September 2025 as Forzinity for Barth syndrome only
Approved, but with limits on who can get it or how.
Elamipretide (also known as SS-31) is FDA-approved as Forzinity to improve muscle strength in adults and children with Barth syndrome who weigh at least 30 kg. It was approved under accelerated approval, based on an intermediate endpoint (knee muscle strength), and continued approval may depend on a confirmatory trial. It is not approved for any other condition; in August 2026 FDA cited a seller marketing 'SS-31' with research-use-only labels as offering an unapproved new drug.
Last verified 2026-09-29 · how we verify
Elamipretide (SS-31) elsewhere
Sources (2)
- 01FORZINITY (elamipretide) prescribing information (original approval)U.S. Food and Drug Administration · 2025-09 · accessed 2026-09-29
- 02FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'U.S. Food and Drug Administration · 2026-08-24 · accessed 2026-09-29