Is SS-31 / Elamipretide FDA approved?

Question

DIRECT ANSWER

SS-31 / Elamipretide FDA status.

Current U.S. status for SS-31 / Elamipretide: FDA accelerated approval as Forzinity for Barth syndrome patients weighing at least 30 kg; other uses remain unapproved.

Reviewed August 7, 2026. Each statement links to its evidence record, followed by the primary and official sources used for this answer.

01U.S. FDA

FDA accelerated approval as Forzinity for Barth syndrome patients weighing at least 30 kg; other uses remain unapproved.

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02Evidence is a separate question

SS-31 is no longer simply an unapproved research peptide: elamipretide now has one narrow accelerated-approval pathway, with confirmatory evidence still required.

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03Why the distinction matters

Approval, evidence maturity, commercial access, and sport status answer different questions. The full record keeps them separate.

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PRIMARY & OFFICIAL SOURCES

Sources for this answer.

2 source records, with duplicates removed.

FDA / 2025FDA grants accelerated approval to first treatment for Barth syndromeU.S. FDA FDA / 2025Forzinity prescribing informationU.S. FDA

SS-31 / Elamipretide FDA status.

Sources for this answer.

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