Is elamipretide FDA approved?

Yes, for one condition. This site's US field is FDA-approved as Forzinity for Barth syndrome only, prescription only; other uses investigational. UK: not licensed. Australia: not registered. Canada: not approved. Accelerated approval on September 19, 2025 covers patients weighing 30 kg or more, on a muscle-strength endpoint, with a confirmatory trial required. MMPOWER-3 in 218 people with primary mitochondrial myopathy missed walking-distance and fatigue endpoints. A research-chemical vial labeled SS-31 is not Forzinity. This FAQ does not invent a longevity approval. Full record at /compounds/elamipretide.

Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use.

Part of immune and longevity peptides. Thymosin alpha-1, thymalin, epitalon, MOTS-c, humanin, and the bioregulator family.