Is elamipretide FDA approved?
Yes, for one condition. This site's US field says FDA-approved as Forzinity for Barth syndrome only, prescription only, with other uses still experimental. UK: not licensed. Australia: not registered. Canada: not approved. The fast-track (accelerated) approval on September 19, 2025, covers patients who weigh 30 kg or more. It was based on a muscle strength measure, and a follow-up study to confirm it is required. MMPOWER-3, in 218 people with a muscle disease caused by faulty mitochondria, missed its goals for walking distance and tiredness. A research-chemical vial labeled SS-31 is not Forzinity. This FAQ does not invent a longevity approval. Full record at /compounds/elamipretide.
Every FDA-approved compound in the archive, as a list
Studies in people from the compound pages this answer belongs to
- Elamipretide
- Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial 2023 PMID 37268435
- Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER 2024 PMID 38602181
- ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation 2025 PMID 39605874
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.