Stealth has FDA approval for mitochondria-targeted drug

Stealth BioTherapeutics CSO says bioenergetic dysfunction lies at the center of the aging process. The FDA last year granted accelerated approval to elamipretide, now marketed as Forzinity, to improve muscle strength in patients with Barth syndrome. The drug, developed by Stealth BioTherapeutics, became the first approved mitochondria-targeted therapeutic.

Longevity watchers may wonder why all the excitement over a drug approval for a disease that only affects a few hundred people worldwide, however mitochondrial dysfunction is increasingly viewed as a fundamental driver of many common diseases, particular those related to aging. Stealth is now seeking to build on its momentum with a pipeline includes age-related conditions such as age-related macular degeneration and neuromuscular disorders, while also advancing next-generation candidates aimed at neurological and cardiac indications.

Opinions?

Steve, we have a long, ongoing discussion thread on this peptide here: Hazel Szeto, SS-31 peptide, the World's First FDA-Approved Mitochondria-targeted Drug (Longevity Summit, 2025)

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