Is Elamipretide FDA approved?

Elamipretide is FDA approved, but only for a specific indication — not for general use.

FDA-approved (Forzinity, accelerated approval) to improve muscle strength in Barth syndrome, an ultra-rare mitochondrial disease. Approval does not extend to general anti-aging use.

An approval for one condition is not an approval for everything a compound is marketed for. That distinction is where most confusion in this category comes from — a drug approved for one use is frequently sold for several others it was never evaluated for.

Source
Checked against the public registry
This answer is generated from ClinicalTrials.gov records, counting interventional human studies only. It is automated aggregation, not medical advice, and no physician has reviewed it. See how we count or open the Elamipretide page to check every trial yourself.