Elamipretide

Status

FDA-approved. Approved, narrowly. The FDA granted Forzinity (elamipretide) accelerated approval on 19 September 2025 to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg — the first treatment approved for that disease. The accelerated approval rests on improved knee extensor muscle strength, an intermediate endpoint, and continued approval may depend on a confirmatory trial. Barth syndrome is the whole of the label. It is not an approval of SS-31 for longevity, energy, ageing or any general use, and nothing sold online as SS-31 is the approved product.

What it is

A mitochondria-targeted peptide that binds cardiolipin in the inner mitochondrial membrane — the lipid that holds the respiratory chain in shape. It is the rare compound in this library that finished the journey to approval, but only for one rare genetic disease, and the approved product is not what circulates online as SS-31.

Caution

Two different things share this name. Forzinity is an FDA-approved, prescription-only medicine for Barth syndrome, and its label is the only approved use. "SS-31" sold online as a research chemical is not Forzinity: it is not an approved product, its contents are not verified, and the dosing charts that circulate with it come from no label and no trial. Nothing on this page applies the Barth label to longevity, energy or general use.

Source

FDA label, Forzinity (elamipretide), NDA 215244, revised 9/2025: accelerated approval for Barth syndrome in patients weighing at least 30 kg only Primary source

Sources

• FDA label, Forzinity (elamipretide), NDA 215244, revised 9/2025: accelerated approval for Barth syndrome in patients weighing at least 30 kg only