For Research Use Only – Not for Human Consumption. For Research Use Only. Not for Human Consumption. Not for diagnostic, therapeutic or medical use. Statements have not been evaluated by the FDA.
SS-31 (Elamipretide): The Mitochondria-Targeting Tetrapeptide
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Key points
- A tetrapeptide that binds cardiolipin in the inner mitochondrial membrane.
- The FDA granted accelerated approval in 2025 (as Forzinity) for Barth syndrome only; a confirmatory trial is required.
- All other studied uses remain investigational.
What it is
SS-31, also called elamipretide, is a four-amino-acid peptide of about 640 daltons from the Szeto-Schiller family of mitochondria-targeting compounds. It is built to accumulate at the inner membrane of mitochondria.
How researchers study it
Experiments look at how it interacts with cardiolipin, a lipid in that membrane, and what that means for energy production and oxidative stress in cell and organelle models.
What the evidence shows
An accelerated approval is based on a surrogate measure rather than proof of clinical benefit, and a confirmatory trial is required. That is why this card carries a 'mixed' evidence label. Apart from that single use, everything else is investigational.
Regulatory status
The FDA granted accelerated approval in 2025 to a product named Forzinity, for Barth syndrome only. This research-use-only material is not that product and is not prescribing information.
