Research guide

SS-31 (Elamipretide)

SS-31 · Forzinity · MTP-131 · Bendavia

SS-31 is the research name commonly associated with elamipretide, the ingredient in Forzinity.

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Product statusApproved
Development snapshotAccelerated approval

How it works, simply

It interacts with cardiolipin, a lipid in the inner membrane of mitochondria, the cell's energy-producing structures.

What the evidence tells us

FDA accelerated approval is indication-specific and based on a surrogate endpoint. Confirmatory evidence is required to verify clinical benefit.

Forzinity has a narrow accelerated US approval for Barth syndrome in patients weighing at least 30 kg. This does not validate general anti-aging or recovery claims.

Approved use: United States: Forzinity to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg, under accelerated approval. Other mitochondrial research and RUO SS-31 vials do not inherit this approval.

Watch with PEP 7

A short introduction; the sources and limitations remain important.

Open video guide

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Risks and open questions

This brief guide does not summarize every contraindication or interaction. Use the current label for the exact product; the label directory is linked below.

Research and education only. PepGuide does not recommend medicines, doses or protocols.

Technical details and study context

Mechanism: Binds mitochondrial cardiolipin and localizes to the inner mitochondrial membrane.

Sponsor or developer: Stealth BioTherapeutics

Studied or labeled topics: Barth syndrome, Mitochondrial disease research

2025-09-19: Accelerated US approval for the labeled Barth syndrome population.

Commercial blend names and research vials do not inherit a medicine’s approval or manufacturing controls.

Sources and review dates

Readability updated October 10, 2026. Evidence review: October 10, 2026 (FDA indication and approval context). A wording update is not a new clinical review.