HomeLongevity & Cellular › SS-31

Mitochondria-targeted (cardiolipin-binding) tetrapeptide (elamipretide)

SS-31

FDA-approved

Written by pep4U Editorial Team · Last reviewed July 8, 2026

A peptide (also called elamipretide) that concentrates in mitochondria to protect and restore their energy-producing function, now an approved drug for a rare mitochondrial disease.

Class / typeMitochondria-targeted (cardiolipin-binding) tetrapeptide (elamipretide)
CategoryLongevity & Cellular
Status (Jul 2026)FDA-approved

How it works

It selectively binds cardiolipin on the inner mitochondrial membrane, stabilizing membrane structure and the electron transport chain to improve ATP production and reduce reactive oxygen species.

Known / used for

FDA-approved (as FORZINITY) to improve muscle strength in Barth syndrome; in clinical trials for heart failure, primary mitochondrial myopathy, and dry age-related macular degeneration; also researched for aging.

Positives

First approved mitochondria-targeted therapeutic; clinical data support a muscle-strength benefit in Barth syndrome; broadly investigated for energy metabolism and mitochondrial dysfunction.

Negatives & risks

Several endpoints in prior trials (some heart-failure and myopathy studies) were mixed or negative; injection-site reactions reported; continued approval is contingent on a confirmatory trial; benefits outside Barth syndrome remain investigational.

Frequently asked questions

What is SS-31?
A peptide (also called elamipretide) that concentrates in mitochondria to protect and restore their energy-producing function, now an approved drug for a rare mitochondrial disease. It selectively binds cardiolipin on the inner mitochondrial membrane, stabilizing membrane structure and the electron transport chain to improve ATP production and reduce reactive oxygen species.
What is SS-31 used or researched for?
FDA-approved (as FORZINITY) to improve muscle strength in Barth syndrome; in clinical trials for heart failure, primary mitochondrial myopathy, and dry age-related macular degeneration; also researched for aging.
Is SS-31 FDA-approved or legal?
FDA-approved: granted accelerated approval in September 2025 (marketed as FORZINITY) to improve muscle strength in Barth syndrome; all other uses remain investigational and continued approval depends on a confirmatory trial.
What are the main risks or downsides of SS-31?
Several endpoints in prior trials (some heart-failure and myopathy studies) were mixed or negative; injection-site reactions reported; continued approval is contingent on a confirmatory trial; benefits outside Barth syndrome remain investigational.

Legal / regulatory status

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