SS-31 (elamipretide)
Also: Elamipretide, MTP-131, Bendavia, Forzinity
7 papers: 3 human studies, 3 animal studies, 1 review or preprint.
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Summary
SS-31, known as elamipretide in clinical development, is a synthetic four-amino-acid peptide that concentrates in mitochondria and binds cardiolipin, a lipid of the inner mitochondrial membrane. It was developed by Stealth BioTherapeutics. In September 2025 the US FDA granted it accelerated approval, under the brand name Forzinity, for Barth syndrome, a rare genetic mitochondrial disease. That is the only approved use; its other studied uses remain investigational.
What it targets
Elamipretide is described in the literature as stabilising mitochondrial membrane structure, reducing oxidative stress and supporting ATP production. In a phase 3 trial of 218 adults with primary mitochondrial myopathy it did not improve walking distance or fatigue over placebo at 24 weeks, though it was well tolerated. In Barth syndrome, a 168-week open-label extension in ten patients reported sustained improvements in walking distance and cardiac measures, and a single newborn case report described improved heart function under expanded access. A 2025 review collects the preclinical models (heart failure, neurodegeneration, ischaemia) and the clinical programme.
Clinical Research
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