SS-31 (Elamipretide, Forzinity)
A mitochondria-targeting peptide that protects a key membrane fat, cardiolipin. Granted accelerated FDA approval for Barth syndrome in 2025.
- Evidence
- Ongoing clinical research
- Half-life
- Hours
- Sources
- 3 cited
Is SS-31 (Elamipretide) FDA-approved?
FDA accelerated approval (Forzinity, 2025) to improve muscle strength in Barth syndrome. Other uses are investigational.
Overview
Elamipretide sits on the inner membrane of mitochondria, where it binds cardiolipin and helps the energy-making machinery work properly. It's been tested for heart failure, mitochondrial muscle disease, an eye disease (dry AMD) and Barth syndrome, a rare inherited condition. Several large trials missed their main goals; in Barth syndrome, long-term data showed better walking distance.
How it works
It binds cardiolipin, a fat that holds the energy-producing protein complexes together, which may improve energy output and reduce oxidative stress.
How long does SS-31 (Elamipretide) stay in the body?
Hours.
What it's studied for
- Barth syndrome
- Primary mitochondrial myopathy
- Heart failure
- Dry age-related macular degeneration
Reported side effects
- Injection-site reactions (most common)
Related: Epitalon, Humanin, Pinealon, FOXO4-DRI.
Sources
The studies and prescribing labels this page is written from.
- Long-term efficacy and safety of elamipretide in Barth syndrome: 168-week TAZPOWER extension. Genet Med, 2024 PubMed
- Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential. Int J Mol Sci, 2025 PubMed
- Forzinity (elamipretide) prescribing information. DailyMed DailyMed