What is Elamipretide?
The short answer
Elamipretide, or SS-31, is a short lab-made chain of four amino acids. In the US, you need a prescription to get Elamipretide.
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- Status as of
- How we source
- Ellum doesn't sell peptides.
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What it is
- Type
- Mitochondria-targeted tetrapeptide
- Also known as
- ss-31
- How it works
- Binds cardiolipin in the inner mitochondrial membrane.
Regulatory status
FDA-approved (Rx) How we label status
As of October 4, 2026, Elamipretide is an FDA-approved prescription drug for Barth syndrome (accelerated approval).
- Federal (FDA)
- Approved Rx (Forzinity NDA215244, 2025-09-19, accelerated approval)
- 503A compounding
- Approved-drug component (not in any 503A category) (as of May 14, 2026)
US enforcement actions
5 US enforcement actions since 2025.
Actions by US federal and state agencies whose documents name Elamipretide. Each row links to the government's own document.
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US enforcement actions table
| Date | Agency | Action | Document |
|---|---|---|---|
| FDA | Warning letter | FDA document, warning letter, August 24, 2026, 1 of 4 that day, on fda.gov | |
| FDA | Warning letter | FDA document, warning letter, August 24, 2026, 2 of 4 that day, on fda.gov | |
| FDA | Warning letter | FDA document, warning letter, August 24, 2026, 3 of 4 that day, on fda.gov | |
| FDA | Warning letter | FDA document, warning letter, August 24, 2026, 4 of 4 that day, on fda.gov | |
| FDA | Warning letter | FDA document, warning letter, December 8, 2025, on fda.gov |
Forms and brands
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Forms and brands table
| Name | Kind | Status | FDA status | As of |
|---|---|---|---|---|
| Forzinity | Brand | FDA-approved (Rx) | Approved Rx (NDA215244, 2025-09-19, accelerated approval; Barth syndrome) |
References
Sources as of October 4, 2026