SS-31 (elamipretide) regulatory status
Current status of SS-31 (elamipretide) in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of SS-31 (elamipretide)?
Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 27, 2026
- FDA and compounding
- FDA granted accelerated approval to elamipretide (Forzinity) in September 2025 for Barth syndrome, making it the first approved treatment for that disease. Because an FDA approved product exists, elamipretide is not eligible for routine 503A compounding, and it has not been listed on the 503A bulks list. Material sold online as SS-31 for research use is not the approved drug and is not lawful for human use.
- WADA
- Not WADA prohibited
- Access path
- Prescription from a specialist for Barth syndrome, dispensed through specialty pharmacy as Forzinity.
- Clinical trials for other mitochondrial and age related conditions.
- Products labeled research use only are not lawful for human use and are not verified for purity.
Full SS-31 (elamipretide) page: evidence, dosing in the literature, and sources
How has the status of SS-31 (elamipretide) changed over time?
- FDA
FDA grants accelerated approval of elamipretide for Barth syndrome
In September 2025 FDA granted accelerated approval of elamipretide (SS-31), a mitochondria-targeted tetrapeptide, for Barth syndrome, following an earlier complete response letter. Continued approval depends on confirmatory evidence.
Regulatory: FDA approvedSource: DailyMed: elamipretide labeling
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for SS-31 (elamipretide) and the source of each dated event.