Is SS-31 (Elamipretide / MTP-131) legal?
SS-31 (Elamipretide / MTP-131) is an FDA approved drug. For drug-tested athletes it is not on the WADA prohibited list. Yes for Barth syndrome (FORZINITY, 40 mg sub-q daily), via specialty pharmacy. Not commercially available for off-label longevity use.. Legal status depends on your country and changes over time. This reflects US status at the time of writing and is not legal or medical advice.
Regulatory status
- FDA: FDA-approved as FORZINITY (elamipretide) on Sept 19, 2025 under accelerated approval, to improve muscle strength in adult and pediatric Barth syndrome patients weighing >=30 kg. The first FDA-approved mitochondria-targeted drug. Approved only for Barth syndrome, every other use (longevity, general mitochondrial support) is off-label and unapproved.
- WADA: Not listed
- Prescription: Yes for Barth syndrome (FORZINITY, 40 mg sub-q daily), via specialty pharmacy. Not commercially available for off-label longevity use.
References
- Elamipretide in primary mitochondrial myopathy (MMPOWER trials) — Karaa A et al., Neurology, 2018
- Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER — Thompson WR, Manuel R, Abbruscato A, et al. — Genetics in Medicine, 2024
- FORZINITY (elamipretide hydrochloride) injection — FDA Prescribing Information — FDA / DailyMed (Stealth BioTherapeutics), 2025
Pepdex is an editorial reference, not medical advice. Peptides vary in legal and approval status by country, many are research compounds without full human safety data. Talk to a qualified clinician before starting anything.
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Last updated 2026-06-06.