For research and educational purposes only. Not medical advice.
Elamipretide Reference
Educational, not medical advice reference for Elamipretide: Longevity, Metabolic; regulatory status, evidence posture, source review, and schedule notes. Als…
Reference summary
Human clinical trial data exist across several mitochondrial-disease programs. pepSmart displays elamipretide only as trial-context educational content and does not imply approved use.
- Categories
- Longevity, Metabolic
- Aliases
- SS-31, MTP-131, Bendavia, D-Arg-Dmt-Lys-Phe-NH2
- Evidence posture
- human — Human trial data exist, but elamipretide is not FDA-approved — the Phase 3 mitochondrial-myopathy submission received an FDA Complete Response Letter.
- Regulatory status
- Investigational. Elamipretide (SS-31 / MTP-131) is a cardiolipin-binding mitochondrial peptide developed by Stealth BioTherapeutics. Phase 3 programs have been conducted in primary mitochondrial myopathy, Barth syndrome, and related conditions. FDA issued a Complete Response Letter on the primary mitochondrial myopathy submission; elamipretide is not FDA-approved.
- Content review status
- investigational verified