Educational — Not Legal AdviceReviewed
Is SS-31 legal? FDA status and US regulatory standing
Current status
FDA-approved. SS-31 is an FDA-approved drug (status recorded ).
Primary source: www.fda.gov
Federal legal status
FDA approval status
SS-31 is an FDA-approved drug. Mitochondria-targeting tetrapeptide (elamipretide) by Stealth BioTherapeutics. FDA issued CRL for Barth syndrome NDA 2021 (additional data required). Continued by Mitobridge/AstraZeneca. Investigational.
Also known as
Elamipretide · Bendavia · MTP-131
Status history
- SS-31 is an FDA-approved drug. [source]
Frequently asked questions
- Is SS-31 FDA approved?
- SS-31 is an FDA-approved drug (status recorded 2025-09-19). Primary source linked on this page.
- Can doctors prescribe SS-31?
- SS-31 is listed as prescription-availability in the PeptideBase library. Prescribing rules vary by state and prescriber licensure — consult a licensed clinician.
PeptideBase provides educational research tools and provider discovery. It does not provide medical advice, diagnosis, treatment, prescribing guidance, or dosing instructions. Consult a qualified healthcare professional before making health decisions.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .