▶ SS-31 · SUBTOPIC · SAFETY PROFILE
SS-31 Safety Profile
For Laboratory Research Use Only. This page summarises observed adverse events and regulatory status reported in the peer- reviewed literature. It is not medical advice and does not recommend any human use of SS-31.
OBSERVED ADVERSE EVENTS IN LITERATURE
The following adverse events have been observed in trials or animal studies of SS-31. Severity, frequency, and attribution depend on the source publication.
- Injection-site reactions
- Mild headache reported in trials
DRUG INTERACTIONS
The following interactions are reported in or theorised from the published mechanism for SS-31.
- No major drug-drug interactions documented
CONTRAINDICATIONS REPORTED IN LITERATURE
Contraindications recorded for SS-31 in the published record:
- Pregnancy/lactation (unstudied)
- Hypersensitivity
FDA REGULATORY STATUS
Investigational. Stealth BioTherapeutics has submitted regulatory packages for elamipretide in Barth syndrome and dry AMD; full FDA approval not granted as of 2026-05.
WADA REGULATORY STATUS
Not listed on the WADA Prohibited List (2026).
SAFETY Q+A FROM LITERATURE
▶ How does SS-31 work?
SS-31 partitions into the inner mitochondrial membrane and binds cardiolipin · the unique phospholipid that anchors respiratory-chain supercomplexes. By stabilizing cardiolipin-protein interactions, SS-31 preserves OXPHOS efficiency, reduces electron leak (ROS generation), and protects against ischemia-reperfusion injury.
▶ Is SS-31 FDA-approved?
No. Stealth BioTherapeutics has submitted regulatory packages for elamipretide in Barth syndrome and dry age-related macular degeneration; full FDA approval has not been granted as of 2026-05. Research-grade SS-31 is supplied for laboratory use only.
▶ Is SS-31 banned in sports?
Not currently listed on the WADA Prohibited List as of 2026.
▶ Side effects of SS-31?
Clinical trials report mostly mild injection-site reactions and occasional headache. The peptide has been well-tolerated across multiple Phase 2/3 trials.
CITED LITERATURE
The safety statements above are drawn from the following peer-reviewed sources. Refer to the originals for adverse- event tables, attribution, and full context.
- Szeto HH, Schiller PW. Mitochondria-targeted peptide accelerates ATP recovery and reduces ischemic kidney injury. J Am Soc Nephrol 2011. link
- Pfeiffer K, Gohil V, Stuart RA, et al.. Cardiolipin stabilizes respiratory-chain supercomplexes. J Biol Chem 2003. link
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▶ LAST UPDATED · 2026-05-19