SS-31 (Elamipretide)
Elamipretide (also known as MTP-131, Bendavia; trade name elamipretide)
Approved status applies to specific products, routes, and indications, not every use context discussed online.
A mitochondria-targeted peptide (elamipretide) investigated for Barth syndrome -- a rare and serious genetic disease affecting the heart and muscles -- that works by improving energy production inside cells. It has strong clinical trial data (Phase 2/3) but has not received full FDA approval. Broader clinical trials for other energy-related and age-related conditions have shown mixed results so far.
SS-31 (Elamipretide) is FDA-approved.
Use according to current labeled indication and prescribing guidance.
Safety Summary
No treatment-related serious adverse events or fatalities have been reported in clinical trials across all indications doi:10.1212/wnl.0000000000207402. The ELViS-FA trial (NCT05168774, n=16) in Friedreich ataxia reported SAEs including aspiration pneumonia, acute perforated appendicitis, vasovagal episode, pneumonia, and pulmonary embolism, but these were assessed as likely related to underlying disease rather than study drug. Injection site reactions are the most common adverse events and are generally mild, self-limiting, and manageable with site rotation. Well-tolerated in open-label extensions up to 168 weeks (TAZPOWER OLE, PMID 38602181). No abuse potential identified; not a controlled substance, elamipretide FDA label.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Cited sources
Every claim on this page links to one of the 10 sources below. Identifiers are PubMed (PMID), ClinicalTrials.gov (NCT), or DOI; click through to the source of record before acting on a claim.
- 1PMID 29540575PubMed
- 2PMID 36759381PubMed
- 3PMID 33082543PubMed
- 4PMID 38602181PubMed
- 5PMID 23813215PubMed
- 6PMID 32554501PubMed
- 7NCT02245620ClinicalTrials.gov
- 8PMID 39600327PubMed
- 9NCT05168774ClinicalTrials.gov
- 10NCT05162768ClinicalTrials.gov