SS-31 (Elamipretide) Compound Reference
Published · Last updated · Publisher: ENOS Labs USA
What is SS-31 (Elamipretide)?
SS-31, known as elamipretide, is a synthetic tetrapeptide that concentrates in the inner mitochondrial membrane and binds cardiolipin. In September 2025 the FDA granted elamipretide (Forzinity) accelerated approval for muscle strength in Barth syndrome. It is not approved for any other use, and research grade SS-31 is not that drug product.
- Synonyms
- Elamipretide; MTP-131; Bendavia; Forzinity (approved drug product)
- Classification
- Synthetic aromatic cationic tetrapeptide that binds cardiolipin
What is SS-31 (Elamipretide)?
SS-31 has the sequence D-Arg-2',6'-dimethyl-Tyr-Lys-Phe-NH2. It was developed in the Szeto laboratory as one of the Szeto-Schiller peptides and later developed clinically by Stealth BioTherapeutics.
Research context
Preclinical work spans kidney ischemia, heart failure and aging models. Clinical work includes trials in primary mitochondrial myopathy and in Barth syndrome.
Mechanisms being investigated
- Binding to cardiolipin in the inner mitochondrial membrane.
- Effects on cristae structure, electron transport and reactive oxygen species reported in models.
Research status
Approval status: FDA approved (limited indication). Highest evidence tier in the cited literature: clinical trials.
FDA approved for one narrow indication. The phase 3 MMPOWER-3 trial in primary mitochondrial myopathy did not meet its primary endpoints. The accelerated approval in Barth syndrome is limited to that indication.
Established findings
- Cardiolipin binding and mitochondrial localization.
- Regulatory approval for Barth syndrome (accelerated approval, September 2025).
Preliminary or experimental findings
- Effects in common age related diseases, which remain preclinical or in trials.
- Benefit in primary mitochondrial myopathy, which phase 3 did not establish.
Chemical reference information
| Molecular formula | C32H49N9O5 |
|---|---|
| Molecular weight | 639.8 g/mol |
| CAS number | 736992-21-5 |
| PubChem CID | 11764719 |
Values taken from the PubChem record.
Testing considerations
- Contains a D amino acid and a modified tyrosine: identity by mass alone will not distinguish stereoisomers, so chiral or reference standard methods matter.
- Typically supplied as an acetate or trifluoroacetate salt, which affects net content.
General methods are explained in purity versus identity testing.
What is still unknown
- Confirmatory outcome data required under accelerated approval.
- Effects outside rare mitochondrial disease.
Related resources
ENOS catalog listing: SS-31 (Elamipretide) 10MG
Research use limitations
This page summarizes published research and regulatory status. It is not medical advice and does not describe any use in people. Material supplied by ENOS Labs USA is for in-vitro laboratory research only and is not a drug product, even where a related drug has been approved.
To continue, see mitochondrial peptide research, the MOTS-c compound reference, how to read a certificate of analysis, why purity and identity are separate tests, the compound directory and the peptide testing glossary.
References
Each source below was opened and checked against its PubMed, ClinicalTrials.gov or PubChem record. Links open in a new tab.
- The mitochondrial-targeted compound SS-31 re-energizes ischemic mitochondria by interacting with cardiolipin (PMID 23813215)Journal of the American Society of Nephrology, 2013 · PubMed
- First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics (PMID 24117165)British Journal of Pharmacology, 2014 · PubMed
- Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial (PMID 37268435)Neurology, 2023 · PubMed
- A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension (NCT03323749)ClinicalTrials.gov · NIH National Library of Medicine
- Elamipretide: First Approval (PMID 41335372)Drugs, 2026 · PubMed
- Elamipretide compound record (PubChem CID 11764719)PubChem · NIH National Library of Medicine
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