FDA
1 application listed (Prescription)Drugs@FDA lists 1 application naming this active ingredient: NDA215244. Marketing status as listed: Prescription. Checked 2026-10-05.
Drugs@FDA via openFDASS-31: chemistry, literature and regulatory status
Research-use information. This page summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.
What is SS-31?
SS-31, also called elamipretide, is the tetrapeptide D-Arg-Dmt-Lys-Phe-NH2, designed to target the inner mitochondrial membrane. Published work describes its interaction with cardiolipin and its effects on electron transport and ATP synthesis in isolated mitochondria and animal models. It is supplied here as a research material for laboratory use only.
What are the chemical facts for SS-31?
- Name
- SS-31
- Also written
- Elamipretide; MTP-131; Bendavia
- Sequence
- D-Arg-Dmt-Lys-Phe-NH2
- Length
- 4 residues
- Molecular formula
C32H49N9O5(matches the formula computed from the sequence)- Average molecular weight
- 639.8 g/mol
- CAS number
736992-21-5(confirmed in PubChem)- PubChem
- CID 11764719
Chemistry checked against PubChem on 2026-10-05. Where the formula can be computed from the listed sequence, it was, and the two routes agree.
How does the literature describe the mechanism of SS-31?
- Cell-permeable peptide antioxidants targeted to the inner mitochondrial membrane were tested on mitochondrial swelling, cytochrome c release and oxidative cell death.[4]
- SS-31 was studied for its interaction with cardiolipin and for ATP recovery in ischaemic mitochondria in a kidney model.[2]
- SS-31 was shown to bind cardiolipin and to affect the cytochrome c and cardiolipin complex, electron transport and ATP synthesis.[1]
- A review covers the discovery and development of peptides that target the inner mitochondrial membrane.[3]
Receptor and pathway background: Mitochondria-linked peptides.
What has published research on SS-31 looked at?
4 studies are cited for SS-31. Each is labelled by design below, and each entry says what the paper measured.
- 2 animal study
- 1 review
- 1 in vitro and animal study
PubMed returns 469 records for the search terms published on the method page (96 of them with a review publication type, 23 with a clinical-trial publication type), checked 5 October 2026. ClinicalTrials.gov lists 21 registered studies whose intervention matches the name (20 interventional), checked 5 October 2026.
Studies are listed by what they measured. Papers whose titles state an amount or schedule, or describe a clinical outcome of an approved medicine, are not listed. This is a wording rule, not a quality filter; see the method page.
What is the regulatory status of SS-31?
EMA
No centrally authorised medicine listedNo centrally authorised procedure in the EMA medicines database (checked 5 October 2026) names elamipretide as an active substance. National authorisations are not in this dataset.
EMA medicines dataMHRA
No product document foundNo SmPC, PIL or PAR document in MHRA Products matches the exact name "elamipretide". Checked 2026-10-05; the control lookup (semaglutide) returned 271 documents.
MHRA ProductsWADA
Not namedThe WADA 2026 Prohibited List, in force 1 January 2026 does not name this substance. The list names substances by example, so this is not a statement that it is permitted in sport.
WADA Prohibited List 2026A regulator record is information about a database entry. It is not advice and not a statement that any use is lawful or unlawful in any country. How regulators approach research peptides.
Data dates: regulatory records 2026-10-05; WADA list 2026-10-05.
Which studies are cited for SS-31?
[1] Birk AV, Chao WM, Bracken C, Warren JD, Szeto HH. Targeting mitochondrial cardiolipin and the cytochrome c/cardiolipin complex to promote electron transport and optimize mitochondrial ATP synthesis. Br J Pharmacol. 2014;171:2017-28.
Studied SS-31 binding to cardiolipin and its effect on the cytochrome c and cardiolipin complex, electron transport and ATP synthesis.
[2] Birk AV, Liu S, Soong Y, Mills W, Singh P, Warren JD, et al.. The mitochondrial-targeted compound SS-31 re-energizes ischemic mitochondria by interacting with cardiolipin. J Am Soc Nephrol. 2013;24:1250-61.
Studied SS-31 interaction with cardiolipin and ATP recovery in ischaemic mitochondria in a kidney model.
[3] Szeto HH, Schiller PW. Novel therapies targeting inner mitochondrial membrane: from discovery to clinical development. Pharm Res. 2011;28:2669-79.
Review of the discovery and development of peptides targeting the inner mitochondrial membrane, including SS-31.
[4] Zhao K, Zhao GM, Wu D, Soong Y, Birk AV, Schiller PW, et al.. Cell-permeable peptide antioxidants targeted to inner mitochondrial membrane inhibit mitochondrial swelling, oxidative cell death, and reperfusion injury. J Biol Chem. 2004;279:34682-90.
Tested cell-permeable, mitochondria-targeted peptide antioxidants on mitochondrial swelling, cytochrome c release and oxidative cell death.
Data dates: citations read from PubMed 2026-10-05.
Where else in the research library is SS-31 covered?
Who wrote this page and how is it checked?
Peptency editorial team, last reviewed 5 October 2026. Citations are read back from PubMed, chemistry is checked against PubChem, and regulator records are read from each regulator's own database on the dates shown. The method page lists every source, search term and rule. Corrections are welcome through the contact details on the About page.