SS-31: molecular data, studies & sources

Molecular formula, weight & structure

Molecular formula (MF)

C32H49N9O5

Molecular weight (MW)

639.8 g/mol

PubChem compound ID

11764719

Record title

Elamipretide

Values describe the selected PubChem molecular entity. Counterions, salt forms, hydration and sequence changes can alter the supplied material. Confirm the exact identity against the supplier specification.

Source: PubChem CID 11764719 · retrieved 2026-09-21

US regulatory status & drug development

SS-31 (elamipretide; listed as elamipretide hydrochloride) is the active ingredient of FORZINITY, approved by the FDA under NDA 215244 (STEALTH BIOTHERAPS) on September 19, 2025; Drugs@FDA lists it as a marketed prescription product (checked October 7, 2026). Research-labelled SS-31 listings are not FORZINITY and are not FDA-approved drugs.

An FDA approval covers a defined medicine, formulation and labelled use. It does not extend to research-labelled material sold under the same compound name. Identity basis: SS-31 is the development name of elamipretide; the approved product lists elamipretide hydrochloride (research record PubChem CID 11764719).

Source: Drugs@FDA via openFDA (application records; DailyMed label set IDs) · checked 2026-10-07. openFDA data are not intended for clinical decisions.

Registered clinical trials

Studies registered on ClinicalTrials.gov that list Elamipretide as an intervention. Studies that only measure the molecule as a biomarker, or use it only as a comparator or background arm for another drug, are excluded. A registration describes a planned or completed protocol; it does not report a result. Active studies are listed first.

30 registered studies matched, 3 currently active or recruiting, 14 with results posted on ClinicalTrials.gov.

By highest phase

Phase 4 · 1Phase 3 · 4Phase 2 · 15Phase 1 · 9Not applicable · 1

By registry status

Completed · 22Terminated · 3Recruiting · 2Active Not Recruiting · 1Available · 1Withdrawn · 1

Registry check 2026-10-09 · Run this search on ClinicalTrials.gov

Human intervention studies

Selected studies in which participants received Elamipretide, with their indexed or reviewed study type. Check the original article for the formulation, population and controls. Studies that only measured the molecule, or used it as a comparator, are listed separately below and are not counted as intervention studies.

1. Human study · PubMed trial index Compound given to participants

   Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER.

   Thompson WR, Manuel R, Abbruscato A et al. · Genetics in medicine : official journal of the American College of Medical Genetics · 2024

   PMID 38602181 · DOI: 10.1016/j.gim.2024.101138 · Registration NCT03098797

2. Human study · PubMed trial index Compound given to participants

   Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial.

   Karaa A, Bertini E, Carelli V et al. · Neurology · 2023

   PMID 37268435 · DOI: 10.1212/WNL.0000000000207402 · Registration NCT03323749

3. Human study · PubMed trial index Compound given to participants

   Genotype-specific effects of elamipretide in patients with primary mitochondrial myopathy: a post hoc analysis of the MMPOWER-3 trial.

   Karaa A, Bertini E, Carelli V et al. · Orphanet journal of rare diseases · 2024

   PMID 39574155 · DOI: 10.1186/s13023-024-03421-5 · Registration NCT03323749

4. Human study · PubMed trial index Compound given to participants

   A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy.

   Karaa A, Haas R, Goldstein A et al. · Journal of cachexia, sarcopenia and muscle · 2020

   PMID 32096613 · DOI: 10.1002/jcsm.12559

5. Human study · PubMed trial index Compound given to participants

   A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism.

   Reid Thompson W, Hornby B, Manuel R et al. · Genetics in medicine : official journal of the American College of Medical Genetics · 2021

   PMID 33077895 · DOI: 10.1038/s41436-020-01006-8

Preclinical research, reviews & other publications

Animal studies, laboratory experiments, reviews and other indexed papers answer different questions. A review is secondary evidence; a case report does not estimate how often an outcome occurs.

1. Review · secondary evidence

   Targeting mitochondrial dysfunction with elamipretide.

   Obi C, Smith AT, Hughes GJ et al. · Heart failure reviews · 2022

   PMID 35037146 · DOI: 10.1007/s10741-021-10199-2

2. Review · secondary evidence

   Elamipretide: First Approval.

   Shirley M · Drugs · 2026

   PMID 41335372 · DOI: 10.1007/s40265-025-02269-8

SS-31 supplier sources

Scientific sources describe molecules and experiments. The commercial links below identify recorded supplier packages. A publication or chemical database entry does not verify the seller, purity, sterility or contents of a lot. Some links are affiliate links; see our disclosure.

SS-31 for sale: compare prices, sizes and forms from every tracked supplier →

Reference sources & further reading

• PubChem compound record 11764719 — chemical identity and structure.
• ChEMBL drug record CHEMBL3833370 — development stage, mechanism and synonyms.
• FDA Global Substance Registration System: UNII 87GWG91S09 — substance identity, names and codes.
• Drugs@FDA: NDA 215244 — US approval record for a medicine with the same active ingredient.
• Wikipedia: Elamipretide — Background encyclopedia; not a primary clinical source.

The citations above link directly to publication records. Encyclopedia links are background reading and are not used to establish clinical effectiveness.

Research information is not a dosing guide or a recommendation for personal use. Study findings are specific to the formulation, population and methods tested. Read our source and correction policy.

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