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Longevity · FDA Approved

SS-31 (Elamipretide)

FDA-approved

Explore lawful clinical options for longevity and healthy ageingOr: how to ask your own doctor →
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A mitochondria-targeted tetrapeptide (D-Arg-dimethylTyr-Lys-Phe-NH2) that selectively binds cardiolipin in the inner mitochondrial membrane. In laboratory studies, SS-31 inhibited the peroxidase activity of the cytochrome c/cardiolipin complex while preserving its electron-carrier function, improving electron transport and ATP synthesis (PMID 24134698).

It was approved in the US in 2025 as elamipretide (Forzinity) for Barth syndrome, the first disease-specific therapy for that condition (PMID 41335372).

02 · Research summary & key findings

Granted FDA accelerated approval in September 2025 to improve muscle strength in patients with Barth syndrome weighing at least 30 kg; a confirmatory trial is required (PMID 41260682). In the TAZPOWER trial, neither primary endpoint (6-minute walk test, symptom score) was met in the randomized crossover phase, but the open-label extension showed improvements in walk distance and symptoms (PMID 33077895), sustained to 168 weeks (PMID 38602181). The phase 3 MMPOWER-3 trial in primary mitochondrial myopathy did not meet its primary endpoints, though the drug was well tolerated (PMID 37268435). In aged mice, SS-31 rapidly restored skeletal muscle mitochondrial energetics (PMID 23692570) and partially reversed age-related diastolic dysfunction (PMID 32779818).

03 · Regulatory status

SS-31 (Elamipretide) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

SS-31 (Elamipretide) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

Looking for a lawful, clinician-prescribed option for longevity and healthy ageing?

SS-31 (Elamipretide) is prescribed for the conditions on its label, and it is not part of our intake. If you are working on longevity and healthy ageing, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.

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04 · Administration routes

  • Subcutaneous injection
  • Intravenous

References

  1. [1]Mitochondrial-targeted peptide rapidly improves mitochondrial energetics and skeletal muscle performance in aged mice Aging Cell, 2013. PMID 23692570
  2. [2]Targeting mitochondrial cardiolipin and the cytochrome c/cardiolipin complex to promote electron transport and optimize mitochondrial ATP synthesis Br J Pharmacol, 2014. PMID 24134698
  3. [3]SS-31 and NMN: Two paths to improve metabolism and function in aged hearts Aging Cell, 2020. PMID 32779818
  4. [4]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 Genet Med, 2021. PMID 33077895
  5. [5]Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial Neurology, 2023. PMID 37268435
  6. [6]Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER Genet Med, 2024. PMID 38602181
  7. [7]Elamipretide: The first cardiolipin-directed mitochondrial therapeutic for Barth syndrome approved under accelerated approval Drug Discov Ther, 2026. PMID 41260682
  8. [8]Elamipretide: First Approval Drugs, 2026. PMID 41335372

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.