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Content reviewed by clinical research staff

Last reviewed: March 2026Sources: PubMed, FDA, WADA Prohibited List

Evidence graded using the PeptideScholar A-D system

Elamipretide

BHuman Studies
55
Moderate Credibility
1 cited studyy · Evidence level B

Mitochondrial-targeted peptide (SS-31) · 4 amino acids

Not FDA ApprovedPrescription Required

Elamipretide (SS-31) is a first-in-class mitochondria-targeted tetrapeptide that binds to cardiolipin in the inner mitochondrial membrane. It was granted FDA Breakthrough Therapy designation for Barth syndrome and is the first cardiolipin-directed therapeutic to reach late-stage clinical trials. It stabilizes mitochondrial structure and improves ATP production.

Mechanism of Action

Selectively accumulates in mitochondria via its dimethyltyrosine residue and binds to cardiolipin, a phospholipid essential for inner mitochondrial membrane integrity. This binding prevents cardiolipin peroxidation, stabilizes respiratory supercomplexes, maintains cristae structure, and improves electron transport chain efficiency — ultimately enhancing ATP synthesis and reducing reactive oxygen species production.

Benefits

  • First cardiolipin-directed mitochondrial therapeutic in clinical development[1]
  • Improves exercise capacity and muscle function in primary mitochondrial myopathy[1]
  • FDA Breakthrough Therapy designation for Barth syndrome
  • Potential applications in age-related mitochondrial dysfunction and heart failure
Not Medical Advice — Research-Reported Information Only

This content is for informational purposes only and does not constitute medical advice.

Elamipretide — Dosing in Published Research

Reported Routes: Subcutaneous injection
Investigational dosing in trials: 40-80 mg SC daily. Phase 3 trials ongoing for Barth syndrome and primary mitochondrial myopathy. Not commercially available outside clinical trials as of 2026.

The dosing information above is sourced from published research literature and clinical trials. These are not recommendations. Individual responses vary. Always consult a healthcare provider before considering any peptide-based therapy.

Side Effects

  • Injection site reactions
  • Headache
  • Nausea
  • Dizziness
  • Limited long-term safety data in large populations

Considering Peptide Research?

Elamipretide is not FDA-approved. Always consult a licensed healthcare provider before considering any peptide.

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Research & Evidence

RCTNeurology, 2023

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

Elamipretide did not meet primary endpoint in MMPOWER-3 for mitochondrial myopathy, but post-hoc analyses suggested benefit in specific genetic subgroups and biomarkers

PMID: 37268435

References

  1. 1. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial.. Neurology, 2023. “Elamipretide did not meet primary endpoint in MMPOWER-3 for mitochondrial myopathy, but post-hoc analyses suggested benefit in specific genetic subgroups and biomarkers” [PMID: 37268435]

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Elamipretide FAQ

Medical Disclaimer

This content is for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations.

Always consult a qualified healthcare provider before starting, stopping, or modifying any treatment. Do not disregard professional medical advice based on information found on this site.

No claims of therapeutic efficacy are made for substances that are not FDA-approved for the discussed indications. Research citations reflect published findings and do not imply endorsement.

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