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Longevity · FDA Approved

Mitochondrial-Targeted Peptides (MTP)

FDA-approved

Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

Mitochondrial-targeted peptides are short synthetic sequences designed to localize to mitochondria and limit oxidative damage and organelle dysfunction. The representative compound is elamipretide, also known as SS-31, a tetrapeptide that binds cardiolipin in the inner mitochondrial membrane.

Elamipretide was approved by the FDA in September 2025 as Forzinity, a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg, under accelerated approval based on knee extensor muscle strength as an intermediate clinical endpoint. The broader longevity rationale for this class rests on the mitochondrial theory of aging rather than on human outcome data.

02 · Research summary & key findings

The pivotal phase 3 MMPOWER-3 trial randomized 218 participants with genetically confirmed primary mitochondrial myopathy to elamipretide or placebo for 24 weeks and did not meet its primary endpoints of 6-minute walk distance or total fatigue score, although treatment was well tolerated (PMID 37268435). In Barth syndrome, the 168-week open-label extension of TAZPOWER in 10 patients reported sustained tolerability with significant improvements in 6-minute walk distance and improvement in fatigue scores and cardiac measures, though this phase was uncontrolled (PMID 38602181). No trials have evaluated mitochondrial-targeted peptides for lifespan extension or general aging outcomes, so longevity claims remain preclinical.

03 · Regulatory status

Mitochondrial-Targeted Peptides (MTP) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Mitochondrial-Targeted Peptides (MTP) 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?

Mitochondrial-Targeted Peptides (MTP) 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]Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial Neurology, 2023. PMID 37268435
  2. [2]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

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.