Compound profile

SS-31

Mitochondrial peptide

A mitochondria-targeting tetrapeptide (elamipretide) that binds cardiolipin in the inner mitochondrial membrane, studied across several trials with mixed results.

Reviewed for accuracy · Last reviewed July 7, 2026
ClassMitochondria-targeting tetrapeptide
RouteSubcutaneous injection
Approved useBarth syndrome (accelerated approval, 2025)
StorageRefrigerated once mixed

Overview

SS-31, known as elamipretide, is a synthetic tetrapeptide that targets mitochondria: it binds cardiolipin in the inner mitochondrial membrane, helps stabilize the membrane's structure, and is studied for improving mitochondrial function. Unlike most research peptides, it has been through a substantial clinical program, including trials in mitochondrial myopathy, heart failure, and eye disease.

The evidence is genuinely mixed. In September 2025 it received FDA accelerated approval as FORZINITY for the ultra-rare Barth syndrome, based on a muscle-strength endpoint, with confirmatory trials still required. But its larger MMPOWER-3 trial in primary mitochondrial myopathy did not meet its primary endpoints. So it is narrowly and conditionally approved for one rare disease, not a broadly proven compound, and other uses are off-label or investigational.

Dosing

The approved Barth syndrome product (FORZINITY) and the mitochondrial myopathy trials used 40 mg subcutaneously once daily. Research use outside that narrow indication has no established dose.

Read the full SS-31 dosage guide →

Side effects

In its clinical program the most consistent reactions were injection-site reactions. Because approval is narrow and recent, its adverse-effect profile outside the studied populations is not well characterized.

Read the full SS-31 side effects guide →

Storage

The approved product has its own storage instructions. For research vials, keep the unmixed peptide refrigerated and away from light, and store any reconstituted solution refrigerated. See the full storage & safety guide for handling and disposal basics.

FAQ

Is SS-31 FDA-approved?Narrowly. Elamipretide received FDA accelerated approval in 2025 as FORZINITY for Barth syndrome, a specific ultra-rare disease, with confirmatory trials still required. It is not broadly approved, and other uses are off-label or investigational.
Did SS-31 work in mitochondrial myopathy trials?Not on its primary endpoints. The MMPOWER-3 trial in primary mitochondrial myopathy did not show a significant benefit on its main measures, which is part of why its evidence picture is called mixed.
How does SS-31 target mitochondria?It binds cardiolipin, a lipid concentrated in the inner mitochondrial membrane, which helps stabilize the membrane's structure and is thought to support mitochondrial function.

References

  1. Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic PotentialInternational Journal of Molecular Sciences (MDPI) · 2025 · PMID 39940712 · DOI 10.3390/ijms26030944
  2. The mitochondria-targeted peptide SS-31 binds lipid bilayers and modulates surface electrostatics as a key component of its mechanism of actionJournal of Biological Chemistry · 2020 · PMID 32273339 · DOI 10.1074/jbc.RA119.012094
  3. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical TrialNeurology · 2023 · PMID 37268435 · DOI 10.1212/WNL.0000000000207402
  4. FORZINITY (elamipretide) injection: DailyMed labelDailyMed (U.S. National Library of Medicine) · 2025 · DailyMed setid 146bf34c-76f2-48db-ac07-fb29cce2cd75 · NDA 215244
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This page is an independent educational reference and is not medical advice. Talk to a doctor before starting any compound.