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Longevity

SS-31

Mitochondria-targeted tetrapeptide that stabilizes cardiolipin and restores oxidative phosphorylation. FDA-approved for rare Barth syndrome, investigational in heart failure and aging-related conditions.

FDA Accelerated Approval (2025) for Barth Syndrome Longevity Fitness & muscle Recovery & healing

Reviewed 2026-09-12
Full name
Elamipretide; Szeto-Schiller peptide 31
Also known as
elamipretide, Bendavia, MTP-131
Regulatory status
FDA Accelerated Approval (2025) for Barth Syndrome | Investigational in heart failure/HFpEF | Not approved for longevity use

Origin

Designed by Hazel Szeto and Peter Schiller to cross the mitochondrial membrane and stabilize cardiolipin. Developed by Stealth BioTherapeutics/Reata, it received FDA Accelerated Approval in 2025 for Barth syndrome, a rare cardiolipin-remodeling genetic disorder, the first FDA-approved mitochondrial medicine.

Mechanism

Accumulates in the inner mitochondrial membrane, binding and stabilizing cardiolipin, essential for respiratory chain complex assembly. Restoring cardiolipin integrity improves electron transport efficiency, raises ATP production, and cuts mitochondrial ROS.

Research summary

Evidence

Preclinical/animal models show reduced oxidative stress and prevention of cardiomyocyte/skeletal muscle senescence. Phase 2 heart failure trials (HFrEF/HFpEF) show modest-to-moderate functional improvements. Barth syndrome trial data led to accelerated approval, but clinical benefit size is still being characterized. Human longevity/aging evidence is extremely limited.

Evidence tier: FDA Accelerated Approval (2025) for Barth Syndrome — see the methodology note for how this is assessed.

Citations

Reported benefits

  • improved mitochondrial respiratory capacity
  • reduced oxidative stress (preclinical)
  • prevention of cellular senescence (cell/animal models)
  • FDA-approved benefit in Barth syndrome

Dosing protocols reported in the literature & community

These are protocols reported by compounding pharmacies, published trials, or self-experimentation communities — not a prescription. Start low, especially for anything new.

Reported dosing protocols
RouteReported protocol
Intravenous infusionInvestigational off-label protocols: ~0.05-0.1 mg/kg IV once daily or 2-3x weekly; no consensus dosing outside approved indication.

Side effects

  • generally well tolerated in Phase 2 trials
  • headache/dizziness
  • infusion-site reactions
  • rare hypotension/syncope

Safety notes

Safety: Excellent tolerability in Phase 2 trials to date, no major organ toxicity reported. Long-term safety outside rare-disease populations isn't established.
Community & reddit notes (anecdotal — not clinical evidence)

High interest in longevity forums based on the mitochondrial mechanism, but human access is limited to clinical trials or high-cost research sourcing. Enthusiasm exceeds current human evidence.