Peptide Knowledge Base · Longevity
SS-31 / Elamipretide: what it is, what the evidence says, and its real status
A mitochondria-targeting peptide that binds cardiolipin to restore ATP production, and, as of Sept 2025, an FDA-approved drug for one rare disease.
Short version: the credibility magnet. A real, fresh FDA approval (elamipretide / Forzinity, Sept 2025), but only for Barth syndrome. Every longevity use is off-label and unproven. We foreground that two-signal nuance: approved is not the same as approved-for-this.
Can you actually get it?
Plain-English verdict: Waitlist / education.
Regulatory status: FDA-approved (Barth syndrome) · off-label otherwise · Approved Sep 19, 2025.
Approved for one thing, not for longevity. Elamipretide (Forzinity) received FDA accelerated approval on Sep 19, 2025 for Barth syndrome (≥30 kg), a genuine first. Any energy/longevity use is off-label, unproven, and not something we offer as such.
How does SS-31 / Elamipretide work?
A tetrapeptide that concentrates in the inner mitochondrial membrane and binds cardiolipin, stabilizing the electron-transport chain to restore ATP output and cut reactive oxygen species.
What it does — and what it does not do
What it does: In Barth syndrome, supports mitochondrial energy production; that is the approved, evidenced use.
What it does not do: It is not approved for aging, energy, or longevity, and the two-signal rule holds: a real approval for one disease is not a green light for off-label use.
How honest is the evidence?
Evidence grade B — grade B for Barth syndrome (approval-grade); grade D for longevity (off-label, unproven). Read our grading methodology for what each grade means.
What we still don't know: Longevity and general-energy benefits in healthy adults are not established; the approval is narrow (Barth syndrome).
WADA status: Not prohibited.
How it is taken
What the literature reports for the approved indication: subcutaneous. Educational only, no dose figures.
Who should not take it
Off-label longevity use is not characterized for safety; clinician-gated. Approved use is specialist-managed.
Sources
FDA accelerated approval, elamipretide (Forzinity), Sep 19 2025, Barth syndrome · Stealth BioTherapeutics labeling (re-verify)
Compounded medications are not FDA-approved. We keep two signals separate and never collapse them: whether you can get something, and what the rule currently says. See the live FDA Peptide Tracker or the knowledge base.
Last reviewed 2026-08-11 · Peptós.LIFE · Not medical advice.