FDA Peptide Tracker

SS-31 / Elamipretide: live FDA regulatory status

Mitochondrial cardiolipin binder · Approved (narrow)

The two signals

Plain-English verdict: amber.

Regulatory status: Approved (Barth) · off-label otherwise.

These two never collapse into one. Removal from a list is not the same as legal-to-compound, and neither is the same as available.

Availability at Peptós.LIFE

Education only

What happens next

Longevity use remains off-label — Ongoing

Regulatory timeline

• 2025-09 — FDA accelerated approval, Barth syndrome
• Ongoing — Energy / longevity use is off-label

PCAC is advisory: its Jul 2026 recommendation leads to rulemaking, not instant availability. A favorable advisory vote is a recommendation, not FDA approval or authorization to compound. Realistic earliest legitimate access is late 2026 into 2027. Reclassification is not the same as FDA approval. Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or quality, where that applies, we say so, plainly.

Primary source: FDA source record

See the full status board or this molecule's knowledge-base monograph.

Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.