● TIER 1 — FDA-approved / recognizedGRADE BLongevity / mitochondrial
Elamipretide (SS-31)
Cardiolipin-binding tetrapeptide. Research verification: Yes (TGA pending). 2 human study record(s) in the FitClinicMD studies database.
GOALS · Longevity
FDA status
Accelerated approval Sep 19 2025: Forzinity (Barth syndrome, ≥30 kg) — confirmatory trial NCT07531251.
Compounding (503A/503B)
Approved product.
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
Binds inner mitochondrial membrane cardiolipin.
Human evidence · 2
Barth syndrome long-term 168-wk follow-up. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER.
MMPOWER-3, primary mitochondrial myopathy, n=218: missed primary endpoint. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial.
Reference only. This page summarizes publicly available regulatory and research information about Elamipretide (SS-31). It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.