The cardiolipin-binding peptide that concentrates inside mitochondria and restores energy production — actively trialed for Barth syndrome, primary mitochondrial disease, and heart failure.
SS-31, also known as elamipretide (older trade name Bendavia), is a mitochondrial-targeted tetrapeptide that selectively accumulates in the inner mitochondrial membrane by binding to cardiolipin — a phospholipid essential to mitochondrial function that becomes oxidatively damaged with age and disease.
FDA accelerated approval was granted on September 19, 2025 as Forzinity (elamipretide HCl injection, NDA 215244, Stealth BioTherapeutics) for treatment of Barth syndrome in adults and pediatric patients weighing ≥30 kg. Continued approval is conditional on confirmatory trials. Distribution in the U.S. is through AnovoRx Specialty Pharmacy as a single distributor (since December 2025). Pivotal trials in primary mitochondrial myopathy (MMPOWER-3), dry AMD / geographic atrophy (ReCLAIM-2), and heart failure (PROGRESS-HF) all missed their primary endpoints — Forzinity’s approval is Barth-specific. Off-label use of Forzinity for non-Barth indications is “off-label of a Barth-syndrome drug,” with no FDA-blessed efficacy outside that indication.
FDA-approved (Forzinity, Sept 19 2025) for Barth syndrome only. Not specifically listed on the WADA prohibited list as of the 2026 list, though general "non-approved substance" framing could apply outside approved use. Branded Forzinity (single-distributor, pharmaceutical-grade) and gray-market “SS-31” sold by research-peptide vendors are not the same supply chain — identity, purity, and sterility cannot be assumed equivalent.
Selectively binds cardiolipin in the inner mitochondrial membrane at ~1000× the extracellular concentration. This restores membrane curvature and protects cristae structure.
Stabilizes complexes I, III, and IV — the enzymes that generate ATP. Restores ATP production in aged or damaged mitochondria without supplying exogenous electrons.
Because it stabilizes the ETC, fewer electrons leak to form reactive oxygen species. This is different from an antioxidant — it prevents ROS production instead of scavenging it after the fact.
| Benefit | Evidence |
|---|---|
| Barth syndrome | FDA-approved (Forzinity, Sept 19 2025). Approval based primarily on TAZPOWER open-label extension; the original double-blind randomized phase (n=12) did not meet its primary endpoints, but the long-term OLE data + ultra-rare-disease context (US n≈150) supported accelerated approval. |
| Primary mitochondrial myopathy | MMPOWER-3 (Phase 3, n=218, PMID 37268435) failed both co-primary endpoints. A post-hoc nuclear-DNA subgroup signal exists but does not constitute a positive trial. Not approved for this indication. |
| Heart failure | PROGRESS-HF Phase 2 (Butler 2020, PMID 32068002) explored HFrEF; subsequent program missed primary endpoints. Not approved. |
| Dry AMD | ReCLAIM-2 Phase 2b missed both primary endpoints (LLVA and GA growth). Only a secondary endpoint — ellipsoid zone preservation, P=0.0034 — was positive. Not approved. |
| Muscle recovery / aging | Improves oxygen utilization in aged muscle; explored for sarcopenia |
| Renal protection | Preclinical data for ischemic and contrast-induced AKI |
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Start Tracking FreeThe commonly cited 5–40 mg/day human subcutaneous dose range comes from Stealth BioTherapeutics investigational protocols and community reporting, not from a single validated published trial we could cite here. Treat it as derived from investigational programs rather than independently established dose-ranging data, and start at the low end.
NAD+ (complementary mitochondrial support), MOTS-C (AMPK synergy), CoQ10, and urolithin A (mitophagy). SS-31 handles the membrane; NAD+ and MOTS-C boost energy metabolism.
50 mg vial + 2 mL BAC water = 25 mg/mL
| Dose | Volume | Syringe Units |
|---|---|---|
| 5 mg | 0.20 mL | 20 units |
| 10 mg | 0.40 mL | 40 units |
50 mg vial at 5 mg/day = 10 days; at 10 mg/day = 5 days
Pre-filled with a typical SS-31 (Elamipretide) setup. Edit any field — the draw updates live.
Dose requires 2.000 ml but your 0.5 ml syringe can't hold that much. Use a larger syringe or add more BAC water.
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Clinical and preclinical studies to date suggest a generally favorable safety profile, with injection site reactions being the most commonly reported adverse event. Specific cumulative “thousands of patient-doses” counts vary by program and are not directly cited from the abstracts here.
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Start Tracking FreeYes — for one rare indication. SS-31 (elamipretide) was FDA approved September 2025 under the brand name Forzinity (NDA 215244) for the treatment of Barth syndrome, a rare X-linked cardiolipin disorder. Use outside of Barth syndrome (anti-aging, mitochondrial dysfunction, athletic recovery, etc.) is off-label and not FDA validated. Research-grade SS-31 sold by peptide vendors is NOT the approved Forzinity product.
The FDA-approved Forzinity label uses 40 mg subcutaneously once daily for Barth syndrome. Community and anti-aging-clinic protocols typically use 1–10 mg subcutaneously daily — far below the approved dose. Multiple Phase 2/3 trials in other indications (Stealth BioTherapeutics MMPOWER, ReCLAIM-2, etc.) failed on primary endpoints at the 40 mg/day dose. There is no clinical-trial validation for the 1–10 mg community range.
For a 5 mg lyophilized vial, a typical reconstitution is 5 mg + 2 mL of bacteriostatic water, yielding 2.5 mg/mL. A 5 mg dose draws to 2.00 mL (use a 3 mL syringe), 2.5 mg = 1.00 mL (full 100u insulin syringe). The 40 mg/day Forzinity label dose requires either a larger vial or multiple draws — research-grade vials topping out at 10 mg are not designed to support the approved Barth syndrome dose.
SS-31 selectively concentrates in the inner mitochondrial membrane (~1000-fold over cytoplasm) by binding cardiolipin. There it stabilizes the electron transport chain, reduces reactive oxygen species production, and preserves ATP synthesis under stress. Preclinical evidence is extensive across kidney, heart, brain, and skeletal muscle ischemia-reperfusion models. Human RCT data in indications outside Barth syndrome (heart failure, primary mitochondrial myopathy, dry AMD) was largely NEGATIVE on primary endpoints.
In the Barth syndrome open-label extension (the basis for FDA approval), functional improvements emerged over 48+ weeks of continuous daily dosing. Pharmacokinetics: Tmax ~1–2 hours SC, plasma half-life ~4 hours. The mitochondrial accumulation half-life is much longer than plasma — the peptide stays sequestered in mitochondrial membranes well beyond plasma clearance, which is why daily dosing produces sustained effect.
Not currently specifically named on the WADA Prohibited List as of 2025–2026. WADA could sweep it under S0 (Non-Approved Substances) for the non-Barth-syndrome use case. Competitive athletes should verify the current-year list before use.
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StackTrax guides cover peptides and compounds that are not FDA-approved for the uses discussed. The dosing, reconstitution, and safety information is compiled from published research and community protocols for educational purposes only.
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