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, restoring membrane curvature and protecting cristae structure. The biophysics has been characterised directly — Mitchell 2020 (J Biol Chem, PMID 32273339) examined how Szeto-Schiller tetrapeptides interact with and alter lipid bilayers rather than assuming the cardiolipin affinity explains everything, and a follow-up mapped structure–activity relationships across the class (PMID 35913044).
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), on a very small dataset. The supporting long-term data is the TAZPOWER open-label extension (Thompson 2024, PMID 38602181): 10 patients entered, 8 reached week 168 on 40 mg subcutaneous daily, with a cumulative 96.1 m gain on the 6-minute walk test (p = 0.003), improved fatigue scores, improved 3D left-ventricular volumes and an improved MLCL/CL ratio. The preceding 28-week randomised double-blind phase did not meet its primary endpoints |
| 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 (Ehlers 2025, PMID 39605874), 176 patients on 40 mg daily for 48 weeks, missed both primary endpoints (low-luminance BCVA and geographic atrophy area). The positive results were ellipsoid-zone measures — 43% less total EZ loss and 47% less partial attenuation — at nominal p-values (0.0034, 0.0040), meaning unadjusted for multiplicity. 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 FreeNot medical advice. These figures describe what is reported in the literature and what practitioners and communities do — not a recommendation, and for most compounds here no human dose-finding study exists. Talk to a qualified healthcare provider.
Worth knowing before you pick a number: every published elamipretide trial used 40 mg subcutaneously per day. That is the dose in the TAZPOWER extension behind the Barth approval (PMID 38602181), in ReCLAIM-2 (PMID 39605874), and across the Stealth programme. The 1–2 mg/day figure above is community convention sitting roughly twenty to forty times below the studied dose — the reverse of the usual pattern, where community doses exceed trial doses.
One trial did test a low dose, and it is the closest thing to evidence bearing on the range this guide recommends. PROGRESS-HF (Butler 2020, PMID 32068002) randomised heart-failure patients 1:1:1 to placebo, 4 mg, or 40 mg daily. Neither dose separated from placebo on left ventricular end-systolic volume at week 4. That is a null result in one indication over four weeks rather than a verdict on the dose — but it is the only head-to-head of a low against a high dose that exists, and it did not favour either.
That cuts two ways and neither is a recommendation. A lower dose has less safety data behind it, not more, and it may simply be underdosed relative to anything that has been tested. Equally, 40 mg/day was studied in specific disease populations, not in healthy adults for longevity. There is no validated dose for the use most people here are considering.
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.
Not medical advice. These figures describe what is reported in the literature and what practitioners and communities do — not a recommendation, and for most compounds here no human dose-finding study exists. Talk to a qualified healthcare provider.
50 mg vial + 2 mL BAC water = 25 mg/mL
| Dose | Volume | Syringe Units |
|---|---|---|
| 1 mg | 0.04 mL | 4 units |
| 2 mg | 0.08 mL | 8 units |
50 mg vial at 1 mg/day = 50 days; at 2 mg/day = 25 days.
At 25 mg/mL a 1 mg dose is only 4 units on an insulin syringe, which is a small and error-prone draw. Reconstituting the same 50 mg vial in 5 mL instead gives 10 mg/mL, making 1 mg = 10 units and 2 mg = 20 units — easier to measure accurately at this dose.
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.
SS-31 (Elamipretide) is sold for research use only. If you are sourcing it for research, we recommend Lyvn — every batch third-party tested with the full laboratory panel published on the product page.
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For research use only. Not for human consumption. 21+.
Build your protocol, log every dose, monitor your body's response, and get reminders so you never miss a dose.
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.
Disclaimer: This guide is for educational and informational purposes only and is not intended as medical advice, diagnosis, or treatment. The compounds discussed are not FDA approved for human use. Always consult a qualified healthcare provider before starting any new supplement or peptide protocol. StackTrax does not sell peptides or supplements directly — purchase links go to third-party vendors. StackTrax is not responsible for the products, quality, or business practices of any third-party vendor.
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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.
Before using any compound mentioned here, consult a qualified healthcare provider. StackTrax does not sell, prescribe, or recommend these substances for personal use.