SS-31 / Elamipretide (10mg)
SS-31 / Elamipretide is a mitochondria-targeted tetrapeptide studied for its binding to cardiolipin on the inner mitochondrial membrane. This entry pertains to a 10 mg vial and uses 2 mL of bacteriostatic water as an educational reconstitution example (5 mg/mL).
Reviewed by the AllPeptides.eu Editorial Team·Last reviewed: 2026-06-16
Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.
⚠️ For informational/educational purposes only. Not medical advice. We do not sell any products. Self-treatment carries serious risks — consult a healthcare professional. Disclaimer
Research monograph
See the full SS-31 encyclopedia page with mechanism, evidence tier, related variants and research context.
How It Works
SS-31 / Elamipretide is designed to concentrate in the inner mitochondrial membrane and interact with cardiolipin. The literature examines how this interaction may affect the stability of respiratory complexes, electron flow, mitochondrial energy production, and markers of oxidative stress.
Quick Start
- Vial: SS-31 / Elamipretide 10 mg.
- Reference Reconstitution: 2 mL → 5 mg/mL.
- Mechanistic Context: Cardiolipin, inner mitochondrial membrane, mitochondrial energy function.
- Regulatory Context: Forzinity™ (elamipretide) has FDA accelerated approval only for Barth syndrome in patients ≥30 kg.
Reference Table — SS-31 10mg (2 mL = 5 mg/mL)
Route: Subcutaneous research context | Frequency: Daily reference schedule
| Week | Dose | Units (per injection) |
|---|---|---|
| 1–2 | 5mg | 100 Units (1.00 mL) |
| 3–4 | 10mg | 2 × 100 Units (1.00 mL) — 1 vial |
| 5+ | 20mg | 4 × 100 Units (1.00 mL) — 2 vials |
The rows are presented as an educational calculation example with a 10 mg vial. They do not extend the approved indication of Forzinity™ beyond Barth syndrome.
Related compounds
Reconstitution Steps
- Clean the stoppers with an alcohol wipe.
- Draw 2mL of bacteriostatic water.
- Inject slowly against the vial wall.
- Gently swirl until fully dissolved.
- Store in the refrigerator (2–8°C).
Protocol Overview
- Identity: SS-31 / Elamipretide (D-Arg-Dmt-Lys-Phe-NH2), a mitochondria-targeted tetrapeptide.
- Core Context: Binding to cardiolipin on the inner mitochondrial membrane.
- Research Areas: Barth syndrome, primary mitochondrial myopathies, heart failure, and ophthalmological models have been evaluated at different levels of evidence.
- Vial on this page: 10 mg, with a 2 mL reconstitution example.
Dosing Protocol
- Educational Framework: The 10 mg vial allows for simple unit correspondence when a 5 mg/mL concentration is used.
- Table Titration: The 5 mg, 10 mg, and 20 mg rows are shown as a calculation example, not a personalized instruction.
- Literature Context: Human documentation varies by indication, population, endpoint, and study design.
- Claim Limitation: The FDA approval for Forzinity™ applies only to Barth syndrome and does not transfer to other uses.
- Break between cycles: The concept of a washout appears as a general field in the template. For SS-31 / Elamipretide, it should not be interpreted as a personalized plan or instruction for use.
Washout & Cycle Restart
When can I restart?
The concept of a washout appears as a general field in the template. For SS-31 / Elamipretide, it should not be interpreted as a personalized plan or instruction for use.
Minimum wait period: 4 weeks
Storage Instructions
- Reconstituted: 2–8°C, use within 28 days.
- Powder: -20°C.
Important Notes
- Forzinity™ (elamipretide) received FDA accelerated approval in September 2025 only for Barth syndrome in patients weighing at least 30 kg.
- Research data outside of Barth syndrome do not constitute approved indications.
- This page is educational and does not constitute medical advice, personalized instruction, or an encouragement of use.
Regulatory Status
In September 2025 the FDA granted accelerated approval to Forzinity™ (elamipretide) for improvement of muscle strength in adult and paediatric patients with Barth syndrome weighing at least 30 kg. The indication rests on an intermediate clinical endpoint and may be contingent on confirmatory studies. Other uses remain investigational and are not approved indications.
FDA — approval announcementRegulatory history
(5)FDA accelerated approval — Forzinity™ (elamipretide) for Barth syndrome in patients weighing at least 30 kg.
FDA Press AnnouncementOrphan Drug Designation — the FDA confirmed orphan drug status for use in rare mitochondrial diseases.
FDA Orphan Drug DatabaseBreakthrough Therapy Designation — the FDA granted breakthrough designation for Barth syndrome, based on Phase 2/3 data (TAZPOWER study).
Start of Phase 3 (MMPOWER-3 study) in patients with primary mitochondrial myopathy, run by Stealth BioTherapeutics.
First publication of SS-31 (Szeto–Schiller peptide-31) as a cell-permeable antioxidant peptide targeted to the inner mitochondrial membrane.
Potential Benefits & Side Effects
Potential Benefits:
- Cardiolipin and inner mitochondrial membrane stability.
- Markers of oxidative stress and ROS production in preclinical and translational models.
- Mitochondrial bioenergetics, electron flow, and ATP as research endpoints.
- Cardiac, muscular, and ophthalmological research literature with varying data quality.
- Barth syndrome as a specific regulatory context for the approved pharmaceutical product Forzinity™.
Potential Side Effects:
- The public information for the approved product most frequently reports injection site reactions.
- In elamipretide studies, tolerability, laboratory markers, and adverse events have been evaluated by population.
- Safety depends on indication, formulation, population, and clinical context; it should not be generalized from one study to all uses.
⚠️ Serious Warnings & Long-Term Risks
The following warnings are based on published literature, FDA labels, and post-marketing surveillance. They do not constitute medical advice. Consult a healthcare professional.
Renal safety under evaluation
Elamipretide is being evaluated for renal mitochondriopathies. Phase 3 in Barth syndrome did not meet primary endpoint.
📄 Stealth BioTherapeutics — Phase 3 ResultsReferences
- Br J Pharmacol (2014) — Szeto HH. First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics.
View Source - Circ Heart Fail (2017) — Daubert MA, et al. Novel mitochondria-targeting peptide in heart failure treatment: a randomized, placebo-controlled trial of elamipretide.
View Source - J Cachexia Sarcopenia Muscle (2020) — Karaa A, et al. Randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy.
View Source - JACC Basic Transl Sci (2019) — Butler J, et al. Effects of elamipretide on left ventricular function in heart failure with reduced ejection fraction.
View Source - Aging Cell (2014) — Siegel MP, et al. Mitochondrial-targeted peptide rapidly improves mitochondrial energetics and skeletal muscle performance in aged mice.
View Source - Free Radic Biol Med (2016) — Campbell MD, et al. Improving mitochondrial function with SS-31 reverses age-related redox stress and improves exercise tolerance in aged mice.
View Source - J Am Soc Nephrol (2011) — Szeto HH, et al. Mitochondria-targeted peptide accelerates ATP recovery and reduces ischemic kidney injury.
View Source - Ophthalmology (2020) — Elamipretide Phase II trial for dry age-related macular degeneration (ReCLAIM study).
View Source
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CoQ10 (Ubiquinol)
Vitamin E (Mixed Tocopherols)
External Sources & Regulatory Status
Regulatory Approvals
Elamipretide · Barth syndrome / Mitochondrial disorders (2020)
Barth syndrome (NCT05168774)
FDA Breakthrough Therapy
Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.
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