SS-31 FAQ: common questions answered
A peptide approved for Barth syndrome muscle strength; benefit needs confirmation and broader energy benefits remain unproven.
Also called: Elamipretide, SS31, SS 31, MTP-131, Bendavia, Forzinity.
Mitochondria-targeted peptides · Mitochondrial cardiolipin-binding tetrapeptide · Evidence: Approved drug.
- Is SS-31 (elamipretide) FDA-approved? Yes: Forzinity (improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg.). Accelerated approval 2025-09-19; benefit still needs confirmation. No SS-31-specific bulks-list inclusion or PCAC decision was found; July’s peptide agenda did not include it.
- How do people take it? Under the skin, once daily. Ongoing; label gives no cycle. Source: drug label.
- What's the difference between SS-31 (elamipretide) and MOTS-c? SS-31 (elamipretide): a peptide approved for Barth syndrome muscle strength; benefit needs confirmation and broader energy benefits remain unproven. MOTS-c: a peptide the body makes; injection benefits and safety remain unproven. Why people pair them: people use it together with SS-31 or after an SS-31 “primer,” hoping for more energy. No controlled human combination trial was found.
- Can I take it with MOTS-c? People use it together with SS-31 or after an SS-31 “primer,” hoping for more energy. No controlled human combination trial was found. Combined safety and the claimed need to repair mitochondria before MOTS-c are unproven. Source: reported by users. Ask a doctor before combining anything.
- Is it banned in sport? It is unclear (WADA 2026). Not named in the 2026 list. S0 concerns drugs without any human approval; ask the anti-doping authority for a specific ruling.
- How do I store it once opened? After first use: refrigerate at 2–8°C or store at room temperature, 20–25°C. Discard 8 days after first opening.
Related to SS-31 (elamipretide)
- Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
- NAD+ and precursors: NAD+ helps cells use energy; wellness injection benefits remain unproven.
- MOTS-c: A peptide the body makes; injection benefits and safety remain unproven.
Sources
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee - 07/23/2026, FDA · FDA · 2026
- MHRA-101705-PIP01-24 | MHRA, 2026
- Peptide products, Therapeutic Goods Administration · TGA · 2026
- Pyrogen and Endotoxins Testing: Questions and Answers, FDA · 2026
- TGA warning on the risks of importing unapproved peptide products, Therapeutic Goods Administration · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- The Prohibited List, World Anti-Doping Agency · World Anti-Doping Agency · 2026
- Darmerica, LLC - 716152 - 12/08/2025, FDA · FDA · 2025
- FORZINITY (elamipretide) injection, for subcutaneous use, U.S. Food and Drug Administration · FDA · 2025
- NDA 215244 Forzinity (elamipretide): Integrated Review, 2025
- EU/3/21/2430 - orphan designation for treatment of Barth syndrome | European Medicines Agency (EMA), 2021
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, FDA · FDA · 2000
Sources checked: 2026-10-18.
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