Storing SS-31: Best Practices
Recommended Laboratory Storage Conditions
Commercial (Forzinity sterile solution): Refrigerate at 2–8°C (36–46°F). Shelf life 48 months. Protect from light and freezing. Single-use vials — no preservative for multi-dose use.
Research-Grade (Lyophilized Powder): Store at -20°C to -80°C in desiccated, airtight container. Stable at room temperature for limited time during shipping.
Reconstitution: Use sterile water or bacteriostatic water. Do not shake vigorously. Reconstituted solution: refrigerate at 4°C; use within 24–48 hours or aliquot and freeze at -80°C.
Formulations available: 280 mg/3.5 mL (80 mg/mL) sterile SC injection solution (commercial); lyophilized powder (research-grade); IV formulation (clinical trials); topical ophthalmic solution (investigational).
Salt forms: Acetate (clinical development/research) vs. HCl (commercial Forzinity); bioequivalence established between forms.
“Preclinical & Clinical Research Summary Key Preclinical Studies StudyModelKey FindingsRef Sabbah et al.”
References
- Szeto HH. First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics. British Journal of Pharmacology. 2014;171(8):2029-2050.
- Birk AV, Liu S, Soong Y, et al. The Mitochondrial-Targeted Compound SS-31 Re-Energizes Ischemic Mitochondria by Interacting with Cardiolipin. Journal of the American Society of Nephrology. 2013;24(8):1250-1261.
- FDA Press Announcement. FDA approves first treatment for rare genetic heart muscle disease. September 19, 2025.
- Campbell MD, Duan J, Samuelson AT, et al. Improving mitochondrial function with SS-31 reverses age-related redox stress and improves exercise tolerance in aged mice. Free Radical Biology and Medicine. 2019;134:268-281.
- Sabbah HN. Elamipretide (SS-31) improves mitochondrial function and prevents cellular apoptosis in heart failure and its comorbidities. Expert Opinion on Investigational Drugs. 2021;30(12):1227-1244.
- Sabbah HN, Gupta RC, Kohli S, et al. Chronic therapy with elamipretide (MTP-131), a novel mitochondria-targeting peptide, improves left ventricular and mitochondrial function in dogs with advanced heart failure. Circulation: Heart Failure. 2016;9(2):e002206.
- Sabbah HN, Alder NN, Sparagna GC, Bruce JE, et al. Contemporary insights into elamipretide's mitochondrial mechanism of action and therapeutic effects. Biomedicine & Pharmacotherapy. 2025;187:118056.
- Zhao W, Xu Z, Cao J, Fu Q, et al. Elamipretide (SS-31) improves mitochondrial dysfunction, synaptic and memory impairment induced by lipopolysaccharide in mice. Journal of Neuroinflammation. 2019;16(1):230.
- Thompson WR, Hornby B, Manuel R, et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Genetics in Medicine. 2024;101138.
- Karaa A, Haas R, Goldstein A, et al. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy. Neurology. 2018;90(14):e1212-e1221.
- Birk AV, Chao WM, Bracken C, et al. Targeting mitochondrial cardiolipin and the cytochrome c/cardiolipin complex to promote electron transport and optimize mitochondrial ATP synthesis. British Journal of Pharmacology. 2014;171(8):2017-2028.
- Ehlers JP, Hu A, Boyer D, et al. ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation. Ophthalmology Science. 2025;5(1):100628.
- Saad A, Herrmann SMS, Eirin A, et al. Phase 2a clinical trial of mitochondrial protection (elamipretide) during stent revascularization in patients with atherosclerotic renal artery stenosis. Circulation: Cardiovascular Interventions. 2017;10(9):e005487.
- Dai DF, Hsieh EJ, Chen T, et al. Global proteomics and pathway analysis of pressure-overload-induced heart failure and its attenuation by mitochondrial-targeted peptides. Circulation: Heart Failure. 2013;6(5):1067-1076.
- Chiao YA, Zhang H, Sweetwyne M, et al. Late-life restoration of mitochondrial function reverses cardiac dysfunction in old mice. eLife. 2020;9:e55513.
- Gibson CM, Giugliano RP, Kloner RA, et al. EMBRACE STEMI study: a Phase 2a trial to evaluate the safety, tolerability, and efficacy of intravenous MTP-131 on reperfusion injury in patients undergoing primary percutaneous coronary intervention. Eur Heart J. 2016;37(16):1296-1303.
- FDA Integrated Review NDA 215244 — Forzinity (elamipretide) Approval Package. 2025.
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