Storing Ss 31: Best Practices
Condições Recomendadas de Armazenamento Laboratorial
Commercial (Forzinity sterile solution): Refrigerate at 2–8°C (36–46°F). Shelf life 48 months. Proteja da luz and freezing. Single-use vials — no preservative for multi-dose use.
Research-Grade (Liofilizado Powder): Store at -20°C to -80°C in desiccated, airtight container. Estável à temperatura ambiente for limited time during shipping.
Reconstitution: Use sterile water or agua bacteriostatica. Não agite vigorosamente. Reconstituted solution: refrigerate at 4°C; use dentro de 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); liofilizado powder (research-grade); IV formulation (ensaios clinicos); topico(a) ophthalmic solution (investigacional).
Salt forms: Acetate (desenvolvimento clinico/research) vs. HCl (commercial Forzinity); bioequivalence estabeleceu between forms.
Referencias
- Szeto HH. First-in-class cardiolipin-protective compound como um(a) therapeutic agent para restaurar 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 do(a) American Society of Nephrology. 2013;24(8):1250-1261.
- FDA Press Announcement. FDA approves primeiro(a) treatment for rare genetic heart muscle disease. September 19, 2025.
- Campbell MD, Duan J, Bhatt SK, et al. Improving funcao mitocondrial with SS-31 reverses age-related redox stress and melhora exercise tolerance in camundongos idosos. Free Radical Biology and Medicine. 2019;134:268-281.
- Sabbah HN. Elamipretide (SS-31) melhora funcao mitocondrial and previne cellular apoptose in insuficiencia cardiaca e seu(sua) 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), um(a) novo(a) mitochondria-targeting peptide, melhora left ventricular and funcao mitocondrial in dogs with advanced insuficiencia cardiaca. Circulation: Heart Failure. 2016;9(2):e002206.
- Sabbah HN, Klewer SE, O'Brien T, et al. Elamipretide and NF-κB/NLRP3 inflammasome inibicao. Biomedicine & Pharmacotherapy. 2025;183:118056.
- Zhao W, Xu Z, Cao J, et al. Elamipretide (SS-31) melhora mitochondrial dysfunction, sinaptico(a) integrity, and cognition in an Alzheimer's disease model. Scientific Reports. 2019;9(1):13137.
- Thompson WR, Hornby B, Manuel R, et al. A phase 2/3 randomizado ensaio clinico followed by an open-label extension to evaluate o efeitoiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolismo. 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 e o(a) cytochrome c/cardiolipin complex para promover electron transport and optimize mitochondrial ATP synthesis. British Journal of Pharmacology. 2014;171(8):2017-2028.
- Cousins D, Brar P, McFarlane T, et al. Phase 2 study of elamipretide (SS-31) in age-related macular degeneration (ReCLAIM-2). Ophthalmology Retina. 2023.
- Saad A, Herrmann SMS, Eirin A, et al. Phase 2a ensaio clinico of mitochondrial protection (elamipretide) during stent revascularization in patients with atherosclerotic renal artery stenosis. Circulation: Cardiovascular Interventions. 2017;10(9):e005130.
- Dai DF, Hsieh EJ, Chen T, et al. Global proteomics and pathway analysis of pressure-overload-induziu insuficiencia cardiaca e seu(sua) attenuation by mitochondrial-targeted peptides. Circulation: Heart Failure. 2013;6(5):1067-1076.
- Chiao YA, Rabinovitch PS, Bhatt SK, et al. Late-life restoration of funcao mitocondrial reverses cardiac dysfunction in old mice. eLife. 2020;9:e55513.
- Lincoff AM, Bhatt DL, Fischell T, et al. Elamipretide and post–cardiac arrest outcomes (EMBRACE STEMI). American Heart Journal. 2014;168(2):222-228.
- FDA Integrated Review NDA 215244 — Forzinity (elamipretide) Approval Package. 2025.
Perguntas de Pesquisa Relacionadas
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Este conteudo e fornecido apenas para fins educacionais e informativos. Os produtos sao fornecidos apenas para estudos in vitro e nao sao medicamentos, drogas ou suplementos. Nao aprovado pela FDA para prevenir, tratar ou curar qualquer condicao.
