SS-31: Safety Profile & Research Summary
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Buy SS-31 Peptide 50mg (Elamipretide)Preclinical & Clinical Research Summary
Key Preclinical Studies
| Study | Model | Key Findings | Ref |
|---|---|---|---|
| Sabbah et al. (2016) | Dogs, microembolization HF β 0.5 mg/kg Γ 3 mo | LVEF 30%β36% (p<0.05); NT-proBNP β774 pg/mL (p<0.001); ATP/ADP 1.16 vs 0.38 control | [6] |
| Dai et al. (2013) | C57BL/6 mice TAC β osmotic minipump Γ 4 wk | Fibrosis reduced ~5% vs ~15% control (p=0.005); protected 84% of mitochondrial proteins | [14] |
| Campbell et al. (2019) | Aged-mouse model (26-mo female C57BL/6) | Exercise-tolerance endpoint reported; ATPmax and mitochondrial-content endpoints reported | [4] |
| Chiao et al. (2020) | Aged C57BL/6 mice β cardiac dysfunction model | Late-life SS-31 administration reversed age-related cardiac dysfunction; restored diastolic function | [15] |
| Zhao et al. (2019) | LPS cognitive impairment mice β 5 mg/kg | Escape latency β (p<0.01); hippocampal TNF-Ξ±/IL-6 β (p<0.05); BDNF signaling enhanced | [8] |
| Birk et al. (2013) | Ischemic renal tubules β 1 nMβ1 Β΅M in vitro; rodent ARAS model | Re-energized ischemic mitochondria; restored tubular ATP; protected brush border membranes | [2] |
| 26-wk Rat Tox (FDA NDA) | Sprague Dawley rats β 5β15 mg/kg/day Γ 26 wk | Systemic NOAEL 40/15 mg/kg/day (~6.2-fold human AUC); no systemic toxicity | [17] |
| 39-wk Dog Tox (FDA NDA) | Beagles β 2.5β20 mg/kg/day Γ 39 wk | Systemic NOAEL 20/10 mg/kg/day (~5.7-fold human AUC); no ECG/BP/HR effects up to 100 mg/kg | [17] |
Safety Summary
| Parameter | Finding |
|---|---|
| Genotoxicity | Negative in Ames, chromosomal aberration, and in vivo micronucleus assays |
| Reproductive toxicity | No teratogenicity in rats or rabbits (published nonclinical data) |
| Concentrations used | In vitro: 1 nMβ1 Β΅M (published range) |
| Handling | Handle with standard laboratory PPE. Consult the SDS. |
The products offered on this website are furnished for in-vitro studies only. In-vitro studies (Latin: in glass) are performed outside of the body. These products are not medicines or drugs and have not been approved by the FDA to prevent, treat or cure any medical condition, ailment or disease. Bodily introduction of any kind into humans or animals is strictly forbidden by law.
For Laboratory Research Only. Not for human use, medical use, diagnostic use, or veterinary use.
ALL ARTICLES AND PRODUCT INFORMATION PROVIDED ON THIS WEBSITE ARE FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY.
βPreclinical & Clinical Research Summary Key Preclinical Studies StudyModelKey FindingsRef Sabbah et al.β
References
- Szeto HH. 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. September 19, 2025.
- Campbell MD, Duan J, Samuelson AT, et al. Free Radical Biology and Medicine. 2019;134:268-281.
- Sabbah HN. Expert Opinion on Investigational Drugs. 2021;30(12):1227-1244.
- Sabbah HN, Gupta RC, Kohli S, et al. Circulation: Heart Failure. 2016;9(2):e002206.
- Sabbah HN, Alder NN, Sparagna GC, Bruce JE, et al. Biomedicine & Pharmacotherapy. 2025;187:118056.
- Zhao W, Xu Z, Cao J, Fu Q, et al. Journal of Neuroinflammation. 2019;16(1):230.
- Thompson WR, Hornby B, Manuel R, et al. Genetics in Medicine. 2024;101138.
- Karaa A, Haas R, Goldstein A, et al. 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. Ophthalmology Science. 2025;5(1):100628.
- Saad A, Herrmann SMS, Eirin A, et al. Circulation: Cardiovascular Interventions. 2017;10(9):e005487.
- Dai DF, Hsieh EJ, Chen T, et al. Circulation: Heart Failure. 2013;6(5):1067-1076.
- Chiao YA, Zhang H, Sweetwyne M, et al. eLife. 2020;9:e55513.
- Gibson CM, Giugliano RP, Kloner RA, et al. Eur Heart J. 2016;37(16):1296-1303.
- Cited source. 2025.
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This content is provided for educational and informational purposes only. Products are furnished for in-vitro studies only and are not medicines, drugs, or supplements. Not approved by the FDA to prevent, treat, or cure any condition.
