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Vial - lyophilised powderSubcutaneous (SQ)10 mg
A mitochondria-targeting tetrapeptide that concentrates in the inner mitochondrial membrane, developed through multiple Phase II and Phase III clinical trials.
Delivery and return
Delivery and return
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Composition and care
We speak a lot about the importance of gut health—not only for beauty—but also in terms of our overall health, wellbeing and immunity. But before we can fully understand why the gut is so integral to our health, it’s first essential to learn more about the physiology of the gut itself—and how it works.
Research Handling Note
Allow sealed vials to equilibrate to ambient laboratory temperature before opening. This helps minimise the risk of condensation forming within the vial. Keep unopened vials stored at 2-8 C, protected from direct light and moisture. All handling, storage after opening, and laboratory procedures should be carried out according to the receiving laboratory’s established protocols and applicable requirements.
SS-31, known in clinical development as elamipretide, is a cell-permeable tetrapeptide with an unusual property: it concentrates selectively in the inner mitochondrial membrane, reaching local concentrations orders of magnitude above plasma, where it binds the phospholipid cardiolipin. Cardiolipin is essential to the structural organisation of the electron transport chain, and its peroxidation is a central event in mitochondrial dysfunction. Unlike most compounds in this portfolio, elamipretide has been through substantial formal clinical development, with trials in primary mitochondrial myopathy, heart failure with reduced ejection fraction, Barth syndrome and dry age-related macular degeneration. Results have been mixed – several trials did not meet their primary endpoints – and it does not hold marketing authorisation. It nonetheless represents one of the better-characterised molecules here.
Active Compound: SS-31 / Elamipretide (D-Arg-dimethylTyr-Lys-Phe-NH2)
Permitted Claim GuidelinesA mitochondria-targeting peptide evaluated in a clinical trial programme across several conditions. Used under practitioner supervision. Not approved as a medicine.
Mechanism of Action
Concentrates in the inner mitochondrial membrane and binds cardiolipin, stabilising the structural organisation of cristae and the supercomplexes of the electron transport chain. This improves the efficiency of oxidative phosphorylation and reduces electron leak and consequent reactive oxygen species generation. The action is structural and protective rather than antioxidant scavenging in the conventional sense.
Evidence Grade: B - Extensive human clinical trial programme; primary endpoints not consistently met; not approved
Clinical Evidence BaseMultiple Phase I, II and III trials across primary mitochondrial myopathy, heart failure, Barth syndrome and macular degeneration. Some studies reported improvements in functional and biomarker endpoints; several failed to meet their primary endpoint. No marketing authorisation has been granted. Evidence for use in healthy adults for energy, ageing or performance is absent.
Literature & ReferencesSzeto HH. Br J Pharmacol, 2014 - first-in-class cardiolipin-protective compound as a therapeutic agent. | Karaa A et al. Neurology, 2018 - elamipretide in primary mitochondrial myopathy (MMPOWER-2). | Daubert MA et al. Circ Heart Fail, 2017 - elamipretide in heart failure with reduced ejection fraction. | Birk AV et al. J Am Soc Nephrol, 2013 - the mitochondrial-targeted compound SS-31 and cardiolipin.
Safety & Precautions
Tolerability in trials was generally acceptable. Injection-site reactions were the most frequently reported adverse event and were common in some studies. Other reported effects include headache, nausea and dizziness. Long-term safety in healthy adults is not established, as the trial populations were disease-specific. Not for use in pregnancy or breastfeeding. Patients with fatigue or exercise intolerance should be appropriately investigated rather than treated empirically.
ContraindicationsPregnancy and breastfeeding; known hypersensitivity. Undiagnosed fatigue or exercise intolerance requires assessment first.
Storage & HandlingStore lyophilised vial or cartridge at 2-8 C, protected from light.
Regulatory Status
Not authorised as a medicine in the UK, EU or US; investigational status with an active clinical development history. Supplied only through appropriate professional, prescription-led channels.
