What it is claimed to help
These are the uses attached to Elamipretide (SS-31) in research, clinical practice, or marketing. Listing a claim is not endorsing it — tap any of them to see every other compound carrying the same claim.
What the human evidence actually is
Approved by the FDA with randomised human trial data behind the label.
Real, and mixed, which makes it worth reading carefully. FDA approved elamipretide in 2025 for Barth syndrome, a rare genetic cardiomyopathy, on trial and extension data. Where it did not succeed: the MMPOWER-3 trial in primary mitochondrial myopathy missed its primary endpoints, and earlier cardiac reperfusion work did not deliver. The ReCLAIM-2 trial in dry AMD produced signals on some endpoints but not the primary. So: approved for one thing, not a general mitochondrial or heart-failure treatment.
How it is supposed to work
Concentrates in the inner mitochondrial membrane and binds cardiolipin, stabilising cristae structure and improving electron transport efficiency.
Safety
Injection site reactions are common. The approved population is small and closely monitored.
Storage and handling
Lyophilised peptide is generally stored at 2–8 °C, or below −20 °C for long-term storage. Reconstituted in bacteriostatic water (0.9% benzyl alcohol) a solution is typically treated as usable for about 28 days refrigerated, versus roughly 24 hours for plain sterile water, which has no preservative. Add the water slowly down the vial wall and swirl — never shake, which shears peptide chains and foams the solution.
Whatever number a protocol or a prescriber gave you, converting it into syringe units is where a misplaced decimal becomes a tenfold error. Our calculators do that conversion and nothing else — they never invent a dose.
Open the calculatorsSources
- FDA approval, elamipretide for Barth syndrome, 2025
- MMPOWER-3 trial results, Neurology
- ReCLAIM-2 dry AMD trial results
- Szeto HH. Cardiolipin-targeted peptides
Verified against primary sources on 27 August 2026. Regulatory status in this field changes several times a year. See How We Rate Evidence.