Protocol Reference
Elamipretide
Elamipretide (SS-31) — clinical trial protocols as registered
Summarise the administration structure used in registered trials in primary mitochondrial myopathy and related conditions.
Clinical TrialsReviewed September 1, 2026
Research Context
- Source of this information
- Elamipretide has been studied under registered protocols, which makes its administration structure a matter of public record rather than inference.
- Evidence level
- Grade C — randomised trials with mixed primary endpoint results
- Population studied
- Adults with primary mitochondrial myopathy; separate trials in Barth syndrome and retinal disease.
- Duration studied
- Typically 12 to 48 weeks depending on the trial, with open-label extensions.
- Route reported
- Daily subcutaneous injection in the mitochondrial myopathy programme
Protocol as Reported
- 01Registered trials used a fixed daily subcutaneous dose, with functional testing including six-minute walk distance and patient-reported outcome instruments.
- 02Earlier cardiac research used intravenous infusion in acute settings.
- 03Ophthalmic research used topical formulations in separate protocols.
Adverse Events Reported
- Injection-site reactions were the most common trial finding.
- Gastrointestinal effects and headache were reported.
Limitations
- Primary endpoints have not been met consistently across trials.
- Rare-disease populations are small, limiting power and generalisability.
- No approval existed at last review, so no clinical label defines the protocol.
Sources
- Randomised controlled trial
Elamipretide in primary mitochondrial myopathy: randomised trial
- Regulatory document
Registered elamipretide trials
Educational reference only. Peptide Atlas does not provide medical advice or individualised dosing guidance, and nothing on this page should be used to guide personal use.