SS-31: Side Effects & Safety
Part of the SS-31 Complete Guide
Research Peptides
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Overall Safety Profile
SS-31 (elamipretide) has the most clinical safety data among mitochondria-targeted peptides, thanks to its clinical trial program for Barth syndrome and other conditions. The safety profile has been generally favorable in clinical settings, with most adverse events being mild to moderate.
Reported Side Effects
- Injection site reactions: The most commonly reported adverse event in clinical trials — redness, swelling, or induration at the injection site
- Headache: Reported at rates modestly above placebo in clinical trials
- Fatigue: Mild fatigue reported in some participants
- Nausea: Occasional, typically mild
Clinical Trial Safety Data
In the TAZPOWER and TAZPOWER2 clinical trials for Barth syndrome, elamipretide was generally well-tolerated with daily subcutaneous dosing of 40 mg. No dose-limiting toxicities were observed at therapeutic doses. The most common reason for discontinuation was injection site reactions rather than systemic effects.
Preclinical toxicology studies in multiple species showed no significant organ toxicity at doses well above therapeutic levels.
Potential Contraindications
- Renal impairment — dose adjustment may be needed as elamipretide is renally cleared
- Pregnancy and breastfeeding (insufficient data)
- Known hypersensitivity to the peptide components
Return to the SS-31 overview for general information.