SS-31 / Elamipretide

Elamipretide (SS-31) is a tetrapeptide that selectively targets mitochondria and binds to cardiolipin, a key mitochondrial membrane phospholipid. By stabilizing cardiolipin, it improves mitochondrial bioenergetics and reduces oxidative stress. Clinical trials have been conducted for heart failure, mitochondrial diseases, and age-related conditions.

PubMed results: 3 · Human studies: 3 · Animal studies: 3

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

• Subcutaneous Injection — standard range 0.25-0.5 mg/kg, Daily. Based on clinical trials for heart failure

3-4 hours (moderate confidence)

• Mitochondrial bioenergetics support (Moderate clinical): Elamipretide (SS-31) selectively targets mitochondria and binds cardiolipin; clinical and preclinical research has studied improvements in mitochondrial bioenergetics and reduced oxidative stress markers in models of mitochondrial dysfunction
• Cardiolipin membrane stabilization research (Strong preclinical): Studies indicate that stabilizing cardiolipin at the inner mitochondrial membrane can preserve electron transport chain organization and reduce reactive oxygen species generation under stress conditions
• Investigational research in mitochondrial and cardiac conditions (Moderate clinical): Clinical development programs have examined elamipretide in heart failure, primary mitochondrial disease contexts, and age-related functional endpoints; Friedreich ataxia has been among researched indications

• Injection site reactions — Mild, Common. Clinical trial reports for subcutaneous elamipretide commonly note local injection-site reactions including erythema, pruritus, or mild pain
• Headache or mild systemic symptoms — Mild, Uncommon. Research protocols have reported occasional headache, fatigue, or nonspecific systemic symptoms; overall tolerability profiles in published trials have generally been favorable

• Known hypersensitivity to elamipretide or formulation components (Clinical): As with investigational peptides, documented or suspected hypersensitivity is a standard exclusion in clinical research protocols
• Unstable advanced cardiac disease outside controlled research settings (Clinical): Given clinical study of elamipretide in heart-failure and mitochondrial-myopathy populations, research programs typically restrict enrollment to carefully selected cardiac status criteria

Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months. Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), 4-6 weeks. Solvent: Bacteriostatic water

• NCT05168774 — FRDA Investigator Initiated Study (IIS) With Elamipretide (PHASE1 / PHASE2), status: COMPLETED. Indications: Friedreich Ataxia