SS-31 (Elamipretid)

A mitochondria-targeted tetrapeptide studied in several clinical trials for heart failure and mitochondrial disease, not yet approved.

SS-31, also known under the generic name elamipretide as MTP-131 or Bendavia, is a synthetic tetrapeptide that binds specifically to cardiolipin, a lipid in the mitochondrial membrane. It has been studied in several phase 1 to phase 3 clinical trials for heart failure, primary mitochondrial myopathy, and Barth syndrome. Despite a comparatively broad clinical data base, none of these studies has yet led to approval as a medication.

Facts

• CAS number: 736992-21-5
• Molecular weight: 639.8 g/mol
• Amino acids: 4
• Purity specification: ≥ 98 % (HPLC, commercial standard)

Evidence

• A randomized, placebo-controlled phase 3 trial in people with primary mitochondrial myopathy did not meet its predefined primary endpoints on either the 6-minute walk test or the fatigue score, though the study drug was described as well tolerated. Karaa et al. 2023, Neurology, PMID 37268435
• A placebo-controlled phase 1 trial with stepwise increasing infusion amounts in people with heart failure and reduced ejection fraction described a single infusion of elamipretide as safe and well tolerated. Daubert et al. 2017, Circulation: Heart Failure, PMID 29217757
• A study in rats with cardiac ischemia-reperfusion injury described a significantly smaller infarct area when SS-31 was given beforehand compared with control animals. Cho et al. 2007, Coronary Artery Disease, PMID 17429296

Frequently asked questions

Is elamipretide an approved medication?
No. Despite several clinical trials in heart failure, mitochondrial myopathy, and Barth syndrome, no approval has been granted, a US approval submission was not accepted for review in 2021.

What does SS-31 target in the body?
It binds to cardiolipin in the inner mitochondrial membrane and is associated with reduced reactive oxygen species and stabilization of membrane structure.

Did the clinical trials meet their goals?
Several trials did not meet their predefined primary efficacy endpoints, for example in mitochondrial myopathy and Barth syndrome, while tolerability was consistently described as good.

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