SS-31 (elamipretide): a narrow approval, not a general energy peptide

How does it work?

SS-31 is also known as elamipretide. It associates with cardiolipin in mitochondrial membranes. The rationale is that it may improve aspects of mitochondrial function in a rare disease, but a mechanistic theory does not prove improved energy or athletic performance in healthy people. [1]

What do trials show?

The FDA granted accelerated approval to prescription Forzinity to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg. The key study enrolled only 12 people; the initial randomized portion did not beat placebo on its primary walking and fatigue outcomes. Improvement in knee extensor strength during the open-label extension supported accelerated approval, with confirmatory work required. These data cannot be generalized to healthy adults or unverified research vials. [1,2]

Safety

The prescription label reports injection-site reactions and possible serious allergic reactions. Dose adjustment and monitoring depend on kidney function and medical context. The approved sterile formulation is not equivalent to the catalog powder sold under an SS-31 name. [1,2]