MOTS-c

FDA says compounded drugs containing MOTs-C may pose significant immunogenicity risks for certain routes. It also identifies complexities involving peptide-related impurities and active-ingredient characterization.

The agency says it has not identified human exposure data for MOTs-C drug products through any route. That statement concerns the drug products in this compounding review, not a claim that the naturally occurring molecule has never been studied.

FDA lacks important information about possible harm when administered to humans. This does not establish an exercise, metabolic or longevity benefit. No dose or treatment recommendation is given.