MOTS-c

What is MOTS-c and what is it studied for?

FDA's July 2026 briefing describes MOTS-c as a 16-amino-acid peptide encoded by a short open reading frame within the mitochondrial 12S rRNA gene [1]. Its nominations proposed products of 5 mg and 10 mg for subcutaneous injection, for uses including insulin resistance, obesity, osteoporosis, vascular calcification, and muscle and fat metabolism [1]. A 2023 review reports that MOTS-c plasma levels decrease with age and that the peptide improves glucose metabolism in skeletal muscle in animal and lab studies, adding that no method for using it in the clinic has been developed [4].

Is MOTS-c FDA-approved or eligible for compounding?

No. FDA reports it found no nonclinical data to inform safety considerations and no clinical studies assessing MOTS-c's safety or effectiveness in humans, and it has no USP monograph [1]. Its 503A nomination was placed in Category 2 and then withdrawn; FDA's Category 2 page says it lacks human exposure data and cannot rule out harm from any route of administration [2]. On July 23, 2026, the Pharmacy Compounding Advisory Committee reviewed MOTS-c for obesity and osteoporosis and voted 7 to 5, with two abstentions, to recommend it, but placement on the list still requires formal rulemaking, which has not happened [3].