MOTS-c

Investigated uses

• Obesity, metabolism, exercise and bone outcomes in preclinical research.

Mechanism and hypotheses

• MOTS-c is a mitochondrial-derived peptide with metabolic effects in preclinical models; FDA found no human administration studies for the reviewed uses.
• Hypothesized: Exercise, obesity, glucose and bone effects remain animal or laboratory hypotheses.

Human evidence

• FDA found no human administration studies supporting the reviewed MOTS-c uses. Limitations: Animal and laboratory findings cannot establish human benefit or safety.

Safety highlights

• No controlled human adverse-event incidence exists.
• Immunogenicity, off-target metabolic effects, impurities and injection-related risks are unresolved.

Regulatory context

No FDA-approved MOTS-c drug was identified. In July 2026, PCAC recommended MOTS-c-related bulk drug substances for possible inclusion on the 503A Bulks List for obesity and osteoporosis. The recommendation is nonbinding and was not a final FDA listing as of August 9, 2026.