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What is MOTS-c?

MOTS-c is a mitochondrial-derived peptide studied for its role in metabolism and the body’s response to exercise. It has drawn interest for weight- and bone-related effects. It is not an FDA-approved drug.

What the evidence shows

EVIDENCE GRADE · EARLY · LIMITED HUMAN DATA

MOTS-c research is at an early stage and mostly preclinical. Human trial evidence for obesity or osteoporosis is limited, and its safety and effectiveness in people are not established.

Is it legal?

MOTS-c is not FDA-approved. In April 2026 it was removed from FDA Category 2 but not moved to the approved Category 1 list, so legal compounding is not authorized; the PCAC reviews it on July 23, 2026.

FDA approvalNot approved
Compounding statusRemoved from Category 2 (Apr 2026, nominations withdrawn) · not on Category 1 — compounding not authorized
Under FDA reviewPCAC · July 23, 2026
Use under reviewObesity
Earliest pharmacy accessLate 2026–Q1 2027 (if cleared)
Will MOTS-c become legal in 2026?+
Not automatically. The committee meets July 23, 2026; a favorable vote is a recommendation only — the FDA must then issue a final rule, which typically takes months. Realistic legal compounded access is late 2026 to Q1 2027, and only if both steps go through.
Is “research-grade” MOTS-c the same as a medicine?+
No. Material sold “for research use only” is not made or tested to pharmaceutical standards, is not authorized for human use, and carries no guarantee of identity, purity or sterility. This site does not link to or evaluate these sellers.

Primary sources: FDA 503A interim list · FDA Advisory Committee Calendar; Federal Register docket FDA-2025-N-6895.

Medical & editorial disclaimer. This article is independent reference information, not medical advice and not a recommendation to use any substance. MOTS-c is not FDA-approved. Nothing here should be used to obtain, prepare, or self-administer any drug. Talk to a licensed clinician about your health. Peptide Docket is not affiliated with the FDA and does not sell peptides.