● TIER 3 — Information onlyGRADE CLongevity / mitochondrial
MOTS-c
Mitochondrial-derived peptide. Research verification: Yes (TGA pending). 0 human study record(s) in the FitClinicMD studies database (plus 1 preclinical animal/lab record(s), shown for context only).
GOALS · Longevity · Weight loss
FDA status
Not approved.
Compounding (503A/503B)
Removed from 503A Category 2 on ~Apr 22 2026 after nominations were withdrawn; PCAC voted Jul 23-24 2026 to recommend 503A bulks-list inclusion, but no rulemaking yet, so not lawfully compoundable and not in Category 1. FDA list:
DEA
Not controlled.
WADA (sport)
S4.4 Metabolic modulators (incl. insulins & mimetics, AMPK activators) — Listed by WADA as an AMPK activator under S4.4 (verify wording in PDF section S4.4); also captured by S0 as non-approved.
Mechanism
AMPK activation.
Human evidence · 1
Discovery paper (mouse). The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance.
Reference only. This page summarizes publicly available regulatory and research information about MOTS-c. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.