Mitochondria-derived peptide
MOTS-c
A mitochondria-derived peptide with active preclinical research but no established human drug-product outcomes or adequate clinical safety record.
Also known as MOTS-c peptide · mitochondrial open reading frame 12S rRNA-c
01 · Evidence profile
One molecule, four evidence questions
FDA's 2026 review found no published studies administering MOTS-c drug products to humans.
Preclinical metabolic and mitochondrial signals are hypothesis-generating.
Human exposure, immunogenicity, long-term effects, and route-specific safety are unresolved.
Substance naming does not establish purity, sterility, or product equivalence.
02 · Identity
What it is
MOTS-c is a 16-amino-acid peptide encoded within mitochondrial 12S rRNA. Its discovery and animal research are scientifically interesting, but discovery is not a clinical outcome.
03 · Product identity
The molecule is not the finished product.
A recognized substance identity and compelling animal biology do not establish the identity, quality, safety, or efficacy of a marketed injectable product.
None identified in the United States.
- No FDA-approved indication
04 · Evidence snapshot
What the evidence can and cannot say
FDA's current review describes metabolic and bone-related preclinical research and found no published study in which a MOTS-c drug product was administered to humans.
There is no established human evidence for weight loss, exercise enhancement, glucose control, osteoporosis treatment, DNA repair, or slower aging from a MOTS-c drug product.
05 · Claim check
Three claims under the lens
“MOTS-c has promising metabolic effects in animal research.”
Preclinical metabolic findings are a real research signal, but they remain preclinical.
- Evidence basis
- Preclinical evidence
- Scope
- Laboratory and animal research, not patient outcomes.
“MOTS-c produces weight loss in people.”
FDA found no published human drug-product administration studies in its 2026 review.
- Evidence basis
- No reliable human outcome evidence
- Scope
- Clinical weight outcomes from administered MOTS-c drug products.
“A UNII number means MOTS-c is FDA-approved.”
FDA's substance registry explicitly states that UNII availability does not imply regulatory review or approval.
- Evidence basis
- Regulatory or product record
- Scope
- Substance identification versus drug-product approval.
06 · Safety boundary
Before this becomes personal
No dosing, injection, sourcing, or performance-use guidance is provided. The absence of human exposure data is a reason for caution, not a blank space to fill with anecdotes.
MOTS-c is prohibited as an AMPK activator under the hormone and metabolic modulators section of the 2026 WADA Prohibited List.
Reviewed 2026-07-23. This status is not personal clearance to compete.Check the governing record ↗07 · Sources
Check the primary record
08 · Provenance
Review history
Initial brief reflects FDA's July 2026 evidence review before final agency action.
Responsible editor: Anthony Treviso. Editorial source review completed. This page has not been independently medically reviewed by a physician or pharmacist.