PP / MONOGRAPH 061 Peptide or related research compound

MOTS-c

Discovery history, preclinical evidence, human studies, current FDA context, and the questions that still need to be answered.

Evidence is not equivalence.

Research on a named molecule does not establish that a catalog material is the studied drug product. Identity, sequence, salt, formulation, purity, sterility, route, labeling, and indication can change the scientific and regulatory conclusion.

ORIGIN / HISTORY

When was MOTS-c first described?

MOTS-c was identified by Lee and colleagues in 2015 as a mitochondrial-DNA-encoded peptide with metabolic effects in cell and mouse models. [1]

PRECLINICAL EVIDENCE

What do animal and laboratory studies show?

Rodent metabolic data; early human interest; no approved use. [2]

Translation limitCell and animal findings can generate mechanisms and safety signals, but they do not predict clinical benefit on their own.

CLINICAL EVIDENCE

Are there human studies?

No qualifying human efficacy evidence was identified in the reviewed summary for the exact named material. A registry search is linked below so readers can check current recruiting, completed, terminated, or unpublished studies. [2][3]

Check the live study registry ↗

U.S. REGULATORY STATUS

Is MOTS-c FDA cleared or approved?

Drug terminology: FDA generally approves drug products; “clearance” is typically a medical-device pathway.

MOTS-c was among substances discussed at FDA’s July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting. Advisory-committee recommendations are non-binding and the meeting is not FDA drug approval or, by itself, final inclusion on the 503A bulks list. This page does not identify an FDA-approved product corresponding to this catalog name. [4][5][6][7]

RESEARCH OUTLOOK

Where is the scientific promise?

The scientific promise of MOTS-c is a hypothesis for further testing, not a demonstrated product benefit. Useful next steps would include independent replication, validated identity and purity, dose–response and toxicology work, pharmacokinetics, prespecified endpoints, and properly registered human trials before clinical conclusions are drawn. [2][3]

LIMITATIONS / PRECAUTIONS

What should professionals keep in view?

Unproven in humans; unapproved. [2]

Professional-use boundary

This page does not provide a diagnosis, treatment recommendation, protocol, dose, reconstitution instruction, route, or administration schedule. Any lawful program requires independent regulatory, quality, toxicology, and clinical review.

SOURCE REGISTER

References and live evidence maps

Primary papers support specific historical claims where available. PubMed and ClinicalTrials.gov links are live evidence maps, not proof that every result applies to the exact catalog material. FDA links should be rechecked because regulatory pages and product labels can change.