As a mitochondrial-derived peptide, MOTS-c sits at the intersection of metabolism, exercise, aging, and body-composition interest.
FDA reported no identified human exposure data for the drug products it reviewed for obesity and osteoporosis.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
3 names in this peptide family.
MOTS-c spelling variants and acetate/free-base forms resolve to one family without erasing the reviewed form.
4 evidence questions.
Human benefitNo identified human exposureDoes MOTS-c have established human clinical benefit for obesity and osteoporosis?
FDA approvalNo FDA approval identifiedIs MOTS-c FDA approved?
503A statusRegulatory recordIs MOTS-c on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled MOTS-c automatically interchangeable?
See every MOTS-c evidence question →Open the machine-readable record ↗PCAC gave a favorable advisory recommendation
The committee recommended MOTS-c-related bulk drug substances for possible inclusion on the 503A Bulks List.
FDA received advice from its expert compounding committee.
The compound was not FDA-approved, and the vote alone did not add it to the final 503A Bulks List.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
PCAC gave a favorable advisory recommendation
The committee recommended MOTS-c-related bulk drug substances for possible inclusion on the 503A Bulks List.
Read the source ↗FDA published its scientific briefing
FDA released its evaluation of MOTS-c-related bulk drug substances for the committee meeting.
Read the source ↗MOTS-c entered FDA's 503A nomination record
MOTS-c was nominated for several metabolic, musculoskeletal, and longevity-related uses. The nomination was later withdrawn, and FDA continued the evaluation on its own initiative.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
FDA reported no identified human exposure data for drug products containing MOTS-c.
Read the FDA review ↗Researchers measured the body's own MOTS-c before and after exercise. Participants were not treated with MOTS-c, so the study does not establish the effects or safety of taking it as a drug.
Read the study on PubMed ↗Preclinical findings were reviewed separately and do not establish clinical benefit in people.
Read the FDA review ↗Important unknowns.
- FDA reported no identified human exposure data for the drug products it reviewed.
- FDA identified uncertainty around active-ingredient characterization, peptide-related impurities, or aggregation.
- Limited evidence of harm should not be interpreted as evidence of safety.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
3 dated changes. 3 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.