Home | Regulatory Tracker | MOTS-c
MOTS-c
PCAC recommended
as of October 2026
By Stephen Kimball, 26+ years researching the health, wellness, supplement, and peptide industries
As of October 2026, MOTS-c isn’t approved for any use and isn’t on the compounding list. It left FDA’s safety-risk list in April 2026 because its nominators withdrew; FDA’s page still says it hasn’t identified any human exposure data. In July 2026, an advisory panel voted 7–5, with two abstentions, to recommend adding it for obesity and osteoporosis, the narrowest margin of the day. That vote is advice only. Today it’s sold mainly by “research use only” sites, with no check on purity or dose.
Sources
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (withdrawn table)
U.S. Food & Drug Administration
dated Apr 2026
FDA Briefing Document — MOTS-c-Related Bulk Drug Substances
U.S. Food & Drug Administration
dated Jul 2026
Change log
September 2023
FDA places MOTS-c in Category 2.
April 2026
Moves to the “nominated but withdrawn” table; FDA’s safety note stays listed.
May 2026
FDA staff briefing recommends against adding MOTS-c.
July 2026
Advisory panel votes 7–5 (2 abstentions) to recommend adding MOTS-c, for obesity and osteoporosis.
