MOTS-c: FDA, Compounding & WADA Status

No drug approval

MOTS-c is not an FDA-approved drug. The substance record that lists the sixteen-residue sequence is an identity record. FDA itself warns that UNII availability does not imply regulatory review or approval.³

This page covers compounding in the United States and anti-doping status. It is not Mexican law and it does not speculate about COFEPRIS. The scientific context is in the MOTS-c hub.

Three sentences get mixed up online: “FDA reviewed it,” “a committee voted,” and “it can now be compounded as an approved drug.” The first can be true in a narrow sense. The second, if cited, is advisory. The third is not supported by a final rule identified in this review.

July 2026 PCAC

On 23 July 2026, the Pharmacy Compounding Advisory Committee discussed MOTS-c-related bulk drug substances: MOTS-c free base and MOTS-c acetate. The meeting is part of consideration for the 503A bulks list.¹

That is an advisory compounding proceeding. It is not a new-drug approval. It does not “legalize” MOTS-c. It does not place MOTS-c on the final 503A list merely because the committee met.^1,2

Uses evaluated

The meeting chart identifies the uses FDA evaluated for MOTS-c free base and MOTS-c acetate: obesity and osteoporosis. Evaluating a nominated use does not mean the use is demonstrated or authorized as an indication.¹

What FDA’s briefing noted

FDA staff’s briefing document for MOTS-c-related substances noted a lack of sufficient clinical safety information, a lack of human data from drug products containing those bulk substances, and a lack of information needed to assess immunogenic safety risk.²

That language is quoted here without expansion. It is not turned into a finding of “demonstrated danger,” and it is not softened out of existence. It describes gaps.

The briefing also notes that FDA-approved therapies already exist for some of the nominated uses. That observation situates the compounding nomination. It is not a judgment about a catalog research material.

NCT07505745 can be recruiting and, at the same time, FDA can accurately state that completed human product data are not available. A trial record is not trial results.^7,2

Advisory recommendation versus final action

A published tally from a law firm describes a vote of 7 yes, 5 no, and 2 abstentions for MOTS-c. It is cited only as a report of an advisory committee recommendation. It is not official FDA minutes.⁴

A PCAC recommendation is non-binding. It is not a final rule. This page does not write that “FDA approved MOTS-c,” that “FDA legalized MOTS-c,” or that “MOTS-c is on the final 503A list.” Those sentences would require a final Agency action that this review does not identify.^4,1

WADA 2026

The 2026 WADA Prohibited List includes MOTS-c under S4.4 metabolic modulators, specifically among AMPK activators. Under that framework it is prohibited at all times.^5,6

This page reports status. It does not provide detection windows, washout periods, ways to avoid detection, or athlete protocols. Anti-doping status is not a medical approval and is not a compounding determination.

An athlete subject to that framework should consult the current official list. This page does not replace that consultation and does not interpret an individual case.

United States versus Mexico

• The text above is United States law and policy, plus the WADA framework.^1,5
• No COFEPRIS status is asserted.
• A research material with a certificate of analysis does not inherit a clinical authorization from any country.
• Human administration evidence remains a recruiting trial, not a result.⁷

The definition is in What Is MOTS-c. The human inventory is in what evidence exists in humans.