MOTS-c regulatory status: FDA, compounding and WADA

Regulatory information below was verified on 2026-11-11 and is dated throughout. Positions change; check the primary documents linked in the references before relying on any of it.

United States: approval status

MOTS-c has never been approved as a drug. FDA’s 2026 evaluation records that neither MOTS-c nor MOTS-c acetate is a component of an FDA-approved drug and that neither has an applicable USP or NF drug substance monograph [FDA 2026]. Material sold online is labelled for research use, a category that carries no finding of safety or effectiveness for people.

The July 2026 compounding review

Under section 503A of the Federal Food, Drug, and Cosmetic Act, pharmacies may compound using bulk drug substances only if the substance appears on an approved list. Someone nominated MOTS-c for that list. FDA has noted the nomination was later withdrawn, but evaluated the substance anyway and brought it to its Pharmacy Compounding Advisory Committee on 23–24 July 2026 [FDA 2026] [FDA 2026].

The committee was asked two separate voting questions, one for the free base and one for the acetate [FDA 2026]. FDA’s own briefing document, dated 11 May 2026, set out its position plainly: a balancing of the criteria weighed against either form being placed on the list, and the agency proposed not adding them [FDA 2026]. Its reasoning rested on four findings.

• Neither form is well characterised from a physical and chemical standpoint.
• There is no record of MOTS-c being used in compounded products in humans; outsourcing facilities have not reported preparing them.
• There is a lack of evidence to evaluate effectiveness, with the pharmacology limited to cell and rodent studies and the molecular target unknown.
• There is a lack of clinical and nonclinical safety information, leaving potential human risks unknown.

Two things follow. First, an advisory committee recommendation is non-binding: FDA decides, and it does so through notice-and-comment rulemaking. Second, nothing about the legal status of MOTS-c changed on the day of the vote. Until a final rule issues, it is not a substance pharmacies may lawfully compound with.

Anti-doping status

MOTS-c appears on the WADA Prohibited List within class S4, hormone and metabolic modulators, named as an example of an activator of AMP-activated protein kinase alongside AICAR and BAM15 [WADA 2026]. Substances in this class are prohibited at all times, meaning both in and out of competition, and are non-specified substances.

It was added with the 2025 edition of the list [USADA 2024]. USADA’s athlete guidance also points out that MOTS-c is not approved by FDA for human use or in compounded medications [USADA]. Athletes subject to anti-doping rules should check the list edition currently in force, since class numbering shifts between years.

FDA’s briefing document also notes MOTS-c as prohibited in the Global DRO database, citing the WADA list[FDA 2026].

Clinical development

An investigational path is open: a Phase 2a randomised, placebo-controlled trial of administered MOTS-c in adults with prediabetes was recruiting at the time of writing, with estimated completion in 2028 [NCT07505745]. Running a registered trial under an investigational framework is a different thing from approval, and does not change the status described above. See human studies.

Other jurisdictions

This page covers the United States and the global anti-doping position, which are the two frameworks this site has verified against primary documents. Status elsewhere, including the European Union, United Kingdom, Canada and Australia, has not been verified here and is deliberately not summarised rather than guessed at.