U.S. regulatory status

MOTS-c

Also known as MOTs-C · Mitochondrial-derived peptide · MOTS-c acetate

In limboPCAC recommended listing (7-5, Jul 23, 2026) - advisory only; still not on the 503A list

Is MOTS-c legal right now?

MOTS-c is a mitochondrial-derived peptide studied in metabolic research, largely in animal and observational work rather than controlled human trials. It is not FDA-approved and is not on the FDA's Section 503A Bulk Drug Substances List, so it is not eligible for pharmacy compounding. On July 23, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 7-5, with 2 abstentions, to recommend adding it, against the FDA review staff's own recommendation. The vote is advisory and does not bind the FDA. Nothing about MOTS-c's legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months. Separately, MOTS-c is named on the 2026 WADA Prohibited List as a metabolic modulator, which the FDA process does not affect.

In limbo: Nominated or removed from a restricted list but NOT approved - the headline implies a change, but the legal reality did not move.

Verified Aug 11, 2026 (ET) · status held since Jul 23, 2026

Primary source: Federal Register All 9 sources

The committee vote

July 23, 2026 ET

Question put to the FDA Pharmacy Compounding Advisory Committee (PCAC)“Should MOTS-c (free base) be placed on the list? - and, as a separate vote, MOTS-c acetate?”

Recommended by the committee

7 in favour
5 against
2 abstained

14 votes recorded. Tally reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes - the FDA has not yet published the meeting minutes, so treat the counts as reported rather than official.

What this does not do: an advisory committee recommendation is not an FDA decision and does not bind the agency. MOTS-c is not on the 503A Bulk Drug Substances List, and a pharmacy compounding it today has no more federal authorisation than it did the day before the vote. Only a completed FDA rulemaking can change that.

Where it sits in the process

Nominated (completed)
Under review (advisory committee recommended it - not yet legal)
Rulemaking (upcoming)
Compounding-legal (upcoming)

Recommended by the advisory committee - and still not legal to compound. The vote is advisory and does not bind the FDA. Nothing changes until the FDA accepts the recommendation and completes notice-and-comment rulemaking. This is real forward motion, not a green light.

What changed last

Jul 23, 2026
FDA advisory committee (PCAC) voted 7-5, with 2 abstentions, to recommend adding MOTS-c to the 503A list, against the FDA review staff's own recommendation. Advisory only - MOTS-c is still not on the list and still not legal to compound.
Not legalizedView on healio.com

Status elsewhere

MOTS-c: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	In limbo	Not on the 503A Bulks List. PCAC recommended adding it on Jul 23, 2026 (7-5, 2 abstentions); the recommendation is advisory and the FDA has not acted.
Australia (TGA)	Unscheduled	Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides.
Sport / anti-doping (WADA)	Restricted	Explicitly named on the 2026 Prohibited List under S4.4.1 (metabolic modulators / AMPK activators); prohibited at all times.

Sources & transparency

Sources for this entry

Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) Federal Register · primaryMOTS-c (free base and acetate) on the July 23, 2026 agenda.
FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryMOTS-c is not on the 503A (Category 1) list; the FDA 503A categories govern compounding eligibility.
FDA - PCAC meeting page, July 23-24, 2026 FDA · primaryOfficial meeting record. FDA has not yet published the minutes or vote tallies.
FDA - PCAC July 23-24, 2026: questions put to the committee FDA · primaryFDA's own vote questions. Confirms each substance was voted on twice - free base and acetate separately - and gives the session order.
FDA - PCAC July 23-24, 2026: meeting roster FDA · primaryVoting members plus temporary voting members seated for single topics, which is why the vote totals differ between substances.
WADA - 2026 Prohibited List analysisMOTS-c is named under S4.4.1 (metabolic modulators); prohibited at all times in sport.
FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisConfirms MOTS-c on the July 2026 PCAC agenda; the vote is advisory and any listing requires rulemaking.
Healio - FDA committee recommends looser restrictions for several peptides analysisReported per-substance vote tallies; also records that FDA review staff recommended against all seven.
Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do analysisLegal analysis: the vote is not an agency action and nothing has legally changed.

Last verified by a human: Aug 11, 2026 (ET) · how we verify
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