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 addition, nominations to add MOTS-c to the 503B bulks list - the list for outsourcing facilities, not the 503A list the committee reviewed - were posted to the FDA’s docket on August 25, 2026; a nomination starts a review and changes nothing on its own.

In limbo: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.

Verified Sep 22, 2026 (ET) · status held since Jul 23, 2026

Primary source: Federal Register All 15 sources

The committee vote

July 23, 2026

The 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 minutes, so treat the counts as reported, not 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 committee - not yet legal. Next step: FDA rulemaking.

What changed last

Aug 25, 2026
BPI Labs’ nominations to add MOTS-c (free base and acetate) to the 503B bulks list - the list for outsourcing facilities, not the 503A list the July panel reviewed - were posted to the FDA docket. A nomination starts a review and changes nothing on its own.
Review scheduledView on regulations.gov
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.
United Kingdom (MHRA)	Restricted	No UK marketing authorisation; supply for human use treated as an unlicensed medicine.
European Union (EMA)	Restricted	No EU marketing authorisation in the Union Register; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level.
Canada (Health Canada)	Restricted	Named in Health Canada’s April 2026 advisory on unauthorized injectable peptides; unauthorized drug products are illegal to sell in Canada.
Sport / anti-doping (WADA)	Restricted	Explicitly named on the 2026 Prohibited List under S4.4.1 (metabolic modulators / AMPK activators); prohibited at all times. Still listed on the 2027 List (published Sep 21, 2026; in force Jan 1, 2027).

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

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.
Regulations.gov - 503B bulks nomination, MOTS-c (free base), BPI Labs (posted Aug 25, 2026) Regulations.gov · primaryA nomination to the 503B bulks list; it does not change any status.
Regulations.gov - 503B bulks nomination, MOTS-c (acetate), BPI Labs (posted Aug 25, 2026) Regulations.gov · primaryA nomination to the 503B bulks list; it does not change any status.
WADA - 2026 Prohibited List WADA · primaryMOTS-c is named under S4.4.1 (metabolic modulators); prohibited at all times in sport.
MHRA Products database (no entry) UK gov · primaryBasis for the United Kingdom (MHRA) status row.
Health Canada public advisory (Apr 9, 2026) Health Canada · primaryBasis for the Canada (Health Canada) status row.
Union Register of medicinal products (EC) EU · primaryBasis for the European Union (EMA) status row.
WADA - 2027 Prohibited List published (Sep 21, 2026) WADA · primaryThe 2027 List takes effect Jan 1, 2027.
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: Sep 22, 2026 (ET) · how we verify
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