U.S. regulatory status

MOTS-c

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

Under reviewRemoved from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 23, 2026

Is MOTS-c legal right now?

MOTS-c is a mitochondrial-derived peptide studied in metabolic research and examined in connection with obesity, osteoporosis, and related metabolic outcomes, largely in animal and observational work rather than controlled human trials. In the United States it is not FDA-approved, there is no approved MOTS-c product, and it is not on the FDA's Section 503A list of bulk substances eligible for compounding. It was removed from the interim Category 2 list in April 2026, but that step reflects a withdrawn nomination rather than any authorization to compound, and MOTS-c was never on the permitted Category 1 list. It is scheduled for FDA advisory committee (PCAC) evaluation on July 23, 2026 (Docket FDA-2025-N-6895); that vote is advisory only and any listing would require formal rulemaking. Separately, MOTS-c is named on the 2026 WADA Prohibited List as a metabolic modulator.

Under review: Actively before the FDA advisory committee; a decision is pending and the status can move.

Verified Jul 16, 2026 (ET) · status held since Apr 16, 2026

Primary source: Federal Register All 4 sources

Where it sits in the process

Nominated(completed)
Under review(current stage)
Rulemaking(upcoming)
Compounding-legal(upcoming)

Next milestoneFDA advisory committee (PCAC) evaluates MOTS-c for the 503A list - Jul 23, 2026 (in 7 days)

What changed last

No recorded changes yet - this entry has held one status since it was added.

Status elsewhere

MOTS-c: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Under review	Not on the 503A list; removed from Category 2 in April 2026 (never in Category 1); under active PCAC review, meeting July 23-24, 2026 (Docket FDA-2025-N-6895).
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.
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.

Last verified by a human: Jul 16, 2026 (ET) · how we verify
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