mitochondrial-derived 16-residue peptide

Is MOTS-c legal in the United States?

Answer

MOTS-c is not on the FDA register of medicines in the United States. Read on 2026-10-03.

RegulatorFDA register

Not legal advice.

StatusNot on the registerRegulator FDA
Products on the register0none listed
Read2026-10-03FDA

FDA COMPOUNDING LIST (503A)

MOTS-c is on FDA's 503A bulk-substances list (nominated for compounding, withdrawn by the nominator).

Compounded drugs containing MOTs-C may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified any human exposure data on drug products containing MOTs-C administered via any route of administration. FDA lacks important information regarding any safety issues raised by MOTs-C, including whether it would cause harm if administered to humans.

Regulator FDA list, read 2026-10-03. Not legal advice.

ACTIONS BY NAMED AUTHORITIES

1 action naming MOTS-c

US-OH
Ohio Board of Pharmacy, 2026-04-16 Regulator
During the inspection, [redacted] was found to possess multiple vials of the following illegal dangerous drugs, in either a white powder, purple powder, or clear liquid form, intended for injection, which were obtained from an unlicensed, foreign source: l. MOTS-C 10mg, 5 vials; aa. MOTS-C 40mg, 4 vials;
State of Ohio Board of Pharmacy, Order, Case No. A-2026-0037, Findings of Fact paragraphs 2(l) and 2(aa) · quoted with the party redacted

MOTS-c in every country read: legal status by country. All peptides: are peptides legal?

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