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16-residue peptide encoded by a short open reading frame in mitochondrial 12S rRNA

MOTS-c

A mitochondrial-derived peptide with no FDA-approved drug product. FDA reviewed MOTS-c-related bulk substances at the 23 July 2026 PCAC meeting (nominated uses: obesity and osteoporosis).

Also listed as: MOTS-C, Mitochondrial ORF of the 12S rRNA type-c

Chemical identity

Compound class
16-residue peptide encoded by a short open reading frame in mitochondrial 12S rRNA
Sequence
MRWQEMGYIFYPRKLR
Molecular formula
C101H152N28O22S2
Molecular weight
2174.6 g/mol
CAS number
1627580-64-6
PubChem CID
146675088
Research categories
Mitochondrial-derived peptides, Preclinical research compounds

United States regulatory status

No FDA-approved product

  • No approved drug product exists in Drugs@FDA.
  • Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn. FDA states it has not identified human exposure data.
  • On 23 July 2026 PCAC discussed MOTS-c (free base) and MOTS-c acetate (uses evaluated: obesity and osteoporosis). FDA briefing materials proposed that they NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. Committee recommendations are non-binding; FDA has not published a listing decision as of this review.

Regulatory status describes how a substance is classified. It is not a safety assessment, and it says nothing about the quality of any particular material.

Evidence overview

3 records in this file

  • ANIMAL1
  • REGULATORY2

Research areas. Metabolic models; United States compounding.

Publication span. 2015–2026.

Open the evidence file

What we know

  • Lee et al. 2015 (Cell Metabolism) is the originating characterisation of MOTS-c in mouse metabolic models.
  • No FDA-approved product exists. FDA's withdrawn-nominations table states that human exposure data have not been identified.
  • PCAC discussed MOTS-c-related bulk substances on 23 July 2026. FDA briefing materials proposed against inclusion. That is not a listing decision.

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

  • Human interventional data on MOTS-c itself. CB4211 is a related analogue and is not this compound.
  • Which PubChem representation a given certificate uses.

Sources

  1. PubChem CID 146675088
  2. FDA — Pharmacy Compounding Advisory Committee, 23–24 July 2026
  3. FDA — Certain bulk drug substances for use in compounding may present significant safety risks

Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built