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- Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn.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 Nominations had been withdrawn; FDA elected to proceed.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 fileWhat 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 FDA's withdrawn-nominations table states that human exposure data have not been identified.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
Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built
