MOTS-c
Also called Mitochondrial open reading frame of the 12S rRNA-c, MOTS-c (free base), MOTS-c acetate
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In 30 seconds
A 16-amino-acid peptide encoded in the mitochondria's own DNA.[1]
Studied in mice; in July 2026 FDA said it found no human data on giving it to people.[1][4]
How far has the research gotten?
One human trial is listed as recruiting, with no results yet.[5]
The molecule
Research over time
Papers on PubMed each year that mention MOTS-c.48 papers in 2025In one study, exercise raised the body's own MOTS-c levels in human muscle and blood.[2]
What studies used
What each paper reports. A record of published research, not a recommendation.Identification of MOTS-c in the mitochondrial genome, its cellular mechanism (folate cycle inhibition leading to AMPK activation), and its effects on age-related and high-fat-diet insulin resistance and diet-induced obesity in mice.
Cell metabolism · 2015 · PubMed 25738459What the paper reports
not stated in abstract
Who: Mouse (plus cell studies)Effects of MOTS-c treatment on physical performance and healthspan in young, middle-aged and old mice, plus measurement of the body's own MOTS-c levels in human skeletal muscle and blood after exercise.
Nature communications · 2021 · PubMed 33473109What the paper reports
not stated in abstract (abstract describes intermittent treatment 3x/week begun at 23.5 months of age in mice; no dose given)
Who: Mouse; human (endogenous levels only)FDA's list of bulk substances it says may raise significant safety risks if pharmacies compound them. MOTS-c was on it until its nomination was withdrawn.[3]
What it is, in full 4
MOTS-c is a short peptide, 16 amino acids long, that researchers found is encoded within the mitochondria's own DNA, in the region for the 12S ribosomal RNA.[1]
In the original mouse work, giving MOTS-c prevented insulin resistance linked to aging and to a high-fat diet, as well as diet-induced weight gain, with skeletal muscle proposed as its main target and AMPK activation as part of the mechanism.[1]
A later study reported that MOTS-c improved physical performance in young, middle-aged and old mice, and that exercise raised the body's own MOTS-c levels in human muscle and blood.[2]
In a July 2026 review, FDA said it found no publicly available studies or human exposure data on giving MOTS-c to people, and that published pharmacology work was limited to cell and small-rodent models.[4]
Regulatory details 4
FDA's July 2026 compounding-committee presentation states that neither MOTS-c (free base) nor MOTS-c acetate is a component of an FDA-approved drug. A Drugs@FDA (openFDA) search and a DailyMed label search on 2026-10-06 returned no matches.[4]
Checked 2026-10-06FDA's category 2 page lists MOTs-C in its table of substances that were previously in category 2 and whose nominations were withdrawn. FDA's stated concerns: possible immunogenicity for certain routes, peptide impurity and characterization issues, no human exposure data identified by any route, and missing information on whether it would cause harm in humans. Page content current as of 04/22/2026.[3]
Checked 2026-10-06Although the nomination was withdrawn, FDA chose to evaluate MOTS-c (free base) and MOTS-c acetate itself and presented them to the Pharmacy Compounding Advisory Committee on July 23, 2026. FDA proposed that neither be added to the 503A Bulks List. The committee's vote is not reported here because no minutes were posted on the meeting page (source 7) when it was checked (page last updated 08/06/2026).[4]
Checked 2026-10-06The 2026 Prohibited List, in effect from 1 January 2026, names MOTS-c as an example of an AMP-activated protein kinase (AMPK) activator under S4.4.1 Metabolic modulators. S4 substances are prohibited in and out of competition, and those in S4.4 are classed as non-Specified.[6]
Checked 2026-10-06Human trials on ClinicalTrials.gov
An intervention search of ClinicalTrials.gov for 'MOTS-c' on 2026-10-06 returned 5 records, of which one (NCT07505745, a Hudson Biotech phase 2a placebo-controlled study of subcutaneous MOTS-c in adults with prediabetes and overweight/obesity, recruiting, started 2026-02-02) gives MOTS-c as an intervention; the other records appear to measure MOTS-c levels or match the term incidentally.[5]
All sources 9
- Lee C et al. Cell Metab 2015 (PMID 25738459)PubMed / NCBI
- Reynolds JC et al. Nat Commun 2021 (PMID 33473109)PubMed / NCBI
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (category 2 page)U.S. Food and Drug Administration
- July 23, 2026 Pharmacy Compounding Advisory Committee - FDA Presentations (MOTS-c section)U.S. Food and Drug Administration
- ClinicalTrials.gov API intervention search: MOTS-cClinicalTrials.gov / NLM
- WADA Prohibited List 2026World Anti-Doping Agency
- July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (meeting page)U.S. Food and Drug Administration
- openFDA Drugs@FDA search: MOTS-c (no matches)U.S. Food and Drug Administration (openFDA)
- DailyMed SPL search: MOTS-c (0 results)DailyMed / NLM
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