PeptideAmerica

Mitochondrial

MOTS-c

US status
PCAC-recommended · pending
Class
Mitochondrial
Approved product
None
Route
None lawful; sold as research-use-only material

Regulatory record

April 2026
Removed from Category 2 without Category 1 listing.
July 2026
PCAC votes 7–5 (two abstentions) to recommend 503A listing; advisory only.
FDA final action
None as of August 2026.

Status verified for this index · August 2026

Definition

MOTS-c is a 16-amino-acid peptide encoded within the mitochondrial genome, one of a small family of mitochondrial-derived peptides described over the past decade; it acts as a metabolic signaling molecule rather than a structural protein.

Interest in the compound comes from exercise physiology and metabolism, where it is studied as a messenger linking mitochondrial state to whole-body insulin sensitivity.

Evidence

The foundational work is preclinical: the 2015 discovery paper showed MOTS-c promoting metabolic homeostasis and reducing diet-induced obesity and insulin resistance in mice [1]. Human data remain early and largely observational; no efficacy trial supports a clinical use.

The compound is marketed to athletes and biohackers well ahead of that record, which is the pattern this index exists to make visible.

Lawful access

MOTS-c was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing, and in July 2026 the Pharmacy Compounding Advisory Committee voted 7–5, with two abstentions, to recommend adding it to the section 503A list. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound MOTS-c as of August 2026.

Material sold online today is research-use-only supply, outside pharmacy oversight.

References

  1. Lee C, Zeng J, Drew BG, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443–454. PMID 25738459