Is MOTS-c legal? FDA status and US regulatory standing
Current status
Compounding nomination withdrawn. MOTS-c was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists.
Primary source: www.fda.gov
Federal legal status
FDA approval status
MOTS-c was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Mitochondria-derived peptide encoded in 12S rRNA. Regulates metabolism and exercise capacity. No FDA approval, no NDA or IND. Pure research compound; no clinical development program.
Also known as
Mitochondrial ORF of the 12S rRNA type-c
Frequently asked questions
- Is MOTS-c FDA approved?
- MOTS-c was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Primary source linked on this page.
- Is MOTS-c legal to buy?
- MOTS-c is available in the U.S. as a research-use-only compound. It was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Sale for human consumption is not permitted.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .