18+ · Research Use Only · Not for Human Consumption
Regulation answer
Is MOTS-c FDA approved?
No. As of 23 September 2026, MOTS-c has no approved application with the US FDA and no record with the EMA. FDA lists it among compounding substances that may present significant safety risks and says it has not identified human exposure data by any route. No FDA Philippines advisory names MOTS-c.
Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.
Updated 23 September 2026
01
FDA's statement
From FDA's compounding page, current as of 22 April 2026: "Compounded drugs containing MOTs-C may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified any human exposure data on drug products containing MOTs-C administered via any route of administration. FDA lacks important information regarding any safety issues raised by MOTs-C, including whether it would cause harm if administered to humans."
Drugs@FDA holds "no record found" for MOTS-c, and the EMA medicines report "no record found".
02
Why FDA can say there is no human exposure data
MOTS-c is a 16-amino-acid peptide encoded in mitochondrial DNA. Its research is in mice and cells, which is why the Research Desk rates it animal and cell. People make MOTS-c naturally, and some studies measure its blood levels as a marker, but that is not the same as giving it as a product.
03
Philippines
A search of fda.gov.ph for "MOTS-c" on 23 September 2026 returned no advisory, and the registration record could not be read from the FDA Philippines verification portal.
04
What the mouse work found
In mice, MOTS-c prevented insulin resistance linked to age and a high-fat diet, and prevented diet-induced obesity.
An approval would need human trials first, and none has been published.
05
How it is thought to act
MOTS-c is a 16-amino-acid peptide encoded in mitochondrial DNA. In mouse and cell studies it acts mainly on skeletal muscle, where it inhibits the folate cycle and linked purine synthesis, which activates the energy sensor AMPK. In people, exercise raises the body's own MOTS-c levels; it has not been given to people in a published study.
This is general information, not legal advice.
Sources
Where every figure comes from
- US FDA record for MOTS-c · checked 23 September 2026
- EMA record for MOTS-c · checked 23 September 2026
- FDA, bulk drug substances that may present significant safety risks in compounding · checked 23 September 2026
- FDA Philippines site search, MOTS-c · checked 23 September 2026
Last reviewed 23 September 2026