MOTS-c

FDA status

Not FDA-approved. The FDA says it has found no data on MOTS-c in people. It was on FDA's compounding safety-risk list until the nomination was withdrawn. In July 2026 FDA advisers voted to add it to the pharmacy list for obesity and osteoporosis. On October 30, 2026 HHS published a draft policy: it does not intend to act against pharmacies and doctors that compound MOTS-c, as injections only, under set conditions while that list is worked out. That is not an approval. It covers only compounding for a patient's prescription, with peptide from an FDA-registered maker; HHS says it aims to move people away from research-use-only peptides from foreign suppliers to a more controlled alternative. FDA safety-risk list ↗McDermott ↗Federal Register ↗HHS ↗

Its research stage

Stage 1: no trial has given people MOTS-c itself; a modified version, CB4211, had a small early trial. A stage counts only trials of the peptide itself. The counts behind it

FDA advisers, July 2026

The FDA's compounding advisory committee recommended adding it to the substances pharmacies may use, for obesity and osteoporosis (7–5, 2 abstaining). The FDA hasn't decided. What's changing →

What's changing

A draft HHS policy, published October 30, 2026: no action against pharmacies that compound it under set conditions while the pharmacy list is worked out. Comments are open for two weeks. See what's changing →

In people so far

• A modified version, CB4211, which its maker CohBar calls an improved analog of MOTS-c, was tested in an early (phase 1) trial of 88 people that finished in April 2021. No results are posted on ClinicalTrials.gov. CohBar reported that in people with fatty liver disease, liver-damage markers (ALT and AST) and blood sugar fell more than on placebo after four weeks, and that this version of the drug wasn't suitable for further development. ClinicalTrials.gov ↗SEC filing ↗SEC filing ↗
• Studies in people so far have measured the body's own MOTS-c, for example in the blood after exercise. PubMed ↗

Safety

• The FDA says it has no human data on MOTS-c and that it may pose a significant risk of immune reactions. FDA safety-risk list ↗
• The CB4211 trial was paused in 2018 to deal with reactions where it was injected, according to CohBar. SEC filing ↗
• A 2026 review lists it among unapproved peptides marketed directly to patients, with scarce human safety data. PubMed ↗

In sport

Banned in sport at all times: WADA names MOTS-c among metabolic modulators (class S4). WADA ↗

One of the peptides we follow. We don't give doses or say where to buy. Talk to your doctor before trying any of them.