MOTS-c: legal status and evidence

Short answer: MOTS-c is not FDA-approved. Since October 30, 2026, a state-licensed pharmacy may compound MOTS-c acetate for one patient with a prescription under an interim HHS policy, in these forms only: subcutaneous or intramuscular injection [1], [2]. FDA’s own staff reviewed the evidence and recommended against it [2], [3].

At a glance

Legal status	HHS interim policy: compounding with a patient-specific prescription [1]
Form covered	MOTS-c acetate [2]
Routes allowed	Subcutaneous or intramuscular injection [2]
FDA Category 2	September 29, 2023 to April 22, 2026 [2]
FDA staff view	Recommended against adding it to the 503A bulks list [2], [3]
Advisory committee	Voted in favor [2]
Human evidence (FDA review)	No human studies. FDA found no clinical data on MOTS-c’s safety or effectiveness in people. [3]
Last checked	November 5, 2026

What FDA’s staff found

FDA’s drug center (CDER) reviewed MOTS-c for the uses it was nominated for: insulin resistance, obesity, osteoporosis and other uses [3].

• FDA found no information on MOTS-c given to people for any of the nominated uses, and no clinical studies of its safety or effectiveness in humans. [3]
• Animal studies looked at how MOTS-c works, but FDA said their relevance to people is unknown. [3]
• FDA said it was particularly concerned about the lack of human data, so the risks in people are unknown. [3]

Why HHS allowed it anyway

HHS gave three reasons in Appendix B to its policy [2]:

1. Lot-specific certificates from FDA-registered manufacturers now report the impurity, residual solvent, endotoxin and microbial results FDA’s review found missing;
2. Use is now documented and counted, and most of it is single-ingredient products;
3. A randomized, placebo-controlled trial of a MOTS-c analogue (a related molecule, not MOTS-c itself) reported no serious adverse events, and rodent studies reported no systemic toxicity.

HHS may revisit the policy if a safety signal or a product quality problem appears, and the policy lasts until FDA decides in a final rule whether to add the peptide to the 503A bulks list [1].

How to get it legally

1. A licensed clinician decides it is right for you and writes a prescription in your name.
2. A state-licensed compounding pharmacy (503A) prepares it from an ingredient made at an FDA-registered facility, with a valid certificate of analysis [1].
3. The label says: “This is a compounded drug product. Not for resale.” It contains only one active ingredient [1].

See how to check a compounding pharmacy and how to read a peptide COA.

What is not known

FDA’s review found too little human data to describe how well MOTS-c works or how safe it is over time [3]. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed [1]. Talk to a licensed clinician before you use any compounded peptide.

Change log

• November 5, 2026: page created from the HHS policy, Appendix B and FDA’s July 2026 briefing document.