MOTS-c: what it is, prescription status and cost

MOTS-c is a 16-amino-acid peptide encoded in mitochondrial DNA, first described in 2015 (Lee et al., PubMed 25738459). It is not FDA-approved. Since 28 October 2026 an interim HHS policy lets licensed 503A pharmacies compound it on a prescription, and the one program we list charges $199 a month; see every MOTS-c price.

Below: where MOTS-c came from, what human studies exist (and what they do not show), its legal status, the sport ban, and what a prescription program costs. Compounded drugs are not FDA-approved, and the HHS policy is interim and can be withdrawn; we checked it on 30 October 2026.

What is MOTS-c?

Most of the proteins in your cells are coded by the DNA in the nucleus. Mitochondria, the parts of the cell that turn food into usable energy, carry a small genome of their own. In 2015 a team at the University of Southern California reported a short stretch of that mitochondrial DNA coding "a 16-amino-acid peptide named MOTS-c (mitochondrial open reading frame of the 12S rRNA-c) that regulates insulin sensitivity and metabolic homeostasis" (Lee et al., Cell Metabolism 2015). The paper found its main target appeared to be skeletal muscle and that it acted through AMPK, the cell's energy sensor.

The effects on insulin resistance and weight gain in that paper were preclinical. Your body makes its own MOTS-c; the prescription product is a lab-made copy injected under the skin.

What human studies exist?

Almost all human data on MOTS-c measure the body's own levels. None of these studies gave people MOTS-c as a treatment.

These show that exercise can raise MOTS-c in the blood, and that levels change with age and insulin resistance. They do not show that injecting MOTS-c improves energy, weight or aging. Two of the four list a researcher with a financial tie to CohBar, the company that developed a MOTS-c drug.

FDA's own review for its July 2026 advisory committee found the same gap. FDA wrote that "we did not identify data, such as clinical studies, evaluating the administration of MOTS-c to humans" and that "FDA identified an in-vitro study reporting that MOTS-c is quickly hydrolyzed in human blood" (FDA briefing document, MOTS-c). That second point raises the question of whether an injected dose stays active long enough to do anything.

The CB4211 trial: a MOTS-c analog

CB4211 is a modified version of MOTS-c, not MOTS-c itself. CohBar ran a Phase 1a/1b trial (NCT03998514) in healthy adults and adults with fatty liver disease; ClinicalTrials.gov lists it as completed in April 2021 with 88 people enrolled and no results posted (ClinicalTrials.gov). We found no peer-reviewed paper on PubMed.

The company's own topline release said "CB4211 was well-tolerated and appeared safe with no serious adverse events" and that "Both the CB4211 and placebo groups had substantial reductions in liver fat content compared to baseline" (CohBar press release, SEC filing, 10 August 2021). The four-week phase had 20 people. It reported lower liver enzymes and glucose than placebo, but no difference in liver fat. These are company-reported numbers for an analog, so they say little about compounded MOTS-c. Our MOTS-c side effects guide covers the safety findings.

Is MOTS-c legal to prescribe?

MOTS-c has no USP monograph and is not part of any approved drug, so it did not meet the usual test for 503A compounding. FDA had placed it in category 2 (substances that may pose significant safety risks); in April 2026 the nomination was withdrawn and FDA moved it to a list headed "Bulk drug substances nominated but withdrawn" (FDA category 2 page). On that page FDA says it "has not identified any human exposure data on drug products containing MOTs-C administered via any route of administration."

FDA staff then recommended against adding it to the 503A list: "a balancing of the criteria weighs against MOTS-c free base or MOTS-c acetate being placed on that list" (FDA briefing document).

HHS acted anyway. On 28 October 2026 the Secretary said "HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A" (Federal Register, FR Doc. 2026-22192). MOTS-c is one of the six peptides in Appendix A. The same notice states "Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed" and that the policy "does not establish any rights for any person and is not binding on HHS or the public" (Federal Register).

What we could not verify: the policy's appendix with the exact salt forms, routes and conditions is on hhs.gov, which refused our reader (HTTP 403). Superpower's summary of it says "Six peptides, in specified forms only. Blends aren't covered" (Superpower). Our HHS peptide policy guide and peptide legal status tracker follow the policy as it changes. States can still set their own rules.

Is MOTS-c banned in sport?

Yes. The 2026 WADA Prohibited List names it under S4.4.1, activators of AMPK: "mitochondrial open reading frame of the 12S rRNA-c (MOTS-c)" (WADA 2026 Prohibited List). USADA states that "MOTS-c is prohibited at all times under Section 4.4 Metabolic Modulators" (USADA). A prescription does not change that for a tested athlete.

What MOTS-c costs

One program in our database publishes a MOTS-c price. The table reads from our live price data:

Superpower's MOTS-c page states "Compounded MOTS-c is not FDA-approved. A patient-specific prescription is required" (Superpower). It charges the first month at preorder and refunds it if a clinician does not approve you. Read our Superpower review and Superpower peptides guide for the plan detail. Sellers offering MOTS-c vials "for research use" with no prescription are outside this site; research vs prescription peptides explains why.

Your clinician sets the form and schedule; we do not publish doses.

FAQ

MOTS-c: what is it, and is it available by prescription?

MOTS-c is a 16-amino-acid peptide coded by mitochondrial DNA, described in 2015 and studied for metabolism. It is not FDA-approved. Under an interim HHS policy dated 28 October 2026, licensed 503A pharmacies can compound it for an individual prescription. The policy can be withdrawn, so check the date on any status claim.

What is the MOTS-c peptide used for?

Programs market it for energy, metabolism and healthy aging. The evidence for those uses is preclinical. FDA's 2026 review found no clinical studies giving MOTS-c to people, and Superpower's own page says benefits in people are not proven. Treat any claim of fat loss or longer life as unproven.

Is MOTS-c FDA approved?

No. MOTS-c has never been approved, and FDA staff recommended against adding it to the list of substances pharmacies may compound. The October 2026 HHS policy is a decision not to enforce, not an approval. FDA does not review compounded drugs for safety, effectiveness or quality before they are sold.

How much does MOTS-c cost?

The one program we list charges $199 a month, with a clinician review and a blood panel included. It is a preorder, and the first month is charged up front. Prices change, so see the MOTS-c price table for the current figure and its source.

Has MOTS-c been tested in people?

Not as a treatment, as far as FDA and we could find. Human studies measure the body's own MOTS-c, which rises with exercise. The only drug trial used CB4211, a modified analog, with 88 people enrolled; results came from a company press release and were never published in a journal.

Can athletes use MOTS-c?

No. The 2026 WADA Prohibited List names MOTS-c as a metabolic modulator, and USADA says it is prohibited at all times, in and out of competition. A doctor's prescription does not exempt a tested athlete, and USADA considers an exemption unlikely because there is no approved medical use.

Compare MOTS-c and other prescription peptide programs on price, labs and oversight on our best peptide programs page, or see every plan on the price table.