MOTS-c

What people use it for

• Energy, endurance and exercise support (often called an exercise mimetic)S1S3
• Metabolic health, fat loss and insulin sensitivityS1S2
• Longevity and mitochondrial supportS1S2

Reported regimens

Reported side effects

• injection-site irritationS2
• fatigueS2

Reported benefits (claims, not shown in trials)

• more energy and endurance during exerciseS1
• fat loss, mostly visceral fat (confounded by diet and exercise)S1
• better post-exercise recoveryS1

Cautions

• No human clinical trial of injected MOTS-c has been completed, so there is no tested human dose.S1S2
• Pinchas Cohen, who discovered MOTS-c, told the Los Angeles Times that product sold online is black market, with unknown sources, unknown purity and unknown sterility.S3
• Mouse results, not human results, are the basis for most of the claims.S1S3
• MOTS-c is prohibited for tested athletes as a metabolic modulator.S1S2

Status notes

• As of 2026-10-30, HHS's draft policy says it does not plan to act against licensed pharmacies or physicians that make MOTS-c acetate for a patient with a prescription, under strict conditions. It gives no legal rights and does not bind HHS or the public. It does not grant FDA approval or add the substance to the 503A bulks list, the list of ingredients allowed for this compounding. The listed routes are injection under the skin (subcutaneous) or into a muscle (intramuscular).S6S7
• Only a licensed pharmacist in a state-licensed pharmacy or federal facility, or a licensed physician, can compound under this policy. They need a valid prescription for the individual patient. The original manufacturer must register with FDA under section 510 and meet current good manufacturing practice (CGMP) standards and other applicable federal drug requirements. A valid certificate of analysis, the batch's test report, must identify the manufacturing site and meet Appendix B's testing standards. The ingredient must match Appendix B's identity, including its amino acid sequence, chemical structure, molecular weight, and molecular formula. Tests must cover identity, purity, potency, and harmful contaminants, including endotoxins, heavy metals, microbes, and impurities. If an FDA-registered repacker, relabeler, or reseller supplies it, that business must document checks of the original manufacturer and its certificate. The product must contain only one active ingredient from Appendix A.S6
• Compounders must report products, serious adverse events, and product quality problems to FDA and the states where they make and send the products. Each product report must give the active ingredient, its strength per unit, the original manufacturer, and the manufacturing facility's unique identifier. It must also give the dosage form and route. Compounders must report serious adverse events to FDA MedWatch even if they do not consider the drug responsible. The patient's label must explain how to report adverse events and problems with identity, strength, purity, or quality. It must state: "This is a compounded drug product. Not for resale."S6
• Any device packaged with the drug, or containing it, must be an FDA 510(k)-cleared syringe. All other applicable federal drug requirements still apply, including sanitary conditions.S6
• This 503A policy does not cover 503B outsourcing facilities, research chemicals, supplements, or blends. It applies only until a final rule includes or excludes the substance from the 503A bulks list. HHS may reconsider the policy, including if safety or product quality problems arise.S6
• Federal Register document 2026-22192 was filed on 2026-10-28 and published on 2026-10-30. Docket: HHS-OASH-2026-0496. The notice allows comments for two weeks after publication. That gives a comment date of 2026-11-13.S7
• The FDA Pharmacy Compounding Advisory Committee met on 2026-07-23 and 2026-07-24. It recommended adding MOTS-c to the 503A bulks list (with BPC-157, KPV, TB-500, epitalon and semax). This is a recommendation, not an FDA decision.S4S3
• On 2026-04-15, HHS confirmed removal of MOTS-c from FDA Category 2 because the nominations were withdrawn. Removal from Category 2 does not give Category 1 status.S5
• MOTS-c is not FDA-approved. S3 reports it is sold online in vials marked for research use only.S3

Community sources

• S1MOTS-c: Community Protocols & Reportspeptideprotocolwiki.comcarries seller links, not linked
• S2MOTS-c: Benefits, Dosage & Side Effectsoutliyr.comcarries seller links, not linked
• S3From mice to gym rats: unregulated use of peptides (Los Angeles Times) (opens in a new tab)newstribune.com
• S4FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do (opens in a new tab)mintz.com
• S5What's changing with peptide regulation in 2026 (opens in a new tab)bscg.org
• S6HHS interim 503A peptide enforcement policy, Appendix B (opens in a new tab)hhs.gov
• S7Federal Register 2026-22192, published 2026-10-30 (opens in a new tab)federalregister.gov