MOTS-c
MOTS-c is a 16-amino-acid peptide encoded in mitochondrial DNA, studied in cells and mice for effects on metabolism, with no human trial results published yet.
US regulatory status
Not approved for human use in the US
MOTS-c is not approved by the FDA for any use. The FDA moved it off its Category 2 safety-risk list after the nomination was withdrawn, and it is not on any list that lets pharmacies compound it. In July 2026 an FDA advisory committee narrowly voted to recommend adding it to the 503A bulks list, against the FDA staff’s proposal; the vote is not binding, and as of October 16, 2026 the FDA had not published a proposed or final rule.
At a glance
- Also known as
- Mitochondrial open reading frame of the 12S rRNA-c
- Supplied as
- Freeze-dried powder, mixed before use
- Research
- Animal or lab studies only
- US status
- US status: Not approvedchecked
What the research shows
Evidence grade
Animal or lab studies only
Studied in cells or animals, not properly in people. Animal results may not apply to humans.
The 2015 study that named MOTS-c found that it prevented age-related and high-fat-diet insulin resistance and diet-induced obesity in mice; it appeared to act mainly on skeletal muscle, leading to AMPK activation. In its 2026 review for the advisory committee, the FDA found that all the research is in cells and rodents, that no dose-response data exist, that the molecular targets of MOTS-c remain unknown, and that the relevance of these findings to people is unknown. It found no published human studies of compounded MOTS-c from January 2017 to December 2025. The only pharmacokinetic study was in vitro: MOTS-c broke down quickly in human blood, which, the FDA wrote, raises the question of whether an injection can reach active levels at all. The first registered placebo-controlled trial (NCT07505745, Phase 2a, 12 weeks, about 120 adults with prediabetes and overweight or obesity) started in February 2026, is recruiting and measures insulin sensitivity; it has posted no results.
How we grade evidence
Strong human evidence
Consistent results from large randomized controlled trials in people.
Limited human evidence
Some studies in people, but they are small, short, early-phase or uncontrolled.
Mixed evidence
Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.
Animal or lab studies only · this page
Studied in cells or animals, not properly in people. Animal results may not apply to humans.
The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.
Side effects and safety
Safety in people is unknown. The FDA has found no human exposure data for MOTS-c by any route and says it cannot rule out immune reactions, especially when injected. It considers MOTS-c not well characterized, notes it has no USP or NF quality standard and is not part of any FDA-approved drug, and warns that peptides can clump or break down with heat, pH, concentration and impurities. The World Anti-Doping Agency bans MOTS-c at all times, in and out of competition.
Vial math
Pre-filled calculators turn your vial, water and prescribed dose into syringe units.
Pre-filled for your vial size
This is arithmetic, not medical advice. Confirm with your prescriber or pharmacist.
Questions people ask
What is MOTS-c?
MOTS-c stands for mitochondrial open reading frame of the 12S rRNA-c. It is a peptide of 16 amino acids encoded in the DNA of mitochondria, the energy-producing parts of cells. Researchers described it in 2015 as a regulator of insulin sensitivity and metabolism in mice. No MOTS-c product is FDA-approved, and it has no USP or NF quality standard.
Sources
- Cell Metab, 2015: The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance (opens in a new tab)
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
Does MOTS-c help with weight loss?
That has not been shown in people. In mice on a high-fat diet, MOTS-c prevented weight gain and insulin resistance. The FDA’s 2026 review found no human data on MOTS-c products and called the relevance of the animal findings to people unknown. A 12-week placebo-controlled trial in adults with prediabetes and overweight or obesity is recruiting; its main measure is insulin sensitivity, and its primary data collection is estimated to finish in February 2027.
Sources
- Cell Metab, 2015: The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance (opens in a new tab)
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
- ClinicalTrials.gov, 2026: MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity (Phase 2a), NCT07505745 (opens in a new tab)
Is MOTS-c FDA-approved?
No. MOTS-c is not approved for any use, and it is not on any list that lets pharmacies compound it. In July 2026 the FDA’s staff proposed not adding it to the 503A bulks list, the list of substances pharmacies may compound from, citing the lack of human data. The advisory committee narrowly voted the other way, but its vote is only a recommendation. The FDA would have to publish a rule, and as of October 16, 2026 it had not.
Sources
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
- U.S. Food and Drug Administration, 2026: July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (opens in a new tab)
- ABC News, 2026: FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next? (opens in a new tab)
What are the side effects of MOTS-c?
Nobody knows yet, because no human study of MOTS-c has published results. The FDA says the safety risks in people are unknown and flags possible immune reactions to injected MOTS-c, along with impurities from how the peptide is made and stored.
Sources
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (opens in a new tab)
Is MOTS-c banned in sports?
Yes. The World Anti-Doping Agency’s 2026 Prohibited List, in effect since January 1, 2026, names MOTS-c among the hormone and metabolic modulators (activators of AMPK) that are prohibited at all times, in and out of competition.
How much bacteriostatic water do I mix with 10 mg of MOTS-c?
There is no single correct amount. The water only sets the concentration: mg in the vial ÷ mL of water = mg per mL. For example (numbers for illustration only, not a dose), 10 mg of MOTS-c in 1 mL makes 10 mg/mL, so each unit on a U-100 insulin syringe holds 0.1 mg (100 mcg). The same vial in 2 mL makes 5 mg/mL, or 0.05 mg (50 mcg) per unit. More water means each unit holds less; less water means each unit holds more. The reconstitution calculator does this arithmetic for your vial. Because this product is not FDA-approved, no official label sets a water volume, and the contents of unapproved vials are not verified. Talk to a licensed prescriber or pharmacist before using any unapproved product.
Sources
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (updated May 14, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What’s next?ABC News, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistanceCell Metab, 2015 · Accessed Oct 16, 2026 (opens in a new tab)
- MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity (Phase 2a), NCT07505745ClinicalTrials.gov, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- World Anti-Doping Code International Standard: Prohibited List 2026World Anti-Doping Agency, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
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Guides
Every medical and regulatory statement on this page links to a checkable source, listed above. Peptinote does arithmetic and education, not medical advice, and never sells or links to sellers of peptides.