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MOTS-c

Also called Mitochondrial open reading frame of the 12S rRNA-c, Mitochondrial-derived peptide MOTS-c, MOTSC.

MOTS-c is a tiny protein piece that your own cells make from their mitochondria, the parts that produce energy. In mice and cell studies it changes how muscle handles sugar and fat. It is not an approved medicine anywhere we could verify, and there are no published results from trials of MOTS-c itself in people.

MOTS-c is not an approved medicine for these uses in most countries. This page explains the science and the law; it does not give dosing, sourcing or usage advice.

How strong is the evidence?

AnecdoteAnimalsHuman trialsApproved
Animals. Tested in animals, not properly in people.For MOTS-c itself the published therapeutic evidence is animal (mainly mice and rats) and cell work, plus human observational data (levels rise with exercise and are reported lower in type 2 diabetes). FDA's 2026 briefing document states it identified no clinical studies or human exposure data for MOTS-c by any route. The only completed human trial connected to the peptide tested CB4211, a modified analogue, in a phase 1a/1b safety study (NCT03998514); the sponsor reported acceptable tolerability, and although liver enzymes (ALT, AST) and glucose fell more than on placebo in the 20-person phase 1b portion, the reported drop in liver fat (MRI-PDFF) was about the same as placebo (5.03% vs 4.88%). A phase 2a trial of MOTS-c in prediabetes (NCT07505745, sponsor Hudson Biotech, estimated 120 participants) began in February 2026 and has no results yet. Animal effects should not be assumed to carry over to people.

Last verified 2026-09-29 · how we verify

7. G · GlycineG14. K · LysineK3. W · TryptophanW11. Y · TyrosineY10. F · PhenylalanineF4. Q · GlutamineQ15. L · LeucineL6. M · MethionineM8. Y · TyrosineY13. R · ArginineR1. M · MethionineM2. R · ArginineR12. P · ProlineP9. I · IsoleucineI5. E · GlutamateE16. R · ArginineRNC

Schematic

  • Water-avoiding
  • Positive charge
  • Water-loving
  • Negative charge
  • Glycine or proline

Schematic from the amino-acid sequence — not an experimental structure

16 amino acids, one bead each, coloured by type, N-terminus to C-terminus. The helix shape is illustrative; it is not the real 3D shape of MOTS-c.

Acts on
No confirmed receptor. Reported to act inside cells: folate cycle and purine synthesis inhibition leading to AMPK activation, and nuclear gene regulation (including NRF2-linked antioxidant response genes) after entering the nucleus
Taken as
No approved route because there is no approved product. In published animal studies MOTS-c has been given by injection (for example into the abdominal cavity of mice). The completed human trial of the analogue CB4211 and the registered phase 2a trial of MOTS-c both list subcutaneous injection. FDA's 2026 review found no clinical studies or human exposure data for MOTS-c by any route, including by mouth.
What it is
A 16-amino-acid peptide (MRWQEMGYIFYPRKLR), formula C101H152N28O22S2, molecular weight 2174.6 g/mol, encoded within the mitochondrial 12S rRNA gene and first described in 2015.[src]
Regulatory status (US)
As of FDA's 11 May 2026 briefing, MOTS-c and its acetate were not components of any FDA-approved drug and had no USP/NF monograph; FDA identified no clinical studies or human exposure data for MOTS-c.[src]
FDA advisory committee vote
On 23 July 2026 the Pharmacy Compounding Advisory Committee voted 7-5 with 2 abstentions to recommend MOTS-c for the 503A Bulks List, against FDA staff's written recommendation. The vote is non-binding; FDA makes the final decision.[src]
Completed human trial (analogue only)
CB4211, a modified MOTS-c analogue, was tested in a placebo-controlled phase 1a/1b study (NCT03998514): phase 1a in 65 healthy adults, phase 1b in 20 obese adults with NAFLD. In the 4-week phase 1b portion (11 on CB4211, 9 on placebo) ALT changed by -21% vs +4% and AST by -28% vs -11%, but the reported liver-fat reduction was 5.03% vs 4.88%, essentially the same.[src]

Inside the body

What MOTS-c does, step by step

Watch the 3D journey →
  1. 01Elsewhere

    Made inside the cell's power plants

    Cells have small power plants called mitochondria, and these carry a bit of their own DNA. A short stretch of that DNA carries the recipe for MOTS-c, a peptide only 16 building blocks long. So MOTS-c is a message that mitochondria send out.

    For experts

    MOTS-c is translated from a 51-nucleotide short open reading frame within the mitochondrial 12S rRNA gene (MT-RNR1), giving a 16-residue peptide. It is reported to be expressed in several tissues, including skeletal muscle, and to be present in blood. It was described as a mitochondrial-DNA-encoded peptide that regulates insulin sensitivity and metabolic homeostasis.[src][src][src]

  2. 02Bloodstream

    Travels in the blood and rises with exercise

    MOTS-c can be measured in blood. In a small study of healthy young men, cycling raised MOTS-c in muscle and in blood for a while. So the body seems to make more of it when muscles work hard. This shows a link, not a treatment effect.

    For experts

    In 10 sedentary healthy young men (mean age 24.5) performing stationary cycling, endogenous MOTS-c in skeletal muscle (western blot) rose 11.9-fold after exercise and stayed raised after 4 hours of rest, with a trend back toward baseline; plasma MOTS-c (ELISA) rose 1.6-fold during and 1.5-fold after exercise and returned to baseline after 4 hours of rest. Measurement of endogenous plasma MOTS-c is unsettled: an LC-MS method could not confirm the ELISA-derived concentration range in 20 healthy subjects, and FDA notes the peptide is rapidly cleaved in human whole blood in vitro, so how long an injected dose stays active is unknown.[src][src][src]

  3. 03Muscle

    Switches on the cell's energy sensor in muscle

    Skeletal muscle looks like the main place MOTS-c acts. In mouse muscle and in lab cells it slows one chemical pathway and that flips on AMPK, the cell's fuel gauge. This makes muscle cells better at using sugar. It has not been shown to work this way in a person given MOTS-c.

    For experts

    In cells, MOTS-c inhibits the folate cycle and tethered de novo purine biosynthesis, causing AICAR accumulation and AMPK activation. In mice, MOTS-c treatment activated AMPK in skeletal muscle and raised expression of the glucose transporter GLUT4, and the authors concluded that skeletal muscle appears to be the primary target organ. All of this is preclinical (mouse and cell) evidence; the upstream molecular target is unknown.[src][src][src]

  4. 04Elsewhere

    Moves into the cell nucleus under stress

    When cells are short of sugar, MOTS-c can travel into the nucleus, the cell's control room, and help turn certain genes on, including genes that protect against damage. This was seen in cells grown in a dish.

    For experts

    Following metabolic stress (glucose restriction) MOTS-c translocates to the nucleus in an AMPK-dependent manner, where it regulates a broad set of genes including those with antioxidant response elements and interacts with stress-responsive transcription factors such as NFE2L2 (NRF2). This was shown in cultured cells; the in-vivo and human significance is not established.[src]

  5. 05Fat tissue

    In mice: less weight gain and better insulin response

    In mice fed a fatty diet, MOTS-c injections stopped much of the weight gain and kept insulin working well. This is mouse-only evidence. No published trial has shown the same result in people.

    For experts

    In male CD-1 mice on a high-fat diet, MOTS-c treatment prevented diet-induced obesity and hyperinsulinemia, and in C57BL/6 mice it prevented high-fat-diet-induced and age-dependent insulin resistance; FDA reviewers cite about 20% lower body weight than vehicle after 8 weeks of treatment on a high-fat diet. FDA also notes that dose-response relationships are missing and that the clinical relevance of these rodent findings is unknown. Mouse-only evidence.[src][src]

  6. 06Pancreas

    In mice: protects insulin-making cells from ageing

    Insulin-making cells in the pancreas slow down as they age. In mouse studies, MOTS-c reduced this ageing and improved how mice handled sugar. Separately, people with type 2 diabetes were found to have lower MOTS-c in their blood, which is a link, not proof of cause.

    For experts

    MOTS-c levels fall with ageing and senescence in pancreatic islet cells. In aged C57BL/6 mouse islets MOTS-c reduced senescence by modulating nuclear gene expression and metabolites, and it improved glucose intolerance in S961-treated and non-obese diabetic mice. In humans, circulating MOTS-c was lower in people with type 2 diabetes than in healthy controls (cross-sectional association only). A separate short report proposed that the m.1382A>C variant in the MOTS-c coding region, specific to Northeast Asian populations, may help explain the high longevity of Japanese people; this is a hypothesis, not a demonstrated effect.[src][src]

  7. 07Bone

    In rodents and cells: possible effects on bone and vessels

    A few animal and lab-dish studies suggest MOTS-c may help bone-building cells and lower bone loss and calcium build-up in blood vessels. These studies are early, and none has been tested in people.

    For experts

    As summarised by FDA reviewers, preclinical studies report that MOTS-c promoted osteogenic differentiation of rat bone marrow mesenchymal stem cells in vitro, inhibited osteolysis in vivo and in vitro, and reduced vascular calcification with associated myocardial remodeling in a rat model. These are rodent and cell findings only, and FDA did not identify clinical studies for osteoporosis or vascular uses.[src]

For experts

The detail

MOTS-c (mitochondrial open reading frame of the 12S rRNA-c) is a 16-residue peptide, MRWQEMGYIFYPRKLR (C101H152N28O22S2, 2174.6 Da), encoded by a short open reading frame inside the mitochondrial MT-RNR1 (12S rRNA) gene; it was described in 2015 (Lee et al., Cell Metab). It is a natural, unmodified linear peptide; FDA notes it can be made by standard solid-phase peptide synthesis. Proposed mechanism: in cells it inhibits the folate cycle and de novo purine biosynthesis, raising AICAR and activating AMPK; under metabolic stress it translocates to the nucleus in an AMPK-dependent way and interacts with stress-responsive transcription factors such as NRF2 (Kim et al., 2018). No cell-surface receptor has been established, and FDA reviewers noted that the molecular target remains unknown. In mice, injected MOTS-c reduced diet-induced obesity and insulin resistance and improved physical performance in young, middle-aged and old animals; rodent and cell work also reports effects on bone cells, vascular calcification and pancreatic islet senescence. No in-vivo pharmacokinetic study was identified by FDA; the only pharmacokinetic-type data found was in-vitro degradation in human whole blood, which is rapid. In humans, endogenous MOTS-c rose in skeletal muscle (11.9-fold after exercise) and plasma (1.6-fold during exercise) in 10 healthy young men, and circulating levels are reported lower in type 2 diabetes, but these are observations rather than treatment trials. MOTS-c has no approval from any regulator we verified. The only completed clinical trial linked to the peptide used CB4211, a modified analogue (CohBar phase 1a/1b, NCT03998514, 88 enrolled), which the sponsor reported as well tolerated, with a liver-fat reduction similar to placebo in its small phase 1b portion. A phase 2a trial of MOTS-c in prediabetes with overweight or obesity (NCT07505745) is registered as recruiting, with no results. In the US, MOTS-c is a non-approved substance; the FDA's Pharmacy Compounding Advisory Committee voted 7-5 (2 abstentions) on 23 July 2026 to recommend it for the 503A Bulks List (as reported by AJMC), against FDA staff's written proposal not to add it. That vote is non-binding and no final FDA decision had been verified.

Evidence: For MOTS-c itself the published therapeutic evidence is animal (mainly mice and rats) and cell work, plus human observational data (levels rise with exercise and are reported lower in type 2 diabetes). FDA's 2026 briefing document states it identified no clinical studies or human exposure data for MOTS-c by any route. The only completed human trial connected to the peptide tested CB4211, a modified analogue, in a phase 1a/1b safety study (NCT03998514); the sponsor reported acceptable tolerability, and although liver enzymes (ALT, AST) and glucose fell more than on placebo in the 20-person phase 1b portion, the reported drop in liver fat (MRI-PDFF) was about the same as placebo (5.03% vs 4.88%). A phase 2a trial of MOTS-c in prediabetes (NCT07505745, sponsor Hudson Biotech, estimated 120 participants) began in February 2026 and has no results yet. Animal effects should not be assumed to carry over to people.[src][src][src][src][src][src]

Known safety signals

  • FDA's 2026 review found no clinical studies or human exposure data for MOTS-c by any route, so its safety risks in humans are unknown; it also found no in-vivo pharmacokinetic, acute toxicity, genotoxicity, reproductive or carcinogenicity studies.[src]
  • FDA searches of its adverse event database (through 9 March 2025) retrieved no reports for MOTS-c, but FDA notes compounders generally do not report adverse events, so absence of reports is not evidence of safety.[src]
  • FDA is concerned that an injected 16-amino-acid peptide could provoke an immune response, and that impurities or peptide aggregation in formulated products could raise this risk; FDA found only limited information on MOTS-c immunogenicity and could not rule this risk out.[src]
  • Product identity is a documented problem: MOTS-c is a common name rather than a formal nonproprietary name, and FDA has seen different salts and derivatives, including different active moieties, sold under the same name; FDA calls this a safety risk because patients may receive a different substance than the one ordered.[src]
  • For the analogue CB4211 (not MOTS-c itself), the sponsor reported no serious adverse events in its phase 1a/1b study; the only adverse events in more than 10% of treated participants were mild to moderate injection-site reactions.[src]

Around the world

Is MOTS-c legal where you live?

CountryStatusWhat it meansVerified
AustraliaNot approvedNo MOTS-c product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.Details →source2026-09-29
BrazilNot approvedNo Brazilian registration for MOTS-c; the unregistered-peptide rules applyDetails →source2026-09-29
CanadaProhibitedNot authorised; named in Health Canada's April 2026 seizure advisory and banned in sportDetails →source2026-09-29
ChinaNot approvedNot an approved medicine in China; unlawful to sell as a drug, and it is named on the WADA banned list.Details →source2026-09-29
European UnionNot approvedNo EU marketing authorisation; named on the WADA 2026 prohibited list (S4.4.1)Details →source2026-09-29
IndiaNot approvedNot approved in India: no CDSCO marketing permission found for MOTS-c; making or selling it as a medicine would be unapprovedDetails →source2026-09-29
JapanNot approvedNot an approved medicine in Japan; MOTS-c is absent from PMDA's lists, and WADA bans it in sportDetails →source2026-09-29
MexicoNot approvedNo registration for MOTS-c found in COFEPRIS listsDetails →source2026-09-29
New ZealandNot approvedNo Medsafe-approved medicine contains MOTS-c; mitochondria-derived peptides are prescription-onlyDetails →source2026-09-29
United Arab EmiratesNot approvedNot approved in the UAE: no marketing authorisation for MOTS-c; unapproved peptide products are under EDE enforcementDetails →source2026-09-29
United KingdomNot approvedMOTS-c is not licensed in the UKDetails →source2026-09-29
United StatesNot approvedNo FDA approval; FDA found no human exposure data, and a July 2026 advisory vote to consider it is non-bindingDetails →source2026-09-29

Recent history

  1. 2026-07-23

    FDA advisory committee votes on seven peptides for the 503A compounding list, against FDA staff advice

  2. 2026-04-15

    FDA removes 12 peptides from the 'Category 2' safety-risk list

Full timeline →

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Sources (57)

  1. 01The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistanceCell Metabolism (via PubMed) · 2015-03-03 · accessed 2026-09-29
  2. 02MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasisNature Communications (via PubMed) · 2021-01-20 · accessed 2026-09-29
  3. 03FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026US Food and Drug Administration · 2026-05-11 · accessed 2026-09-29
  4. 04A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease (NCT03998514)ClinicalTrials.gov (CohBar, Inc.) · 2021-05-11 · accessed 2026-09-29
  5. 05CohBar Announces Positive Topline Results from the Phase 1a/1b Study of CB4211 Under Development for NASH and ObesityCohBar, Inc. (GlobeNewswire) · 2021-08-10 · accessed 2026-09-29
  6. 06MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity (NCT07505745)ClinicalTrials.gov (Hudson Biotech) · 2026-04-01 · accessed 2026-09-29
  7. 07MOTS-c: A promising mitochondrial-derived peptide for therapeutic exploitationFrontiers in Endocrinology (via PubMed) · 2023 · accessed 2026-09-29
  8. 08UniProtKB A0A0C5B5G6 (MOTSC_HUMAN): Mitochondrial-derived peptide MOTS-cUniProt Consortium · 2026 · accessed 2026-09-29
  9. 09Development of a mass spectrometry based detection method for the mitochondrion-derived peptide MOTS-c in plasma samples for doping control purposesRapid Communications in Mass Spectrometry (via PubMed) · 2019-02-28 · accessed 2026-09-29
  10. 10The Mitochondrial-Encoded Peptide MOTS-c Translocates to the Nucleus to Regulate Nuclear Gene Expression in Response to Metabolic StressCell Metabolism (via PubMed) · 2018-09-04 · accessed 2026-09-29
  11. 11Mitochondrial-encoded peptide MOTS-c prevents pancreatic islet cell senescence to delay diabetesExperimental & Molecular Medicine · 2025-08-25 · accessed 2026-09-29
  12. 12The mitochondrial-derived peptide MOTS-c: a player in exceptional longevity?Aging Cell (via PubMed) · 2015-12 · accessed 2026-09-29
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