Prof. PeptideProf. Peptide
Guide

How is MOTS-c dosed?

No completed human trial of MOTS-c itself exists. One trial is currently recruiting. A Phase 1 trial sometimes cited in MOTS-c discussions actually tested a different, related molecule — the analog CB4211 — and this page keeps that distinction sharp throughout, never presenting the analog’s result as MOTS-c’s own.

Topic: Reading what has actually been studied under the name MOTS-c, and keeping its analog CB4211 clearly separate

Audience: Anyone comparing a MOTS-c dose figure against what has (and hasn’t) actually been studied

Reading time: 8–10 minutes

No approved product, no completed human trial of MOTS-c itself

MOTS-c has not been approved by the FDA, EMA, or any regulatory body. FDA’s own July 2026 evaluation states plainly that it has not identified any human exposure data for MOTS-c administered by any route. One trial is currently recruiting. Every figure on this page is a fact about a specific study — not a recommendation.

On this page
  1. 1.MOTS-c and CB4211: a peptide and its analog
  2. 2.The one recruiting trial of MOTS-c itself
  3. 3.The CB4211 trial: real data, different molecule
  4. 4.The animal evidence, reported as animal doses
  5. 5.Is there a community-reported dose?
  6. 6.Regulatory position: withdrawn from Category 2, weighed against 503A
  7. 7.Related pages
  8. 8.FAQ
  9. 9.References

MOTS-c and CB4211: a peptide and its analog

MOTS-c is a 16-amino-acid mitochondrial-derived peptide, encoded within the mitochondrial genome, studied for effects on insulin sensitivity and metabolic homeostasis. CB4211 is a separate, synthetic molecule — an engineered analog of MOTS-c developed by CohBar Inc., described in the company’s own materials as such, not as MOTS-c itself. FDA’s own evaluation of MOTS-c does not reference CB4211 at all, confirming that FDA does not treat CB4211’s trial data as evidence for MOTS-c either. The MOTS-c profile covers the mechanism and broader research context in more depth; this page exists specifically to read every study directly and keep that molecule distinction visible throughout.

The evidence below is ordered the way the site’s own convention places it: the one trial of MOTS-c itself first, then the CB4211 trial (clearly labeled as a different molecule), then the animal evidence — always reported as animal doses, never converted to a human figure — then community-reported practice last, attributed and marked unverified.

The one recruiting trial of MOTS-c itself

MOTS-c for Improving Insulin Sensitivity — Prediabetes/Overweight/Obesity

NCT07505745

RECRUITING (confirmed against the live ClinicalTrials.gov API on the date this page was built); no results yet

Design: Phase 2 trial testing MOTS-c for insulin sensitivity in adults with prediabetes and overweight or obesity.

Arms: 120 participants planned (estimated): MOTS-c or placebo, subcutaneous injection, fixed dose once daily for 12 weeks.

The only trial of MOTS-c itself found for this page — currently recruiting, with no efficacy or safety results posted yet.

The MOTS-c reconstitution calculator performs the arithmetic of converting a vial and reconstitution volume into syringe units for a given milligram figure; it does not set a schedule.

The CB4211 trial: real data, different molecule

CB4211 — a MOTS-c Analog, Not MOTS-c Itself (Phase 1a/1b)

NCT03998514

COMPLETED, but with a temporary suspension mid-trial; topline results only, no peer-reviewed publication found

Molecule: CB4211, CohBar Inc.'s own engineered analog of MOTS-c — described by the company's own materials as such, not MOTS-c itself.

Design: 3-part randomized, double-blind, placebo-controlled study of single and multiple ascending subcutaneous doses in healthy non-obese subjects and subjects with nonalcoholic fatty liver disease (NAFLD).

Arms: 88 participants (actual, per the registry) across ascending dose cohorts in Phase 1a, and 20 subjects with NAFLD in Phase 1b, receiving 25 mg subcutaneously once daily for 4 weeks versus placebo.

Endpoint reported: Phase 1b topline (August 2021 company announcement, not peer-reviewed): reported reductions in ALT and AST, a reduction in glucose, and a trend toward lower body weight after 4 weeks, versus placebo.

Adverse events reported: Phase 1a dosing was temporarily suspended on November 5, 2018 (per CohBar's own SEC 8-K filing) due to "mild injection site reactions that have been unexpectedly persistent" — described as painless subcutaneous bumps where some of the dose remained at the injection site. The trial resumed under an amended protocol and was later reported as safe and well tolerated.

Topline company data — a real, registered, completed trial, but its efficacy findings were never published in a peer-reviewed paper, and every finding here describes CB4211, an analog, not MOTS-c itself.

The animal evidence, reported as animal doses

The dose below is what was given to an animal in a specific published study. Prof. Peptide does not convert it into a human-equivalent figure by allometric scaling or any other method.

Lee et al. 2015 — Metabolic Homeostasis, Obesity, and Insulin Resistance (MOTS-c Itself)

Lee C, Zeng J, Drew BG, et al. Cell Metab. 2015;21(3):443–454. PMID 25738459.

Species: Mouse — C57BL/6 (insulin sensitivity arm) and CD-1 on a 60% high-fat diet (obesity arm)

Dose: 5 mg/kg/day (C57BL/6, insulin sensitivity arm); 0.5 mg/kg/day (CD-1 high-fat-diet arm)

Route: Intraperitoneal

Duration: 7 days (insulin sensitivity arm, N=6–8 per group); 8 weeks (diet-induced obesity arm, N=10 per group)

Finding: MOTS-c treatment prevented age-dependent and high-fat-diet-induced insulin resistance, and prevented diet-induced obesity, without suppressing food intake. This is the landmark paper establishing MOTS-c's metabolic effects in animal models.

Is there a community-reported dose?

Yes — 5–10 mg subcutaneously once daily, sometimes 5 mg twice weekly for maintenance, over a 4–12 week cycle, is the figure consistently reported across vendor and community sources and already documented on the MOTS-c profile. It is reported here, below the trial and animal evidence above, as observed practice attributed to where it circulates — not derived from either.

It diverges from the one animal study on this page in both magnitude and units: a flat 5–10 mg human dose, versus a 0.5–5 mg per kilogram body-weight-based animal dose in Lee et al. 2015. No source was found deriving the community figure from that study’s own numbers, or from CB4211’s 25 mg human dose (itself a different molecule’s figure, not MOTS-c’s).

Regulatory position: withdrawn from Category 2, weighed against 503A

FDA’s own staff evaluation weighs against 503A eligibility, on the complete absence of human data.

Read directly from FDA’s own July 2026 Pharmacy Compounding Advisory Committee briefing document for MOTS-c: the conclusion states that “a balancing of the criteria weighs against MOTS-c free base or MOTS-c acetate being placed” on the 503A Bulks List. Separately, checked directly against FDA’s bulk-substance safety-risk page, MOTS-c appears in the 503A “nominated but withdrawn” table, with the stated concern that “FDA has not identified any human exposure data on drug products containing MOTs-C administered via any route of administration.”

At the same July 23–24, 2026 PCAC public meeting where BPC-157 and TB-500 were voted on, the committee voted 8-6 (one abstention) in favor of adding MOTS-c to the 503A Bulks List — against FDA staff’s own recommendation. That count is attributed to convergent press reporting of the public meeting, the same sourcing basis used on the BPC-157 and TB-500 guides. The vote is non-binding; FDA had not acted on it as of this page’s build. No FDA warning letter specifically naming MOTS-c was found.

Research-grade MOTS-c, of the kind sold by the vendors Prof. Peptide tracks elsewhere on this site, is neither an approved product nor a verified lawfully compounded one under the current regulatory position above. It is sold labeled for laboratory research use, not for human administration, and it is not dispensed against a prescription.

FAQ

Has MOTS-c been tested in a completed human trial?
No. FDA's own July 2026 evaluation states directly that FDA "has not identified any human exposure data on drug products containing MOTs-C administered via any route of administration." One trial of MOTS-c itself, NCT07505745, is currently recruiting, with no results yet.
Is CB4211 the same thing as MOTS-c?
No. CB4211 is a synthetic analog of MOTS-c, engineered and developed by CohBar Inc. — its own conference materials describe it explicitly as "a novel analog of MOTS-c," not MOTS-c itself. FDA's own MOTS-c evaluation document does not mention CB4211 at all, meaning FDA does not treat its trial data as evidence for MOTS-c either. Any figure or finding attributed to CB4211 on this page is reported as being about CB4211, not MOTS-c.
What happened in the CB4211 Phase 1 trial?
NCT03998514, a Phase 1a/1b trial of CB4211 (N=88 total), was temporarily suspended in November 2018 — confirmed directly from CohBar's own SEC filing — after "mild injection site reactions that have been unexpectedly persistent," described as painless bumps felt under the skin where some of the dose remained. The company reported the drug was safe and well tolerated after an amended protocol, and Phase 1b (25 mg subcutaneously once daily for 4 weeks in 20 subjects with NAFLD) later reported topline improvements in liver enzymes (ALT/AST) and glucose in an August 2021 announcement — that result is topline company data, with no peer-reviewed publication found, and it describes CB4211, not MOTS-c.
What is the MOTS-c trial that's currently recruiting?
NCT07505745, a Phase 2 trial testing subcutaneous MOTS-c once daily for 12 weeks, in adults with prediabetes and overweight or obesity, for insulin sensitivity. It is currently recruiting, with an estimated 120 participants planned and no results posted yet.
What doses have been studied in animals?
Lee et al. 2015, the landmark MOTS-c paper, used two separate mouse arms: 5 mg/kg/day, intraperitoneal, for 7 days in C57BL/6 mice (improved insulin sensitivity on glucose tolerance testing), and 0.5 mg/kg/day, intraperitoneal, for 8 weeks in CD-1 mice on a high-fat diet (reduced diet-induced obesity and restored glucose tolerance). These are animal doses from a specific published study, reported as such — not converted into a human figure.
Is there a commonly reported MOTS-c dosing protocol?
Yes — 5–10 mg subcutaneously once daily, sometimes 5 mg twice weekly for maintenance, over a 4–12 week cycle, is the figure consistently reported across vendor and community sources and already documented on the MOTS-c profile. It diverges from the one animal study on this page in both magnitude and units: a flat 5–10 mg human dose versus a 0.5–5 mg/kg body-weight-based animal dose — no source was found deriving the community figure from the animal study's own numbers.
What is MOTS-c's current FDA compounding status?
Checked directly against FDA's own bulk-substance safety-risk page: MOTS-c is in the 503A "nominated but withdrawn" table, not the active Category 2 list — the Category 2 listing (added 2023) was withdrawn in April 2026, the same procedural pattern as several other peptides. Separately, FDA's own July 2026 PCAC briefing document concludes the evaluation criteria "weigh against" MOTS-c being placed on the 503A Bulks List, citing the complete absence of human exposure data. The Pharmacy Compounding Advisory Committee's public meeting on July 23–24, 2026 voted 8-6 (one abstention) in favor of listing it anyway, per convergent press coverage of the same meeting reported for BPC-157 and TB-500 — non-binding, and FDA had not acted on it as of this page's build. No FDA warning letter naming MOTS-c was found.

References

  1. ClinicalTrials.gov. MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity, NCT07505745. https://clinicaltrials.gov/study/NCT07505745
  2. ClinicalTrials.gov. A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease, NCT03998514. https://clinicaltrials.gov/study/NCT03998514
  3. CohBar, Inc. CohBar Provides Update on CB4211 Clinical Trial. SEC Form 8-K exhibit, 2018-11-05. https://www.sec.gov/Archives/edgar/data/1522602/000121390018014875/f8k110518ex99-1_cohbar.htm
  4. Lee C, Zeng J, Drew BG, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443–454. PMID 25738459. https://pubmed.ncbi.nlm.nih.gov/25738459/
  5. U.S. Food and Drug Administration. FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23–24, 2026 — Evaluation of MOTS-c Bulk Drug Substances. https://www.fda.gov/media/193347/download
  6. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

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