MOTS-c has a new human trial, not proven human benefits.
MOTS-c is widely sold for weight loss, energy, longevity, and exercise claims. The foundational results come from cells and rodents, while human studies mostly measure naturally circulating MOTS-c. One exact-named Phase 2a trial is now recruiting with no results posted. This guide keeps all four records separate.
There is now a MOTS-c intervention study, but there is still no posted human outcome.
ClinicalTrials.gov lists a recruiting 120-participant Phase 2a study of an intervention named MOTS-c in adults with prediabetes and overweight or obesity. Its first posted date is April 1, 2026. The registry has no results and does not state whether the intervention is MOTS-c free base or acetate.
FDA's May 11, 2026 briefing says it found no MOTS-c clinical study or human exposure data. The two dated primary records do not currently reconcile, so this guide preserves the conflict instead of silently choosing one.
Read the MOTS-c record in four fields.
This is a sourced status snapshot, not a safety score, treatment recommendation, or seller certification. Each field links back to the detailed record below.
Recruiting Phase 2a
The exact-named 120-participant trial is recruiting and has no posted results.
Inspect the human evidenceNo posted human outcome
Circulating-peptide studies and preclinical findings do not prove a treatment benefit.
Audit the popular claimsNo FDA-approved product
The current FDA and registry records conflict on whether a human intervention was found.
Check status and destination routesDated US price boards
Two primary records do not currently reconcile
FDA's dated briefing says it searched ClinicalTrials.gov and found no human administration study. The NCT07505745 record says it was first posted forty days earlier and describes a recruiting Phase 2a MOTS-c intervention. The public records do not explain the mismatch. Possible differences in search timing, identity matching, record availability, or review workflow cannot be resolved from the documents alone.
FDA says no administered human record identified
The agency briefing states that its review included ClinicalTrials.gov and did not identify clinical studies or human exposure data for MOTS-c by any route.
Inspect the FDA document →ClinicalTrials.gov posts a recruiting Phase 2a record
NCT07505745 describes randomized subcutaneous MOTS-c treatment in 120 estimated participants, with an actual February 2026 start and no results posted.
Inspect the registry record →Preserve both dated claims
Preserve both records. Treat the FDA conclusion as the agency's dated compounding review and the registry as a current study plan with no results. Do not convert either into proof that treatment works or is safe.
Read the evidence method →Biology, biomarkers, intervention trials, and approval answer different questions.
The strongest useful answer preserves the exact intervention and study stage. Endogenous MOTS-c in a blood sample, synthetic MOTS-c in a mouse, CB4211 in a person, and a seller vial are not interchangeable.
MOTS-c is a 16-amino-acid mitochondrial-derived peptide
FDA evaluates MOTS-c free base and MOTS-c acetate as distinct bulk drug substances. The exact form, sequence, formulation, route, and finished product still have to match before evidence can transfer to a vial or claim.
Weight and glucose signals come mainly from cells and rodents
The foundational record includes AMPK-linked mechanisms and mouse findings involving diet-induced obesity and insulin resistance. FDA says dose-response information is incomplete and the clinical relevance of these nonclinical findings remains unknown.
People have been studied as a source of endogenous MOTS-c data
Human exercise, metabolic, and cardiovascular studies measure MOTS-c already circulating in blood or present in tissue. Those studies can describe association or physiology, but they do not show that injecting synthetic MOTS-c causes weight loss or improves health.
One new exact-named Phase 2a trial is recruiting
ClinicalTrials.gov lists NCT07505745 as a 120-participant recruiting study of subcutaneous MOTS-c for insulin sensitivity in adults with prediabetes and overweight or obesity. No results are posted, and the registry does not specify free base versus acetate.
No FDA-approved MOTS-c product
FDA staff proposed not adding MOTS-c free base or acetate to the 503A Bulks List. On July 23, PCAC recommended inclusion after reported 7-5-2 votes on the paired form questions. That advice is nonbinding and does not itself approve a drug, immediately change the list, or finally decide either substance.
What the MOTS-c record shows, and what it cannot prove.
Each row keeps the signal, exact evidence type, and missing inference together.
MOTS-c causes weight loss in people
Foundational studies reported lower weight gain and improved metabolic measures in high-fat-fed mice. A new 120-participant Phase 2a registry record includes body weight and metabolic outcomes.
The mouse results are not human treatment results. NCT07505745 is recruiting and has no posted outcomes, so the current record cannot establish average weight loss, responder rates, durability, or comparison with approved obesity medicines.
MOTS-c improves insulin sensitivity
Cell and animal research provides a mechanistic and preclinical signal. Human studies also report associations between endogenous circulating MOTS-c and metabolic measures.
An endogenous biomarker association does not show that an administered product produces the same effect. The recruiting Phase 2a trial is designed to test insulin sensitivity, but it has not posted results.
Exercise proves MOTS-c works as a performance peptide
Human studies have measured changes in circulating or skeletal-muscle MOTS-c around endurance and resistance exercise conditions.
Exercise-induced physiology is not an administration trial. Measuring a naturally occurring peptide after exercise does not establish that an injected research product improves strength, endurance, recovery, body composition, or performance.
The CB4211 human trial proves MOTS-c safety
NCT03998514 studied CB4211 in 88 participants. The sponsor described CB4211 in an SEC filing as an improved MOTS-c analog.
An analog is not the exact native MOTS-c sequence or necessarily the same active moiety, pharmacokinetics, formulation, impurity profile, or risk. The registry also has no posted results, so it cannot supply a public event rate here.
No reported side effects means MOTS-c is safe
FDA's FAERS searches through March 9, 2025 retrieved no MOTS-c adverse-event reports, while the agency also found no administered human exposure data in its review.
No report is not a safety study. FDA highlights unresolved immunogenicity, aggregation, peptide-related impurity, endotoxin, formulation, route, sterility, and characterization concerns, and event rates remain unknown.
One FDA review, one recruiting treatment trial, two biomarker records, and one analog trial.
Only NCT07505745 lists an exact-named MOTS-c treatment intervention. It has no posted result. Every other row has a boundary that prevents it from proving the same claim.
FDA search for administered MOTS-c evidence
- Identity
- MOTS-c free base or MOTS-c acetate
- Design
- Regulatory literature, trial-registry, safety, and chemistry review
- Participants
- 0 identified by FDA
The May 11 FDA briefing says the agency did not identify a clinical study or human exposure record for either reviewed bulk drug substance. It therefore could not estimate pharmacokinetics, effectiveness, adverse-event frequency, or long-term safety.
MOTS-MET insulin-sensitivity trial
- Identity
- Intervention named MOTS-c; free base or acetate not stated
- Design
- Phase 2a, randomized, double-blind, placebo-controlled
- Participants
- 120 estimated
ClinicalTrials.gov first posted this record on April 1, 2026. It lists 12 weeks of subcutaneous treatment in adults with prediabetes and overweight or obesity, followed through week 16 for safety. A recruiting registry record is a study plan, not evidence of benefit or safety.
MOTS-c as a cardiovascular biomarker
- Identity
- Endogenous circulating MOTS-c measurement
- Design
- Prospective observational follow-up
- Participants
- 120 estimated
This study measures naturally circulating MOTS-c alongside platelet reactivity and cardiovascular outcomes in people with type 2 diabetes and coronary artery disease. It can test association, but it cannot establish the effects of administering synthetic MOTS-c.
Acute exercise and endogenous MOTS-c
- Identity
- Plasma and skeletal-muscle MOTS-c measurement
- Design
- Randomized endurance, resistance, or control experiment
- Participants
- 30
The investigators measured MOTS-c before and after controlled exercise conditions. This helps explain human physiology, but does not test a seller vial, an injected dose, weight loss, recovery, or clinical treatment benefit.
CB4211 in healthy participants and NAFLD
- Identity
- CB4211, described by its sponsor as a MOTS-c analog
- Design
- Completed Phase 1a/1b randomized, placebo-controlled study
- Participants
- 88 actual
This is a real human administration record for a related development candidate, not direct evidence for exact MOTS-c free base or acetate. Molecule identity and public results must match before safety or efficacy findings can transfer.
The research market is already larger than the completed human-result record.
Public availability is a market fact, not clinical validation. These figures describe dated 10 mg US seller pages and exclude coupons, checkout-only discounts, shipping, and unconfirmed rows from the in-stock range.
07
Seven public US seller pages met the current 10 mg comparison rules. Inclusion does not mean approval, recommendation, product authentication, or provider certification.
Open every source row →05
Four rows carried an in-stock signal when checked. Availability can change and does not establish legality, fulfillment, composition, sterility, or destination access.
Check source freshness →$37.00-$99.00
The current in-stock range spans 168% from low to high before landed cost. Compare documentation and availability beside price, then verify the exact product and seller.
Compare landed cost →The July 23 recommendation is meaningful, but it is not approval or final action.
FDA staff analysis, advisory committee discussion, and final agency action are separate stages.
Do not add either MOTS-c form
FDA proposes not adding MOTS-c free base or MOTS-c acetate to the 503A Bulks List after weighing characterization, historical use, effectiveness, safety, and available alternatives.
Read the briefing →Favorable committee recommendation
PCAC recommended inclusion of both reviewed forms after reported 7-5-2 votes. The advice is nonbinding, does not approve MOTS-c, and does not immediately change the 503A Bulks List.
Open the verified vote record →Final FDA determination
FDA can complete its review after considering advisory input. Until a later agency record is published, the current position remains a proposal.
Track the full process →MOTS-c product status and access depend on the destination.
Health Canada currently names MOTS-C among seized unauthorized injectable peptide drugs. That is an important Canadian product finding, but it does not decide approval, prescription, import, compounding, seller, or product status in every other jurisdiction.
Eleven MOTS-c questions, answered from the current record.
This is educational reporting, not medical advice, a prescription, or a use protocol.
What is MOTS-c?
MOTS-c, short for mitochondrial open reading frame of the 12S rRNA-c, is a 16-amino-acid mitochondrial-derived peptide. FDA separately evaluates MOTS-c free base and MOTS-c acetate as distinct bulk drug substances. A product label using the common name does not establish which form is present, exact sequence, identity, purity, aggregation, endotoxin level, sterility, formulation, storage integrity, or vial contents.
What does MOTS-c do?
The research record links endogenous MOTS-c to cellular energy and metabolic signaling, with AMPK-related pathways commonly discussed. Synthetic MOTS-c produced metabolic, weight, bone, and cardiovascular signals in cell and rodent models reviewed by FDA. Those mechanisms and animal findings generate hypotheses. They do not establish what an administered product does in people, how large an effect would be, or whether benefits exceed risks.
Does MOTS-c help with weight loss?
No completed controlled human result cited here establishes MOTS-c weight loss. Mouse studies reported less weight gain under specific experimental conditions, but FDA says the clinical relevance is unknown. NCT07505745 is now recruiting adults with prediabetes and overweight or obesity and includes body-weight outcomes, but it has no posted results. A planned endpoint is not a measured effect and cannot support a pounds-lost or percentage-lost claim.
Does MOTS-c improve insulin sensitivity?
Preclinical work and human biomarker studies provide a plausible metabolic signal, but they answer different questions. Measuring naturally circulating MOTS-c and finding an association with insulin-related measures does not prove that administering synthetic MOTS-c improves insulin sensitivity. The recruiting MOTS-MET Phase 2a trial is designed to test an oral-glucose-tolerance-derived insulin-sensitivity endpoint, and no outcome has been posted.
Has MOTS-c been tested in humans?
The most accurate current answer needs two dates. FDA's May 11, 2026 briefing says it found no MOTS-c clinical study or human exposure. ClinicalTrials.gov says NCT07505745 was first posted April 1, 2026 and is recruiting 120 participants for a Phase 2a study of an intervention named MOTS-c. That trial has no posted results, and its registry does not specify free base versus acetate. Human biomarker studies are not administration studies.
What are the side effects of MOTS-c?
A dependable MOTS-c side-effect profile or event rate cannot yet be calculated from completed exact-intervention results. FDA found no administered human exposure in its review and says potential human risks are unknown. The agency highlights immunogenicity, aggregation, peptide-related impurities, active-ingredient characterization, formulation, route, endotoxin, sterility, and product-quality concerns. A recruiting trial's safety endpoint does not supply results before data are posted.
Is MOTS-c FDA approved?
No FDA-approved MOTS-c drug is established by the cited records. FDA states that neither MOTS-c free base nor MOTS-c acetate is a component of an FDA-approved drug. FDA staff proposed non-inclusion, but PCAC recommended inclusion after reported 7-5-2 votes on July 23, 2026. That nonbinding advice does not immediately change the 503A Bulks List, approve a drug, or decide another jurisdiction.
Is there a MOTS-c Phase 2 trial?
Yes, ClinicalTrials.gov lists NCT07505745 as a recruiting Phase 2a randomized, double-blind, placebo-controlled trial with an estimated 120 adults. The record describes daily subcutaneous treatment for 12 weeks and follow-up through week 16, with insulin sensitivity and treatment-emergent adverse events among primary outcomes. No results are posted. Registration, recruitment, estimated enrollment, and planned endpoints do not show completion or success.
Is CB4211 the same as MOTS-c?
No. The CB4211 sponsor described it in a U.S. Securities and Exchange Commission filing as an improved analog of naturally occurring MOTS-c. NCT03998514 studied CB4211 in 88 participants, but an analog can differ in sequence, active moiety, exposure, pharmacokinetics, formulation, and risk. That trial therefore cannot be presented as direct human evidence for MOTS-c free base, MOTS-c acetate, or a seller-labelled MOTS-c vial.
What is the correct MOTS-c dosage?
There is no FDA-approved MOTS-c label or established self-use dosage for the research products discussed here. The new trial registry describes a fixed once-daily regimen but does not publicly state the dose in the summarized intervention record. Animal amounts, seller instructions, forum schedules, CB4211 doses, or unverified clinic protocols should not be converted into a personal regimen. This guide does not provide reconstitution, injection, cycling, dosing, or stacking instructions.
Can you buy MOTS-c legally?
The answer depends on the exact product, intended use, destination, import route, medicine authorization, pharmacy rules, professional status, and seller record. Health Canada specifically names MOTS-C among seized unauthorized injectable peptide drugs and warns that research-use-only wording does not create an exemption. That Canadian finding does not decide another country's law. Use the linked country and local regulator routes rather than relying on a seller's shipping claim.
Endogenous biology is not a finished product.
A naturally circulating peptide, synthetic free base, acetate salt, analog, animal intervention, registered trial product, compounded preparation, and online research vial can differ in identity, exposure, impurities, formulation, and risk. The exact intervention must match before a result transfers.
FDA approval, 503A list status, country access, seller availability, documentation, and product authentication are separate records. None supplies an individual treatment recommendation.