Is MOTS-c FDA-Approved? Status and Research (Checked Nov 5, 2026)

No. MOTS-c is not an FDA-approved drug for any use (checked Nov 5, 2026). FDA's safety-risk page lists MOTS-c as previously Category 2; FDA's current list shows it as nominated but withdrawn [FDA-RISK]. MOTS-c is one of six peptides named in an HHS draft policy (proposed, not final) published Oct 30, 2026 [HHS-FR]. Public comments close Nov 13, 2026 at 11:59 PM ET [DOCKET]. A draft policy is not FDA approval and can change. Compounded drugs are not FDA-approved.

FDA status (checked Nov 5, 2026)

ItemStatusSource, date checked
FDA-approved MOTS-c productNone[FDA-RISK], Nov 5 2026
FDA 503A safety-risk listPreviously Category 2; now shown as nominated but withdrawn[FDA-RISK], Nov 5 2026
FDA advisory committee (Jul 23-24 2026)FDA briefing weighed against adding it to the 503A bulks list; committee vote 7-5 in favor (advisory, not binding)[FDA-MOTS], [AJMC]
HHS draft policy (proposed, not final)Named in Appendix A, one of six peptides (with BPC-157, epitalon, KPV, Semax, TB-500)[HHS-FR], [HHS-APP]
Public comment deadlineNov 13, 2026, 11:59 PM ET[DOCKET] HHS-OASH-2026-0496
What changes nextHHS reviews comments; it may finalize, change or drop the draft. Until then, nothing about MOTS-c's FDA status changes.[HHS-FR]

Links: Full detail on the six peptides -> /rfk-peptides. What the HHS draft says -> /hhs-peptide-draft-policy.

Last updated Nov 5, 2026. Approval line checked Nov 5, 2026. Compounding sources checked Nov 5, 2026.

Research summary (plain language)

  • What it is: a small 16-amino-acid peptide coded by DNA in mitochondria, described in 2015 [R1].
  • In mice: it reduced diet-induced weight gain and insulin resistance [R1], and improved physical performance in young and older mice [R2].
  • In people: no completed clinical trial of MOTS-c itself has posted results (ClinicalTrials.gov, checked Nov 5 2026). A phase 2, placebo-controlled trial in adults with prediabetes and overweight or obesity is recruiting (NCT07505745; about 120 people; primary completion estimated Feb 2027) [CT1]. A related lab-made analog, CB4211, was tested in a completed phase 1a/1b study (88 people) [CT2]; CB4211 is a different molecule than MOTS-c.
  • Safety: FDA says it has identified no human exposure data for MOTS-c, and has raised purity and immune-reaction concerns [FDA-RISK]. Long-term safety in people is unknown.

FAQ (dated Nov 5, 2026)

Is MOTS-c FDA-approved?

No. There is no FDA-approved MOTS-c product for any use, as of Nov 5, 2026 [FDA-RISK].

What is MOTS-c's FDA status?

FDA previously placed MOTS-c in Category 2 (substances that may pose significant safety risks in compounding). FDA's current list shows it as nominated but withdrawn [FDA-RISK]. That is not a safety clearance.

Is MOTS-c in the HHS peptide policy?

Yes. It is one of six peptides in the HHS draft policy (proposed, not final) published Oct 30, 2026 [HHS-FR]. A draft is not binding and is not FDA approval. Compounded drugs are not FDA-approved.

When do comments on the HHS draft close?

Nov 13, 2026 at 11:59 PM ET, on docket HHS-OASH-2026-0496 [DOCKET].

Is MOTS-c one of the "RFK peptides"?

"RFK peptides" is an informal nickname for the six peptides in the HHS draft, not an HHS term. MOTS-c is on that list. See /rfk-peptides.

Has MOTS-c been tested in people?

No completed MOTS-c trial has posted results. A phase 2 trial is recruiting, with results not expected before 2027 [CT1].

What does the research show?

Mouse studies found effects on metabolism and exercise capacity [R1][R2]. Mouse results often do not carry over to people.

Does PeptideX give doses or sellers?

No. This page is education, not medical advice. Talk to a licensed clinician.

Sources (verified Nov 5 2026)

  1. [R1] Lee C et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab 2015;21:443-454. PMID 25738459. https://pubmed.ncbi.nlm.nih.gov/25738459/
  2. [R2] Reynolds JC et al. MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis. Nat Commun 2021;12:470. PMID 33473109. https://pubmed.ncbi.nlm.nih.gov/33473109/
  3. [CT1] NCT07505745, MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity. Phase 2, Recruiting, start Feb 2 2026. https://clinicaltrials.gov/study/NCT07505745
  4. [CT2] NCT03998514, A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With NAFLD. Completed Apr 19 2021, 88 enrolled. https://clinicaltrials.gov/study/NCT03998514
  5. [FDA-RISK] https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  6. [FDA-MOTS] FDA PCAC Jul 23-24 2026 briefing, https://www.fda.gov/media/193347/download (HTTP 200 Nov 5)
  7. [AJMC] https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
  8. [HHS-FR] 91 FR 68526, FR Doc 2026-22192. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances
  9. [HHS-APP] HHS draft policy appendices (PDF). https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
  10. [DOCKET] https://www.regulations.gov/docket/HHS-OASH-2026-0496
  11. History: [OIRA] OIRA. Pending EO 12866 Review, RIN 0910-ZD94. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Last checked 2026-11-05

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