# MOTS-c MOTS-c is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only. No study has given it to people, so nobody knows if it helps or how safe it is. Status checked: 2026-10-25. Last verified: 2026-10-25. Primary source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks This page has not been individually reviewed by a clinician. Information, not medical advice. | Fact | Value | Tier | Checked | Source | |---|---|---|---|---| | Also called | MOTS-c (free base), MOTS-c acetate, mitochondrial open reading frame of the 12S rRNA-c | primary | 2026-10-25 | [source](https://www.fda.gov/media/193347/download) | | Class | mitochondrial | primary | 2026-10-25 | [source](https://www.fda.gov/media/193347/download) | | Regulatory status | limbo | primary | 2026-10-25 | [source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) | | Status source read | 2026-10-23 | primary | 2026-10-25 | [source](https://www.fda.gov/media/94155/download) | | Evidence grade | animal-only | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) | ## Name MOTS-c Source: https://www.fda.gov/media/193347/download ## Summary A chain of 16 amino acids the body makes in small amounts. The kind sold is made in a lab and is in no FDA-approved drug. It is sold for weight loss and aging. Source: https://www.fda.gov/media/193347/download ## Short answer MOTS-c is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only. No study has given it to people, so nobody knows if it helps or how safe it is. Source: https://peptideindex.ai/methodology#short-answer ## Known risks - FDA warns that a MOTS-c shot may set off the immune system. Peptides can clump together, which can make this worse [^1] [^6]. - FDA says the name MOTS-c is used for more than one substance. A product sold as MOTS-c may not hold the form a doctor ordered [^6]. - FDA found no test results for impurities, clumps or germ toxins in MOTS-c powder sold for making shots [^6]. - FDA warns that shots made outside drug rules can carry germs or toxins straight into the blood. That can cause a life-threatening illness [^9]. - Sport rules ban MOTS-c, and labs can find it in an athlete's blood [^6] [^17]. Source: https://www.fda.gov/media/193347/download ## What nobody knows yet - No study has given MOTS-c to people, so nobody knows if it helps any human illness or what harm it does [^6]. - No animal study has checked MOTS-c for harm to organs, genes or unborn babies, or for cancer [^6]. - In a lab test, human blood broke MOTS-c into pieces within minutes. Nobody knows if a shot keeps enough of it in the body to do anything [^6] [^17]. - Nobody knows what MOTS-c attaches to in the body, so nobody can predict which organs it might affect [^6]. - People with diabetes or obesity have different natural levels of MOTS-c. Nobody knows if taking more would help them [^19]. Source: https://www.fda.gov/media/193347/download ## What it is MOTS-c is a chain of 16 amino acids [^6]. Amino acids are the building blocks of proteins. The body makes small amounts of MOTS-c from genes inside mitochondria, the parts of a cell that turn food into energy [^13] [^18]. It is found in the blood of people and rodents [^6]. Scientists first described it in 2015 [^6] [^13]. The MOTS-c that is sold is made in a lab [^6]. MOTS-c is part of no FDA-approved drug and has no official quality standard [^6]. It is sold in two forms, a free base and an acetate salt, and FDA treats them as two different substances [^6]. Websites promote it for energy, weight loss, blood sugar, exercise and slower aging [^6]. Sport rules ban it, and labs test athletes for it [^6] [^17]. Source: https://www.fda.gov/media/193347/download ## Where it stands legally MOTS-c is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 [^1] [^2]. That is not approval, and it does not make compounding lawful. FDA's meeting notice lists obesity and osteoporosis as the uses it reviewed, but websites promote MOTS-c for energy, exercise and slower aging [^4] [^6]. Checked 23 October 2026. Category 2 is FDA's list of substances that may present significant safety risks. Category 1 is the list of substances pharmacies may use while FDA reviews them [^3]. The pharmacy that nominated MOTS-c pulled its nomination, so it came off Category 2 [^1] [^6]. FDA then reviewed it on its own. FDA's scientists found no study of MOTS-c in people and advised against adding it to the list [^6] [^8]. On 23 July 2026, FDA's Pharmacy Compounding Advisory Committee met on MOTS-c [^4] [^5] [^7]. News and legal reports say it voted 7 to 5, with 2 members abstaining, to recommend adding MOTS-c to the list [^10] [^11] [^20]. FDA's meeting page does not show the vote [^5]. A committee vote is only advice [^11]. FDA decides by writing a rule, after public comment [^10] [^11]. Until then, a pharmacy that makes MOTS-c is outside federal law [^3] [^10]. Selling it for people to use is also illegal, even when the label says it is for research only [^9]. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## What the evidence shows The evidence grade is animal-only: the studies that show an effect used mice or rat cells, and FDA found no study that gave MOTS-c to people [^6]. FDA adds that these studies did not test how the effect changes with the amount given [^6]. Weight and blood sugar: in mice fed a fatty diet, MOTS-c shots limited weight gain and insulin resistance [^6] [^13]. Insulin resistance means the body responds poorly to insulin, the hormone that controls blood sugar. In female mice whose ovaries were removed, MOTS-c limited weight gain and fat build-up [^15]. In young, middle-aged and old mice, MOTS-c helped them run longer. Very old mice given it late in life stayed fit longer and lived a little longer [^6] [^14]. Bone: the evidence for osteoporosis, a disease that thins the bones, is thinner still. In a lab dish, MOTS-c pushed rat stem cells to become bone-making cells [^16]. In mice, shots at the top of the skull limited bone loss caused by plastic particles [^6]. Studies in people have only measured the MOTS-c the body makes on its own. Exercise raised it [^14]. A 2024 review found lower natural levels in people with diabetes and higher levels in people with obesity [^19]. These studies gave MOTS-c to nobody, so they are not evidence that taking it helps [^6] [^19]. A review by the team that found MOTS-c calls it a signal that controls muscle and fat, based on lab and animal work [^18]. Source: https://www.fda.gov/media/193347/download ## Legitimate ways to get it There is no legal way to get MOTS-c in the US today [^6]. No approved drug contains it, and Europe's drug agency lists no approved product with it [^6]. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list. MOTS-c is neither [^3] [^6]. That could change if FDA adds it by writing a rule after the committee vote [^10] [^11]. FDA found no clinical study of MOTS-c in people [^6]. Any open trial that gives MOTS-c would appear in the trials block below, with the date the official registry was last checked. FDA notes that approved drugs already exist for obesity and for osteoporosis [^6]. Source: https://www.fda.gov/media/193347/download ## How people are getting it anyway This section describes what happens and is not a recommendation. People who use MOTS-c get it in three main ways [^6]. The first is websites that sell it alone or mixed with other substances [^6]. Peptides sold this way often carry a label saying they are for research use only [^21]. FDA says that label does not make it legal to sell a drug meant for people [^9] [^12]. The second is pharmacies. One clinic says it gets MOTS-c from compounding pharmacies, though no outsourcing facility reported making it from 2017 to 2025 [^6]. The third is clinics. One wellness clinic offers a drip into a vein that contains MOTS-c, without saying what else is in it [^6]. In all three, nobody checks what is in the product the way FDA checks an approved drug. FDA found no test results for impurities, clumps or germ toxins in MOTS-c powder [^6]. FDA found no reports of harm from MOTS-c in its files. FDA says that does not show MOTS-c is free of harm, because pharmacies seldom report problems [^6] [^8]. Source: https://www.fda.gov/media/193347/download ## Access routes Source: https://www.fda.gov/media/193347/download ### None Detail: There is no legal route to MOTS-c in the US today. It is in no approved drug, has no official quality standard, and is not on the list pharmacies may use. Source: https://www.fda.gov/media/193347/download ## Unofficial channels Source: https://www.fda.gov/media/193347/download ### Research use seller What it is: Sold on websites, alone or mixed with other substances, often with a label saying it is for research use only. Legal position: FDA treats these products as unapproved new drugs when the seller's claims show they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) Documented risks: - FDA warns that injected drugs bypass some of the body's defenses and can carry toxins or germs that cause life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) - FDA says products sold under the name MOTS-c can hold different forms, so a person may get a different substance than the one a doctor ordered. (source: https://www.fda.gov/media/193347/download) Enforcement: - 2026-08-24: FDA warning letter to an online seller of research-use peptide shots. The letter did not name MOTS-c. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ### Compounding outside the rules What it is: Made by a pharmacy from bulk MOTS-c powder. One clinic says it gets MOTS-c from compounding pharmacies. Legal position: MOTS-c has no official quality standard, is in no approved drug and is not on the federal list, so a pharmacy may not compound it under section 503A. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act) Documented risks: - FDA found no study of MOTS-c in people by any route, so the safety of a compounded product is unknown. (source: https://www.fda.gov/media/193347/download) - FDA found no test results for impurities, clumps or germ toxins in MOTS-c powder offered for making shots. (source: https://www.fda.gov/media/193347/download) Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### Clinic or med spa What it is: Clinics that offer MOTS-c made by a compounding pharmacy, or a drip into a vein that contains it. Legal position: A clinic's prescription does not make MOTS-c lawful to compound. It is still a substance that is not on the federal list. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act) Documented risks: - FDA found no human exposure data on any product with MOTS-c, by any route, so it cannot say whether it causes harm. (source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) - One clinic's drip lists MOTS-c but not the other substances in it. (source: https://www.fda.gov/media/193347/download) Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ## Recruiting trials Snapshot date: 2026-10-25. A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record. None in this snapshot. Source: https://clinicaltrials.gov/api/v2/studies?query.intr=MOTS-c+acetate+OR+MOTS-c+free+base&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState ## Sources Source: https://www.fda.gov/media/193347/download ### 1. FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ### 2. FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/media/94155/download ### 3. FDA: bulk drug substances used in compounding under section 503A Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### 4. Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting Type: regulatory Tier: primary Source: https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html ### 5. FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 ### 6. FDA briefing document on MOTS-c for the July 2026 committee meeting, 11 May 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/media/193347/download ### 7. FDA: questions put to the committee at the July 2026 meeting Type: regulatory Tier: primary Source: https://www.fda.gov/media/193711/download ### 8. FDA: presentations to the committee on 23 July 2026, including MOTS-c Type: regulatory Tier: primary Source: https://www.fda.gov/media/193773/download ### 9. FDA warning letter to an online seller of research-use peptides, 24 August 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ### 10. McDermott Will & Schulte: what the July 2026 committee votes on peptides mean Type: legal-analysis Tier: legal-analysis Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ ### 11. FDA Law Blog: the committee recommends four peptides for the 503A list Type: legal-analysis Tier: legal-analysis Source: https://www.thefdalawblog.com/2026/07/peptide-l-wave-pcac-approves-four-bulk-drug-substances-for-the-503a-list/ ### 12. Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers Type: legal-analysis Tier: legal-analysis Source: https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers ### 13. MOTS-c on diet-induced obesity and insulin resistance in mice, 2015 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/25738459/ ### 14. MOTS-c on physical decline with age in mice, with exercise levels in people, 2021 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/33473109/ ### 15. MOTS-c on fat and weight gain after ovary removal in mice, 2019 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/30725119/ ### 16. MOTS-c on bone-forming change in rat stem cells in the lab, 2018 Type: in-vitro Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/30468456/ ### 17. A blood test to detect MOTS-c for sport drug testing, 2019 Type: in-vitro Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/30394592/ ### 18. Review: MOTS-c as a signal from mitochondria for muscle and fat, 2016 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/27216708/ ### 19. Review of natural MOTS-c levels in people with diabetes or obesity, 2024 Type: systematic-review Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/39160573/ ### 20. NBC News: FDA panel recommends easing peptide limits despite agency scientists Type: reference Tier: established-news Source: https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879 ### 21. CNN: people who say experimental peptides hurt them, 13 October 2026 Type: reference Tier: established-news Source: https://www.cnn.com/2026/10/13/health/peptides-maha-access Last verified: 2026-10-25. Sources: - https://clinicaltrials.gov/api/v2/studies?query.intr=MOTS-c+acetate+OR+MOTS-c+free+base&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState - https://peptideindex.ai/methodology#evidence-grade - https://peptideindex.ai/methodology#short-answer - https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - https://www.fda.gov/media/193347/download - https://www.fda.gov/media/94155/download [^1]: FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks [^2]: FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 https://www.fda.gov/media/94155/download [^3]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act [^4]: Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html [^5]: FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 [^6]: FDA briefing document on MOTS-c for the July 2026 committee meeting, 11 May 2026 https://www.fda.gov/media/193347/download [^7]: FDA: questions put to the committee at the July 2026 meeting https://www.fda.gov/media/193711/download [^8]: FDA: presentations to the committee on 23 July 2026, including MOTS-c https://www.fda.gov/media/193773/download [^9]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 [^10]: McDermott Will & Schulte: what the July 2026 committee votes on peptides mean https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ [^11]: FDA Law Blog: the committee recommends four peptides for the 503A list https://www.thefdalawblog.com/2026/07/peptide-l-wave-pcac-approves-four-bulk-drug-substances-for-the-503a-list/ [^12]: Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers [^13]: MOTS-c on diet-induced obesity and insulin resistance in mice, 2015 https://pubmed.ncbi.nlm.nih.gov/25738459/ [^14]: MOTS-c on physical decline with age in mice, with exercise levels in people, 2021 https://pubmed.ncbi.nlm.nih.gov/33473109/ [^15]: MOTS-c on fat and weight gain after ovary removal in mice, 2019 https://pubmed.ncbi.nlm.nih.gov/30725119/ [^16]: MOTS-c on bone-forming change in rat stem cells in the lab, 2018 https://pubmed.ncbi.nlm.nih.gov/30468456/ [^17]: A blood test to detect MOTS-c for sport drug testing, 2019 https://pubmed.ncbi.nlm.nih.gov/30394592/ [^18]: Review: MOTS-c as a signal from mitochondria for muscle and fat, 2016 https://pubmed.ncbi.nlm.nih.gov/27216708/ [^19]: Review of natural MOTS-c levels in people with diabetes or obesity, 2024 https://pubmed.ncbi.nlm.nih.gov/39160573/ [^20]: NBC News: FDA panel recommends easing peptide limits despite agency scientists https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879 [^21]: CNN: people who say experimental peptides hurt them, 13 October 2026 https://www.cnn.com/2026/10/13/health/peptides-maha-access