Mitochondrial
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.
This page has not been individually reviewed by a clinician.
Fact sheet · 5 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | MOTS-c (free base), MOTS-c acetate, mitochondrial open reading frame of the 12S rRNA-c | primary | fda.gov | |
| Class | mitochondrial | primary | fda.gov | |
| Regulatory status | limbo | primary | fda.gov | |
| Status source read | 2026-10-23 | primary | fda.gov | |
| Evidence grade | animal-only | our assessment | peptideindex.ai |
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.
Our assessment, drawn from the sources below.
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].
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MOTS-c is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 [1] [2].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].
What the evidence shows
Evidence grade: animal-only · our assessment
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].
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].
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].
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].
None
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.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
No open trials in the snapshot of .clinicaltrials.gov
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].
Research use seller
Sold on websites, alone or mixed with other substances, often with a label saying it is for research use only.
The lawFDA treats these products as unapproved new drugs when the seller's claims show they are meant for people, whatever the label says.fda.gov
Documented riskFDA warns that injected drugs bypass some of the body's defenses and can carry toxins or germs that cause life-threatening illness.fda.gov
Documented riskFDA 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.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptide shots. The letter did not name MOTS-c.fda.gov
Compounding outside the rules
Made by a pharmacy from bulk MOTS-c powder. One clinic says it gets MOTS-c from compounding pharmacies.
The lawMOTS-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.fda.gov
Documented riskFDA found no study of MOTS-c in people by any route, so the safety of a compounded product is unknown.fda.gov
Documented riskFDA found no test results for impurities, clumps or germ toxins in MOTS-c powder offered for making shots.fda.gov
Clinic or med spa
Clinics that offer MOTS-c made by a compounding pharmacy, or a drip into a vein that contains it.
The lawA clinic's prescription does not make MOTS-c lawful to compound. It is still a substance that is not on the federal list.fda.gov
Documented riskFDA found no human exposure data on any product with MOTS-c, by any route, so it cannot say whether it causes harm.fda.gov
Documented riskOne clinic's drip lists MOTS-c but not the other substances in it.fda.gov
Sources
- [1]FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2Regulatory · primary
- [2]FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026Regulatory · primary
- [3]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
- [4]Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meetingRegulatory · primary
- [5]FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026Regulatory · primary
- [6]FDA briefing document on MOTS-c for the July 2026 committee meeting, 11 May 2026Regulatory · primary
- [7]FDA: questions put to the committee at the July 2026 meetingRegulatory · primary
- [8]FDA: presentations to the committee on 23 July 2026, including MOTS-cRegulatory · primary
- [9]FDA warning letter to an online seller of research-use peptides, 24 August 2026Regulatory · primary
- [10]McDermott Will & Schulte: what the July 2026 committee votes on peptides meanLegal analysis · legal-analysis
- [11]FDA Law Blog: the committee recommends four peptides for the 503A listLegal analysis · legal-analysis
- [12]Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellersLegal analysis · legal-analysis
- [13]MOTS-c on diet-induced obesity and insulin resistance in mice, 2015Animal · peer-reviewed
- [14]MOTS-c on physical decline with age in mice, with exercise levels in people, 2021Animal · peer-reviewed
- [15]MOTS-c on fat and weight gain after ovary removal in mice, 2019Animal · peer-reviewed
- [16]MOTS-c on bone-forming change in rat stem cells in the lab, 2018In vitro · peer-reviewed
- [17]A blood test to detect MOTS-c for sport drug testing, 2019In vitro · peer-reviewed
- [18]Review: MOTS-c as a signal from mitochondria for muscle and fat, 2016Reference · peer-reviewed
- [19]Review of natural MOTS-c levels in people with diabetes or obesity, 2024Systematic review · peer-reviewed
- [20]NBC News: FDA panel recommends easing peptide limits despite agency scientistsReference · established-news
- [21]CNN: people who say experimental peptides hurt them, 13 October 2026Reference · established-news
Last verified · 5 facts · 6 sources
Primary source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
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