Peptide dossier, updated Oct 31, 2026
MOTS-c
A 16-amino-acid peptide encoded in mitochondrial DNA. The name stands for “mitochondrial open reading frame of the 12S rRNA-c.” FDA says it was discovered in 2015 and found no human exposure data for it. It is the one peptide on this site’s paused list that WADA names outright in its 2026 Prohibited List. Since Oct 30, HHS has said it will pause enforcement against some pharmacies that compound it. This page lays out what each source actually says.
See all 8 verified records for MOTS-c on the Records page
Human studies
ClinicalTrials.gov returns 6 records that mention MOTS-c as of Oct 31, 2026. One gives MOTS-c to participants. In the other five it is a blood marker that is measured.
| Registry | Study | Sponsor | Status | What the record says |
|---|---|---|---|---|
| NCT07505745 | Phase 2a, randomized, quadruple-masked, placebo-controlled: MOTS-c for insulin sensitivity in adults with prediabetes and overweight or obesity | Hudson Biotech | Recruiting | Planned 120 participants, 1:1 to MOTS-c or placebo by subcutaneous injection for 12 weeks, followed to week 16. One site, Peking University Shenzhen Hospital. Started Feb 2, 2026. First posted Apr 1, 2026. Primary completion estimated Feb 2027. No results posted. |
Same sponsor as a flagged record. Hudson Biotech is also the sponsor of the TB-500 study on that dossier whose summary calls itself a fictional example. We checked the full MOTS-c record and it does not contain that wording. We still cannot independently confirm the study is running as described.
The other five records list MOTS-c only as something measured: NCT07678073 (anesthesia comparison, Gaziantep), NCT04027712 (diabetes and coronary disease, Athens), NCT03878706 (diabetes drugs, Athens), NCT04013568 (exercise after breast cancer, Hawaii) and NCT07438002 (exercise in dialysis, Italy). Registry entries are written by sponsors and are not reviewed for scientific merit. A registered study is not a result.
FDA review
Two FDA documents address MOTS-c: the safety-risk page (content current Apr 22, 2026) and a briefing document for the July advisory committee, in a memo dated May 11, 2026.
What the briefing document found
- FDA evaluated MOTS-c (free base) and MOTS-c acetate for the 503A bulks list. The nomination was withdrawn, so FDA reviewed both on its own initiative.
- The nominated uses were insulin resistance, obesity, osteoporosis, vascular calcification, muscle and fat metabolism, and longevity. The proposed products were 5 mg and 10 mg subcutaneous injections.
- It describes MOTS-c as a 16-amino-acid peptide and says it was discovered in 2015. No USP or National Formulary monograph exists, and it is not part of an FDA-approved drug.
- No clinical studies or human exposure data by any route, and no human pharmacokinetic data.
- Nonclinical work was limited to cell and rodent models. FDA says dose-response relationships are missing and the molecular targets are unknown. It cites a mouse study in which MOTS-c given three times a week from 23.5 months of age increased physical capacity and lifespan.
- Outsourcing facilities reported preparing no MOTS-c products. FDA’s internet search found one holistic clinic saying it works with compounding pharmacies to obtain it. A search of FDA’s adverse event database (FAERS) retrieved no reports.
What FDA concluded
- It proposed not adding either form to the list.
- FDA called both forms not well characterized: names that do not follow standard nomenclature, and no impurity, aggregate or endotoxin results in the literature or the nomination package.
- It said it cannot rule out immunogenicity from impurities or aggregates, especially for injection.
- It found no human safety or effectiveness information, and said approved therapies exist for obesity and osteoporosis.
- It noted that MOTS-c appears as a prohibited substance in a database that takes its information from the 2024 WADA list. That is FDA describing a third-party database, not the WADA list itself.
Published research
PubMed returns 265 results for “MOTS-c.” Most are cell or rodent studies, reviews, or human studies that measure the body’s own MOTS-c. We found none that gave people injected MOTS-c and reported the outcome.
What the human papers show
- Exercise study, 2021. 30 healthy volunteers were randomized to endurance exercise, resistance exercise or no exercise, with blood and muscle samples before and after. The paper reports that acute endurance exercise stimulated circulating levels of the mitochondrial peptides, including MOTS-c. J Appl Physiol PubMed
- Obesity, 2026. Circulating MOTS-c was higher in 32 adults with obesity than in 22 lean adults (273 versus 223 pg/mL) and stayed unchanged in 10 patients six months after bariatric surgery. J Clin Transl Endocrinol PubMed
- Many more like these. Dozens of 2019–2026 papers compare blood levels of the peptide in people with kidney disease, thyroid disease, polycystic ovary syndrome, sleep apnea, heart disease and other conditions. We read two at abstract level.
Read with care
- Measuring the peptide the body already makes does not test what happens when it is injected. FDA found no human exposure data.
- The nonclinical findings FDA cites come from cell and rodent models. FDA says their clinical relevance is unknown.
- We read abstracts only, not full text, funding or author disclosures.
- Our sorting of the 265 results into human, animal and review was by keyword. It is a starting point, not a count of studies.
FDA warning letters
We did not find an FDA warning letter that names MOTS-c.
This rests on web searches, not a full pull of FDA’s database. FDA’s list of letters cannot be searched by peptide, so a letter could exist that we did not find.
SEC filings
We did not find a verified SEC filing that names MOTS-c. EDGAR’s full-text search was not available to us, so this rests on web searches of sec.gov.
What a company says in a filing is its own claim about its business. It is not a finding about MOTS-c.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six compounded peptides, MOTS-c among them
State-licensed pharmacies, federal facilities and licensed physicians would not face enforcement for compounding it, under conditions including a patient-specific prescription and quality testing. Not FDA approval. HHS says it may revisit the policy if a safety or quality problem arises.
- July 23–24, 2026RegulatoryFDA advisory committee recommends MOTS-c for the compounding list
The committee recommended six of the seven peptides it reviewed; emideltide was the exception. The vote is nonbinding: compounding stays unlawful until FDA finishes rulemaking or Congress changes the law. Vote counts differ between trade-press reports, and no official tally was in the FDA documents we could read.
- May 11, 2026RegulatoryFDA staff brief the committee: it proposes not adding MOTS-c
The briefing memo concludes that the balance of criteria weighs against listing. Details above.
- Apr 22, 2026RegulatoryFDA’s safety-risk page lists MOTS-c
The page showed content current as of Apr 22, 2026. Its wording on this peptide is quoted above.
- Feb–Apr 2026TrialsA Phase 2a MOTS-c trial is registered
Hudson Biotech’s study began Feb 2 and was first posted Apr 1, 2026. See the note on the sponsor above.
- Jan 1, 2026Anti-dopingWADA’s 2026 Prohibited List names MOTS-c in section S4
S4 covers hormone and metabolic modulators. Subsection S4.4.1 reads “mitochondrial open reading frame of the 12S rRNA-c (MOTS-c).” We checked the 2022 and 2026 lists only. The 2022 list does not name it. FDA says a database that follows the 2024 list also shows it as prohibited.
- Sep 2021LiteratureRandomized exercise study measures MOTS-c in blood and muscle
Published in J Appl Physiol. It reports changes in circulating levels after acute exercise in healthy volunteers.
Still not covered
Left off rather than guessed:
- Policy coverage: HHS’s list of covered peptides sits in a policy attachment we could not open. MOTS-c acetate for injectable dosage forms comes from a law-firm summary of that list, not from the document itself.
- Panel vote counts: not in the FDA documents we could read. One law-firm summary and trade-press reports give different tallies.
- WADA history: we checked the 2022 and 2026 lists. Other years were not opened, including the 2024 list FDA cites through a database.
- Patents: not researched for this dossier.
- Seller claims and independent lab reports: how it is marketed versus what testing finds. FDA notes injectable MOTS-c is marketed for many uses, but we have not collected testing data.
- Unread items: full text of every paper, and the full records of the five registry entries that only measure MOTS-c.
- Warning letter and SEC completeness: web searches only. A 2016 prospectus from a company that has worked on the peptide was not verified.