At a glance
- MOTS-c is not an FDA-approved drug: Drugs@FDA has no record of it.
- It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
- PubMed lists 264 publications mentioning it, including 4 randomized controlled trials and 54 animal-only studies.
- ClinicalTrials.gov lists 5 registered studies testing it (4 active).
- FDA’s adverse event system (FAERS) has no reports mentioning it.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) Compounded drugs containing MOTs-C may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified any human exposure data on drug products containing MOTs-C administered via any route of administration. FDA lacks important information regarding any safety issues raised by MOTs-C, including whether it would cause harm if administered to humans. Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Mitochondria-derived peptide hydrogel augments mitochondrial transplantation for promoting cardiac repair via macrophage metabolic reprogramming.
- Integrative transcriptomic and computational analysis associates Ms4a6c+ macrophages with fibrosis in radiation proctitis and computationally nominates MOTS-c as a candidate modulator.
- Associations of Serum MOTS-c with Exercise Capacity and Antioxidant Markers in Young Males: A Cross-Sectional Study.
- MOTS-c attenuates placental vascular endothelial cell apoptosis in intrahepatic cholestasis of pregnancy by inhibiting K33-linked deubiquitination of BACH1.
- Mots-c attenuates diabetic nephropathy by downregulating LARS1 to promote lipophagy and suppress tubular senescence.
- The mitochondrial-derived peptide MOTS-c improves bioenergetics in aging-associated granulosa cells and oocytes.
- Mitochondria-Endoplasmic Reticulum Crosstalk in Pancreatic β-Cell Stress: A Driver of Diabetes.
- Mitochondrial-derived peptides in female reproduction: Emerging regulators of oocyte competence and novel therapeutic opportunities for infertility.
- MOTS-c mediates remote ischemic preconditioning-induced protection against lung ischemia-reperfusion injury via NRF2-dependent mitochondrial biogenesis.
- Synthetic Peptides in Pharmacy Compounding: Analysis of PCAC Recommendations and Industry Safety Standards.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 5
- Active
- 4
- With posted results
- 0
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation | Recruiting | N/A | March 1, 2026 |
| MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity | Recruiting | Phase 2 | February 2, 2026 |
| The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination | Recruiting | — | November 3, 2017 |
| Cohort Of DEafness-gene Screening | Active, not recruiting | — | January 1, 2016 |
| Platelet Reactivity, B-amyloid, MOTS-c and Mortality of Type II Diabetics With CAD | Unknown status | — | January 1, 2014 |
All 5 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
No FAERS reports mention this peptide.
Change history
No changes since monitoring began on October 30, 2026.