MOTS-c
Mitochondrial Open Reading Frame of the Twelve S rRNA-c; MOTS-c; MOTSc; MOTS c; Mitochondrial-derived peptide; MDP
MOTS-c is investigational. It is not approved by the U.S. FDA for any indication, is referenced on the FDA bulk drug substances page that flags compounding-related safety risks, and has no completed placebo-controlled human RCT in the surveyed literature — the only registered Phase 2a trial (NCT07505745) is recruiting with no posted efficacy or safety data. Mechanistic and efficacy claims rest on preclinical animal/cell experiments and on cross-sectional human biomarker associations, neither of which establishes therapeutic causality for exogenous MOTS-c administration in humans.
MOTS-c is a short mitochondrial-derived peptide (a microprotein encoded within mitochondrial 12S rRNA) studied as a regulator of metabolic and mitochondrial function, with most evidence drawn from preclinical and observational research rather than completed human interventional trials.
This entry is a cited research summary, not an established treatment reference. Dosing language is included as source context, not as medical instruction.
MOTS-c is preclinical or hypothesis-only.
MOTS-c is investigational. It is not approved by the U.S. FDA for any indication, is referenced on the FDA bulk drug substances page that flags compounding-related safety risks, and has no completed placebo-controlled human RCT in the surveyed literature — the only registered Phase 2a trial (NCT07505745) is recruiting with no posted efficacy or safety data. Mechanistic and efficacy claims rest on preclinical animal/cell experiments and on cross-sectional human biomarker associations, neither of which establishes therapeutic causality for exogenous MOTS-c administration in humans.
Safety Summary
There is no systematic published human safety database for exogenously administered MOTS-c at the review date; the only interventional Phase 2a trial is still recruiting.NCT07505745 Route-specific human safety data are absent. The single registered interventional trial uses subcutaneous injection but has not yet reported TEAE data.NCT07505745 Long-term safety, immunogenicity, special-population safety (pregnancy, pediatric, hepatic/renal impairment), and drug-interaction profiles for administered MOTS-c are uncharacterized in the published human literature surveyed.NCT07505745 PMID 41543486 PMID 41468641 PMID 41966639 MOTS-c distributed via gray-market or compounded channels has not been characterized in the public literature for identity, purity, peptide-related impurity profile, sterility, endotoxin content, or label concentration accuracy. PMID 41966639 FDA's bulk-substances safety-risk page — which catalogs unapproved peptides flagged for compounding-related safety concerns including immunogenicity and impurity-driven adverse events for related peptides such as Melanotan II and PEG-MGF — also references MOTS-c, indicating regulatory caution rather than endorsement. Theoretical mechanism-linked risks (e.g., systemic AMPK/PGC-1α activation, modulation of mitophagy and ferroptosis pathways, redox effects) have plausible but unproven implications for off-target effects in tissues where mitochondrial dynamics are tightly regulated; these have not been monitored in any human trial reporting outcomes.PMID 41933740 PMID 41654147 PMID 41520850 PMID 41543486 PMID 41468641
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Cited sources
Every claim on this page links to one of the 6 sources below. Identifiers are PubMed (PMID), ClinicalTrials.gov (NCT), or DOI; click through to the source of record before acting on a claim.
- 1NCT07505745ClinicalTrials.gov
- 2NCT04027712ClinicalTrials.gov
- 3PMID 41680431PubMed
- 4PMID 41945630PubMed
- 5PMID 41551324PubMed
- 6PMID 41518474PubMed