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.
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.