Source comparison
MOTS-c FDA Approved Status: Comparison with Other Mitochondrial Peptides
MOTS-c No FDA approval Preclinical (animal models only) Metabolic function, insulin sensitivity, mitochondrial biogenesis None. Research-grade only Promising preclinical data but zero progress toward human therapeutic approval Humanin Early Phase I (limited hu
This comparison does not assign a generated winner or score.
- MOTS-c
- No FDA approval
- Preclinical (animal models only)
- Metabolic function, insulin sensitivity, mitochondrial biogenesis
- None. Research-grade only
- Promising preclinical data but zero progress toward human therapeutic approval
- Humanin
- Early Phase I (limited human safety studies)
- Neuroprotection, apoptosis inhibition, Alzheimer's research
- IND filed by academic institutions
- Slightly further along than MOTS-c but still years from potential approval
- SS-31 (Elamipretide)
- No FDA approval (orphan drug designation)
- Phase III (Barth syndrome, primary mitochondrial myopathy)
- Mitochondrial membrane stabilization, cardiolipin binding
- Active NDA pathway with Stealth BioTherapeutics
- The only mitochondrial peptide with a credible near-term FDA approval pathway
- NAD+ precursors (NMN, NR)
- Classified as dietary ingredients (not approved drugs)
- Not applicable (sold as supplements)
- NAD+ repletion, sirtuin activation
- Dietary supplement pathway under DSHEA
- Legal to sell but not FDA-approved as therapeutics. Different regulatory framework
- The comparison clarifies where MOTS-c sits: it has less human data than Humanin, no active NDA pathway like SS-31, and cannot claim the dietary supplement exemption that NAD+ precursors leverage. Its regulatory status is the most restrictive of the group.