MOTS-c: Human Evidence, Regulatory Status, and the Therapy Gap

Human studies measuring naturally occurring MOTS-c are not evidence that injected or compounded MOTS-c improves health. A recruiting trial is evidence that a question is being tested—not that it has been answered.

Human physiology is not therapeutic proof

A small exercise experiment measured endogenous mitochondrial-derived peptides before and after exercise; it did not administer MOTS-c as a treatment.¹ A study in women with PCOS and healthy participants also measured endogenous MOTS-c responses; it was not an injection-efficacy trial.²

Three evidence categories

Measured in humans

Endogenous levels and physiology have been studied.¹²

Investigational administration

NCT07505745 is a Phase 2a trial record with no posted results.³

Compounding policy

FDA’s July 2026 materials proposed not including MOTS-c free base or acetate on the 503A Bulks List.⁴

What FDA’s assessment means

FDA evaluated MOTS-c-related bulk substances for a compounding-policy decision and documented scientific and safety questions.⁵ This regulatory evaluation is not a consumer dosing guide, and the committee proposal should not be described as a final rule.

No protocol is supplied here

This page does not provide a dose, route, cycle, vendor, source or self-experiment protocol. Product identity, sterility, impurities, stability, pharmacology and human safety cannot be inferred from the peptide name alone.

Claim-level evidence

Sources and exact limits

Acute endurance exercise stimulates circulating levels of mitochondrial-derived peptides in humans. Human physiology study. PMID 34351816. Design/population: Small randomized exercise experiment; Approximately 30 adults across endurance, resistance and control groups. Limit: Measured endogenous mitochondrial-derived peptides after exercise; did not administer MOTS-c as a therapy. Disclosure: Public/nonprofit funding; authors declared no financial conflicts. Checked 2026-09-02.
Lipids and insulin regulate mitochondrial-derived peptide (MOTS-c) in PCOS and healthy subjects. Human physiology study. PMID 31066084. DOI 10.1111/cen.14007. Design/population: Infusion/clamp study with an exercise follow-up; Women with PCOS and healthy comparison participants. Limit: Measured endogenous circulating MOTS-c; does not test injected or compounded MOTS-c as treatment. Disclosure: See full record for disclosures. Checked 2026-09-02.
MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity. ClinicalTrials.gov registry record (NCT07505745). Design/population: Phase 2a randomized double-blind placebo-controlled study; no posted results; Planned enrollment: 120 adults with prediabetes and overweight/obesity. Limit: Recruiting record with no results posted; registration is not evidence of efficacy or established safety. Disclosure: Sponsor: Hudson Biotech. Checked 2026-09-02.
July 2026 Pharmacy Compounding Advisory Committee: MOTS-c recommendation. FDA advisory-committee presentation. Design/population: Regulatory proposal presented to PCAC; Section 503A compounding policy; not a therapeutic trial. Limit: FDA proposed that MOTS-c free base and acetate not be included on the 503A Bulks List; a proposal is not a final rule. Disclosure: Not reported or not applicable. Checked 2026-09-02.
FDA briefing document: MOTS-c-related bulk drug substances. FDA scientific/regulatory assessment. Design/population: Agency evaluation for 503A consideration; Compounding-policy evidence; not a patient treatment study. Limit: Regulatory evaluation does not establish clinical efficacy or provide a consumer dosing pathway. Disclosure: Not reported or not applicable. Checked 2026-09-02.