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No FDA-approved product

MOTS-c

Also called mitochondrial open reading frame of the 12S rRNA-c.

MOTS-c has no FDA-approved product. This page cites 2 sources, and the strongest evidence comes from human observational.

Status
No FDA-approved product
Form
Injection
Half-life
Not modeled
Strongest evidence
Human observational
Cited claims
2
Last updated
November 6, 2026

What the evidence says

Each claim names the kind of study behind it, what it can't tell you, and where it comes from.

  1. Animal studies

    MOTS-c treatment prevented insulin resistance in mouse models of aging and high-fat feeding.

    Limits: The experiments studied mice, including diet-induced obesity models. They do not establish a treatment effect, safe exposure, or regimen in people.

  2. Human observational

    Endogenous MOTS-c levels in muscle and blood rose after exercise in a study of ten healthy young men.

    Limits: Researchers measured the body's own peptide during a cycling study. Participants did not receive MOTS-c as treatment, so this is not an injection efficacy trial. CB4211 is a different, engineered analog.

Regulatory status

United States

As of November 6, 2026, MOTS-c has no FDA-approved drug product. FDA's May 11, 2026 evaluation found insufficient human safety and effectiveness information for MOTS-c free base and acetate.

United States

The October 2026 HHS interim policy describes conditional 503A enforcement discretion for MOTS-c acetate in subcutaneous or intramuscular dosage forms. The October 30 notice calls the policy a nonbinding draft. This does not grant FDA approval or establish a validated regimen.