MOTS-c

Not FDA-approved Evidence grade D — animal or in-vitro data only Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: MOTS c, MOTSc, mitochondrial open reading frame of the 12S rRNA-c, MOTS-c acetate.

Regulatory status

Not approved and not a component of any FDA-approved drug. FDA's briefing for the 23-24 July 2026 PCAC proposed NOT adding MOTS-c (free base or acetate) to the 503A bulks list, citing poor characterisation, no nonclinical safety data and no human data [1][2]; PCAC outcome UNVERIFIED: FDA has posted no minutes or vote summary as of 2026-10-20 (non-FDA reports describe a non-binding vote for inclusion, rulemaking pending). FDA's compounding-risk page lists it as nominated then withdrawn [3]. No FDA warning letter naming MOTS-c was found on fda.gov (searched 2026-10-20; the August 2026 peptide-seller letters checked name other products).

What it is

16-amino-acid mitochondrial-derived peptide (encoded in mitochondrial 12S rRNA).

A 16-amino-acid peptide encoded in mitochondrial DNA, studied in mice for insulin sensitivity, obesity and ageing. No human study of injected MOTS-c has been published.

What the published research shows

Mouse and cell studies (obesity, insulin resistance, bone); FDA found no clinical studies or human exposure data by any route.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

Mouse diet-induced obesity (Lee et al. 2015): Mice on a high-fat diet: 0.5 mg/kg/day IP for 8 weeks prevented diet-induced obesity and insulin resistance (about 20 % lower weight than vehicle, per FDA's summary).
Compounding nomination (withdrawn): 5 mg and 10 mg SC injection for insulin resistance, obesity, osteoporosis and related uses; no dosing frequency given.

Mechanism, as reported

In mouse and cell work it acts mainly on skeletal muscle, inhibits the folate cycle and purine synthesis and activates AMPK; FDA notes the molecular target is still unknown.

Practical record

Elimination half-life: 1.0 h (confidence: low). Placeholder: no in-vivo half-life has been published for any species. The only PK-type data are in vitro: MOTS-c was broken down rapidly in human whole blood within 15-60 min (Knoop 2019, as summarised by FDA), which suggests the real value may be shorter. Treat the curve as a guess.
Studied routes: subcutaneous.
Typical supply: No approved product. Nominated as 5-10 mg SC injection; sold by clinics and online sellers, including in IV 'cocktails' (FDA).
Reconstitution: Acetate water-soluble at 6.25 mg/mL (supplier data cited by FDA); no published in-use stability.
Storage: Free base at or below -20 °C, desiccated and protected from light (supplier data cited by FDA).

Safety signals on record

Reported adverse events: Unknown: no human data; no reports in FDA's adverse-event database.
Contraindications: None established (no label).
Interactions: None documented.
Notes: No toxicology studies of any kind. FDA flags possible immune reactions to injected peptide, including antibodies against the body's own MOTS-c. Listed as prohibited in sport (WADA, via Global DRO, per FDA).

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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