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Peptide.Guide

FDA Category 2 · restricted from compounding

This compound is on the FDA’s interim Section 503A Category 2 bulks list and cannot be legally compounded by US pharmacies. An HHS announcement in February 2026 signaled intent to restore several peptides to Category 1, but no Federal Register action has been published. Check the FDA PCAC schedule for updates.

Read the full regulatory context
PreclinicalMitochondrialSubQ3x per week

MOTS-c

Mitochondrial Open Reading Frame of 12S rRNA-c

Mitochondrial-derived peptide that acts as an exercise mimetic, improving insulin sensitivity and metabolic flexibility.

§ 01   Overview

Overview

Mitochondrial-derived peptide that acts as an exercise mimetic, improving insulin sensitivity and metabolic flexibility.

Strong preclinical data in mice; early human pharmacokinetic studies. No Phase III human outcome trials.

§ 02   Mechanism

Mechanism of action

MOTS-c is a 16-amino-acid peptide encoded within the mitochondrial 12S rRNA. It activates AMPK, enhances glucose uptake, and translocates to the nucleus under stress to regulate adaptive nuclear gene expression.

  • 01Improved insulin sensitivity and glucose handling
  • 02Enhanced exercise capacity
  • 03Mitochondrial biogenesis support
  • 04Reductions in visceral adiposity

§ 03   Dosing

Dosing protocol

Standard Protocol

Vial
10 mg
BAC Water
2 ml BAC water
Dose Range
5 – 10 mg per dose
Starting Dose
5 mg
Route
SubQ
Timing
AM, pre-workout
Frequency
3x per week
Cycle
8–12 weeks

§ 04   Evidence

Evidence & research

Preclinical

Strong preclinical data in mice; early human pharmacokinetic studies. No Phase III human outcome trials.

FDA Status

Not FDA-approved.

§ 05   Stacks

Common stacks

§ 06   News

In the news

8 articles from the last 12 months · updates hourly

§ 07   Sourcing

Sourcing & supply

Regulatory status

Restricted from compounding

Placed on the FDA's 503A Category 2 list and cannot be lawfully compounded in the US. No brand pharmacy alternative exists. US buyers encounter only research-use-only (RUO) channels, which the FDA's Intended Use Doctrine treats as unapproved drug sales.

International · 1

International

Rupharma

12+ year Russian pharmacy reseller. Reviews.io 4.84/5 (81+). Has a genuine US warehouse for common peptides.

Visit

Research-use-only · 1

Research-use-only

Core Peptides

Broad catalog, widest payment range. Mid-credibility: Knoji 2.5/5 and one scam-impersonation report.

Third-Party Testing1 flag on record
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Listings are informational, not endorsement. Verify credentials and flags against FDA and PCAB databases before purchasing. Full directory & how to verify →

§ 09   Safety

Safety & side effects

Side effects

  • 01Mild injection site irritation
  • 02Limited long-term safety data

Contraindications

None specified.

This site is for educational and research purposes only. It does not constitute medical advice. Always consult a qualified healthcare provider before using any peptide or supplement.