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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
ExperimentalMitochondrialSubQ3x per weekPartial data

Omega (MOTS-C + SS-31)

Compounded blend combining MOTS-C and SS-31 in a single vial for a broad mitochondrial intervention.

§ 01   Overview

Overview

Compounded blend combining MOTS-C and SS-31 in a single vial for a broad mitochondrial intervention.

Individual components have preclinical/clinical data. The blend has none specifically.

§ 02   Mechanism

Mechanism of action

The blend stacks the exercise-mimetic and AMPK-activating effects of MOTS-C with the cardiolipin-stabilizing effects of SS-31, targeting both signaling and structural aspects of mitochondrial function.

  • 01Combined mitochondrial signaling and structural support
  • 02Convenience of single-vial administration

§ 03   Dosing

Dosing protocol

Standard Protocol

Vial
Compounded vial
BAC Water
2 ml BAC water typical
Dose Range
1 – 3 mg per dose
Route
SubQ
Timing
AM
Frequency
3x per week
Cycle
8 weeks

§ 04   Evidence

Evidence & research

Experimental

Individual components have preclinical/clinical data. The blend has none specifically.

FDA Status

Not FDA-approved.

§ 05   Stacks

Common stacks

§ 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.

No suppliers in our directory currently stock this compound. For investigational or research-only compounds, legitimate channels may not exist outside clinical trials.

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§ 09   Safety

Safety & side effects

Side effects

  • 01As per components

Contraindications

None specified.

§ 10   Questions

Omega (MOTS-C + SS-31) FAQ

What is Omega (MOTS-C + SS-31)?
Compounded blend combining MOTS-C and SS-31 in a single vial for a broad mitochondrial intervention. The blend stacks the exercise-mimetic and AMPK-activating effects of MOTS-C with the cardiolipin-stabilizing effects of SS-31, targeting both signaling and structural aspects of mitochondrial function.
What is Omega (MOTS-C + SS-31) used for?
Reported uses include combined mitochondrial signaling and structural support and convenience of single-vial administration. Evidence strength is rated Experimental — see the evidence section for detail.
How is Omega (MOTS-C + SS-31) dosed?
Commonly referenced dosing is 1 – 3 mg per dose, typically 3x per week, administered SubQ. This is educational reference only; consult a licensed clinician before use.
How do you reconstitute Omega (MOTS-C + SS-31)?
For Omega (MOTS-C + SS-31), vials commonly come in Compounded vial and a common reconstitution is 2 ml BAC water. Use the reconstitution calculator to convert any vial size and water volume into exact insulin-syringe units.
What are the side effects of Omega (MOTS-C + SS-31)?
Commonly reported side effects include as per components. This list is not exhaustive.
Is Omega (MOTS-C + SS-31) legal?
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. FDA status: Not FDA-approved..

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.