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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
PreclinicalSkin & HairSubQ2–3x weekly during loading

Melanotan II

Synthetic α-MSH analog producing tanning and libido effects; non-selective melanocortin agonist.

§ 01   Overview

Overview

Synthetic α-MSH analog producing tanning and libido effects; non-selective melanocortin agonist.

Small safety reports and case studies. Not formally approved.

§ 02   Mechanism

Mechanism of action

Melanotan II is a non-selective agonist of MC1R (melanogenesis), MC3R/MC4R (sexual function, appetite), and MC5R. MC1R activity drives tanning; MC3/4R produces the libido effects.

  • 01Tanning without UV exposure
  • 02Libido enhancement

§ 03   Dosing

Dosing protocol

Standard Protocol

Vial
10 mg
BAC Water
2 ml BAC water
Dose Range
100 – 500 mcg
Starting Dose
100 mcg
Route
SubQ
Timing
Before sun exposure for tanning
Frequency
2–3x weekly during loading
Cycle
Loading 2–4 weeks; maintenance after

§ 04   Evidence

Evidence & research

Preclinical

Small safety reports and case studies. Not formally approved.

FDA Status

Not FDA-approved. Sold as research chemical.

§ 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 · 2

International

Rupharma

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

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International

Trident Peptides

1,299+ Trustpilot reviews (5-star). Strongest review base in UK research peptides. No visible ISO/GMP; COAs not posted.

1 flag on record
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Research-use-only · 3

Research-use-only

Swiss Chems

Established SARMs/peptide vendor. FDA warning letter Dec 2024 for GLP-1s. Weaker peptide QC than SARMs QC.

Third-Party Testing1 flag on record
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Research-use-only

Limitless Life Nootropics

'Only BBB-accredited peptide company' (since 2020). Claims three-lab third-party testing. Broad catalog.

BBB Accredited +1
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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

  • 01Nausea
  • 02Darkening of moles (monitor for dysplastic changes)
  • 03Increased libido
  • 04Blood pressure changes

Contraindications

None specified.

§ 10   Questions

Melanotan II FAQ

What is Melanotan II?
Synthetic α-MSH analog producing tanning and libido effects; non-selective melanocortin agonist. Melanotan II is a non-selective agonist of MC1R (melanogenesis), MC3R/MC4R (sexual function, appetite), and MC5R. MC1R activity drives tanning; MC3/4R produces the libido effects.
What is Melanotan II used for?
Reported uses include tanning without uv exposure and libido enhancement. Evidence strength is rated Preclinical — see the evidence section for detail.
How is Melanotan II dosed?
Commonly referenced dosing is 100 – 500 mcg, typically 2–3x weekly during loading, administered SubQ. This is educational reference only; consult a licensed clinician before use.
How do you reconstitute Melanotan II?
For Melanotan II, vials commonly come in 10 mg 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 Melanotan II?
Commonly reported side effects include nausea, darkening of moles (monitor for dysplastic changes), increased libido, and blood pressure changes. This list is not exhaustive.
Is Melanotan II 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. Sold as research chemical..

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.