Inclusion of a compound does not constitute endorsement. Information sourced from published research and regulatory filings.

Melanotan II

Removed from Cat 2

Neuropeptide · Research peptide (multiple suppliers)

Synthetic cyclic α-MSH analog and non-selective melanocortin receptor agonist investigated for melanogenesis and effects on appetite, libido, and inflammation. Not FDA-approved for any indication.

About

Mechanism

Synthetic cyclic peptide analog of α-melanocyte-stimulating hormone (α-MSH). Non-selective agonist of melanocortin receptors (MC1R, MC3R, MC4R, MC5R). Stimulates melanogenesis via MC1R, affects appetite, libido, and inflammation through other melanocortin pathways.

Half-Life

Approximately 1-2 hours

Route

subcutaneous

Frequency

Once daily (community-derived, highly variable)

Clinical Dosing

0.25-1 mgonce daily (community-derived, highly variable)

Not FDA-approved. Health authorities have historically warned against unregulated use due to side effects (nausea, flushing, mole darkening, priapism) and unknown long-term risks including potential for skin cancer promotion from melanocyte stimulation.

Community-derived dose range. Original Phase I human study (Dorr 1996) used 0.01-0.03 mg/kg single SC doses. No established chronic dosing schedule.

Regulatory Status

FDA Category

Previously placed in Category 2 (Sept 2023). Removed from Category 2 following April 15, 2026 announcement. Scheduled for PCAC review before end of February 2027.

Reclassification

removed-from-cat2

Date Restricted

2023-09-29

Announced Return

2026-02-27

Status based on publicly available FDA communications. Verify at FDA.gov for authoritative guidance.

View full regulatory timeline →

Titration Protocols

Research Reference Range

Source: Dorr et al., Life Sciences, 1996 (Phase I pilot)

Dose	Duration	Draw (5 mg vial in 2mL)	Notes
250 mcg	Maintenance	0.10 mL (10 units)	Representative low-end community starting dose. Highly variable in practice.

Available Vial Sizes

5 mg

5 mg vial

10 mg

10 mg vial

Citations

[1]Evaluation of Melanotan-II, a Superpotent Cyclic Melanotropic Peptide in a Pilot Phase-I Clinical Study. Life Sciences, 58(20), 1777-1784. Link(Reviewed: 2026-04-16)