Melanotan II

Not FDA-approved Evidence grade C — small or uncontrolled human studies / case series 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: MT-II, MT2, MTII, Melanotan, MT-2.

Regulatory status

Not FDA-approved. FDA treats it as an unapproved drug, has named it in warning letters (2020 compounder; 2024 online seller) [5][6], and lists it among bulk substances that may present significant safety risks, citing case reports including melanoma [4]. Australia's TGA has issued a 2026 safety alert that it is prescription-only, not approved as a tanning agent, and that illegal products were inconsistently dosed [7] (UNVERIFIED: TGA page could not be retrieved; content from its search summary).

What it is

Synthetic cyclic heptapeptide analogue of alpha-MSH (non-selective melanocortin receptor agonist).

An unapproved synthetic melanocortin peptide studied in the 1990s for skin tanning and erectile dysfunction and sold illegally as a 'tanning' injection or nasal spray. It is not an approved medicine in the US or Australia.

What the published research shows

Tiny human studies only: a 3-man pilot phase 1 (1996) and a 10-man crossover RCT in erectile dysfunction (1998); harms known mainly from case reports.

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

Pilot phase 1, healthy men (Dorr et al. 1996): 3 men, single-blind, SC on weekdays for 2 weeks alternating with saline; dose escalated from 0.01 mg/kg in 0.005 mg/kg steps to 0.025-0.03 mg/kg. Authors proposed 0.025 mg/kg/day for further phase 1 work. Increased pigmentation in 2 subjects.
Psychogenic erectile dysfunction (Wessells et al. 1998, crossover RCT): 10 men, double-blind placebo-controlled crossover, 0.025 mg/kg SC; erections in 8 of 10; duration of tip rigidity above 80 % 38 min vs 3 min with placebo.

Mechanism, as reported

Activates melanocortin receptors: MC1R in skin pigment cells (increasing melanin, so darker skin and moles) and central MC3R/MC4R (causing erections, nausea, yawning and reduced appetite).

Practical record

Elimination half-life: 1.0 h (confidence: low). The app's 1 h is attributed to Dorr et al. 1996, but that abstract states no half-life or PK data, so the figure is unverified pending the full text. Treat the curve as a guess.
Studied routes: subcutaneous, intranasal.
Typical supply: No approved product; sold illegally as lyophilised vials and nasal sprays. TGA testing found 22-54 mg per nasal-spray bottle (UNVERIFIED: page not directly readable here).

Safety signals on record

Reported adverse events: In studies: nausea, yawning and stretching, spontaneous erections lasting 1-5 h, flushing, somnolence and fatigue, reduced appetite, darker skin. Case reports: eruptive and atypical moles within days of injection, and (per FDA) melanoma, brain-swelling syndrome and prolonged painful erection.
Contraindications: None established (no label).
Interactions: None documented.
Notes: Rapid new or changing moles after use have been reported, so skin changes need medical review. Illegal products are of unknown dose and purity. Not the same compound as bremelanotide (PT-141) or afamelanotide.

Sources

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

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