Melanotan II is a cyclic analogue of alpha-melanocyte-stimulating hormone, synthesised at the University of Arizona in the 1980s and studied in three small human trials in the decade that followed. It is the compound on this site with the clearest published dose — one figure, 0.025 mg/kg, recommended by name in the trial that established it — and simultaneously the one with the sharpest gap between that figure and how it is actually sold. This page reports the trial figures, converts them to milligrams and syringe units, sets them beside the two approved drugs in the same family, and records the regulatory history. It reports and does not recommend.
The Melanotan II calculator runs the sums for any vial and volume, the dosage hub indexes every compound covered here, and the all-compounds chart carries the one-line version beside every other compound's.
The three human studies
| Study | Subjects | Dose and schedule | Reported | Opened |
|---|---|---|---|---|
| Life Sci, PMID 8637402 (1996) | 3 male volunteers | 0.01 mg/kg subcutaneously, escalated in 0.005 mg/kg steps to 0.03 (two subjects) and 0.025 (one); daily Monday to Friday for two consecutive weeks | Spontaneous erections 1 to 5 hours after dosing, preceded by a stretching and yawning complex; increased facial, upper-body and buttock pigmentation a week after dosing ended; grade II somnolence and fatigue at 0.03 mg/kg in one of two; mild nausea at most levels. Recommends 0.025 mg/kg/day for future phase I studies | 2026-09-19 |
| J Urol, PMID 9679884 (1998) | 10 men, psychogenic erectile dysfunction | 0.025 mg/kg, double-blind, placebo-controlled crossover | Clinically apparent erections in 8 of 10; mean duration of tip rigidity above 80% was 38.0 minutes against 3.0 for placebo; transient nausea, stretching and yawning, decreased appetite | 2026-09-19 |
| Urology, PMID 11018622 (2000) | 10 men, organic risk factors | 0.025 mg/kg, twice each of drug and vehicle, double-blind crossover | Erections reported after 12 of 19 injections against 1 of 21 placebo doses; mean tip rigidity above 80% for 45.3 minutes against 1.9; higher reported sexual desire; severe nausea after 4 of 19 injections | 2026-09-19 |
Twenty-three subjects in total, all male, all subcutaneous, all from one group at the University of Arizona, the most recent published twenty-six years ago. Nothing larger, longer or more recent was found.
The trial figure in milligrams
The published dose is per kilogram, and every figure circulating for the vial is a flat amount. The two only meet once a body weight is named.
| Body weight | 0.025 mg/kg | 0.03 mg/kg (the step that produced grade II somnolence) |
|---|---|---|
| 60 kg | 1.50 mg | 1.80 mg |
| 70 kg | 1.75 mg | 2.10 mg |
| 80 kg | 2.00 mg | 2.40 mg |
| 90 kg | 2.25 mg | 2.70 mg |
One line of arithmetic is worth stating on its own, because it is exact and because it is a coincidence rather than an equivalence. The 1996 recommendation, worked for a 70 kg adult, is 1.75 mg — the same number as the fixed labelled dose of VYLEESI, whose active ingredient is the carboxylate derivative of this molecule. The two are different substances with different labels, indications and legal status, and nothing about the one figure licenses the other; that two independent processes landed on the same number is an observation about melanocortin pharmacology, not a bridge between an approved product and an unapproved one.
The two approved relatives, for scale
| Product | Active substance | Labelled dose | Route and frequency | Label read |
|---|---|---|---|---|
| VYLEESI | bremelanotide 1.75 mg in 0.3 mL | 1.75 mg | Subcutaneous, as needed at least 45 minutes before anticipated sexual activity; no more than one dose in 24 hours; more than 8 doses a month not recommended | 2026-09-19 (effective 2025-11-18) |
| SCENESSE | afamelanotide 16 mg | 16 mg | A single implant inserted subcutaneously above the anterior supra-iliac crest every 2 months, by a trained health care professional | 2026-09-19 (effective 2026-05-13) |
The VYLEESI label is the only document in this family that states a maximum frequency, and it states two: one dose per day and a recommendation against exceeding eight a month, the second tied in the label's own text to the risk of focal hyperpigmentation and to the time per month with raised blood pressure. No comparable limit exists for Melanotan II, because no label exists for it.
The arithmetic per vial
The calculator's presets are the 5 mg and 10 mg vials; 10 mg is the size most commonly sold. One U-100 unit is a hundredth of a millilitre (MedlinePlus, "Giving an insulin injection", reviewed 2024-07-21). The columns are three circulating figures and the 1996 trial figure worked at 70 kg.
| Vial and water | mcg/mL | mcg per unit | 100 mcg | 250 mcg | 500 mcg | 1,750 mcg |
|---|---|---|---|---|---|---|
| 5 mg in 1 mL | 5,000 | 50 | 2 units | 5 | 10 | 35 |
| 5 mg in 2 mL | 2,500 | 25 | 4 | 10 | 20 | 70 |
| 5 mg in 3 mL | 1,667 | 16.7 | 6 | 15 | 30 | 105 |
| 10 mg in 1 mL | 10,000 | 100 | 1 | 2.5 | 5 | 17.5 |
| 10 mg in 2 mL | 5,000 | 50 | 2 | 5 | 10 | 35 |
| 10 mg in 3 mL | 3,333 | 33.3 | 3 | 7.5 | 15 | 52.5 |
The 5 mg vial in 3 mL cannot hold the trial-scale figure in one draw at all: 105 units is more than a full 1 mL insulin syringe. At the other end, a 10 mg vial in 1 mL puts 100 mcg in a single unit. A 10 mg vial holds between two and five trial-scale amounts, or twenty to a hundred of the circulating ones — the two kinds of figure describe quite different rates of consumption for the same vial.
The regulatory record
Melanotan II has never been approved anywhere that could be found, and its sale in the United States has produced a criminal conviction. The Federal Register notice debarring Edward Manookian sets out the facts as FDA found them: Melanocorp Inc., of which he was president and owner, marketed, sold and shipped Melanotan II to customers in the United States and abroad, advertising it as an injectable tanning product and as 100 percent US made when some of it was manufactured in and imported from China; FDA sent a warning letter on or about 30 August 2007 stating that the product was a new drug that could not enter interstate commerce without an approved application; and on 28 August 2015 the US District Court for the Middle District of Tennessee entered judgment on two counts of conspiracy to commit an offense against the United States under 18 U.S.C. 371. The permanent debarment took effect on 14 November 2016.
The registry position is the second half of the record. On 2026-09-19 ClinicalTrials.gov held one study naming Melanotan II as an intervention, NCT07437560, first posted 2026-02-27 and listed as recruiting. Its brief summary begins "This example interventional study record describes a randomized Phase 2 clinical trial"; its detailed description says "This example trial evaluates the safety and preliminary efficacy"; and its two drug interventions are described as "administered per protocol" and "matched, administered per protocol", with no dose in either. A search on its sponsor returns eight registrations first posted between 27 February and 1 April 2026, every one listing Peking University Shenzhen Hospital as its single location, several naming compounds sold on the research market and two naming molecules developed by Eli Lilly. These are the registry's own contents on the date read, stated here as public record and without any inference about why they are as they are. The practical consequence for a reader searching for a Melanotan II dose is simply that this registration supplies none.
What the figures omit
The trial figures carry three small studies of male subjects, a monitored setting, a two-week maximum duration, and side effects the papers name — nausea, severe in 4 of 19 injections in the 2000 study, somnolence and fatigue at the higher step, and the stretching and yawning complex the 1996 report describes. They carry no long-term safety data, no data in women, no pharmacokinetic profile, and no information on the pigmentary consequences beyond a week after dosing stopped. PubMed held 195 records for Melanotan II in title or abstract on 2026-09-19, of which 15 also mention melanoma and 7 mention rhabdomyolysis or priapism; that literature is a separate subject from dosage and is not summarised here, but its existence is part of what the dose figures do not carry. The compound's mechanism and evidence file are covered in Medibact's Melanotan II guide; Peptifact's Melanotan II dosage page reads the same trials from the journalism side.
What this page does not do
It does not state an amount of Melanotan II to use, a frequency, or a course, and it does not suggest that the approved relatives' labels can be read across to it. It reports three human studies, converts their per-kilogram figure into milligrams and syringe units, records two approved labels for scale, and states the regulatory and registry position as the documents read on the date given. Decisions about administering anything to a person belong with a clinician.
Sources and dates
Opened 2026-09-19: PubMed through the NCBI E-utilities for Melanotan II in title or abstract (195 records) with the abstracts of PMIDs 8637402, 9679884, 11018622 and 17584130 read; the DailyMed SPL search API and the full structured product labels for VYLEESI (bremelanotide, Cosette Pharmaceuticals, effective 2025-11-18) and SCENESSE (afamelanotide, Clinuvel, effective 2026-05-13), dosage and description sections read; PubChem compound records 92432 and 9941379 for the two molecular formulas and masses; the ClinicalTrials.gov v2 API for Melanotan II as an intervention and for the sponsor's registrations, with NCT07437560 read in full; Federal Register document 2016-27244, "Edward Manookian (Also Known as Ed Manning): Debarment Order", published 2016-11-14, read in full text; MedlinePlus, "Giving an insulin injection" (reviewed 2024-07-21). The circulating figures are as recorded in this site's dosage chart on 2026-09-18. Corrections go to the contact page.