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MlHuman trials

Melanotan-2 protocol

Melanotan-2 is a lab-made copy of a skin pigment hormone. It has only a tiny human pilot study and is not an approved medicine.

Not approved: no approved product found. FDA warned in 2007 that it is unapproved; the UK regulator treats such products as unlicensed medicinesNo approved regimen. A phase 2 vitiligo trial (NCT07437560) is listed as recruiting
ProtocolMixingResultsSide effectsHow it worksSources

The protocol at a glance

The only dosing data are a 1996 pilot in 3 men: 0.01 mg per kg a day, raised in steps to about 0.025-0.03 mg per kg, Monday to Friday for 2 weeks. Its authors suggested 0.025 mg per kg a day for later early-phase studies.

StudyAmount and schedule
Approved human doseNone
1996 pilot (3 men), under the skin, Monday-Friday for 2 weeksStart 0.01 mg per kg; steps of 0.005 mg per kg up to 0.025-0.03 mg per kg
Dose the authors suggested for future studies0.025 mg per kg a day
Phase 2 vitiligo trial, NCT07437560Amount not given in the record

Dorr RT et al. Life Sci 1996 (pilot phase I, single-blind, 3 volunteers). The abstract is inconsistent about 'every other day' vs daily dosing. Too small to set a safe regimen.

Community reports

Community reports commonly describe a loading phase of 0.25-0.5 mg daily for 7-14 days.

What people say they do, collected from community discussions. Not tested in a trial; shown so you can compare it with the evidence above.

Mixing

No mixing table here: this one is used as a capsule, nasal spray or skin product, or has no human amount to calculate from. The general mixing calculator works for any vial.

What the trials found

Only a 3-man pilot exists, so these are small numbers. Measured: skin pigment, side effects and effects on erections:

2 of 3Men with more skin pigment
1-5 hSpontaneous erections after doses, by dose
1 of 2Men at 0.03 mg per kg with moderate sleepiness and tiredness
3Men in the whole study

Dorr RT et al. Life Sci 1996 (abstract). Mild nausea occurred at most dose levels.

Side effects

  • In the pilot: mild nausea, stretching and yawning, spontaneous erections lasting 1-5 hours, and moderate sleepiness and fatigue at the top dose.
  • The UK COMARE 13th report notes regulator warnings about melanotan products and cites a BMJ letter on rapid changes in existing moles after use.
  • The UK regulator says melanotan II products it identifies as medicines are unlicensed, with safety, quality and effectiveness not demonstrated. It logged 13 suspected adverse reaction reports from 2011 to 2021, which may or may not be caused by the drug.
  • No long-term human safety data.

How it works

Melanocortin receptors

It copies alpha-MSH and acts on several melanocortin receptors, raising skin pigment. Because it acts broadly, effects beyond tanning (nausea, erections, sleepiness) were seen.

Sources

  • Dorr RT et al. Life Sci 1996 (pilot phase I), University of Arizona research record
  • ClinicalTrials.gov NCT07437560 (MT-II with NB-UVB in vitiligo)
  • COMARE 13th Report (UK), section on tanning accelerators, gov.uk
  • MHRA Freedom of Information response FOI 21/1237, 20 December 2021, gov.uk