What Melanotan I is, and what it became once an agency reviewed it

Melanotan I is an analogue of alpha-melanocyte-stimulating hormone. Unlike almost everything sold under that prefix, this molecule went the whole way of a medicine and reached the end: it is called afamelanotide and it holds a marketing authorisation in the European Union [4].

That is what is interesting about the compound. What happened along the way is more interesting still.

What it became on approval

Three things changed relative to what circulates under the same name, and all three are on the public record of the European agency [4]:

• The form. The approved medicine is a subcutaneous implant, not a vial for injection. Same molecule, different pharmaceutical form, and the form is part of what was evaluated.
• The indication. It is for erythropoietic protoporphyria, a rare disease causing light intolerance and severe pain on sun exposure. Not for tanning.
• The type of authorisation. It is authorised "under exceptional circumstances", a specific category rather than a turn of phrase: it is used when complete information could not be obtained, usually because the disease is too rare.

What was measured to get there

Two multicentre, randomised, double-blind, placebo-controlled trials, one in the European Union with 74 patients and one in the United States with 94 [1].

• Pain-free time in the sun. In the US study the median at six months was 69.4 hours with afamelanotide against 40.8 with placebo. In the European study at nine months, 6.0 hours against 0.8 [1].
• Phototoxic reactions. In the European study there were 77 with afamelanotide and 146 with placebo [1].
• Adverse events. Mostly mild; serious ones were not considered related to the study drug [1].

Those figures are worth reading closely. The European and US medians differ greatly from each other because patients started from different situations; what they share is direction and statistical significance, not magnitude.

And what to know about what circulates outside

A 2017 review of the unregulated use of these analogues expressly separates the two: afamelanotide has been thoroughly tested and deemed safe in its indication, while the melanotans used on one's own raise questions of preparation, administration and dose, and are associated in a growing number of published cases with changes in existing moles and with new naevi [3].

This page describes published literature. It is not medical information, it does not describe a therapeutic use, and it does not replace any healthcare professional. A change in a mole is a reason to see a dermatologist, not to consult a product page.

What to look at when comparing suppliers

• HPLC purity for the specific batch, with a certificate you can read before buying.
• Identity confirmation: Melanotan I and Melanotan II are different molecules with almost identical names, and that is the most frequent confusion in this family.
• A real cold chain and verified net content of the vial.