Melanotan II

Approval status

Not approved anywhere. Ireland's HPRA says no medicines regulator has authorised it. Australia's TGA says it is not approved and is illegal to supply without a prescription. In 2007 the FDA warned a US seller that it could not be sold without approval; its former owner and staff later pleaded guilty. FDA lists safety risks from published case reports.³⁴⁶⁷⁸

What it’s used or studied for

• Human studies

  Skin tanning without sun: a small 1990s pilot study in three healthy men found it darkened the skin.²

• Human studies

  Erectile dysfunction: two small placebo-controlled trials in men found it caused erections. A close variant, bremelanotide (PT-141), was developed for sexual function.⁹¹⁰¹¹

Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.

Side effects

Common effects come from small 1990s trials and Australia's TGA. Serious effects come from case reports and regulator warnings. Ireland's HPRA also lists vision loss, stroke, muscle tremors and anaphylaxis among reported effects.^{2347911121314151617}

Cautions

• Products are unregulated. Regulators say buyers cannot know what they contain, and seized nasal sprays varied in strength between bottles.⁴⁵
• Sharing needles can spread blood-borne viruses such as HIV and hepatitis; the UK MHRA has warned about this and about impure products.¹⁸
• It does not protect skin from sun damage. Australia's TGA says sunscreen is still needed.⁴
• Regulators advise anyone using it to stop and to see a doctor about concerns, such as new or changing moles.³⁴