At a glance: Melanotan I is the same molecule as afamelanotide, sold as Scenesse, an FDA-approved implant for adults with erythropoietic protoporphyria (EPP), a rare disorder that makes sunlight painful. It works by darkening the skin through the body's own pigment system. The approved implant has solid trial data; injectable "Melanotan I" sold online for tanning is not approved and is not the same product.
What is Melanotan I?
Melanotan I is a lab-made version of alpha-melanocyte-stimulating hormone (alpha-MSH), the natural hormone that tells skin cells to make pigment. It is a 13-amino-acid peptide identical to alpha-MSH except for two changes (at positions 4 and 7) that make it far more stable and potent. Its scientific names are afamelanotide and NDP-MSH.
It was developed in the 1980s at the University of Arizona by researchers Mac Hadley and Victor Hruby, originally as a sunless tanning agent that might also protect against skin cancer. Australian company Clinuvel Pharmaceuticals later developed it into a medical treatment.
How does Melanotan I work?
- Activates the melanocortin-1 receptor (MC1R) on pigment cells (melanocytes) in the skin
- Increases eumelanin, the dark brown-black pigment that absorbs ultraviolet and visible light, without needing sun exposure
- Protects skin: in a placebo-controlled study of fair-skinned people, it increased melanin and reduced UV-related DNA damage
- Less broad than Melanotan II: Melanotan II acts on several melanocortin receptors, which is why it also affects appetite and sexual arousal; Melanotan I's approved use relies on its pigment effect
What the research shows
| Study | Who was studied | Main finding |
|---|---|---|
| Phase 3, US trial (Langendonk et al., NEJM 2015) | 93 to 94 adults with EPP, 180 days | Median pain-free time in direct sunlight about 64 to 69 hours vs 41 hours on placebo |
| Phase 3, EU trial (NEJM 2015) | 74 adults with EPP, 270 days | Median pain-free time in direct sunlight about 6 hours vs under 1 hour on placebo |
| Long-term observational study | 115 EPP patients followed up to 8 years | Two new moles reported; no melanoma |
| Small phase 2 studies | Solar urticaria (sun allergy), acne | Increased skin pigment and reduced light sensitivity; fewer acne lesions in 3 patients |
More than 1,000 patients have been treated with afamelanotide in studies and practice without reported melanoma, according to a 2024 review.
Why it gets attention
- A life-changing option for EPP, a rare condition where minutes of sunlight can cause severe burning pain
- Sunless tanning: its origin as a tanning agent drives demand for unregulated "Melanotan I" injections
- Skin-cancer prevention interest, since darker pigment protects against UV damage
- Other skin conditions: it is being studied for vitiligo and other light-related disorders
How it is used
Scenesse is a small implant placed under the skin by a trained healthcare professional, slowly releasing the drug. In the trials it was given about every two months, mainly during sunnier seasons. Patients still need sun protection. Injectable products sold online are a different, unregulated product. This page does not provide dosing guidance.
What about side effects?
From the FDA label and trials, for the approved implant:
- Common: implant-site reactions, nausea, headache, sore throat and cough, fatigue, dizziness or drowsiness
- Skin darkening: expected, including darkening of existing moles and freckles; new moles were reported rarely
- Skin checks: the label advises a full-body skin exam twice a year, because darkened moles can make changes harder to spot
- Allergic reactions: serious allergic reactions have been reported after approval
Unregulated tanning injections carry extra risks: unknown purity and strength, non-sterile products, and unsupervised use. Melanoma cases have been reported in people using the related Melanotan II, typically alongside other risk factors like fair skin and tanning-bed use.
Regulatory status
- FDA-approved (October 2019) as Scenesse to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP. It was approved in the EU in 2014.
- Not approved for cosmetic tanning. Regulators in several countries have warned against injectable Melanotan products sold online as unapproved and not quality-controlled.
- Only trained providers can administer the implant; it is not sold for self-use.
Melanotan I vs Melanotan II
| Melanotan I (afamelanotide) | Melanotan II | |
|---|---|---|
| Structure | 13-amino-acid linear alpha-MSH analog | Shorter, ring-shaped (cyclic) analog |
| Receptors | Mainly MC1R in practice (pigment) | Several melanocortin receptors (pigment, appetite, sexual function) |
| Side effects | Nausea, headache, skin and mole darkening | Nausea, flushing, spontaneous erections, appetite loss, mole changes |
| Human evidence | Phase 3 trials and long-term follow-up | Small early studies |
| US status | FDA-approved implant for EPP | Not approved |
The bottom line
Melanotan I has made an unusual journey from tanning experiment to approved medicine. As the Scenesse implant, it has real trial evidence and a reassuring long-term safety record for people with EPP. That evidence does not cover cosmetic tanning, and injectable products sold online are unregulated. Anyone interested should see a dermatologist, and people using any tanning agent should keep up regular skin checks.
Frequently asked questions
What is Melanotan I?
A synthetic version of alpha-MSH, the hormone that signals skin to tan.
How is Melanotan I taken?
Subcutaneous implant, placed by a clinician.
Is Melanotan I FDA approved?
FDA-approved as Scenesse (implant) for EPP.
What has research shown about Melanotan I?
- Pain-free time in sunlight for people with erythropoietic protoporphyria (EPP), a rare condition.
- Skin pigmentation in early human studies.
What side effects have been reported?
- Implant site reaction (21%)
- Nausea (19%)
- Sore throat (7%)
- Cough (6%)
- Fatigue (6%)
- Skin darkening (4%)
Serious or less common risks are listed in the Side Effects section above.
What is still unknown about its safety?
Side effects that are rare, or that only appear after many years of use, are still being tracked through post-marketing surveillance. Talk to a prescriber about your own risk.
References
- Bohm M, et al. An overview of benefits and risks of chronic melanocortin-1 receptor activation. Journal of the European Academy of Dermatology and Venereology. 2025;39(1):39-51. View source
- Superpower: Afamelanotide, what it is and how the Scenesse implant works (history, NEJM 2015 trial data). View source
- OrthoAtlanta / HealthDay: Implant approved for patients with phototoxic reactions from rare disorder (FDA approval, October 2019). View source