Melanotan I (Afamelanotide) Research Evidence
The Melanotan I (Afamelanotide) evidence base: trials, journals, and what the data does not yet show.
FDA-Approved for a Rare Disease
Afamelanotide was FDA-approved in 2019 under the brand Scenesse — a subcutaneous implant — specifically for erythropoietic protoporphyria, where it meaningfully increases pain-free light exposure time for patients. Separately, a 2015 trial (Lim et al., JAMA Dermatology, n=55) found monthly afamelanotide added to narrowband UVB phototherapy improved vitiligo repigmentation compared to phototherapy alone, with a larger effect in darker skin tones.
Regulatory and Legal Status
Melanotan I is FDA-approved as Scenesse specifically for EPP. Use for general tanning or cosmetic purposes is not what was tested or approved — that use is off-label at best, and unapproved research-chemical use in that context should be treated as RUO. Researchers and users should verify the legal status of non-EPP afamelanotide use in their jurisdiction.
Trials and reviews
- Lim vitiligo trialJAMA Dermatology2015
Monthly afamelanotide + NB-UVB repigmented more than phototherapy alone (n=55)
References
- Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo · Lim HW, et al. · 2015