This was done by 2004.As of 2010, afamelanotide was in Phase III trials for erythropoietic protoporphyria and polymorphous light eruption and was in Phase II trials for actinic keratosis and squamous cell carcinoma; as well, it had been trialled in phototoxicity associated with systemic photodynamic therapy and solar urticaria. Clinuvel had also obtained orphan drug status for afamelanotide in the US and the EU by that time.In May 2010, the Italian Medicines Agency (AIFA, or Agenzia Italiana del Farmaco) approved afamelanotide as a treatment for erythropoietic protoporphyria.In January 2015, afamelanotide was approved by the European Medicines Agency (EMA) in Europe for the treatment of phototoxicity in people with EPP.There were three trials that evaluated afamelanotide in those with erythropoietic protoporphyria (EPP).In Trial 1, subjects received afamelanotide or vehicle implant every two months and were followed for 180 days. Subjects recorded every day the number of hours spent in direct sunlight and whether they experienced any phototoxic pain that day. The trial measured the total number of hours over 180 days spent in direct sunlight between 10 am and 6 pm on days with no pain.In Trial 2, subjects received afamelanotide or vehicle implants every two months and were followed for 270 days. Subjects daily recorded the number of hours spent outdoors as well as whether "most of the day" was spent in direct sunlight, shade, or a combination of both, and whether they experienced any phototoxic pain that day.
It is additionally known as [Nle4,D-Phe7]-α-MSH, which is sometimes abbreviated as NDP-MSH or NDP-α-MSH. Afamelanotide is the International Nonproprietary Name. History
After the isolation and primary structure determination of a-MSH in the 1950s, many investigators initiated studies into the synthesis of this peptide. The role of α-MSH in promoting melanin diffusion has been known since the 1960s. In the 1980s, teams at the University of Arizona started to synthesise more potent analogs of a-MSH, including afamelanotide, which they initially named melano-tan (or melanotan-I) due to its ability to tan skin with minimal sun exposure, and later synthesised melanotan-II.Following initial development at the University of Arizona as a sunless tanning agent; the Australian company Clinuvel conducted further clinical trials in that and other indications, and brought the drug to market in the European Union, the United States, and Australia. To pursue the tanning agent, melanotan-I was licensed by Competitive Technologies, a technology transfer company operating on behalf of University of Arizona, to an Australian startup called Epitan, which changed its name to Clinuvel in 2006.Early clinical trials showed that the peptide had to be injected about ten times a day due to its short half-life, so the company collaborated with Southern Research in the US to develop a depot formulation that would be injected under the skin, and release the peptide slowly.