What is "afamelanotide"

n. A synthetic analogue of the naturally-occurring melanocortin peptide hormone alpha-melanocyte stimulating hormone (α-MSH) that has been shown to induce skin pigmentation through melanogenesis.

Afamelanotide ( ( INN) (brand name Scenesse), also known as melanotan I (or melanotan-1), originally developed at the University of Arizona and now by Clinuvel Pharmaceuticals, is a synthetic peptide and analogue of the naturally occurring melanocortin peptide hormone α-melanocyte stimulating hormone (α-MSH) that has been shown to induce the production of darkening dermal pigmentation through melanogenesis and thereby subsequently reduce sun (UV) damage to UV light-exposed skin in preliminary research and human clinical trials. Its amino acid sequence is Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH, and it is additionally known as [Nle,D-Phe]-α-MSH, which is sometimes abbreviated as NDP-MSH or NDP-α-MSH (especially in the scientific literature).

Afamelanotide is the International Nonproprietary Name for the molecule [Nle,D-Phe]α-MSH initially researched and developed as melanotan-1 and later, CUV1647 (by Clinuvel). A marketing trade name for one brand of afamelanotide was approved in 2010 by the European Medicines Agency (EMA) Name Review Group (NRG) and the agency's Committee for Medicinal Products for Human Use (CHMP) as Scenesse (pronounced "sen-esse"). On May 5, 2010 the Italian Medicines Agency (AIFA, or Agenzia Italiana del Farmaco) became the first governmental health organization ever (even before the drug received approval in Europe) to authorize afamelanotide as a medicine for therapeutic treatment of Italian citizens to reduce painful dermal photosensitivity stemming from the orphan disease erythropoietic protoporphyria (EPP). This approval allowed the drug to be immediately available for prescription in Italy and reimbursable under the country's national health system. Authorities in Switzerland have also allowed prescription of the drug for EPP with reimbursement approved by two unnamed insurers. Afamelanotide is currently being trialed in the form of a "grain of rice"-sized bioabsorbable subcutaneous implant as a potential therapeutic photoprotection-inducing agent for a series of light-related skin indications as well as a potential dermal repigmentation agent for vitiligo. Afamelanotide, as of October 24, 2014, has been approved by the EMA in Europe for the treatment of EPP. Clinuvel now intends to seek approval of afamelanotide in the United States.

Unlicensed and untested powders sold as "melanotan" are found on the Internet and are reported to be used by tens of thousands of members of the general public for sunless tanning. Multiple regulatory bodies have warned consumers that the peptides may be unsafe and ineffective in usage, with one regulatory agency warning that consumers who purchase any product labeled "melanotan" risk buying a counterfeit drug. Clinuvel Pharmaceuticals, the developer of afamelanotide, and medical researchers have warned consumers that counterfeit products sold using the names "melanotan I and II", could "pose a hazard to public health". Clinuvel has stated publicly that products sold online as "melanotan" are not afamelanotide.