Synthetic linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-1 receptor (MC1R) agonist ([Nle4-D-Phe7]-alpha-MSH, NDP-MSH)
Afamelanotide
Approvedaka Scenesse, Melanotan I, NDP-MSH, CUV1647, [Nle4-D-Phe7]-alpha-MSH
Afamelanotide is a linear analogue of alpha-melanocyte-stimulating hormone developed by the Australian company Clinuvel. By activating the melanocortin-1 receptor it increases skin eumelanin, providing photoprotection. It is approved for erythropoietic protoporphyria on the basis of Phase 3 randomized trials and is administered as a controlled-release implant by trained physicians.
Mechanism
In plain terms, afamelanotide increases the skin's own protective brown pigment so that people with an extreme light-sensitivity disorder can tolerate more light without pain. Technically, it is a potent, longer-acting analogue of alpha-MSH ([Nle4-D-Phe7]-alpha-MSH) that agonises the melanocortin-1 receptor (MC1R) on melanocytes, stimulating eumelanin synthesis; eumelanin absorbs and scatters light and helps quench reactive oxygen species, reducing phototoxic reactions in erythropoietic protoporphyria.
Regulatory Status by Region
- United States (FDA)Approved October 2019 as Scenesse (afamelanotide) implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP); a prescription medicine administered by a physician.
- Australia (TGA)Approved by the TGA and registered on the Australian Register of Therapeutic Goods (ARTG) in November 2020 as Scenesse (afamelanotide) implant for the prevention of phototoxicity in adults with erythropoietic protoporphyria; sponsored by the Australian company Clinuvel Pharmaceuticals.
- European Union (EMA)Authorised in 2014 as Scenesse for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria.
- WADANot specifically named on the WADA Prohibited List; as an approved medicine used for a rare photodermatosis it does not fall within a listed prohibited class.
Key Studies
- Afamelanotide for Erythropoietic Protoporphyria (two Phase 3 randomized controlled trials) (opens in a new tab) (Langendonk JG, et al. N Engl J Med. 2015.)
- FDA approval of SCENESSE (afamelanotide) to increase pain-free light exposure in adults with erythropoietic protoporphyria (opens in a new tab) (U.S. Food and Drug Administration, approved October 2019.)
- Scenesse (afamelanotide) marketing authorisation for prevention of phototoxicity in erythropoietic protoporphyria (opens in a new tab) (European Medicines Agency, authorised 2014.)
Related Clinical Trials
- Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental VitiligoPhase 2 · Recruiting
- Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria PatientsPhase 1/Phase 2 · Completed
- A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With VitiligoPhase 3 · Active Not Recruiting
- Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)Phase 2 · Completed
- A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the FacePhase 2 · Unknown
- A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and VPhase 2 · Unknown
- DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy VolunteersPhase 1 · Completed
- A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)Phase 2 · Unknown
Latest research
Common Questions
- What is Afamelanotide?
- Afamelanotide (Scenesse) is a synthetic alpha-MSH analogue and melanocortin-1 receptor agonist that is an approved medicine. It is delivered as a subcutaneous implant to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP), a rare light-sensitivity disorder. It is approved by the EMA (2014) and the US FDA (2019).
- Is Afamelanotide approved for medical use?
- Afamelanotide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved October 2019 as Scenesse (afamelanotide) implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP); a prescription medicine administered by a physician. European Union (EMA): Authorised in 2014 as Scenesse for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria. Australia (TGA): Approved by the TGA and registered on the Australian Register of Therapeutic Goods (ARTG) in November 2020 as Scenesse (afamelanotide) implant for the prevention of phototoxicity in adults with erythropoietic protoporphyria; sponsored by the Australian company Clinuvel Pharmaceuticals.
- How does Afamelanotide work?
- In plain terms, afamelanotide increases the skin's own protective brown pigment so that people with an extreme light-sensitivity disorder can tolerate more light without pain. Technically, it is a potent, longer-acting analogue of alpha-MSH ([Nle4-D-Phe7]-alpha-MSH) that agonises the melanocortin-1 receptor (MC1R) on melanocytes, stimulating eumelanin synthesis; eumelanin absorbs and scatters light and helps quench reactive oxygen species, reducing phototoxic reactions in erythropoietic protoporphyria.
- Is Afamelanotide legal in Australia?
- Afamelanotide in Australia (TGA): Approved by the TGA and registered on the Australian Register of Therapeutic Goods (ARTG) in November 2020 as Scenesse (afamelanotide) implant for the prevention of phototoxicity in adults with erythropoietic protoporphyria; sponsored by the Australian company Clinuvel Pharmaceuticals.
- Is Afamelanotide banned in sport?
- Afamelanotide under the World Anti-Doping Agency (WADA) code: Not specifically named on the WADA Prohibited List; as an approved medicine used for a rare photodermatosis it does not fall within a listed prohibited class.