Scenesse
Evidence Grade A — Regulatory approved. 101 published studies. 23 registered clinical trials.
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Afamelanotide (sold as Scenesse) is a small implant placed under the skin that helps the body produce protective melanin pigment without needing sun exposure. It is approved for people with erythropoietic protoporphyria (EPP), a rare inherited condition where even brief exposure to light causes severe, burning pain. Before Scenesse, there was no approved treatment for EPP.
101 published studies: 70 human, 1 animal, 4 in-vitro, 41 reviews
Afamelanotide is marketed as Scenesse (Clinuvel Pharmaceuticals, approved October 2019 in the US; previously approved in the EU in 2014). It is delivered as a bioresorbable subcutaneous implant administered every two months. Treatment is only available through a restricted distribution programme.
In clinical trials, EPP patients on afamelanotide could spend significantly more time in direct sunlight without pain. EPP is a debilitating condition where even brief light exposure can cause hours of burning pain, and prior to Scenesse there was no approved treatment. Afamelanotide is related to the research compound Melanotan I, but is the only version that has undergone full regulatory approval for a specific medical condition.
Afamelanotide activates melanocortin-1 receptors on melanocytes (the skin's pigment-producing cells), stimulating them to produce eumelanin — the dark, protective form of melanin. Crucially, this happens without UV exposure. In patients with EPP, a build-up of protoporphyrin in the skin causes excruciating pain when activated by light. The increased eumelanin acts as a natural light shield, absorbing the wavelengths that would otherwise trigger this toxic reaction, allowing patients to tolerate more light exposure without pain.
Clinical trials showed that EPP patients receiving afamelanotide could spend significantly more time outdoors without experiencing the debilitating pain that normally confines them indoors. For a condition with no other pharmacological treatment, this represented a meaningful improvement in quality of life. The implant is given every two months and is only available through a restricted distribution programme due to the tiny patient population. Afamelanotide is derived from the same family of melanocortin research as the unregulated tanning peptides Melanotan I and Melanotan II, but it is the only product from this lineage to have completed full regulatory approval for a specific medical condition. The manufacturer is exploring additional uses including vitiligo (a skin pigmentation disorder) and other conditions involving light sensitivity. The ultra-small patient population means the price is high, following the rare disease commercial model.
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
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 Vitiligo
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
EMA Marketing Authorisation
FDA ORIG 1
FDA SUPPL 7
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