About
CLINUVEL has conducted over 15 trials of afamelanotide 16mg involving over 1,000 patients, of which the published research can be purchased online. Below is a selection of published research on afamelanotide. These links direct you to sites outside of the control of CLINUVEL and are not produced or endorsed by CLINUVEL.
Published research
McNeil, M. M., Nahhas, A. F., Braunberger, T. L., Hamzavi, I. H. (2018). Afamelanotide in the Treatment of Dermatologic Disease. Skin Therapy Lett. 2018:23(6):6-10.
Minder, E. I., Barman-Aksoezen, J., Schneider-Yin, X. (2017). Pharmacokinetics and pharmacodynamics of afamelanotide and its clinical use in treating dermatologic disorders. Clinical pharmacokinetics, 2017;56(8):815-823.
Rodrigues M, Ezzedine K, Hamzavi I, Pandya AG, Harris JE, Vitiligo Working Group. Current and emerging treatments for vitiligo. Journal of the American Academy of Dermatology. 2017;77(1):17-29. doi:10.1016/j.jaad.2016.11.010
Langendonk J, Balwani M, Anderson K et al (2015). Afamelanotide for Erythropoietic Protoporphria. New England Journal of Medicine. 2015;373(1):48-59.
Biolcati G, Marchesini E, Sorge F, Barbieri L, Schneider‐Yin X, Minder E. Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. British Journal of Dermatology. 2015;172(6):1601-1612.
Minder, E, Schneider-Yin, X. Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria. Expert review of clinical pharmacology. 2015;8(1):43-53.
Lim HW, Grimes PE, Agbai O, et al. Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo: a randomized multicenter trial. JAMA Dermatology. 2015;151(1):42-50.
Biolcati G, Aurizi C, Barbieri L, Cialfi S, Screpanti I, Talora C. Efficacy of the melanocortin analogue Nle4-D-Phe7-α-melanocyte-stimulating hormone in the treatment of patients with Hailey–Hailey disease. Clinical and experimental dermatology. 2014;39(2):168-175.
Bohm M, Ehrchen J, Luger TA. Beneficial effects of the melanocortin analogue Nle(4) -d-Phe(7) -α-MSH in acne vulgaris. Journal of the European Academy of Dermatology and Venereology. 2014;28(1):108-111.
Rodrigues M, Ezzedine K, Hamzavi I, Pandya AG, Harris JE, Vitiligo Working Group. Current and emerging treatments for vitiligo. Journal of the American Academy of Dermatology. 2017;77(1):17-29. doi:10.1016/j.jaad.2016.11.010
Langendonk J, Balwani M, Anderson K et al (2015). Afamelanotide for Erythropoietic Protoporphria. New England Journal of Medicine. 2015;373(1):48-59.
Biolcati G, Marchesini E, Sorge F, Barbieri L, Schneider‐Yin X, Minder E. Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. British Journal of Dermatology. 2015;172(6):1601-1612.
Minder, E, Schneider-Yin, X. Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria. Expert review of clinical pharmacology. 2015;8(1):43-53.
Lim HW, Grimes PE, Agbai O, et al. Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo: a randomized multicenter trial. JAMA Dermatology. 2015;151(1):42-50.
Biolcati G, Aurizi C, Barbieri L, Cialfi S, Screpanti I, Talora C. Efficacy of the melanocortin analogue Nle4-D-Phe7-α-melanocyte-stimulating hormone in the treatment of patients with Hailey–Hailey disease. Clinical and experimental dermatology. 2014;39(2):168-175.
Bohm M, Ehrchen J, Luger TA. Beneficial effects of the melanocortin analogue Nle(4) -d-Phe(7) -α-MSH in acne vulgaris. Journal of the European Academy of Dermatology and Venereology. 2014;28(1):108-111.
Fabrikant J, Touloei K, Brown SM. “A Review and Update on Melanocyte Stimulating Hormone Therapy: Afamelanotide. Journal of drugs in dermatology: JDD. 2013;12(7):775.
Haylett AK, Nie Z, Brownrigg M, Taylor R, Rhodes L. Systemic photoprotection in solar urticaria with α-melanocyte stimulating hormone analogue [Nle(4) -D-Phe(7) ]-α-MSH. British Journal of Dermatology. 2011;164(2):407-414.
Minder, EI. Afamelanotide melanocortin MC1 receptor agonist photoprotective agent. Drugs of the Future. 2010;35(5):365-372.
Harms JH, Lautenschlager S, Minder CE, Minder EI. Mitigating photosensitivity of erythropoietic protoporphyria patients by an agonistic analog of alpha-melanocyte stimulating hormone. Photochemistry and photobiology. 2009;85(6):1434-1439.
Harms, J, Lautenschlager S, Minder CE, Minder EI. An alpha-melanocyte-stimulating hormone analogue in erythropoietic protoporphyria. New England Journal of Medicine. 2009;360(3):306-307.
Barnetson RS, Ooi TK, Zhuang L, et al. [Nle4-D-Phe7]-α-Melanocyte-Stimulating Hormone Significantly Increased Pigmentation and Decreased UV Damage in Fair-Skinned Caucasian Volunteers. Journal of investigative dermatology. 2006;126(8):1869-1878.
Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006;27(4):921-930.
Fitzgerald LM, Fryer JL, Dwyer T, Humphrey SM. Effect of MELANOTAN®,[Nle4, D-Phe7]-α-MSH, on melanin synthesis in humans with MC1R variant alleles. Peptides. 2006;27(2):388-394.
FAQs
SCENESSE® (afamelanotide 16mg) is CLINUVEL’s proprietary first-in-class photoprotective drug. It is authorised in the European Union, United States and Australia for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
SCENESSE® is administered as an injectable controlled release implant by a trained healthcare professional. More information on the use of SCENESSE® in EPP can be found here.
SCENESSE® (afamelanotide 16mg) is also being assessed as a potential treatment for a range of other indications including variegate porphyria, vitiligo, xeroderma pigmentosum and arterial ischaemic stroke. Information on these indications can be found here. Other indications are planned in the future.
Please refer to the SCENESSE® section of the website.
SCENESSE® (afamelanotide 16mg) has been approved in the European Union for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is also approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. More information on the use of the drug in EPP can be found here. The drug is only available by prescription from trained and accredited Expert Centres.
For information on the safety profile of SCENESSE® (afamelanotide 16mg), please see this document.
CLINUVEL’s stated goal is to register SCENESSE® (afamelanotide 16mg) for those patients most severely affected by UV and light and those living with vitiligo. SCENESSE® (afamelanotide 16mg) is authorised in the European Union for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. These approvals were granted after years of research and development and extensive application and review processes with the European Medicines Agency and the US Food and Drug Administration. CLINUVEL has plans to obtain approval from appropriate authorities to distribute SCENESSE® in other regions and countries of the world.
In contrast, products sold online and elsewhere as ‘melanotan’ are unlicensed unregulated chemicals which are wholly unrelated to CLINUVEL’s development program. The sale of ‘melanotan’ for human use is illegal in most countries. Due to the unlicensed nature of the ‘melanotan’ products, they may pose a serious threat to human health and under no circumstances does CLINUVEL recommend their purchase or use.
At present SCENESSE® (afamelanotide 16mg) is not authorised for the treatment of vitiligo. Clinical trials evaluating SCENESSE® in vitiligo were announced in 2010, with the first of these trials completed in late 2012 and results are available on our website. Follow up results were subsequently announced in September 2013. A subsequent Phase II study, conducted in Singapore, commenced in May 2014, with preliminary results released in December 2015. Full results from the Singaporean Phase II vitiligo study were released in December 2018. Results of these studies can be accessed on our website.
A clinical trial further evaluating SCENESSE® as an adjunct therapy to narrowband UVB (NB-UVB) in generalised vitiligo is underway, with a focus on darker skinned patients (with Fitzpatrick skin types IV to VI).
Details of our vitiligo program can be found in the vitiligo section of our website. Further updates will be provided as the program advances.
A clinical development program to confirm the ability of SCENESSE® to protect skin from photodamage and repair DNA damaged by ultraviolet and high energy visible light. More information can be found here.
In October 2020, CLINUVEL announced world first pilot Phase IIa study (CUV801) to evaluate SCENESSE® (afamelanotide 16mg) in patients suffering from arterial ischaemic stroke (AIS). The focus was on patients who were ineligible to receive standard therapy (IVT/EVT), and in stroke affecting the M2 segment or higher, where there is a great unmet medical need. Results from CUV801 can be accessed here. The second study (CUV803) is underway using the liquid formulation of afamelanotide, PRÉNUMBRA® Instant. More information can be found here.