HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Clinuvel’s melanin stimulant headed for U.S. trials

This article was originally published in The Rose Sheet

Executive Summary

Melbourne, Australia firm Clinuvel Pharmaceuticals says FDA has granted Investigational New Drug status to its photoprotective afamelanotide drug, allowing it to initiate clinical trials in the U.S. A synthetic version of a naturally occurring hormone that controls melanin levels in human skin, Clinuvel's drug has achieved positive interim results in Switzerland in a Phase III trial involving subjects with a severe genetic skin disorder causing absolute intolerance to sun, according to a recent statement. The substance is in clinical studies in Europe and Australia for four other UV-light-related indications, and there is speculation that Clinuvel eventually could pursue the drug's use in healthy populations for aesthetic purposes; the company previously has reported that the tan associated with its product lasts for roughly three months (1"The Rose Sheet" Nov. 24, 2008, p. 4). In late 2008 UK regulators took action to stem the sale of similar, unlicensed Melanotan products promising an "injectable tan" due to potentially serious side effects. This year Clinuvel aims to "finalize" initial data related to afamelanotide use in cancer patients undergoing photodynamic therapy; it also intends to brand and settle on a trade name for its drug that currently goes by "CUV1647.

You may also be interested in...

How Realistic Is Injectable Tan/Sun Protection? UK Cracks Down On Illegals

UK regulators are warning consumers not to use Melanotan, an "injectable tan" being sold illegally online; however, a product in development by Australian firm Clinuvel raises the question of whether self-tanner and sun protection marketers could face competition down the road from such an injectable

On CRN Challenge, Nexus Formulas Gets Lesson On Supporting Ad Claims For Supplements

So full of errors were the firm's online ads for its Plavinol supplement, the National Advertising Division noted support for some claims contained "many of the same flaws" as others. The prevalence of problems prompted NAD to go its "scope of review" and note unclear instructions on Plavinol labels.

FDA’s Cannabidiol Crackdown: What Do Warning Letters Say About CBD In Cosmetics?

Cannabidiol (CBD) represents an intriguing opportunity for cosmetics, without the statutory obstacles faced by food and dietary supplement companies. Cosmetics marketers are taking advantage, but the FDA’s recent warning letter blitz is a reminder that CBD-infused beauty products are bound by the same rules that apply to other cosmetics.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts