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news.Janus Pharmaceuticals has filed an investigational new drug application with the FDA for a cream formulation of its anti-viral product, JA-001, for the treatment of herpes zoster infections.
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JA-001 (sorivudine, also known as ARYS-01 cream) has previously demonstrated activity against the varicella zoster virus in both preclinical and clinical studies. Janus plans to conduct clinical studies evaluating the safety and efficacy of JA-001 in herpes zoster infections (shingles).
Sorivudine is an antiviral nucleoside analog which is transported into viral-infected cells and converted to monophosphate analogs by virus-encoded thymidine kinases. It was originally discovered by Yamasa Corporation of Chiba, Japan, and is being developed as a topical formulation by Janus under a joint development agreement with aRigen Inc of Tokyo, Japan.
aRigen has filed several patents to cover the production method and use of the topical formulation for the treatment of herpes zoster.
Herpes zoster results from a reactivation of a primary varicella-zoster virus infection (chicken pox). Over 90% of adults in the US have serologic evidence of varicella zoster virus infection and are at risk for herpes zoster.