Chemistry:NK012

From HandWiki

NK012 is a 'nanodevice' formulation of SN-38 (an irinotecan metabolite). NK012 is an SN-38-releasing polymeric micelle constructed by covalently attaching SN-38 to the block copolymer PEG-PGlu, followed by self-assembly of amphiphilic block copolymers in aqueous media.[1] [2]

It has completed phase II clinical trials for triple-negative breast cancer and relapsed small cell lung cancer.[3] In 2016, Nippon Kayaku received orphan drug designation for NK012 from the US FDA.[4] This means that if it is approved in the United States, Nippon Kayaku will be entitled to 7 years of market exclusivity. This is intended to incentivize future development, but does not mean the drug has been approved.[citation needed]

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