NK012

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.

See also

References

  1. ↑ "NCI Drug Dictionary". National Cancer Institute. 2011-02-02. Retrieved 2020-11-28.
  2. ↑ Sumitomo; et al. (2008). "Novel SN-38–Incorporated Polymeric Micelle, NK012, Strongly Suppresses Renal Cancer Progression".
  3. ↑ "Search of: NK012 - List Results - ClinicalTrials.gov". www.clinicaltrials.gov. Retrieved 2020-11-28.
  4. ↑ Nippon Kayaku Announces FDA Orphan Drug Designation to New Polymeric micelle Anti-Cancer Drug NK012 for Small Cell Lung Cancer. (2016). Evaluategroup.com. Retrieved 24 November 2017, from http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=644017


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