NK012 explained

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

• Nanomedicine
• Targeted drug delivery

Notes and References

1. Web site: 2011-02-02. NCI Drug Dictionary. 2020-11-28. National Cancer Institute. en.
2. Web site: Novel SN-38–Incorporated Polymeric Micelle, NK012, Strongly Suppresses Renal Cancer Progression . 2008 . Sumitomo. etal.
3. Web site: Search of: NK012 - List Results - ClinicalTrials.gov. 2020-11-28. www.clinicaltrials.gov. en.
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