Nishimura Yuhei, Tagawa Masaaki, Ito Hideki, Tsuruma Kazuhiro, Hara Hideaki
Department of Integrative Pharmacology, Mie University Graduate School of Medicine, Tsu, Japan.
Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.
Front Pharmacol. 2017 Oct 11;8:729. doi: 10.3389/fphar.2017.00729. eCollection 2017.
Drug repositioning (DR) is the process of identifying new indications for existing drugs. DR usually focuses on drugs that have cleared phase-I safety trials but has yet to show efficacy for the intended indication. Therefore, DR can probably skip the preclinical and phase-I study, which can reduce the cost throughout drug development. However, the expensive phase-II/III trials are required to establish efficacy. The obstacles to DR include identification of new indications with a high success rate in clinical studies, obtaining funding for clinical studies, patent protection, and approval systems. To tackle these obstacles, various approaches have been applied to DR worldwide. In this perspective, we provide representative examples of DR and discuss the ongoing efforts to overcome obstacles to DR in Japan.
药物重新定位（DR）是指确定现有药物新适应症的过程。DR通常聚焦于已通过I期安全性试验，但尚未在预期适应症上显示出疗效的药物。因此，DR可能无需进行临床前研究和I期研究，这可以降低整个药物研发过程的成本。然而，建立疗效需要进行昂贵的II期/III期试验。DR面临的障碍包括在临床研究中以高成功率识别新适应症、获得临床研究资金、专利保护和审批系统等。为应对这些障碍，全球已将各种方法应用于DR。从这个角度出发，我们提供DR的代表性实例，并讨论日本在克服DR障碍方面正在进行的努力。
