摘要
根据美国药物研究与生产商协会(PhRMA)发布的相关报告和新药数据库中的数据,对2013年至今进入Ⅲ期临床试验或递交新药申请(NDA)/生物制剂许可申请(BLA)的用于治疗糖尿病及其相关疾病的65种候选新药的临床研发情况进行综述。将这些候选新药分为非胰岛素类、胰岛素类和复方制剂类抗糖尿病药,并重点对递交NDA/BLA或已获得批准的抗糖尿病新药开发进行了分析和讨论。
The international clinical development of 65 new medicines for diabetes and their related diseases in Ⅲ phase clinical trials or their New Drug Application (NDA) or Biological License Application (BLA) submitted and approved from 2013 to the present has been reviewed based on the data in the reports and the Medicines in Development Database published by the Pharmaceutical Research and Manufacturers of America (PhRMA). The 65 new medicines are classified into non-insulins, insulins and fixed-dose combinations for diabetes. And the new antidiabetic candidates that their NDA/BLA was submitted for approval and the new medicines approved from 2013 to the present are mainly analyzed and discussed.
出处
《药学进展》
CAS
2014年第3期185-195,共11页
Progress in Pharmaceutical Sciences
关键词
抗糖尿病药
胰岛素
非胰岛素类抗糖尿病药
复方制剂
新药
antidiabetic medicine
insulin
non-insulin antidiabetic medicine
fixed-dose combination
new medicine