School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, Texas, USA.
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Clin Pharmacol Ther. 2020 Apr;107(4):712-714. doi: 10.1002/cpt.1769. Epub 2020 Feb 3.
It is well recognized that the global pharmaceutical industry now faces challenges such as high costs and low productivity when developing new drugs (e.g., it is estimated that the average cost for developing a new drug ranges from US $2 billion to $3 billion with the total time to bring it to the market being about 13–15 years). Therefore, drug repurposing (also called drug repositioning/reprofiling), which finds new indications for existing drugs, has received great attention in the past decade. Drug repurposing can reduce drug development time, while improving success rates because the toxicity profiles of existing drugs are already known. Studies have shown that new applications for repurposed drugs have nearly a 30% success rate for US Food and Drug Administration (FDA) approval, whereas traditional new drug applications have < 10% approval rate.
人们普遍认识到，全球制药行业在开发新药时面临着诸如高成本和低生产率等挑战（例如，据估计，开发一种新药的平均成本在 20 亿至 30 亿美元之间，将其推向市场的总时间约为 13-15 年）。因此，药物再利用（也称为药物重新定位/重新调整），即寻找现有药物的新适应症，在过去十年中受到了极大关注。药物再利用可以缩短药物开发时间，同时提高成功率，因为现有药物的毒性特征已经为人所知。研究表明，重新利用药物的新应用在美国食品和药物管理局 (FDA) 批准的成功率接近 30%，而传统的新药申请的批准率<10%。
