Osilodrostat: First Approval
Osilodrostat: First Approval
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DOI：
10.1007/s40265-020-01277-0
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发表时间：
2020-04-01
期刊：
影响因子：
11.5
通讯作者：
Duggan, Sean
中科院分区：
文献类型：
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作者：
Duggan, Sean
Osilodrostat（Isturisa（R））是一种口服小分子11 β-羟化酶抑制剂，由诺华公司开发，用于治疗库欣病。根据一项关键III期试验的结果，奥西洛司他在欧盟获批用于治疗成人内源性库欣综合征，并正在美国接受监管审查，用于治疗库欣病。本文总结了奥西洛司他的发展里程碑导致这第一次批准。
Osilodrostat (Isturisa (R)) is an orally available small molecule 11 beta-hydroxylase inhibitor that is being developed by Novartis for the treatment of Cushing's disease. Based on results from a pivotal phase III trial, osilodrostat was approved in the EU for use in the treatment of endogenous Cushing's syndrome in adults and is under regulatory review in the USA for the treatment of Cushing's disease. This article summarises the milestones in the development of osilodrostat leading to this first approval.