环索奈德（拜耳先灵医药公司）

University of Southampton School of Medicine, Division of Infection, Inflammation & Repair, Southhampton General Hospital, UK.

Curr Opin Investig Drugs. 2002 Jan;3(1):78-83.

Ciclesonide, a non-halogenated inhaled corticosteroid with anti-inflammatory activity, is under development by Byk Gulden, Aventis and Teijin as a potential treatment for asthma [213439]. It was also being developed by Byk Gulden for chronic obstructive pulmonary disease (COPD), but no development had been reported for this indication since 1999; however, Teijin was carrying out clinical trials in this indication at the end of 2000. During 2000, Byk Gulden was carrying out phase III trials in the US and Europe and in March 2001, results were expected in the third quarter of 2001 [312399], [383726], [423659]. Two inhalant formulations (multidose powder and propellant filled) and a nasal formulation of ciclesonide are being developed by Byk Gulden for the treatment of asthma and seasonal allergic rhinitis, respectively [337147]. The compound is formulated for once-daily dosing and demonstrated good efficacy without corticosteroid-associated systemic side effects [409257]. In January 2001, Byk Gulden expected launch of a CFC-free multidose inhaler formulation in 2003 [395596]; in March 1999, launch of a nasal formulation was expected in 2004 and a multidose powder inhaler in 2005 [337147]. By September 2001, the compound was in phase III trials in the US for asthma, with a potential US launch anticipated by Aventis in 2004 [423465]. In November 2001, Aventis expected to submit an NDA to the FDA in 2003 [428057]. Teijin, which has a development and licensing agreement with Byk Gulden for the treatment of asthma and COPD in Japan, commenced phase I trials of ciclesonide in Japan in spring 1999, had completed these during 2000, and began phase II trials by September of that year [383726]. An NDA is expected to befiled in Japan in 2003. In October 2000 and April 2001, Merrill Lynch predicted peak sales of Euro400 million in 2007, with sales of Euro5 million in 2002, rising to Euro150 million in 2004 [395562], [420574]. Deutsche Bank predicted in August 2001, that sales of the product would reach Euro70 million in 2004, rising to Euro150 million in 2005 [420814].

环索奈德是一种具有抗炎活性的非卤化吸入性皮质类固醇，Byk Gulden、安万特和帝人公司正在将其开发为哮喘的潜在治疗药物[213439]。Byk Gulden公司也曾将其开发用于慢性阻塞性肺疾病（COPD），但自1999年以来未再有该适应症的开发报道；不过，帝人公司在2000年底正在进行该适应症的临床试验。2000年期间，Byk Gulden公司在美国和欧洲进行III期试验，预计2001年第三季度得出结果[312399]、[383726]、[423659]。Byk Gulden公司正在开发两种吸入剂剂型（多剂量粉末和含推进剂剂型）以及环索奈德的鼻用剂型，分别用于治疗哮喘和季节性过敏性鼻炎[337147]。该化合物采用每日一次给药的剂型，显示出良好疗效且无皮质类固醇相关的全身性副作用[409257]。2001年1月，Byk Gulden公司预计2003年推出不含氯氟烃的多剂量吸入器剂型[395596]；1999年3月，预计2004年推出鼻用剂型，2005年推出多剂量粉末吸入器[337147]。到2001年9月，该化合物在美国进行哮喘的III期试验，安万特公司预计2004年在美国推出[423465]。2001年11月，安万特公司预计2003年向美国食品药品监督管理局提交新药申请[428057]。帝人公司与Byk Gulden公司签订了在日本治疗哮喘和COPD的开发及许可协议，于1999年春季在日本开始环索奈德的I期试验，2000年完成，同年9月开始II期试验[383726]。预计2003年在日本提交新药申请。2000年10月和2001年4月，美林公司预测2007年的峰值销售额为4亿欧元，2002年销售额为500万欧元，2004年增至1.5亿欧元[395562]、[420574]。德意志银行在2001年8月预测，该产品2004年销售额将达到7000万欧元，2005年增至1.5亿欧元[420814]。