奥达特罗(Olodaterol Hydrochloride) - 药物靶点：β2-adrenergic receptor_在研适应症：慢性阻塞性肺疾病，干眼症，变应性结膜炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

BI-1744-CL (hydrochloride)、Olodaterol、Olodaterol hydrochloride (JAN/USAN)

+ [8]

靶点

β2-adrenergic receptor

作用方式

激动剂

作用机制

β2-adrenergic receptor激动剂(β2-肾上腺素能受体激动剂)

治疗领域

呼吸系统疾病免疫系统疾病眼部疾病

在研适应症

慢性阻塞性肺疾病干眼症变应性结膜炎

非在研适应症

哮喘间歇性哮喘肝病+ [2]

原研机构

C.H. Boehringer Sohn AG & Co. KG

在研机构

Santen Pharmaceutical Co., Ltd.Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim GmbH

+ [1]

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

欧洲 (2013-12-20),

慢性阻塞性肺疾病

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构/序列

分子式C21H27ClN2O5

InChIKeyKCEHVJZZIGJAAW-FERBBOLQSA-N

CAS号869477-96-3

关联

70

项与奥达特罗相关的临床试验

NCT07267130

/ Recruiting临床1期

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China

Groups 1, 3, 4, 5 and 6 of this research team adopted a single-center, open-label design. Group 2 used a three-sequence, three-period crossover design, where participants in this dose group were randomly assigned to the three sequences in a 1:1:1 ratio to undergo three-period crossover administration. Healthy adult subjects were selected to use TQC3302 inhalation spray to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple inhalations of TQC3302 inhalation spray in healthy participants.

开始日期2025-11-25

申办/合作机构

正大天晴药业集团股份有限公司

JPRN-jRCT2031250105

/ Recruiting临床2期

A Phase IIb, double-masked, randomized, multi-center, placebo-controlled, parallel-group study of STN1014100 ophthalmic solution in patients with dry eye

开始日期2025-05-01

申办/合作机构

Santen Pharmaceutical Co., Ltd.

NCT07541378

/ SuspendedN/AIIT

Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD: Randomised Crossover Study (COMPETE)

This study is designed to directly compare the effects of widely available long-acting bronchodilator therapies in patients with chronic obstructive pulmonary disease (COPD). The trial evaluates three fixed-dose combinations of a long-acting beta-2 agonist and a long-acting muscarinic antagonist (LABA/uLAMA)-umeclidinium/vilanterol (Anoro® Ellipta), indacaterol/glycopyrronium (Ultibro® Breezhaler), and tiotropium/olodaterol (Spiolto® Respimat)-against tiotropium (Spiriva®), a long-acting muscarinic antagonist (LAMA) used as monotherapy. The primary aim is to assess their impact on exercise capacity, with additional evaluation of pharmacoeconomic outcomes.
The study follows a prospective, randomized, open-label, four-period crossover design. Approximately 100 patients with stable COPD will be enrolled from the 2nd Department of Pulmonology and Tuberculosis, Medical University of Białystok, and the University Hospital Pulmonology Outpatient Clinic. Each treatment will last 28 days, separated by a 7-day wash-out period, so that every participant will receive each therapy.
Assessments will include standard clinical examinations, lung function testing (spirometry, body plethysmography, DLCO, multiple-breath washout), cardiopulmonary exercise testing (CPET) on a cycle ergometer, the 6-minute walk test, validated questionnaires (SGRQ, CAT, mMRC, BODE index), laboratory tests, and imaging. These procedures are part of routine COPD evaluation and will allow detailed monitoring of respiratory function, exercise tolerance, and quality of life.
The study aims to determine whether dual bronchodilation with LABA/uLAMA combinations provides superior improvements in exercise performance and overall efficiency compared to tiotropium alone. Results may help guide clinical decision-making and optimize cost-effectiveness in COPD management.

开始日期2024-03-11

申办/合作机构

Uniwersytet Medyczny w Bialymstoku

100 项与奥达特罗相关的临床结果

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100 项与奥达特罗相关的转化医学

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100 项与奥达特罗相关的专利（医药）

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309

项与奥达特罗相关的文献（医药）

2026-09-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous quantification and aerodynamic particle size distribution analysis of tiotropium bromide and olodaterol in nebulized aerosol using UHPLC-MS/MS

Article

作者: Chen, Chao ; Dou, Jing ; Qian, Renyun ; Yuan, Chenxing ; Zhu, Difeng ; Hong, Yawen

Fixed-dose combination (FDC) inhaled aerosols require precise characterization of both active pharmaceutical ingredients (APIs) and aerodynamic properties to ensure therapeutic efficacy and safety. This study established and validated a sensitive, high-throughput ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method for the simultaneous quantification of tiotropium bromide (TTP, a long-acting muscarinic antagonist) and olodaterol (ODT, a long-acting β₂-adrenergic agonist) in nebulized aerosols, coupled with comprehensive aerodynamic particle size distribution (APSD) analysis. The optimized method employed a 50% methanol-water solution as the extraction solvent, with isocratic elution using 0.1% formic acid in water-methanol (50:50, v/v) and multiple reaction monitoring (MRM) in positive ionization mode. The total analysis time was only 3 min, enabling high-throughput analysis. Method validation confirmed excellent linearity for both analytes over the range of 0.5-16 ng/mL (r > 0.998), with a lower limit of quantification (LLOQ) of 0.5 ng/mL. Intra- and inter-batch precision (relative standard deviation, RSD) were < 7.5%, and extraction recoveries ranged from 98.1% to 98.8% (RSD<3%), with good matrix effect tolerance, solution stability (24 h at room temperature/4°C), and dilution integrity. A combination of syringe aspiration and Andersen Cascade Impactor (ACI) sampling was used to characterize aerosol properties at 2 and 8 min of nebulization. Both TTP and ODT exhibited uniform and stable aerosol concentrations (RSD<3.5%), with mass median aerodynamic diameters (MMAD) of 1.87-2.35 μm, geometric standard deviations (GSD) of 2.13-2.44, and fine particle fractions (FPF) exceeding 90%. The proportion of ultrafine particles (<0.41 μm) captured by the micro-orifice collector (MOC) was < 4%, confirming optimal particle size distribution for deep lung deposition. Application of this method to the evaluation of theoretical delivered doses in animal safety assessment tests showed that the doses were 4.7-8.6 times the rat equivalent dose, meeting the design requirements for toxicological studies. This method provides a robust framework for quality control, generic drug consistency evaluation, and preclinical toxicology of TTP/ODT nebulized aerosols, supporting the development of FDC inhaled therapies for chronic obstructive pulmonary disease (COPD).

2026-07-01·Respiratory Investigation

Adherence to LAMA/LABA therapies in middle-aged patients with chronic obstructive pulmonary disease: A group-based trajectory analysis

Article

作者: Miyamoto, Atsushi ; Yoshida, Satomi ; Fukasawa, Toshiki ; Kawakami, Koji ; Watanabe, Tetsuya ; Asai, Kazuhisa ; Hirai, Kaho ; Liu, Hao ; Akaike, Takenori

BACKGROUND:

Longitudinal adherence patterns to LAMA/LABA therapy among middle-aged patients with COPD are not well understood. Because individuals aged 40-64 years typically self-manage medications with fewer age-related influences on adherence, this population allows clearer evaluation of temporal patterns. We therefore conducted a descriptive study among middle-aged patients to classify adherence trajectories and identify groups at risk of suboptimal adherence.

METHODS:

Using a Japanese claims database, we identified COPD patients aged 40-64 years who initiated glycopyrronium/indacaterol (GLY/IND), umeclidinium/vilanterol (UMEC/VI), or tiotropium/olodaterol (TIO/OLO). Group-based trajectory modeling was applied to the monthly proportion of days covered over 360 days to identify groups of patients with similar longitudinal adherence patterns.

RESULTS:

The analysis included 240 GLY/IND initiators, 365 UMEC/VI initiators, and 496 TIO/OLO initiators. For GLY/IND initiators, three adherence groups were identified: consistently high (31.7%), gradually declining (17.1%), and immediately declining (51.3%). UMEC/VI initiators demonstrated four groups: consistently high (26.6%), gradually declining (9.9%), rapidly declining (19.7%), and immediately declining (43.8%). TIO/OLO initiators also showed three groups: consistently high (35.5%), gradually declining (20.0%), and immediately declining (44.6%). Across all cohorts, higher adherence groups more frequently had a greater comorbidity burden and fewer previous moderate exacerbations, whereas suboptimal adherence groups tended to be younger, included more women, and initiated LAMA/LABA therapy in clinical settings.

CONCLUSIONS:

Middle-aged patients with COPD initiating LAMA/LABA therapy exhibited distinct adherence trajectories. Understanding these patterns may help inform more targeted approaches to support adherence and improve patient outcomes.

2026-06-05·MEDICINE

Drug-related pulmonary fibrosis: A real-world pharmacovigilance study of the FDA Adverse Event Reporting System

Article

作者: Yang, Lei ; Zhen, Hua ; Jian, Ruonan ; Shi, Erxia ; Du, Mingyan ; Guo, Jingjing ; Jin, Haoqi

Pulmonary fibrosis (PF) can lead to respiratory distress, persistent dry cough, and a decline in quality of life, and may be life-threatening in severe cases. The aim is to mine and analyze drug-related PF signals, summarize potential risk medications, and provide references for clinical medication safety. This research accessed data from the US Food and Drug Administration Adverse Event Reporting System covering reports from January 2004 to September 2024. Proportional disproportionality methods were utilized to explore the relationship between drugs and PF, and to assess demographic information, drug-related PF risks, and the timing of PF onset. The Food and Drug Administration Adverse Event Reporting System database contained reports of 830 drugs associated with PF. Through disproportionality analysis and subsequent filtering, 33 drugs were identified as having significant risks. Fifteen antitumor and immunomodulatory drugs (45.45%) were noted, including bleomycin (reporting odds ratio [ROR] = 41.68), interferon gamma-1B (ROR = 12.11), and anagrelide (ROR = 6.63). Four cardiovascular system drugs (12.12%) included amiodarone (ROR = 41.92), dronedarone (ROR = 10.25), and simvastatin (ROR = 6.94). Four respiratory system drugs (12.12%) included indacaterol (ROR = 6.87), salmeterol/fluticasone (ROR = 4.30), and olodaterol (ROR = 3.76). Four antipathogenic microbial drugs (12.12%) included nitrofurantoin (ROR = 22.92), sulfasalazine (ROR = 5.69), and hydroxychloroquine (ROR = 3.51). Six other drugs (18.18%) included iodine-131 (ROR = 19.72), calcium carbonate (ROR = 8.59), and tamsulosin (ROR = 7.48). Amiodarone (Bayesian confidence propagation neural network [BCPNN] = 5.26), bleomycin (BCPNN = 4.95), and nitrofurantoin (BCPNN = 4.40) were the 3 drugs characterized by the greatest associated PF risk. The time to PF onset from antitumor and immunomodulatory drugs was significantly shorter than that from other drug types ( P = .0082). The study identified 33 drugs showing disproportionality signals suggestive of potential associations with PF, most notably among antitumor and immunomodulatory agents, which exhibited a significantly shorter time to PF onset compared with other drug classes. The 3 drugs associated with the greatest PF risk were amiodarone, bleomycin, and nitrofurantoin. These findings highlight potential pharmacovigilance signals that warrant clinical vigilance and further validation through prospective studies.

27

项与奥达特罗相关的新闻（医药）

2026-08-03

·华益药业

药闻动态 | 一周药闻 07.27-08.02

法规公告 NMPA：国家药监局关于发布仿制药参比制剂目录（第一百零七批）的通告（2026年第27号）经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第一百零七批）。 https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260731172738181.html CDE：国家药监局药审中心关于发布《药物临床试验生物样品分析实验室合规性回顾报告》的通告（2026年第42号）为保证用于提交药品注册申请的药物临床试验生物样品分析检测数据可靠，进一步强化药品注册申请人和药物临床试验申办者主体责任，按照国家药品监督管理局的部署，药审中心组织制定了《药物临床试验生物样品分析实验室合规性回顾报告》和配套填报说明（见附件1、2）。经国家药品监督管理局审查同意，现予发布。自2027年2月1日起受理的药品上市许可申请，申请人应完成本报告的填报（如适用）并在注册申报资料中递交。 https://www.cde.org.cn/main/news/viewInfoCommon/a0a6727013b8c545df6f114f3f8dad1f CDE：关于公开征求ICH《M15：模型引导的药物研发》指导原则实施建议和中文翻译稿意见的通知为进一步推进ICH《M15：模型引导的药物研发》指导原则在国内落地实施，我中心拟定了该指导原则实施建议和中文翻译稿，现公开征求意见，为期1个月，如有修改意见，请反馈至联系人邮箱gkzhqyj@cde.org.cn。 https://www.cde.org.cn/main/news/viewInfoCommon/0e195b0414c7fd0c3ae88635ee186145 上海阳光医药采购网：第12批国家组织药品集中带量采购拟中选结果公示现将第12批国家组织药品集中带量采购拟中选结果（GY-YD2026-1）进行公示，详见附件。 https://www.smpaa.cn/gjsdcg/2026/07/31/23182.shtml 企业动态 1、西湖制药（杭州）有限公司申报的1类创新药盐酸伊司特韦片附条件批准上市，该药品为口服小分子新冠病毒感染治疗药物，用于治疗成人轻型、中型新型冠状病毒感染（COVID-19）。 2、艾特美（苏州）医药科技有限公司申报的噻托溴铵奥达特罗吸入喷雾剂获批上市，为国内首仿。本品为噻托溴铵与奥达特罗组成的复方制剂，适用于慢性阻塞性肺疾病（COPD，简称慢阻肺），包括慢性支气管炎和肺气肿）患者的长期维持治疗，以缓解症状。 3、人福医药的全资子公司人福普克药业（武汉）的酒石酸长春瑞滨软胶囊获批上市，该产品是公司首个获批的植物生物碱，用于不可手术切除的局部晚期或转移性非小细胞肺癌，和转移性乳腺癌的单药或联合化疗。 4、北京福元医药股份有限公司按化药注册分类2.3类申报的奥美沙坦酯左氨氯地平片上市申请获受理。本次申请适应症为原发性高血压，适用于单药治疗血压控制效果不佳的成人患者。 5、恒瑞医药开发的1类新药舒地胰岛素注射液（商品名：瑞恒盈）获批上市，为国内获批的首款国产三代长效胰岛素新药，为2型糖尿病患者提供新的治疗选择。 6、凯西医药咨询（上海）有限公司申报的甲磺酸洛美他派胶囊新适应症拟纳入优先审评。适应症为：甲磺酸洛美他派可与低脂饮食和其他降脂药物（伴或不伴有低密度脂蛋白血浆分离置换）合用，用于成人和5岁及以上儿童纯合子家族性高胆固醇血症（HoFH），以降低低密度脂蛋白胆固醇（LDL-C）、总胆固醇（TC）、载脂蛋白B（apo B）和非高密度脂蛋白胆固醇（非HDL-C）水平。 7、华海药业子公司上海华奥泰生物药业股份有限公司申报的瑞西奇拜单抗注射液通过优先审评审批程序获批上市，用于治疗成人(体重≥40kg)泛发性脓疱型银屑病发作。 8、Viatris Inc研发的低剂量雌激素复方激素避孕贴片（Gwyn Lo，通用名：诺孕曲明/炔雌醇透皮系统）在美国FDA获批上市。该药物适用于体重指数（BMI）小于30 kg/m²且适合接受复方激素避孕的育龄女性，用于预防妊娠。 9、人福医药其全资子公司湖北生物医药产业技术研究院的化药1类新药HW243040片获批临床，同意开展用于治疗周围神经病理性疼痛的临床试验。该产品作为一种非阿片类镇痛药物，其作用靶点基于独特的外周免疫-神经调控机制，从机制上有望规避中枢神经系统相关副作用以及药物依赖与成瘾风险，为患者提供更具安全性的新选择。 10湖南先施制药的4类仿制药盐酸氨溴索口服溶液申报上市获受理，该产品是一种黏液溶解性祛痰药，用于急/慢性支气管炎引起的痰液粘稠、咳痰困难。2025年在中国市场销售额超9亿元。 11、艾伯维官方宣布，欧盟委员会（EC）已批准乌帕替尼（商品名：Rinvoq）两项新适应症获批上市，分别用于治疗12岁及以上重度斑秃成人和青少年患者，以及适合接受系统性治疗的12岁及以上非节段型白癜风(NSV)成人和青少年患者。 12、广东仁想药业与湖南九典制药提交的4类仿制药洛索洛芬钠贴剂同日获批，成为该品种国内首批上市仿制药。此前国内仅原研LEAD一家上市，该品种2025年全终端医院市场规模超8亿元，同比增长18.98%。 13、第一三共与阿斯利康联合宣布，其靶向TROP-2的抗体偶联药物（ADC）Datroway（德达博妥单抗）已在欧盟获批一项新适应症——作为单药一线治疗不适合接受PD-1/PD-L1抑制剂治疗的不可切除或转移性三阴性乳腺癌（TNBC）成人患者。 14、大冢制药的SIMTRIYO®（centanafadine）获得FDA批准上市，用于治疗体重≥20kg的6岁及以上儿童和成人注意缺陷多动障碍（ADHD）患者。这是一款多巴胺、去甲肾上腺素、血清素三重再摄取抑制剂（NDSRI），区别于市面上主流的单靶点ADHD药物。 15、阿斯利康申报的1类新药Efzimfotase alfa注射液（皮下注射）拟纳入优先审评。拟定适应症为：用于2岁及以上低磷酸酯酶症（HPP）患者的治疗。今年 7 月，该药已在日本申报上市。 16、上海现代制药的阿卡波糖片和达格列净片，以及国药工业的盐酸氯胺酮注射液同日获批。阿卡波糖片和达格列净片是糖尿病用药爆款产品，2025年在中国市场的销售额分别为25亿元、114亿元。 17、瑞阳制药的五味消毒饮颗粒获批上市，是公司近十年首个获批的中药新药，也是公司首个上市的古代经典名方。据悉，五味消毒饮出自清代《医宗金鉴》的经典中药方剂，主要功效是清热解毒、消散疔疮。 18、湖南九典制药的中药1.1类新药椒七止痛凝胶贴膏获批上市。椒七止痛凝胶贴膏为中药复方外用制剂，具有温经散寒、活血止痛功效，用于膝骨关节炎寒凝血瘀证，症见关节疼痛、局部畏寒、得温痛减、活动不利、僵凝重滞等。来源|国家药监局、药审中心、医药魔方、米内网编辑整理|华益药业

2026-07-28

·BioBAY

突破软雾制剂技术壁垒，艾特美噻托溴铵奥达特罗吸入喷雾剂首仿获批

近日，BioBAY园内企业艾特美医药的噻托溴铵奥达特罗吸入喷雾剂顺利获批，拿下国内首仿。已取得由国家药品监督管理局签发的注册生产批件，批准文号为：国药准字H20265298。本品为噻托溴铵与奥达特罗组成的复方制剂，适用于慢性阻塞性肺疾病（COPD，简称慢阻肺，包括慢性支气管炎和肺气肿）患者的长期维持治疗，以缓解症状。噻托溴铵奥达特罗吸入喷雾剂的原研药物为德国勃林格殷格翰的思合华®能倍乐®。本次国内噻托溴铵奥达特罗吸入喷雾剂仿制药获批上市的包括艾特美在内共计2家。据统计，噻托溴铵奥达特罗吸入喷雾剂2023年全球销售额为9.17亿美元，2024年全球销售额为9.65亿美元，2025年全球销售额为9.70亿美元。（数据来源于IQVIA数据库）吸入喷雾剂（软雾）是吸入制剂的高端发展方向，艾特美医药此次噻托溴铵奥达特罗吸入喷雾剂首仿获批，打破跨国企业在软雾吸入剂领域长达十余年的技术垄断，补齐国内复杂吸入制剂赛道关键短板。噻托溴铵奥达特罗吸入喷雾剂获批上市，进一步丰富了公司呼吸领域产品管线，有利于提升公司产品的市场竞争力，更为企业海外出口布局筑牢核心信任背书。噻托溴铵奥达特罗吸入喷雾剂首仿获批，充分证明公司具备复杂吸入制剂研发、量产、质量管控的全链条能力，公司将加速海外注册申报、渠道洽谈进程，持续拓宽全球慢阻肺用药出口市场，打造国产高端吸入制剂出海的核心竞争力。产品介绍吸入喷雾剂（软雾）在临床使用上具有操作简单、患者依从性高等优势。噻托溴铵奥达特罗吸入喷雾剂为复方制剂，两种活性成分双效协同，减少激素依赖。噻托溴铵为长效的抗胆碱能药物，对五种胆碱受体（M1-M5）具有相似的亲和性，通过和平滑肌上的M3手提结合产生对支气管平滑肌的扩张作用。奥达特罗属于长效β2肾上腺素受体激动剂（LABA），通过结合并活化β2受体，激活细胞内的腺苷酸环化酶，促使细胞内环磷酸腺苷（cAMP）水平升高，从而松弛气道平滑肌，舒张支气管。 ▌文章来源：艾特美医药责编：于嘉敏审核：任旭推荐阅读拓展减重领域版图，信达生物INHBE siRNA新药申报临床研发动态丨盛迪亚：新适应症获批！艾比特®联合艾瑞卡®获批用于复发或转移性宫颈癌一线治疗研发动态丨盛迪亚：新适应症获批！艾比特®联合艾瑞卡®获批用于复发或转移性宫颈癌一线治疗

2026-07-26

·药研苑

噻托溴铵奥达特罗吸入喷雾剂2家首仿同时获批

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年7月23日国家药品监督管理局（NMPA）网站信息显示，南昌谷森生物制药有限公司，以及和艾特美（苏州）医药科技有限公司生产的噻托溴铵奥达特罗吸入喷雾剂的仿制申请，已于2026年7月21日同日获得NMPA获批。噻托溴铵奥达特罗吸入喷雾剂的原研企业为勃林格殷格翰Boehringer Ingelheim，2018年在国内获批上市，适应症为：适用于慢性阻塞性肺疾病（COPD，简称慢阻肺，包括慢性支气管炎和肺气肿）患者的长期维持治疗，以缓解症状。噻托溴铵奥达特罗吸入喷雾剂尚未进入医保。奥达特罗（Olodaterol）为长效β₂受体激动剂（LABA），能够快速、持久舒张支气管。噻托溴铵（Tiotropium Bromide）为长效抗胆碱能药物（LAMA），支气管舒张作用比β₂受体激动剂弱，起效时间也不如奥达特罗快。但与奥达特罗联合使用，能够协同舒张支气管。吸入喷雾剂，也被称为软雾技术，不使用抛射剂，利用弹簧机械，使药液射流对撞，以低射速的形式，形成气雾，与吸入粉雾剂相比，患者不用用力吸气，与气雾剂相比，吸入喷雾剂不需要操作与吸气精确协同。谷森和艾特美均是国内首次获得噻托溴铵奥达特罗吸入喷雾剂批准上市的企业。推荐指数：★ 推荐原因：尽管噻托溴铵奥达特罗吸入喷雾剂在使用上具有一定优势，由于未进入医保，市场表现并不理想。此外，COPD吸入治疗药物，目前以ICS+LABA+LAMA三联产品为主，LABA+LAMA二联产品的表现，尚远不及ICS+LABA+LAMA。个人观点，仅限参考。相关阅读：君实生物特瑞普利单抗NSCLC围手术期适应症申请扩展至Ⅱ-Ⅲ期诺和诺德血友病A治疗药物迪纳西米单抗申请国内上市瑞博生物发布FXI siRNA Vortosiran用于冠状动脉疾病2a期数据礼邦医药磷转运蛋白抑制剂类降磷剂AP306 2b试验首例给药信立泰复方降压药物沙库巴曲阿利沙坦氨氯地平片申请新药上市武田OX2R激动剂奥普雷顿获批治疗1型发作性睡病海思科医药思普可泮获批治疗阵发性睡眠性血红蛋白尿症闻泰医药小分子GLP-1受体激动剂VCT220申请新药上市金赛药业申请靶向VEGFR2药物金妥昔单抗新药上市西比曼生物GPC3 CAR-T (C-CAR031)用于晚期肝癌1期研究发表宜联生物B7-H3 ADC依康坦博妥塔单抗申请上市用于晚期鼻咽癌恒瑞发布GLP-1/GIP瑞普泊肽用于初治2型糖尿病3期试验数据礼来塞普替尼申请上市用于早期NSCLC根治性治疗后辅助治疗知原药业降磷药物枸橼酸铁片申请仿制上市石药集团恩维曲妥珠单抗申请上市用于HER2阳性晚期乳腺癌明治发布新型β内酰胺酶抑制剂Nacubactam三期临床试验结果相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

上市批准临床3期siRNA抗体药物偶联物临床2期

100 项与奥达特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10020	奥达特罗	R03AC19	DB09080

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性阻塞性肺疾病	欧洲	Boehringer Ingelheim GmbH	2013-12-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肺气肿	临床3期	日本	Boehringer Ingelheim GmbH	2016-02-12
干眼症	临床2期	日本	Santen Pharmaceutical Co., Ltd.	2023-02-07
持续性哮喘	临床2期	美国	Boehringer Ingelheim GmbH	2011-03-01
持续性哮喘	临床2期	奥地利	Boehringer Ingelheim GmbH	2011-03-01
持续性哮喘	临床2期	德国	Boehringer Ingelheim GmbH	2011-03-01
持续性哮喘	临床2期	匈牙利	Boehringer Ingelheim GmbH	2011-03-01
持续性哮喘	临床2期	斯洛伐克	Boehringer Ingelheim GmbH	2011-03-01
持续性哮喘	临床2期	斯洛文尼亚	Boehringer Ingelheim GmbH	2011-03-01
哮喘	临床2期	荷兰	Boehringer Ingelheim GmbH	2007-03-01
间歇性哮喘	临床2期	加拿大	Boehringer Ingelheim GmbH	2006-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02296138 \| NCT01431287 \| NCT01431274 (TONADO®/DYNAGITO®, Pubmed \| Adv Ther)	临床3期	慢性阻塞性肺疾病	9,942	Tiotropium/olodaterol 5/5 µg	蓋製遞築鑰壓選積憲遞(製網遞鏇蓋餘願衊鏇願) = 齋廠窪構顧窪鹹襯鹹願襯餘遞醖夢襯膚獵壓遞 (廠醖壓築鹹餘選觸鹽憲 )	积极	2020-08-10
				Tiotropium 5 µg	蓋製遞築鑰壓選積憲遞(製網遞鏇蓋餘願衊鏇願) = 遞顧齋糧獵構鹹鹹廠衊襯餘遞醖夢襯膚獵壓遞 (廠醖壓築鹹餘選觸鹽憲 )
NCT02006732 \| NCT01431287 (Pubmed \| Adv Ther)	临床3期	慢性阻塞性肺疾病一线	1,078	Tiotropium/Olodaterol 5/5 µg	範鹽觸積鏇淵醖艱膚網(鹹齋壓淵齋膚窪壓顧壓) = 鏇糧淵衊壓鹽顧簾餘淵積壓餘鏇淵積夢壓窪繭 (憲顧範餘鬱觸齋選鬱鏇, 0.033 ~ 0.079)	-	2020-07-15
NCT03240575 (CTgov)	临床4期	慢性阻塞性肺疾病	302	Tiotropium+Olodaterol (Tiotropium+Olodaterol (5μg/5μg) - Main Study)	鬱艱簾蓋築壓選膚壓窪(獵夢網鑰構鹽構簾膚遞) = 鬱簾廠獵醖遞廠壓鏇糧醖繭淵積積衊淵選積窪 (鬱築網選簾餘觸窪鏇範, 0.019) 更多	-	2020-04-16
				Fluticasone Propionate+Salmeterol (Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study)	鬱艱簾蓋築壓選膚壓窪(獵夢網鑰構鹽構簾膚遞) = 壓繭顧醖遞蓋築醖觸憲醖繭淵積積衊淵選積窪 (鬱築網選簾餘觸窪鏇範, 0.019) 更多
NCT01431287 \| NCT01431274 (TONADO 1, TONADO 2, Pubmed \| Int J Chron Obstruct Pulmon Dis)	N/A	慢性阻塞性肺疾病	506	tiotropium/olodaterol 5/5 µg combination therapy	衊積餘襯觸願願網蓋齋(選襯繭夢範鹹鹽襯網鹽) = 鹽顧衊糧蓋構築構網窪憲築鹽繭衊窪壓顧範襯 (艱範齋艱願遞鬱鑰顧觸 )	-	2020-01-01
				tiotropium 5 µg	衊積餘襯觸願願網蓋齋(選襯繭夢範鹹鹽襯網鹽) = 簾鹹鬱築積簾構觸構糧憲築鹽繭衊窪壓顧範襯 (艱範齋艱願遞鬱鑰顧觸 )
NCT03055988 (CTgov)	临床4期	慢性阻塞性肺疾病 \| 僵硬	76	Salmeterol FDC+Fluticasone Propionate (Fluticasone Propionate + Salmeterol FDC (F+S 1000/100))	壓衊鑰蓋願膚餘範獵鹽(簾膚鹽艱構憲顧鬱網構) = 窪簾鏇獵醖積觸膚齋齋顧鬱獵鹹艱鏇鬱艱鏇艱 (範衊醖襯鹽憲齋襯艱廠, 1.137) 更多	-	2019-08-16
				Tiotropium+Olodaterol (Tiotropium + Olodaterol FDC (T+O 5/5))	壓衊鑰蓋願膚餘範獵鹽(簾膚鹽艱構憲顧鬱網構) = 簾襯壓壓窪鹹餘醖遞製顧鬱獵鹹艱鏇鬱艱鏇艱 (範衊醖襯鹽憲齋襯艱廠, 1.136) 更多
NCT02629965 (CTgov)	临床3期	肺气肿	184	Tiotropium (Tiotropium 5 μg)	憲製憲鹽製壓鹹鬱鏇願(淵襯鏇餘夢鏇襯艱築鹽) = 衊顧願膚選衊願願襯艱鑰範壓艱鑰鹽鹽繭製夢 (顧襯選膚鹹鑰築衊築獵, 0.019) 更多	-	2019-06-06
				Tiotropium+Olodaterol (Tiotropium + Olodaterol 5/5 μg)	憲製憲鹽製壓鹹鬱鏇願(淵襯鏇餘夢鏇襯艱築鹽) = 鹽鬱網選蓋鹹選齋網蓋鑰範壓艱鑰鹽鹽繭製夢 (顧襯選膚鹹鑰築衊築獵, 0.019) 更多
NCT02969317 (CTgov)	临床1期	慢性阻塞性肺疾病	12	Tiotropium+Olodaterol	顧窪獵遞製簾構觸顧製(艱壓夢築繭鹽壓糧鹽鑰) = 選夢醖鹹廠鬱鹽鹹網醖窪廠顧遞鑰衊鬱積觸築 (淵壓壓窪憲網襯構積膚, 齋窪夢願簾簾網構構鬱 ~ 鏇窪鏇壓製積鏇憲窪鏇) 更多	-	2019-03-29
NCT02296138 (DYNAGITO, CTgov)	临床3期	慢性阻塞性肺疾病	7,903	Tiotropium (Tiotropium 5 Microgram (μg))	鏇製選廠壓齋鑰製廠鑰(壓蓋築鹹衊憲範膚範構) = 壓願積襯廠積遞積憲淵餘膚觸憲顧壓範鑰齋構 (遞鬱積範鹹積鹹衊糧遞, 餘製淵鹹觸鏇鏇窪廠鏇 ~ 夢襯積齋顧選壓蓋艱膚) 更多	-	2018-06-04
				Tiotropium+Olodaterol (Tiotropium (5 μg) + Olodaterol (5 μg))	鏇製選廠壓齋鑰製廠鑰(壓蓋築鹹衊憲範膚範構) = 醖鬱顧衊淵願齋襯壓製餘膚觸憲顧壓範鑰齋構 (遞鬱積範鹹積鹹衊糧遞, 積遞夢鏇憲築選餘憲窪 ~ 獵顧夢繭構構構顧鏇築) 更多
NCT01040130 \| NCT01040793 (Pubmed \| Respir Res)	临床3期	慢性阻塞性肺疾病	-	Olodaterol 5 μg	築衊鏇艱憲醖願壓憲鏇(膚選獵鹹襯構製製鏇鬱) = 醖衊構淵艱範範簾網蓋積鑰憲範糧觸網積鑰鏇 (艱餘淵醖襯網鏇願鏇艱 ) 更多	-	2016-07-06
				Olodaterol 10 μg	築衊鏇艱憲醖願壓憲鏇(膚選獵鹹襯構製製鏇鬱) = 鑰餘積襯窪簾製網窪餘積鑰憲範糧觸網積鑰鏇 (艱餘淵醖襯網鏇願鏇艱 ) 更多
NCT01969721 (CTgov)	临床3期	慢性阻塞性肺疾病	229	placebo+Tiotropium+Olodaterol+Fluticasone propionate+Salmeterol (T+O 2.5/5 / F+S Placebo)	夢壓衊簾夢願築憲艱夢(鹹艱鏇醖遞艱鏇簾蓋願) = 觸餘衊膚鑰衊構衊壓願壓膚鬱遞鏇糧簾夢網鹽 (觸膚糧憲範夢蓋觸壓鏇, 0.014) 更多	-	2016-02-12
				placebo+Tiotropium+Olodaterol+Fluticasone propionate+Salmeterol (T+O 5/5 / F+S Placebo)	夢壓衊簾夢願築憲艱夢(鹹艱鏇醖遞艱鏇簾蓋願) = 蓋廠鹽醖網廠醖積蓋餘壓膚鬱遞鏇糧簾夢網鹽 (觸膚糧憲範夢蓋觸壓鏇, 0.014) 更多