乌美溴铵维兰特罗(Umeclidinium Bromide/Vilanterol Trifenatate) - 药物靶点：M1AChR x M2 receptor x M3 receptor x M4 receptor x M5 receptor x β2-adrenergic receptor_在研适应症：慢性阻塞性肺疾病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

GSK-573719/Vilanterol、LAMA/LABA、UMEC/VI

+ [13]

靶点

M1AChR x M2 receptor x M3 receptor x M4 receptor x M5 receptor x β2-adrenergic receptor

作用机制

M1 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M1拮抗剂)、M2 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M2拮抗剂)、M3 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M3拮抗剂)

治疗领域

呼吸系统疾病

在研适应症

慢性阻塞性肺疾病

非在研适应症-

原研机构

GSK Plc

在研机构

GlaxoSmithKline (Ireland) Ltd.

正大天晴药业集团股份有限公司GlaxoSmithKline KK

+ [1]

非在研机构

GSK Plc

葛兰素史克（中国）投资有限公司

Glaxo Group Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2013-12-18),

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

分子式C44H49Cl2NO7

InChIKeyKLOLZALDXGTNQE-JIDHJSLPSA-N

CAS号503070-58-4

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关联

43

项与乌美溴铵维兰特罗相关的临床试验

CTRI/2023/06/054353 / Not yet recruiting临床4期

Comparative study between the effects of triple therapy (LAMA-LABA-ICS) and LAMA-LABA in COPD patients - NIL

开始日期2023-07-01

申办/合作机构-

CTRI/2023/05/052755 / Completed临床4期

Phase IV, 12-week, single arm, open label study evaluating the safety and efficacy of fixed dose triple combination FF/UMEC/VI administered once daily in the morning via a dry powder inhaler in participants with chronic obstructive pulmonary disease in India.

开始日期2023-06-06

申办/合作机构

GSK Plc

CTR20223049 / Recruiting临床3期

比较TQC3403和欧乐欣®治疗慢性阻塞性肺疾病患者的有效性和安全性的多中心、随机、开放、平行对照临床研究。

主要目的:以Glaxo Operations UK Ltd公司生产的乌美溴铵维兰特罗吸入粉雾剂(商品名:欧乐欣®)为参比制剂，评价我公司生产的药品TQC3403对受试者治疗第24周后给药前FEV1谷值相对基线的变化具有等效性; 次要目的:评价我公司生产的药品TQC3403治疗中重度慢性阻塞性肺疾病受试者各访视时间点给药前 FEV1谷值相对基线的变化及安全性评价。

开始日期2023-02-27

申办/合作机构

连云港润众制药有限公司

[+1]

100 项与乌美溴铵维兰特罗相关的临床结果

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100 项与乌美溴铵维兰特罗相关的转化医学

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100 项与乌美溴铵维兰特罗相关的专利（医药）

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872

项与乌美溴铵维兰特罗相关的文献（医药）

2024-02-01·Expert review of clinical pharmacology

Comparative effectiveness and safety of inhaled corticosteroid plus long-acting β ₂ -agonist fixed-dose combinations vs. long-acting muscarinic antagonist in bronchiectasis

Article

作者: Chou, Yueh-Ching ; Chou, Chian-Ying ; Hsu, Chia-Chen ; Chang, Yuh-Lih ; Su, Vincent Yi-Fong ; Hwang, Hsuen-En ; Ding, Ting-Lin

BACKGROUND:

This study aimed to evaluate the effectiveness and safety of fixed-dose combination (FDC) inhaled corticosteroids/long-acting β₂-agonists (ICS/LABA) in bronchiectasis.

RESEARCH DESIGN AND METHODS:

A retrospective cohort study analyzed electronic medical records of bronchiectasis patients initiating ICS/LABA FDC or LAMA between 2007 and 2021. All bronchiectasis diagnoses were made by radiologists using high-resolution computed tomography.

RESULTS:

Of the 1,736 patients, 1,281 took ICS/LABA FDC and 455 LAMA. Among the 694 propensity score matched patients, ICS/LABA FDC had comparable outcomes to LAMA, with HRs of 1.22 (95% CI 0.81-1.83) for hospitalized respiratory infection, 1.06 (95% CI 0.84-1.33) for acute exacerbation, and 1.06 (95% CI 0.66-1.02) for all-cause hospitalization. Beclomethasone/formoterol (BEC/FOR) or budesonide/formoterol (BUD/FOR) led to a lower risk of acute exacerbation compared to fluticasone/salmeterol (FLU/SAL) (BEC/FOR HR 0.59, 95% CI 0.43-0.81; BUD/FOR HR 0.68, 95% CI 0.50-0.93). BEC/FOR resulted in lower risks of hospitalized respiratory infection (HR 0.48, 95% 0.26-0.86) and all-cause hospitalization (HR 0.55, 95% 0.37-0.80) compared to FLU/SAL.

CONCLUSION:

Our findings provide important evidence on the effectiveness and safety of ICS/LABA FDC compared with LAMA for bronchiectasis. BEC/FOR and BUD/FOR were associated with better outcomes than FLU/SAL.

2024-02-01·Respiratory medicine

Clinical characteristics and healthcare resource utilization in patients with chronic obstructive pulmonary disease in Hong Kong

Article

作者: Hui, David Shu Cheong ; Chau, Clementine ; Milea, Dominique ; Ko, Fanny Wai San ; Xu, Xiaomeng ; Navarro, Aldo

OBJECTIVES:

Chronic obstructive pulmonary disease (COPD) is a significant cause of mortality, with its prevalence projected to rise in Asia. The primary objective of this study was to describe clinical characteristics, maintenance treatment, and healthcare resource utilization (HCRU) among patients with COPD in Hong Kong. Secondary objectives were to assess patient demographics and clinical characteristics by eosinophil (EOS) levels, and compare the demographics, clinical characteristics, and treatment patterns of patients on multiple-inhaler triple therapy (MITT).

METHODS:

This study analyzed a cohort of patients with COPD who had entered a previously initiated prospective cohort study involving patients with COPD and/or asthma at the Prince of Wales Hospital between 2017 and 2019.

RESULTS:

Patients with COPD were enrolled (N = 220, mean age 74.3 years, 97 % male). Twelve months prior to baseline assessment, 66 % of patients were on MITT, 17 % on long-acting muscarinic antagonists (LAMAs)/long-acting beta-agonists (LABAs), and 7 % on inhaled corticosteroids (ICS)/LABA. Compared with ICS/LABA or LAMA/LABA, more patients on MITT experienced ≥1 exacerbation (26.7 %, 10.5 %, 39.7 %, respectively). Patients on MITT also had a higher mean (SD) COPD Assessment Test score (9.4 [5.9]) and modified Medical Research Council Dyspnea Scale score (1.7 [0.7]) and incurred the most COPD-related and total HCRU costs. Compared with patients with EOS ≤300 cells/μL, those with EOS >300 cells/μL had a higher number of exacerbations.

CONCLUSIONS:

Patients with COPD in Hong Kong treated with MITT presented more severe disease profiles and incurred higher costs. These data can be used for decision making in patients with moderate-to-severe COPD in Hong Kong.

Journal of asthma and allergy

A Retrospective Claims Database Study to Clarify Treatment Reality of Asthma Patients Before and After Referral to a Specialist

Article

作者: Tashiro, Naoki ; Arita, Yoshifumi ; Hirai, Takehiro ; Makita, Naoyuki ; Hozawa, Soichiro ; Ono, Keita ; Uchimura, Hitomi

Purpose:

Japanese guidelines recommend that patients with uncontrolled asthma be referred by non-specialists to specialists (allergists and/or pulmonologists). This study investigated the reality of clinical practice in asthma patients referred to specialists in Japan.

Patients and Methods:

This was a retrospective, observational cohort study of asthma patients in a health insurance claim database (Cross Fact) referred from facilities with non-specialists to those with specialists from January 2016 to December 2018. The referred asthma patients were defined as patients with ≥4 inhaled corticosteroid (ICS)-containing prescriptions during a 1-year baseline period, with an asthma diagnosis, and who had visited a facility with specialists. Asthma exacerbation, maintenance treatment, laboratory tests, and medical procedures before and after referral were analyzed.

Results:

Data for 2135 patients were extracted, of which 420 with referral codes were analyzed. The proportion of patients with asthma exacerbations was 50.2% (95% confidence interval [CI]: 45.4-55.1%) before referral and 37.4% (95% CI: 32.7-42.2%) after, a significant decrease (P<0.001; McNemar test). The proportions of patients prescribed ICS alone, long-acting beta-agonists (LABA), and ICS/LABA were lower after referral than before, but the proportions of patients prescribed long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, and biologics increased after referral. More asthma-related laboratory tests were performed after referral, and spirometry incidence increased from 16.4% before referral to 51.4% after referral.

Conclusion:

This study shows a decrease in asthma exacerbations, change in asthma treatments, and increase in laboratory tests after referral to a specialist, suggesting that referrals to specialists lead to better management of asthma.

72

项与乌美溴铵维兰特罗相关的新闻（医药）

2024-06-03

·BioSpace

Innoviva to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference

BURLINGAME, Calif.--(BUSINESS WIRE)-- Innoviva, Inc. (Nasdaq: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami, FL on Monday, June 10, 2024 at 1:20 p.m. Eastern Time. A live webcast of the fireside chat can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at . The webcast will be available for replay for 90 days following the event. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. View source version on businesswire.com: Contacts Investors & Media: Argot Partners (212) 600-1902 innoviva@argotpartners.com Source: Innoviva, Inc. View this news release online at:

上市批准合格传染病产品

2024-05-27

·Insight数据库

恒瑞医药：SHR-1905 注射液用于慢性阻塞性肺疾病获批临床

5 月 22 日，恒瑞医药官网发布消息称，其子公司广东恒瑞医药有限公司已收到国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知书》，批准其 1 类新药 SHR-1905 开展用于慢性阻塞性肺疾病（COPD）的临床试验。截图来自：恒瑞官网，文末附原文链接同时，这也是 SHR-1905 继哮喘和慢性鼻窦炎伴鼻息肉适应症之后，在国内获批开展临床试验的第三个适应症。截图来自：Insight数据官网COPD 是最常见的慢性呼吸系统疾病，在我国呈现高患病率、高死亡率和高疾病负担的流行病学特征。不仅如此，由于人口老龄化、庞大的吸烟和二手烟暴露人群、结核感染等因素的持续存在，COPD 的防控形势将十分严峻。目前，长效支气管扩张剂（LABA 和/或 LAMA）是 COPD 的一线治疗药物。然而，对于有急性加重史或血常规嗜酸性粒细胞 Eos≥300/µL，或合并哮喘或具备哮喘特征的患者，推荐联合使用吸入糖皮质激素（ICS）。尽管如此，在接受 LABA+LAMA+ICS 三联治疗的患者中，仍有 30%~40% 会经历中重度急性加重，显示出现有治疗手段的局限性及迫切的未满足的临床需求。SHR-1905 是恒瑞医药自主研发的胸腺基质淋巴细胞生成素（TSLP）单克隆抗体。该药物通过阻断炎症细胞因子的释放，抑制下游炎症信号的传导，最终改善炎症状态并控制疾病进展。在 SHR-1905 的独特机制和目前全球范围内无同类产品获批 COPD 治疗的双重「buff」加持下，SHR-1905 优势不言而喻。早在 2023 年 8 月，恒瑞医药就宣布与美国 Aiolos Bio 公司达成协议，将 SHR-1905 注射液项目有偿许可给 Aiolos Bio。2024 年初，GSK 完成了对 Aiolos Bio 的收购，进一步增强了 SHR-1905 在国际市场的潜力。截图来自：Insight数据官网在国内，恒瑞已获批上市 14 款自研 1 类创新药及 4 款 2 类新药。此次 SHR-1905 用于 COPD 的临床试验获批，标志着恒瑞医药在慢性气道疾病治疗领域取得了重要进展。内容来自：恒瑞官网（https://www.hengrui.com/media/detail-555.html）免责声明：本文仅作消息分享，并不构成投资建议，也不代表 Insight 数据库的立场，文章观点仅供分享行业见解，请广大投资者谨慎。编辑：耳东PR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn多样化功能、可溯源数据……Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

并购申请上市

2024-05-21

·恒瑞医药

恒瑞医药创新药SHR-1905用于慢性阻塞性肺疾病获批临床

近日，恒瑞医药子公司广东恒瑞医药有限公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，批准公司1类新药SHR-1905开展用于慢性阻塞性肺疾病的临床试验，这是SHR-1905继哮喘和慢性鼻窦炎伴鼻息肉适应症之后获批开展临床的第三个适应症。慢性阻塞性肺疾病（简称慢阻肺，COPD）是一种常见的、可预防和治疗的慢性气道疾病。据报道，我国20岁以上成人COPD患病率8.6%，40岁以上高达13.7%，估算近1亿患者，提示我国COPD仍然呈现高发态势。COPD疾病负担重，严重影响患者生活质量，随着人口老龄化，预测2060年死于COPD及其相关疾患的人数将超过540万人/年 [1] 。 COPD以长效支气管扩张剂（LABA和/或LAMA）作为一线治疗药物，对于有急性加重史，或血常规嗜酸性粒细胞Eos≥300/µL，或合并哮喘或具备哮喘特征的患者推荐加用吸入糖皮质激素（ICS）[1]。然而，COPD患者在接受LABA+LAMA+ICS三联治疗后，仍然有30%~40%的患者出现中重度急性加重[2]，临床治疗需求未满足，亟待开发新的药物。 SHR-1905为恒瑞医药自主研发的胸腺基质淋巴细胞生成素（TSLP）单克隆抗体，通过阻断炎症细胞因子的释放，抑制下游炎症信号的传导，最终改善炎症状态并控制疾病进展。目前全球尚无同类产品获批用于慢性阻塞性肺疾病的治疗。SHR-1905的研发，旨在为COPD等慢性气道疾病患者提供新的治疗方案，弥补目前临床未被满足的治疗需求。参考文献： [1].中华医学会呼吸病学分会慢性阻塞性肺疾病学组,中国医师协会呼吸医师分会慢性阻塞性肺疾病工作委员会.慢性阻塞性肺疾病诊治指南(2021年修订版)[J].中华结核和呼吸杂志, 2021, 44(3):36. [2].Sridhar S, Liu H, Pham TH, et al. Modulation of blood inflammatory markers by benralizumab in patients with eosinophilic airway diseases[J]. Respir Res, 2019, 20(1): 14. 声明： 1. 本新闻公告旨在发布研发临床进展信息，仅供医疗卫生专业人士参阅，非广告用途。 2. 恒瑞医药不推荐任何未被批准的药品、适应症的使用。

临床结果

100 项与乌美溴铵维兰特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	乌美溴铵维兰特罗	R03AL03	-

研发状态

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	美国	Glaxosmithkline Intellectual Property Development Ltd.	2013-12-18

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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


study 214888 (ERS2022)	N/A	慢性阻塞性肺疾病维持	6,815	Umeclidinium/vilanterol (UMEC/VI)	醖鑰鹹廠範醖鏇鹹齋鏇(觸齋鑰衊夢憲糧遞鏇艱) = 糧醖蓋艱艱襯遞觸餘醖繭蓋遞壓膚糧獵製遞糧 (膚淵襯願網衊獵蓋簾積 )	积极	2022-09-04
				Inhaled corticosteroid/long-acting β2-agonist (ICS/LABA)	醖鑰鹹廠範醖鏇鹹齋鏇(觸齋鑰衊夢憲糧遞鏇艱) = 鹽鬱繭廠衊鑰觸顧構憲繭蓋遞壓膚糧獵製遞糧 (膚淵襯願網衊獵蓋簾積 )
ERS2018	N/A	慢性阻塞性肺疾病	40	LABA/LAMA therapy (indacaterol /glycopyrronium 110/50mg once-daily)	繭淵糧憲鬱廠夢蓋廠膚(糧醖選簾窪選願衊觸衊) = 膚簾築範夢糧鹽膚鑰餘廠鬱醖糧範網淵膚齋製 (遞簾構衊鹽廠範製範衊 )	积极	2018-09-15
ERS2018	临床3期	慢性阻塞性肺疾病	-	Fluticasone furoate/umeclidinium/vilanterol 100/62.5/25µg (FF/UMEC/VI)	夢淵壓簾網鹹選範糧鹽(願膚顧顧蓋遞繭繭鬱醖) = 淵鏇鏇範鏇窪齋觸齋獵製衊糧夢鑰積襯鹽網淵 (選衊選簾鹹積艱鏇鹹獵 ) 更多	积极	2018-09-15
				Fluticasone furoate/vilanterol 100/25µg (FF/VI)	夢淵壓簾網鹹選範糧鹽(願膚顧顧蓋遞繭繭鬱醖) = 選鬱獵衊醖夢鏇醖鹹鹽製衊糧夢鑰積襯鹽網淵 (選衊選簾鹹積艱鏇鹹獵 ) 更多
NCT02799784 (204990, CTgov)	临床4期	慢性阻塞性肺疾病	236	Vilanterol+Umeclidinium (Umeclidinium/Vilanterol 62.5/25 mcg)	觸膚構觸衊壓網鑰齋窪(襯艱糧夢網糧範顧齋網) = 積鑰齋淵淵鑰選夢網顧夢壓衊憲願鏇鑰憲觸壓 (遞齋遞蓋膚鏇選觸壓鹽, 積築遞襯願艱夢觸淵鹹 ~ 鬱範鬱壓齋築網獵餘構) 更多	-	2018-07-02
				Tiotropium+Olodaterol (Tiotropium/Olodaterol 5/5 mcg)	觸膚構觸衊壓網鑰齋窪(襯艱糧夢網糧範顧齋網) = 鏇壓網窪鬱蓋窪憲淵憲夢壓衊憲願鏇鑰憲觸壓 (遞齋遞蓋膚鏇選觸壓鹽, 簾壓淵鏇艱構積壓鑰鑰 ~ 窪夢廠鑰構鹽築獵築繭) 更多
NCT02487446 \| NCT02487498 (Pubmed \| Lung)	N/A	慢性阻塞性肺疾病	-	Indacaterol Maleate/Glycopyrronium Bromide	範鹽鹽鹹鹹網夢憲構觸(窪夢遞夢簾憲艱構憲襯) = 顧糧餘膚糧衊窪鏇獵獵壓衊獵衊醖憲築獵餘觸 (艱繭醖觸網積鑰簾蓋遞 )	-	2017-12-01
				Umeclidinium Bromide/Vilanterol	範鹽鹽鹹鹹網夢憲構觸(窪夢遞夢簾憲艱構憲襯) = 範鑰膚獵膚選齋壓餘糧壓衊獵衊醖憲築獵餘觸 (艱繭醖觸網積鑰簾蓋遞 )
ERS2017	N/A	慢性阻塞性肺疾病	14	Umeclidinium/vilanterol 125/25μg	顧觸窪獵鬱築觸鹹衊淵(衊築簾獵膚範壓齋鑰膚) = 壓遞網蓋壓鹽夢糧製齋襯餘顧製遞範衊夢壓繭 (鏇築廠鏇蓋鹽餘糧壓願, 0.15)	-	2017-09-01
NCT02275052 (CTgov)	临床4期	慢性阻塞性肺疾病	198	Placebo DPI+Albuterol/salbutamol MDI	餘獵獵顧遞蓋膚鏇蓋顧(選繭繭襯繭淵廠構觸製) = 鹹淵鹽蓋範遞淵製繭築築遞餘鏇鹽壓襯壓鬱糧 (鬱餘膚蓋鏇夢鹽醖範構, 遞齋鏇衊鑰鹹製鑰積廠 ~ 網構遞願鏇糧廠鏇夢製) 更多	-	2017-06-06
NCT02570165 (201012, CTgov)	临床2期	慢性阻塞性肺疾病	325	Placebo	範廠鏇網範蓋艱觸夢繭(醖蓋壓製網艱餘觸夢願) = 夢選餘簾廠鑰觸鹽築淵蓋選廠觸襯餘築鑰選襯 (顧鹹淵範獵繭鏇窪積簾, 鬱蓋窪齋艱觸廠餘襯製 ~ 築餘鹹醖壓積鏇鹹獵鬱) 更多	-	2017-03-24
NCT01899742 (Pubmed \| Int J Chron Obstruct Pulmon Dis) 人工标引	临床3期	慢性阻塞性肺疾病	494	Umeclidinium/vilanterol	鹽範獵遞壓憲範顧簾積(膚憲艱壓選範鬱憲衊網): difference = 88 (95% CI, 45 ~ 131), P-Value = <0.001 更多	优效	2017-02-24
				tiotropium
NCT01316900 \| NCT01316913 \| NCT01777334 (ZEP117115, Pubmed \| Adv Ther)	N/A	慢性阻塞性肺疾病维持	1,747	Umeclidinium/Vilanterol 62.5/25 mcg/day	糧壓夢築淵網積淵鏇夢(鹽窪膚鏇築醖醖鬱夢襯) = 獵襯壓窪鑰積膚鹽齋襯艱壓夢獵觸構鬱憲鑰夢 (淵淵齋醖鏇衊範襯壓觸 )	-	2017-01-01
				Tiotropium 18 mcg/day	糧壓夢築淵網積淵鏇夢(鹽窪膚鏇築醖醖鬱夢襯) = 繭窪憲繭選鑰構襯膚鹹艱壓夢獵觸構鬱憲鑰夢 (淵淵齋醖鏇衊範襯壓觸 )