预约演示
更新于：2026-03-25
Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate
醋酸茚达特罗/格隆溴铵/莫米松糠酸酯
更新于：2026-03-25
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (2020-06-29), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C28H32N2O7 |
InChIKeyIREJFXIHXRZFER-PCBAQXHCSA-N |
CAS号753498-25-8 |
查看全部结构式(3)
关联
15
项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的临床试验NCT05776927
A Double-dummy, Double-blind, Randomized, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
CTR20253369
茚达格莫吸入粉雾剂（Ⅱ）（150 μg /50 μg/160 μg）在中国健康受试者中随机、开放、两制剂、单次给药、双周期、交叉空腹状态下的生物等效性试验
CTR20242209
茚达格莫吸入粉雾剂（Ⅱ）在中国健康受试者中随机、开放、两制剂、单次给药空腹状态下的生物等效性试验
100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的临床结果
登录后查看更多信息
100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的转化医学
登录后查看更多信息
100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的专利（医药）
登录后查看更多信息
13
项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的文献（医药）2025-12-01CLINICAL THERAPEUTICS
A Novel Metered Dose Inhaler Formulation of Triple-Drug Fixed-Dose Combination of Vilanterol, Glycopyrronium, and Fluticasone Furoate: A Phase III, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety in Indian Patients With Uncontrolled Asthma
Article
作者: Kumar, Deepak ; Panda, Jayanta Kumar ; Pathak, Hardik ; Parmar, Deven ; Jain, Manish Kumar ; Patel, Chintan ; Sahoo, Diptikant ; Kansagra, Kevinkumar ; Koppula, Ravi ; Sheth, Vaishal ; Verma, Sanjay
PURPOSE:
This study aimed to evaluate the efficacy and safety of a fixed-dose combination (FDC) of vilanterol 12.5 µg, glycopyrronium 25 µg, and fluticasone furoate 100 µg (VIL-GLY-FF)-metered dose inhaler (MDI) (developed by M/s. Zydus Healthcare Limited) in comparison with the approved FDC of indacaterol 150 µg, glycopyrronium 50 µg, and mometasone furoate 160 µg (IND-GLY-MF)-dry powder inhaler (DPI) in patients with persistent asthma.
METHODS:
Patients were randomized (1:1) in either the test (VIL-GLY-FF-MDI) or reference (IND-GLY-MF-DPI) group. Fixed-dose combinations were administered once daily for 12 weeks; for VIL-GLY-FF-MDI, patients were instructed to administer TWO actuations at 1 time in a day, doubling the final doses delivered of its components. For IND-GLY-MF-DPI, (Zydus Healthcare Limited, Ahmedabad) patients inhaled 1 capsule via the Respihaler device once daily. The primary objective was to compare the between-group difference in the change in trough forced expiratory volume in 1 second (FEV1) at week 12 from baseline.
FINDINGS:
A total of 256 patients were enrolled. The change in least square mean (SE) in trough FEV1 at week 12 from baseline was 287.15 (18.00) mL and 284.94 (17.93) mL for the test and reference groups, respectively. For a predefined -150 mL noninferiority margin, 2-sided 95% CIs (-47.83 to 52.26 mL) for the difference in the mean change in trough FEV1 (2.21 mL) between the 2 groups reported the noninferiority of VIL-GLY-FF-MDI to IND-GLY-MF-DPI. The test FDC was well tolerated.
IMPLICATIONS:
Efficacy and safety of VIL-GLY-FF-MDI were found to be similar to those of IND-GLY-MF-DPI in Indian patients with persistent asthma. Clinical Trial Registry India identifier: CTRI/2024/01/061230.
2025-11-01The journal of allergy and clinical immunology. Global
Effectiveness of indacaterol/glycopyrronium/mometasone for refractory asthmatic cough after switching from inhaled corticosteroid/long-acting β2-agonist therapy
Article
作者: Saito, Junpei ; Miyao, Naoki ; Kamei, Tadashi ; Ohbayashi, Hiroyuki ; Tochigi, Takao ; Yamagata, Eiji ; Matsuoka, Hirofumi ; Tajiri, Tomoko ; Kiyosue, Arihiro ; Mikami, Toshiaki ; Tsuji, Toshinaga ; Fukushima, Yasushi ; Kanemitsu, Yoshihiro ; Niimi, Akio ; Asamoto, Hitoshi ; Hara, Johsuke
Background:
Cough is a major symptom in poorly or partially controlled asthma, which persists despite treatment, thus impairing quality of life.
Objectives:
The primary objective was to demonstrate the superiority of medium-dose indacaterol, glycopyrronium, and mometasone furoate (IND/GLY/MF) over high-dose inhaled corticosteroids (ICS)/long-acting β2-agonists (LABA) in adult asthma patients with cough refractory to medium-dose ICS/LABA.
Methods:
In this multicenter, randomized, open-label, parallel-group study, 118 patients were randomized to receive either IND/GLY/MF or high-dose ICS/LABA (fluticasone/vilanterol [FF/VI] or budesonide/formoterol [BUD/FM]) for 8 weeks. Efficacy was measured by the Japanese version of the Leicester Cough Questionnaire at week 8. Additional analyses included a visual analog scale, the 6-item Asthma Control Questionnaire, respiratory function, fractional exhaled nitric oxide, and blood eosinophil/neutrophil measurements. Registration: Public clinical trials registry as study jRCTs04122000.
Results:
The change from baseline to week 8 in the total questionnaire score was 1.99 ± 3.48 in the IND/GLY/MF group and 2.50 ± 4.28 in the high-dose ICS/LABA group, with no statistically significant difference between the two groups (P = .5037). However, the change in the total questionnaire score from baseline to week 8 was statistically significant in each treatment group (P < .0001 in the IND/GLY/MF group, P = .0242 in the FF/VI comparator group, and P = .0012 in the BUD/FM comparator group). Fractional exhaled nitric oxide and eosinophil counts significantly decreased in the high-dose ICS/LABA group, while neutrophil counts significantly fell in the IND/GLY/MF group at week 8, by between-group comparison.
Conclusion:
Symptoms improved comparably between medium-dose IND/GLY/MF and high-dose ICS/LABA combinations, although no superiority could be demonstrated. Medium-dose IND/GLY/MF may be an alternative to high-dose ICS/LABA.
2024-07-01Respiratory Investigation
Real-world characteristics of patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol single-inhaler triple therapy in Japan
Article
作者: Yarita, Masao ; Yuanita, Liza ; Oga, Toru ; Ito, Risako ; Requena, Gema ; Noorduyn, Stephen G ; Mita, Chifuku ; Rothnie, Kieran J
BACKGROUND:
Real-world data assessing characteristics of patients with asthma initiating inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) triple therapy in Japan are limited.
METHODS:
Descriptive, observational study of patients with asthma aged ≥15 years newly initiating single- or multiple-inhaler triple therapy (SITT: fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI], SITT: indacaterol/glycopyrronium bromide/mometasone furoate [IND/GLY/MF] or MITT) or ICS/LABA using JMDC/Medical Data Vision (MDV) health insurance databases from February 2021-February 2022 (first prescription date: index date). Patients were assigned to three non-mutually exclusive cohorts: A) new FF/UMEC/VI initiators; B) new FF/UMEC/VI, IND/GLY/MF, or MITT initiators; C) new FF/UMEC/VI, IND/GLY/MF, MITT or ICS/LABA initiators as initial maintenance therapy (IMT). Patient characteristics were assessed descriptively for 12-months pre-treatment initiation (baseline period).
RESULTS:
Cohort A: among new FF/UMEC/VI initiators, 12.8% and 0.1% (JMDC) and 21.7% and 0.9% (MDV) of patients had ≥1 moderate and severe exacerbation; 52.0% (JMDC) and 79.2% (MDV) had ICS/LABA use. Cohort B: most patients initiated FF/UMEC/VI and IND/GLY/MF over MITT (JMDC: 91.3% vs 8.7%; MDV: 67.8% vs 32.2%), with fewer exacerbations and lower rescue medication use. Cohort C: a greater proportion of FF/UMEC/VI initiators as IMT experienced a moderate exacerbation at index versus ICS/LABA initiators as IMT (JMDC: 17.8% vs 10.7%; MDV: 8.0% vs 5.1%).
CONCLUSIONS:
Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation.
14
项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的新闻（医药）2026-01-13
AHA会议
2025-12-17
100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 日本 | 2020-06-29 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 过敏性哮喘 | 临床3期 | 荷兰 | 2020-09-10 | |
| 持续性哮喘 | 临床3期 | 日本 | 2017-04-28 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
Pubmed 人工标引  | 临床3期 | 145 | 夢蓋壓觸構獵築鏇壓簾(蓋鹹築製淵製蓋積壓願) = 製淵淵膚願網壓獵範鏇 築製鏇鹹廠觸顧衊襯願 (憲網淵淵遞鏇鑰鬱鑰觸 ) 更多 | 积极 | 2022-05-30 | ||
夢蓋壓觸構獵築鏇壓簾(蓋鹹築製淵製蓋積壓願) = 簾蓋鬱鏇夢衊衊獵繭蓋 築製鏇鹹廠觸顧衊襯願 (憲網淵淵遞鏇鑰鬱鑰觸 ) 更多 | |||||||
N/A | 135 | 選餘積鏇遞構鬱築廠遞(襯範鏇築餘夢艱餘鑰獵) = 繭網夢蓋範構鏇糧餘艱 艱艱膚夢鏇範齋簾網廠 (壓遞獵築鬱網醖醖積艱 ) | - | 2021-09-05 | |||
临床1期 | - | 24 | IND/GLY/MF medium-dose | 蓋製鏇襯淵壓願鑰襯壓(顧衊憲夢鹽糧範廠鑰獵) = 夢餘艱淵鏇鏇顧簾鏇壓 鹽衊獵積遞窪鑰築鹹夢 (鏇選蓋獵廠簾製廠壓鹽 ) 更多 | - | 2021-02-01 | |
IND/GLY/MF high-dose | 蓋製鏇襯淵壓願鑰襯壓(顧衊憲夢鹽糧範廠鑰獵) = 糧淵簾衊網醖廠選衊餘 鹽衊獵積遞窪鑰築鹹夢 (鏇選蓋獵廠簾製廠壓鹽 ) 更多 | ||||||
临床3期 | 1,426 | (QVM149 150/50/80 μg) | 餘膚醖淵鏇鹽壓觸夢鏇(餘遞選糧膚艱築鹹鏇醖) = 醖襯遞鑰壓繭築選醖淵 餘淵遞齋網顧糧壓醖醖 (鹹鹹繭衊製簾糧艱範膚, 0.070) 更多 | - | 2020-10-14 | ||
(QVM149 150/50/160 μg) | 餘膚醖淵鏇鹽壓觸夢鏇(餘遞選糧膚艱築鹹鏇醖) = 艱糧壓壓鏇糧鏇顧蓋繭 餘淵遞齋網顧糧壓醖醖 (鹹鹹繭衊製簾糧艱範膚, 0.069) 更多 | ||||||
临床3期 | 3,092 | (QVM149 150/50/160 µg o.d.) | 築簾壓製蓋鏇鹹鏇淵網(範獵廠衊積齋壓醖選簾) = 餘壓簾範製蓋鹹廠範壓 獵鏇範鏇觸繭鹹夢夢築 (夢憲醖壓蓋製築願襯製, 0.0128) 更多 | - | 2020-07-22 | ||
(QVM149 150/50/80 µg o.d.) | 築簾壓製蓋鏇鹹鏇淵網(範獵廠衊積齋壓醖選簾) = 廠遞糧積襯廠醖醖窪簾 獵鏇範鏇觸繭鹹夢夢築 (夢憲醖壓蓋製築願襯製, 0.0129) 更多 | ||||||
临床3期 | 4,851 | Mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) | 獵觸遞鏇憲鹹鏇壓願壓(蓋壓鑰網醖網餘鹹遞膚): Δ = 76 (95% CI, 41 ~ 111), P-Value = <0·001 | 积极 | 2020-07-09 | ||
Mometasone furoate and indacaterol acetate (MF-IND) | |||||||
临床3期 | 96 | 淵鹽窪壓鏇窪艱鹽鏇窪 = 選願膚願獵糧遞繭艱壓 構鏇壓鹽積構鏇鹹壓蓋 (廠鹹積鬱鬱願願構鏇蓋, 憲夢鹹遞築艱築鬱構鹹 ~ 鑰餘窪壓繭遞憲簾鑰獵) 更多 | - | 2020-04-07 | |||
临床2期 | 116 | (QVM149 150/50/160 μg o.d.) | 膚壓鑰積齋觸鏇範膚蓋(淵淵糧範觸顧窪憲艱醖) = 範窪簾艱襯鬱築窪衊製 糧簾淵艱製壓積鹹齋壓 (選夢構築積簾淵積觸襯, 0.0750) 更多 | - | 2019-12-13 | ||
(QVM149 150/50/80 μg o.d.) | 膚壓鑰積齋觸鏇範膚蓋(淵淵糧範觸顧窪憲艱醖) = 鬱憲廠膚範範廠選廠鑰 糧簾淵艱製壓積鹹齋壓 (選夢構築積簾淵積觸襯, 0.0750) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用