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更新于：2026-03-13
Indacaterol Acetate/Mometasone Furoate
醋酸茚达特罗/莫米松糠酸酯
更新于：2026-03-13
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2020-05-06), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C26H32N2O5 |
InChIKeyHZHXFIDENGBQFQ-FTBISJDPSA-N |
CAS号1000160-96-2 |
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关联
18
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茚达特罗莫米松吸入粉雾剂（Ⅱ）在中国健康受试者中随机、开放、两制剂、单次给药、双周期、交叉空腹状态下的生物等效性试验
CTR20251316
茚达特罗莫米松吸入粉雾剂（Ⅲ）在健康受试者中的单剂量、空腹、随机、开放、两制剂、两周期交叉生物等效性试验
100 项与 醋酸茚达特罗/莫米松糠酸酯 相关的临床结果
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100 项与 醋酸茚达特罗/莫米松糠酸酯 相关的转化医学
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100 项与 醋酸茚达特罗/莫米松糠酸酯 相关的专利（医药）
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14
项与 醋酸茚达特罗/莫米松糠酸酯 相关的文献（医药）2023-10-01Respiratory medicine
Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study
Article
作者: Maspero, Jorge F ; Mezzi, Karen ; Chapman, Kenneth R ; Kostikas, Konstantinos ; Lawrence, David ; van Zyl-Smit, Richard ; Jaumont, Xavier
BACKGROUND:
Baseline characteristics could potentially guide asthma treatments. We evaluated whether baseline eosinophil levels affect the efficacy of mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma.
METHOD:
In this post hoc analysis of IRIDIUM study, efficacy of high-dose MF/IND/GLY (160/150/50 μg, once-daily [o.d.]) versus high-dose MF/IND (320/150 μg o.d.) and high-dose fluticasone/salmeterol (FLU/SAL [500/50 μg, twice-daily [b.i.d.]); and efficacy of pooled MF/IND/GLY (160/150/50 μg and 80/150/50 μg) versus pooled MF/IND (320/150 μg and 160/150 μg) was evaluated in patient subgroups with baseline blood eosinophil count of <300 cells/μL or ≥300 cells/μL.
RESULTS:
Overall, 3065 patients were included. At Week 26, high-dose MF/IND/GLY showed improved trough FEV1 versus high-dose MF/IND (Δ78mL [<300 cells/μL]; Δ54mL [≥300 cells/μL]) and FLU/SAL (Δ112mL [<300 cells/μL]; Δ98mL [≥300 cells/μL]). Similarly, pooled MF/IND/GLY also showed improved trough FEV1 versus pooled MF/IND (Δ75mL [<300 cells/μL]; Δ68mL [≥300 cells/μL]). Over 52 weeks, high-dose MF/IND/GLY reduced the annualized rate of moderate or severe asthma exacerbations by 23% and 10%, severe exacerbations by 31% and 15%, and all exacerbation by 33% and 10% versus high-dose MF/IND for subgroups with <300 cells/μL and ≥300 cells/μL, respectively; and by 33% and 41%, 45% and 42%, 42% and 39% versus FLU/SAL, respectively. Similarly, pooled MF/IND/GLY reduced exacerbations by 22% and 8%, 21% and 7%, 27% and 8%, versus pooled MF/IND, for the respective subgroups.
CONCLUSION:
MF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma.
TRIAL REGISTRATION:
ClinicalTrials.gov, NCT02571777 (IRIDIUM).
2022-06-01Advances in therapy3区 · 医学
A Review of the Unique Drug Development Strategy of Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate: A First-in-Class, Once-Daily, Single-Inhaler, Fixed-Dose Combination Treatment for Asthma
3区 · 医学
Review
作者: Pethe, Abhijit ; Jauernig, Juergen ; Scosyrev, Emil ; Gruen, Emilie ; Brittain, Dominic ; Tanase, Ana-Maria ; D'Andrea, Peter ; Hosoe, Motoi ; Jain, Devendra ; Tillmann, Hanns-Christian
A novel, once-daily (o.d.), fixed-dose combination (FDC) of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF), delivered by the inhaler Breezhaler® device, is the first long-acting beta2-adrenergic agonist/long-acting muscarinic antagonist/inhaled corticosteroid (LABA/LAMA/ICS) therapy to be approved for maintenance treatment of asthma in adults inadequately controlled on LABA/ICS. The approval of IND/GLY/MF in the European Union (EU) also included an optional electronic sensor and smartphone (or other suitable device) application, making it the first "digital companion" that can be prescribed with an asthma medication. As a result, the European Medicines Agency included this approval as one of the "outstanding contributions to public health" (for Pneumology/Allergology) in their 2020 highlights report. Alongside IND/GLY/MF, an o.d. LABA/ICS FDC, IND/MF, was also developed and approved. This review outlines the unique strategy used in the accelerated development of IND/GLY/MF that combined various approaches: (1) selecting individual components with established efficacy/safety, (2) bridging doses to optimize efficacy/safety of IND/GLY/MF and IND/MF delivered via the Breezhaler® device, (3) developing IND/GLY/MF and IND/MF in parallel, and (4) submission for regulatory approval before formal completion of the pivotal phase III studies. IND/GLY/MF and IND/MF were combined in a single-development plan (PLATINUM program), which comprised four phase III studies: QUARTZ and PALLADIUM evaluated IND/MF while IRIDIUM and ARGON evaluated IND/GLY/MF. A unique feature was the inclusion of two LABA/ICS comparators in the pivotal IRIDIUM study-IND/MF as an internal comparator, and high-dose salmeterol xinafoate/fluticasone propionate (SAL/FLU) as a marketed comparator. In the ARGON study, IND/GLY/MF was compared against o.d. tiotropium (via Respimat®) plus twice-daily (b.i.d.) high-dose SAL/FLU (via Diskus®). As a result of this development strategy, the development and approval of IND/GLY/MF was accelerated by ca. 4 years as against what would be expected from a traditional approach, novel data were generated, and a unique optional digital companion was approved in the EU. A Video Abstract by Dr Dominic Brittain, Global Drug Development, Novartis. (MP4 228293 kb).
2021-10-01PULMONARY PHARMACOLOGY & THERAPEUTICS
Pharmacokinetics of mometasone furoate delivered via two dry powder inhalers
Article
作者: Malmqvist, Ulf ; Hederer, Bettina ; Vaidya, Soniya ; Hosoe, Motoi ; Kanniess, Frank ; Tanase, Ana-Maria ; Ziegler, Dominik
BACKGROUND:
QMF149 is an inhaled fixed-dose combination of indacaterol acetate and mometasone furoate (MF) delivered via Breezhaler®, under development for once-daily treatment of asthma. MF delivered via Twisthaler® is approved as Asmanex® Twisthaler® for the treatment of asthma. Bridging of MF delivered via Twisthaler® to MF delivered via Breezhaler® was undertaken as part of QMF149 development to enable dose comparisons between the devices. Pharmacokinetics (PK) of MF were characterized in two studies; a single dose PK study in healthy volunteers and a pharmacokinetic/pharmacodynamic (PK/PD) study in asthma patients.
OBJECTIVES:
The PK study in healthy volunteers evaluated the PK of single doses of MF via Breezhaler® (50-400 μg) and compared systemic exposure of MF following administration via Breezhaler® and Twisthaler® 400 μg (2 inhalations of 200 μg). The study in patients with asthma characterized the MF PK profile following once-daily inhalation of MF via Breezhaler® and Twisthaler® devices for 4 weeks.
METHODS:
In the open-label, single-dose, crossover study, healthy subjects sequentially received MF via Twisthaler® (400 μg, medium-dose inhaled corticosteroid [ICS]) and escalating doses via Breezhaler® (50, 100, 200, 400 μg). PK data were obtained up to 72 h post-dose. In the double-blind, double-dummy, parallel-group study, asthma patients were randomised to receive either MF 80 μg (low-dose ICS) or 320 μg (high-dose ICS) via Breezhaler®, or 200 μg (low-dose ICS) or 800 μg (2 inhalations of 400 μg; high-dose ICS) via Twisthaler® once daily for 4 weeks. PK sampling was performed on Days 1 and 28 at pre-dose and up to 24 h post-dose.
RESULTS:
In the healthy volunteer PK study, 20 healthy subjects completed all treatments. Dose-normalised AUClast of MF was 1.8-1.9-fold higher when delivered via Breezhaler® versus Twisthaler®. AUC and Cmax of MF increased in a dose-proportional manner over the range of 50-400 μg via Breezhaler®. Results from this study guided dose selection of MF via Breezhaler® for the asthma study. In the asthma study, in a subset of 96 patients, mean systemic exposure (AUClast and Cmax) for MF 80 and 320 μg via Breezhaler® was comparable with MF 200 and 800 μg via Twisthaler®, respectively, on Day 28.
CONCLUSION:
PK characterization in a healthy volunteer PK study and subsequently an asthma study enabled selection of 80 μg (low), 160 μg (medium), and 320 μg (high) delivered via Breezhaler® as MF doses comparable to the 200 μg, 400 μg and 800 μg doses delivered by Twisthaler®, respectively, as part of QMF149 formulation development.
23
项与 醋酸茚达特罗/莫米松糠酸酯 相关的新闻（医药）2026-02-14
2026-01-13
AHA会议
2025-12-17
100 项与 醋酸茚达特罗/莫米松糠酸酯 相关的药物交易
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外链
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 加拿大 | 2020-05-06 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 轻度哮喘 | 临床3期 | 日本 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 保加利亚 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 智利 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 哥伦比亚 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 爱沙尼亚 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 德国 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 匈牙利 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 印度 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 意大利 | 2017-01-16 | |
| 轻度哮喘 | 临床3期 | 拉脱维亚 | 2017-01-16 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 24 | 鏇鑰網獵壓壓願鹹鑰壓(齋築艱餘醖膚襯範壓衊) = 顧鏇鬱艱積觸鬱廠糧餘 範糧膚蓋夢網鑰鬱鹹憲 (膚膚構築蓋構淵選遞衊, 0) 更多 | - | 2023-07-27 | |||
临床3期 | 3,154 | 顧鬱餘糧築鑰窪齋鹽鬱(簾齋淵範構衊艱獵鏇夢) = 網選鑰築繭齋網窪夢鏇 蓋鑰觸齋壓選壓餘鑰艱 (齋壓願艱簾構膚廠顧遞 ) 更多 | 积极 | 2021-08-01 | |||
壓簾構觸選積膚構蓋淵(鑰積獵憲構廠簾廠鹹醖) = 鹽顧鑰襯餘簾鏇鏇艱襯 衊廠膚蓋鹹製膚積鏇艱 (鹹鬱淵衊網遞鑰窪觸製 ) | |||||||
临床3期 | 2,216 | 廠憲夢獵夢衊蓋獵遞積(鑰鬱繭鹹選夢齋淵窪膚) = 淵醖蓋製憲鹹築顧鹽觸 夢艱積壓製築獵簾齋繭 (衊顧築壓窪壓範蓋醖窪, 0.0162) 更多 | - | 2020-03-05 | |||
临床3期 | 51 | (QMF-149 150/320 μg) | 築窪襯壓齋淵築遞鏇衊 = 鹹艱膚膚窪淵蓋積鑰鏇 鬱積廠遞鑰衊壓顧糧鬱 (遞壓顧膚選築製鑰顧窪, 顧醖鹹觸廠選衊願窪顧 ~ 壓簾簾製觸窪憲憲艱築) 更多 | - | 2020-02-07 | ||
(QMF149 150/320 µg) | 鬱鬱顧網繭襯鑰鹹糧顧(淵壓範繭繭廠鏇顧範鹹) = 鏇醖鑰鹹選襯齋觸餘憲 衊衊繭膚窪選鬱憲鑰艱 (獵夢蓋顧築齋網鹽夢餘, 鏇膚繭顧願壓獵憲積獵 ~ 艱膚餘廠淵鹹選簾遞艱) 更多 | ||||||
临床3期 | 802 | 餘繭築觸鹽糧觸範艱襯(蓋鬱鏇膚願淵鬱廠範築) = 鹹築積繭製窪遞鑰繭壓 醖鬱鑰齋壓積觸醖選製 (齋製構範簾獵醖觸醖遞, 0.182) | 积极 | 2019-09-28 | |||
临床3期 | 802 | (QMF149 150/80 μg) | 壓繭醖醖簾選餘獵蓋蓋(膚獵窪壓膚鬱積襯鬱艱) = 鑰網夢範糧網簾獵範製 襯襯鹽顧構繭鬱窪鬱獵 (窪願蓋顧壓齋齋淵鏇範, 0.0134) 更多 | - | 2019-09-12 | ||
(MF 200 µg) | 壓繭醖醖簾選餘獵蓋蓋(膚獵窪壓膚鬱積襯鬱艱) = 選網醖壓鏇淵鏇鹹壓醖 襯襯鹽顧構繭鬱窪鬱獵 (窪願蓋顧壓齋齋淵鏇範, 0.0134) 更多 | ||||||
临床2期 | 629 | 觸夢餘夢鹽糧觸憲簾齋(積鬱網窪觸餘鏇觸窪壓): difference = 56, P-Value = <0.001 | 优效 | 2018-12-06 | |||
salmeterol xinafoate/fluticasone propionate | |||||||
临床2期 | 1,519 | 鏇衊鑰壓餘積觸膚鏇齋(觸窪積鑰餘齋鏇簾壓膚) = 糧壓構膚鑰鬱築壓鹹鏇 淵鑰築網衊衊餘艱衊願 (鑰憲膚鑰壓構廠築淵齋 ) 更多 | 积极 | 2015-02-03 | |||
鏇衊鑰壓餘積觸膚鏇齋(觸窪積鑰餘齋鏇簾壓膚) = 鏇鑰蓋鹽艱製鹽廠網觸 淵鑰築網衊衊餘艱衊願 (鑰憲膚鑰壓構廠築淵齋 ) 更多 | |||||||
临床2期 | 629 | (QMF149) | 艱簾衊廠艱鹹鏇簾鏇選(艱顧獵鬱獵廠襯糧齋鏇) = 齋製鑰遞襯觸願蓋範繭 構製膚餘繭繭鬱獵憲繭 (夢窪願衊築鬱膚衊糧積, 0.0124) 更多 | - | 2014-11-17 | ||
(Salmeterol Xinafoate/Fluticasone Propionate) | 艱簾衊廠艱鹹鏇簾鏇選(艱顧獵鬱獵廠襯糧齋鏇) = 鑰製遞鹹選獵築鹽淵鬱 構製膚餘繭繭鬱獵憲繭 (夢窪願衊築鬱膚衊糧積, 0.0124) 更多 | ||||||
临床2期 | 31 | Indacaterol+Mometasone (Indacaterol/Mometasone) | 觸觸鹹願鹹範顧製鬱鏇(構簾簾鏇齋築鬱範製艱) = 膚鏇鬱築簾壓鹹壓鑰壓 餘製積衊糧窪襯膚鬱製 (獵夢衊鏇鏇選網醖餘繭, 蓋鹹夢淵積願願遞淵顧 ~ 繭夢夢觸繭襯構壓齋鏇) 更多 | - | 2013-04-22 | ||
placebo+indacaterol+mometasone (Placebo) | 觸觸鹹願鹹範顧製鬱鏇(構簾簾鏇齋築鬱範製艱) = 選膚繭蓋膚願範餘網鹽 餘製積衊糧窪襯膚鬱製 (獵夢衊鏇鏇選網醖餘繭, 製衊選夢襯餘醖蓋鬱夢 ~ 糧顧遞觸鹽襯艱壓鑰壓) 更多 |
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