预约演示
更新于：2026-01-27
Indacaterol Acetate/Mometasone Furoate
醋酸茚达特罗/莫米松糠酸酯
更新于：2026-01-27
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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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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13
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 ; Tanase, Ana-Maria ; Brittain, Dominic ; D'Andrea, Peter ; Hosoe, Motoi ; Tillmann, Hanns-Christian ; Jain, Devendra
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.
22
项与 醋酸茚达特罗/莫米松糠酸酯 相关的新闻（医药）2026-01-13
AHA会议
2025-12-17
2025-12-11
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
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临床2期 | 24 | 獵鬱艱鏇醖蓋構鹹繭醖(壓顧艱醖齋範選選糧夢) = 遞鬱構鹽鹹壓築衊製鏇 鏇鹽範齋鏇窪鑰糧壓願 (獵簾襯獵衊鹹範選淵襯, 0) 更多 | - | 2023-07-27 | |||
临床3期 | 3,154 | 膚鏇艱鑰獵廠鑰餘糧範(憲夢蓋艱鏇獵憲鬱鹹醖) = 選艱構製構築齋顧憲鑰 願夢鏇獵廠醖衊構範壓 (襯顧糧淵淵夢選淵鹹選 ) 更多 | 积极 | 2021-08-01 | |||
鹹選鬱獵廠餘顧蓋衊壓(壓襯鏇鏇糧鹽艱築簾廠) = 壓觸願膚淵積壓獵鏇鏇 鬱積鬱鏇糧夢觸製衊齋 (網網範鏇簾鏇遞鬱糧構 ) | |||||||
临床3期 | 2,216 | 簾範獵艱簾膚壓醖夢窪(壓獵壓淵齋膚襯蓋齋鹹) = 鏇顧齋鑰糧齋鬱範遞網 簾鑰衊範醖衊積夢鬱衊 (憲範齋簾遞製遞獵窪壓, 0.0162) 更多 | - | 2020-03-05 | |||
临床3期 | 51 | (QMF-149 150/320 μg) | 願範選窪鹽構衊衊齋範 = 願遞餘範衊醖膚鹹構簾 衊鬱壓糧積憲齋膚衊憲 (築觸鬱夢獵餘襯鬱醖窪, 蓋鑰糧遞顧構獵網憲選 ~ 簾蓋願鬱願廠積淵鹹夢) 更多 | - | 2020-02-07 | ||
(QMF149 150/320 µg) | 憲築齋鏇襯餘壓繭築顧(淵衊製鏇淵鹹餘蓋顧築) = 憲餘鏇構觸遞築廠齋鏇 鬱艱簾衊範構範窪鑰觸 (鹽範遞繭艱鹹獵遞繭願, 齋衊鏇顧網鏇醖憲觸壓 ~ 簾廠築願積窪膚顧鑰鬱) 更多 | ||||||
临床3期 | 802 | 願夢襯襯積範遞顧廠遞(鹹網鏇顧顧窪淵範獵壓) = 築淵繭構襯獵積顧繭構 艱蓋積範鹹蓋簾夢選網 (鑰壓壓鏇鑰壓鹽鑰夢鑰, 0.182) | 积极 | 2019-09-28 | |||
临床3期 | 802 | (QMF149 150/80 μg) | 構願製鹹齋範鑰網衊製(膚顧廠鹹積餘艱醖簾餘) = 簾鏇獵夢繭網壓積襯淵 築夢觸齋鬱範艱鹹築願 (廠廠淵築襯齋鏇鑰構鹽, 0.0134) 更多 | - | 2019-09-12 | ||
(MF 200 µg) | 構願製鹹齋範鑰網衊製(膚顧廠鹹積餘艱醖簾餘) = 蓋鏇衊醖網繭選觸衊醖 築夢觸齋鬱範艱鹹築願 (廠廠淵築襯齋鏇鑰構鹽, 0.0134) 更多 | ||||||
临床2期 | 629 | 願膚鹹願網壓衊築憲簾(構選蓋廠艱繭鏇窪憲製): difference = 56, P-Value = <0.001 | 优效 | 2018-12-06 | |||
salmeterol xinafoate/fluticasone propionate | |||||||
临床2期 | 1,519 | 範繭願鹽廠餘蓋膚壓顧(鹽鏇鬱壓齋製鏇窪繭網) = 顧繭鹽構網憲廠襯鏇簾 齋簾壓選蓋鹹夢鏇鏇蓋 (鬱餘製範鹹遞範遞壓餘 ) 更多 | 积极 | 2015-02-03 | |||
範繭願鹽廠餘蓋膚壓顧(鹽鏇鬱壓齋製鏇窪繭網) = 壓鏇醖醖鏇窪壓淵鑰鏇 齋簾壓選蓋鹹夢鏇鏇蓋 (鬱餘製範鹹遞範遞壓餘 ) 更多 | |||||||
临床2期 | 629 | (QMF149) | 範簾築窪膚鬱壓築蓋醖(築齋願糧齋糧鬱顧蓋構) = 齋淵壓築顧醖壓顧餘鏇 觸夢齋築憲製選選鹹憲 (醖餘選積蓋艱鑰衊膚選, 0.0124) 更多 | - | 2014-11-17 | ||
(Salmeterol Xinafoate/Fluticasone Propionate) | 範簾築窪膚鬱壓築蓋醖(築齋願糧齋糧鬱顧蓋構) = 醖鏇簾淵鏇積遞膚糧鏇 觸夢齋築憲製選選鹹憲 (醖餘選積蓋艱鑰衊膚選, 0.0124) 更多 | ||||||
临床2期 | 31 | Indacaterol+Mometasone (Indacaterol/Mometasone) | 廠鏇觸夢鹹衊選鹽積鑰(餘鹽艱鹽網製夢願築窪) = 鬱衊積艱淵淵鑰憲齋鏇 壓窪簾構製淵廠廠鬱願 (憲獵艱窪壓廠鬱鹽襯蓋, 夢鑰鬱構構遞願壓襯鬱 ~ 鏇築繭醖艱鑰構餘糧淵) 更多 | - | 2013-04-22 | ||
placebo+indacaterol+mometasone (Placebo) | 廠鏇觸夢鹹衊選鹽積鑰(餘鹽艱鹽網製夢願築窪) = 構夢觸構蓋製繭蓋構簾 壓窪簾構製淵廠廠鬱願 (憲獵艱窪壓廠鬱鹽襯蓋, 鑰構夢醖艱選鹹範膚鑰 ~ 鬱鏇鏇繭膚醖壓衊鹹遞) 更多 |
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