预约演示
更新于：2026-07-13
Indacaterol Acetate/Mometasone Furoate
醋酸茚达特罗/莫米松糠酸酯
更新于：2026-07-13
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
19
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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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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 ; Lawrence, David ; Kostikas, Konstantinos ; 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 ; 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.
30
项与 醋酸茚达特罗/莫米松糠酸酯 相关的新闻（医药）2026-06-24
2026-06-03
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 |
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| 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 | 網鹹鑰鬱鬱願鏇網簾選(構鏇製願製範製壓廠簾) = 窪鬱窪襯憲顧築夢觸憲 簾夢範襯築膚襯鏇齋繭 (觸範積鬱簾製鬱壓遞遞, 0) 更多 | - | 2023-07-27 | |||
临床3期 | 3,154 | 範糧淵構遞淵選艱製淵(鑰製艱艱糧襯糧壓製夢) = 構簾膚廠繭鹹壓夢鏇鏇 範鑰築淵廠顧壓鹽壓鹽 (餘遞繭憲膚遞觸襯窪窪 ) 更多 | 积极 | 2021-08-01 | |||
構遞艱獵簾構鬱觸鹽淵(壓壓鬱夢齋窪夢壓夢憲) = 觸糧範衊選選網鑰膚範 衊遞醖願壓簾淵衊齋衊 (觸蓋襯窪膚齋廠壓獵製 ) | |||||||
临床3期 | 2,216 | 選窪鏇遞鑰夢構齋鑰蓋(築顧鑰夢構獵憲壓鹽觸) = 獵餘壓窪選選鹽觸範壓 衊鏇選鹹壓窪願夢衊選 (選選壓蓋觸鹹鑰廠範構, 0.0162) 更多 | - | 2020-03-05 | |||
临床3期 | 51 | (QMF-149 150/320 μg) | 顧糧衊顧簾繭選鹽齋鏇 = 窪齋範獵糧淵鑰鏇構鏇 積淵鹽鑰餘觸窪衊願鏇 (襯繭積選獵壓襯繭膚網, 鑰鹹憲構糧壓夢網構簾 ~ 齋淵鬱繭廠鹹壓窪鹹鑰) 更多 | - | 2020-02-07 | ||
(QMF149 150/320 µg) | 衊觸鹹選鹹鏇願網鏇積(糧願壓憲夢蓋鹹積遞範) = 鬱醖鹽齋醖襯鹹憲顧範 鬱鏇構製獵鑰築範窪夢 (鑰簾顧簾窪鹽艱構顧簾, 憲蓋築觸鏇夢艱製遞顧 ~ 廠艱廠醖鹽醖膚簾淵觸) 更多 | ||||||
临床3期 | 802 | 淵糧膚夢醖鏇憲鹽構衊(選鏇艱齋廠製憲夢遞積) = 鏇遞蓋鹹簾壓衊遞鬱餘 夢觸衊築構夢鹹願鑰願 (餘築簾鑰齋窪願願構鹽, 0.182) | 积极 | 2019-09-28 | |||
临床3期 | 802 | (QMF149 150/80 μg) | 繭鏇鏇製鏇鹽選齋憲艱(齋壓築醖顧鑰糧網積鑰) = 鹽衊鹽遞構願憲糧襯壓 衊鏇繭構製廠簾壓積觸 (蓋淵艱艱選壓築獵窪鏇, 0.0134) 更多 | - | 2019-09-12 | ||
(MF 200 µg) | 繭鏇鏇製鏇鹽選齋憲艱(齋壓築醖顧鑰糧網積鑰) = 遞壓選齋遞夢廠醖糧夢 衊鏇繭構製廠簾壓積觸 (蓋淵艱艱選壓築獵窪鏇, 0.0134) 更多 | ||||||
临床2期 | 629 | 鏇鬱顧壓糧衊築鬱願齋(鑰鏇願遞鬱廠醖鑰簾廠): difference = 56, P-Value = <0.001 | 优效 | 2018-12-06 | |||
salmeterol xinafoate/fluticasone propionate | |||||||
临床2期 | 1,519 | 膚選膚夢鏇鹹網繭餘積(積獵築積鹽築網獵蓋糧) = 憲醖襯衊範艱鑰艱夢網 壓積衊糧構鑰鏇選獵遞 (顧餘繭網襯網憲襯鹽繭 ) 更多 | 积极 | 2015-02-03 | |||
膚選膚夢鏇鹹網繭餘積(積獵築積鹽築網獵蓋糧) = 襯鏇窪鑰淵製製積觸願 壓積衊糧構鑰鏇選獵遞 (顧餘繭網襯網憲襯鹽繭 ) 更多 | |||||||
临床2期 | 629 | (QMF149) | 簾積顧襯選襯壓積壓築(範鹹衊衊範繭醖膚襯積) = 獵鑰糧觸蓋齋簾襯範齋 膚鹹壓廠膚鬱鏇獵窪網 (艱鹹艱獵蓋鹽簾糧鹽蓋, 0.0124) 更多 | - | 2014-11-17 | ||
(Salmeterol Xinafoate/Fluticasone Propionate) | 簾積顧襯選襯壓積壓築(範鹹衊衊範繭醖膚襯積) = 艱襯膚積憲廠蓋壓製鏇 膚鹹壓廠膚鬱鏇獵窪網 (艱鹹艱獵蓋鹽簾糧鹽蓋, 0.0124) 更多 | ||||||
临床2期 | 31 | Indacaterol+Mometasone (Indacaterol/Mometasone) | 鑰齋構壓願糧夢憲壓遞(鹹憲淵淵觸餘餘餘簾顧) = 廠選製簾積觸範艱築廠 鏇顧齋襯簾糧繭夢願廠 (觸築淵襯鹹顧簾窪觸遞, 鬱衊夢廠願觸壓齋構鑰 ~ 衊網鏇糧網鏇襯選襯築) 更多 | - | 2013-04-22 | ||
placebo+indacaterol+mometasone (Placebo) | 鑰齋構壓願糧夢憲壓遞(鹹憲淵淵觸餘餘餘簾顧) = 鬱膚蓋遞窪範願艱願遞 鏇顧齋襯簾糧繭夢願廠 (觸築淵襯鹹顧簾窪觸遞, 壓廠積選鏇壓築蓋夢鏇 ~ 齋顧衊壓蓋願鬱艱遞齋) 更多 |
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