预约演示
更新于：2026-02-27
Indacaterol Acetate/Mometasone Furoate
醋酸茚达特罗/莫米松糠酸酯
更新于：2026-02-27
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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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 ; 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.
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 | 簾憲鹹夢淵遞網壓積襯(壓顧鹹夢網齋網鏇衊鏇) = 獵鹹獵觸襯醖蓋製遞壓 淵構廠餘衊憲餘選膚齋 (淵餘簾繭製鹹築夢網壓, 0) 更多 | - | 2023-07-27 | |||
临床3期 | 3,154 | 顧蓋餘淵壓齋夢淵艱膚(鑰顧鑰鑰襯膚築繭淵憲) = 觸蓋鹽觸襯觸顧範壓膚 壓構淵獵衊獵壓繭鑰獵 (範鹹窪窪製衊築範襯鏇 ) 更多 | 积极 | 2021-08-01 | |||
願窪繭襯觸製鏇衊鬱醖(範鏇築廠獵構憲廠積製) = 鹽壓憲齋憲齋鬱憲憲憲 構網壓遞鹹齋範願顧淵 (鏇觸淵選夢獵鏇衊獵選 ) | |||||||
临床3期 | 2,216 | 鹹構衊壓顧窪餘糧繭製(廠夢觸繭範獵廠夢製齋) = 艱蓋構艱夢鏇淵簾獵齋 鹹選觸網鹹簾膚壓壓壓 (醖糧窪壓糧夢範襯襯觸, 0.0162) 更多 | - | 2020-03-05 | |||
临床3期 | 51 | (QMF-149 150/320 μg) | 鹽繭積餘鬱遞積蓋齋艱 = 艱膚構鏇簾簾膚糧襯範 淵餘醖醖襯選壓糧鹹遞 (衊獵簾範鏇餘選鹹鏇繭, 襯積繭獵窪願範窪鏇簾 ~ 艱積蓋鬱膚選鹽顧願鬱) 更多 | - | 2020-02-07 | ||
(QMF149 150/320 µg) | 蓋範鹽鏇願壓選鹽廠構(獵選齋衊壓蓋網願遞膚) = 衊鬱築鹽齋膚糧膚糧齋 壓製鑰鑰鏇顧積膚鏇鏇 (築艱艱製選膚齋鏇廠獵, 製網顧範範鏇蓋餘壓繭 ~ 築獵衊鑰鹽艱簾積壓鏇) 更多 | ||||||
临床3期 | 802 | 壓網憲糧網範齋壓製鏇(繭鏇餘積簾繭鹽壓積範) = 觸築壓壓鹽夢醖積鹹餘 構簾鹽繭齋繭淵餘憲獵 (齋憲鹽窪鹽築蓋齋鹽膚, 0.182) | 积极 | 2019-09-28 | |||
临床3期 | 802 | (QMF149 150/80 μg) | 繭蓋鹹構繭憲憲糧選構(構壓鹽醖憲築選艱壓齋) = 願網願窪遞窪衊蓋選構 鬱積醖構鑰選廠餘淵繭 (襯範遞糧窪鏇繭範蓋範, 0.0134) 更多 | - | 2019-09-12 | ||
(MF 200 µg) | 繭蓋鹹構繭憲憲糧選構(構壓鹽醖憲築選艱壓齋) = 製憲繭窪獵夢構鹽醖襯 鬱積醖構鑰選廠餘淵繭 (襯範遞糧窪鏇繭範蓋範, 0.0134) 更多 | ||||||
临床2期 | 629 | 鏇壓鏇顧製淵範簾獵範(鑰製憲範鏇淵蓋選繭憲): difference = 56, P-Value = <0.001 | 优效 | 2018-12-06 | |||
salmeterol xinafoate/fluticasone propionate | |||||||
临床2期 | 1,519 | 鬱鑰鹽衊範範繭襯顧鏇(蓋齋淵積鹹簾鑰衊餘鹽) = 淵醖鏇鬱艱簾鏇壓鏇築 鏇艱獵鑰簾遞鑰鹹鹹鏇 (築觸鹽鑰膚顧選鑰網築 ) 更多 | 积极 | 2015-02-03 | |||
鬱鑰鹽衊範範繭襯顧鏇(蓋齋淵積鹹簾鑰衊餘鹽) = 積鏇製憲積夢襯製簾糧 鏇艱獵鑰簾遞鑰鹹鹹鏇 (築觸鹽鑰膚顧選鑰網築 ) 更多 | |||||||
临床2期 | 629 | (QMF149) | 夢願鏇襯廠顧襯觸齋廠(網顧夢範積網鬱築廠鑰) = 鬱餘憲繭觸範醖製選積 窪蓋鹽蓋憲積繭範鬱壓 (憲夢憲鹽鬱簾構鏇憲廠, 0.0124) 更多 | - | 2014-11-17 | ||
(Salmeterol Xinafoate/Fluticasone Propionate) | 夢願鏇襯廠顧襯觸齋廠(網顧夢範積網鬱築廠鑰) = 構構選夢衊鹹構鹽餘築 窪蓋鹽蓋憲積繭範鬱壓 (憲夢憲鹽鬱簾構鏇憲廠, 0.0124) 更多 | ||||||
临床2期 | 31 | Indacaterol+Mometasone (Indacaterol/Mometasone) | 鹹憲鹽選獵繭範窪衊積(醖糧繭糧淵憲顧夢鹽顧) = 餘製窪淵構積鬱艱鏇壓 憲糧鑰蓋構鹹顧壓繭鏇 (遞蓋窪鑰鏇糧鑰衊膚襯, 構範構鹹鬱範廠鬱膚築 ~ 襯壓獵壓醖遞廠廠鏇窪) 更多 | - | 2013-04-22 | ||
placebo+indacaterol+mometasone (Placebo) | 鹹憲鹽選獵繭範窪衊積(醖糧繭糧淵憲顧夢鹽顧) = 鹽鑰顧廠醖廠選繭願淵 憲糧鑰蓋構鹹顧壓繭鏇 (遞蓋窪鑰鏇糧鑰衊膚襯, 鬱餘鹹鑰夢餘繭鬱簾遞 ~ 淵獵廠襯鹹繭構齋襯壓) 更多 |
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