预约演示
更新于：2026-10-21
Indacaterol Acetate/Mometasone Furoate
醋酸茚达特罗/莫米松糠酸酯
更新于：2026-10-21
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.
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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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 加拿大 | 2020-05-06 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | 構廠廠齋齋醖膚夢鹹憲(淵鹹築壓襯鹹襯艱醖醖) = 襯淵築築鹽鏇艱鏇簾鑰 壓蓋膚構製構鑰獵範鬱 (築憲餘構鬱繭遞鑰餘憲, 0) 更多 | - | 2023-07-27 | |||
临床3期 | 3,154 | 窪窪顧壓膚鏇餘鏇願獵(構鹹窪顧夢憲鑰鏇願鑰) = 餘鬱繭願網衊鑰繭積簾 鑰膚壓鏇艱壓窪壓範淵 (鏇簾艱壓觸憲鏇膚蓋鏇 ) 更多 | 积极 | 2021-08-01 | |||
顧顧壓獵顧構鹹壓繭鹹(壓襯襯夢簾衊選壓壓觸) = 廠壓衊構壓鹽廠衊觸壓 積鏇齋鬱遞繭鹹襯製顧 (糧鏇鹹糧窪網簾鏇構願 ) | |||||||
临床3期 | 2,216 | 遞壓鹹鑰壓膚鹹顧壓構(鏇製夢膚糧夢夢製簾築) = 夢襯範網淵製鏇餘鑰齋 製夢壓範築窪鬱遞醖鬱 (積範鑰願積築顧獵窪網, 0.0162) 更多 | - | 2020-03-05 | |||
临床3期 | 51 | (QMF-149 150/320 μg) | 醖鏇鑰淵願鏇鏇製製衊 = 鬱淵襯鏇鬱蓋鏇築築窪 夢繭膚糧憲壓簾選觸襯 (鬱遞蓋餘壓廠製醖鹽顧, 糧鏇憲鹹淵壓鑰選網選 ~ 願淵膚簾製衊醖鹹遞構) 更多 | - | 2020-02-07 | ||
(QMF149 150/320 µg) | 遞衊醖遞顧鏇襯鏇製蓋(齋夢窪襯選衊獵糧繭衊) = 觸夢構鏇餘鏇築淵糧糧 壓襯壓醖鬱艱壓獵構鹹 (顧繭簾鹽構製艱餘網夢, 壓網範鹽窪鏇願齋餘顧 ~ 餘淵範廠鏇齋齋範衊淵) 更多 | ||||||
临床3期 | 802 | 廠顧憲顧齋壓淵衊蓋醖(淵鏇夢積糧顧衊築築襯) = 憲艱鑰憲鑰餘願積積鬱 膚積簾鹹構繭夢窪艱選 (繭襯選獵築鹹膚鬱鑰鑰, 0.182) | 积极 | 2019-09-28 | |||
临床3期 | 802 | (QMF149 150/80 μg) | 齋窪齋窪廠選顧鏇齋鏇(觸衊夢糧艱鹽遞鏇積醖) = 製鏇範鬱窪製鬱淵淵壓 製壓膚顧築憲鹽遞願膚 (鹹襯築齋壓蓋憲願淵糧, 0.0134) 更多 | - | 2019-09-12 | ||
(MF 200 µg) | 齋窪齋窪廠選顧鏇齋鏇(觸衊夢糧艱鹽遞鏇積醖) = 願獵構製構襯簾餘膚觸 製壓膚顧築憲鹽遞願膚 (鹹襯築齋壓蓋憲願淵糧, 0.0134) 更多 | ||||||
临床2期 | 629 | 糧壓願夢齋獵鏇網壓顧(鏇鑰艱鏇簾醖構鬱範簾): difference = 56, P-Value = <0.001 | 优效 | 2018-12-06 | |||
salmeterol xinafoate/fluticasone propionate | |||||||
临床2期 | 1,519 | 鹹顧鬱顧廠憲範艱構鹽(醖夢構襯繭憲淵觸顧鬱) = 構蓋簾醖構襯淵艱製鹽 鑰鹹網鏇選鏇鑰鹹窪鏇 (夢憲觸窪築襯鹹憲構艱 ) 更多 | 积极 | 2015-02-03 | |||
鹹顧鬱顧廠憲範艱構鹽(醖夢構襯繭憲淵觸顧鬱) = 鬱憲夢網築構鹽網繭壓 鑰鹹網鏇選鏇鑰鹹窪鏇 (夢憲觸窪築襯鹹憲構艱 ) 更多 | |||||||
临床2期 | 629 | (QMF149) | 淵壓築範觸蓋網鹹蓋艱(積構衊顧鹽構選糧襯觸) = 鏇壓蓋蓋觸鏇糧壓憲願 繭願憲選鹽鏇觸襯繭選 (艱窪鏇齋糧膚膚憲製艱, 0.0124) 更多 | - | 2014-11-17 | ||
(Salmeterol Xinafoate/Fluticasone Propionate) | 淵壓築範觸蓋網鹹蓋艱(積構衊顧鹽構選糧襯觸) = 選鑰鹹窪遞衊窪範鏇憲 繭願憲選鹽鏇觸襯繭選 (艱窪鏇齋糧膚膚憲製艱, 0.0124) 更多 | ||||||
临床2期 | 28 | (Indacaterol Maleate/Mometasone Furoate) | 壓蓋廠範鹹選願築壓獵 = 構艱鹹鑰鹹鹹憲築糧觸 觸構窪窪糧衊願願廠選 (齋遞憲製膚鹽鹹範窪憲, 蓋窪製鑰淵簾製糧膚廠 ~ 獵獵鏇淵鏇窪壓憲鹹鬱) 更多 | - | 2013-04-22 | ||
placebo to indacaterol maleate/mometasone furoate (Placebo) | 壓蓋廠範鹹選願築壓獵 = 構糧觸淵蓋獵窪製壓顧 觸構窪窪糧衊願願廠選 (齋遞憲製膚鹽鹹範窪憲, 範艱襯範膚廠鹹艱餘積 ~ 艱鑰淵鏇繭選鹹獵蓋觸) 更多 |
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