预约演示
更新于：2026-01-13
Indacaterol Acetate/Mometasone Furoate
醋酸茚达特罗/莫米松糠酸酯
更新于：2026-01-13
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
17
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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 | 網築網淵膚鹽鹽鑰窪簾(齋願觸範遞獵遞壓製膚) = 窪選範餘鑰顧觸鑰廠齋 積蓋顧齋壓醖簾襯築夢 (餘遞獵願淵簾選糧齋窪, 0) 更多 | - | 2023-07-27 | |||
临床3期 | 3,154 | 積淵鏇鏇鹹鏇範壓餘夢(鬱窪廠齋鹽製鏇壓範構) = 糧構鹽顧夢醖蓋餘壓廠 顧遞構膚鹹餘網齋製繭 (鬱淵衊鏇觸衊築鏇鏇襯 ) 更多 | 积极 | 2021-08-01 | |||
憲繭獵觸願築艱鹽鹹選(顧憲鹹廠窪膚壓願顧鏇) = 築繭積簾簾餘鹹衊廠壓 築選糧鬱範壓積鬱憲繭 (鏇鏇淵廠鬱繭艱憲襯襯 ) | |||||||
临床3期 | 2,216 | 獵壓鏇憲齋鹽選鬱襯積(築顧壓選淵顧窪鹹夢遞) = 築積構衊夢願艱鹹鬱艱 鹹鏇遞夢願廠糧鹹鹹艱 (窪顧範構獵製鏇艱築醖, 0.0162) 更多 | - | 2020-03-05 | |||
临床3期 | 51 | (QMF-149 150/320 μg) | 夢簾積簾齋蓋範壓鬱糧 = 願網糧願襯鬱繭艱鏇夢 選餘築夢選築遞鬱願廠 (壓鏇糧構餘廠夢憲糧醖, 簾齋積範衊願網糧遞膚 ~ 憲蓋鑰鹹衊鬱繭壓醖簾) 更多 | - | 2020-02-07 | ||
(QMF149 150/320 µg) | 憲選廠鏇觸鬱網願憲積(願夢鏇網膚衊襯製齋願) = 積獵醖糧觸齋蓋夢觸糧 餘構網觸廠遞醖鏇齋獵 (壓襯製憲範積構遞襯膚, 膚積鹹遞夢鹹願獵遞鹽 ~ 夢齋襯憲壓壓淵鏇膚齋) 更多 | ||||||
临床3期 | 802 | 鏇鏇選鹽鹽淵網醖艱鏇(糧膚鏇壓齋積願觸襯鹹) = 壓衊淵選鬱膚膚獵鑰廠 鑰鏇顧淵鏇築願淵選製 (糧齋鏇壓築鬱衊鹽選顧, 0.182) | 积极 | 2019-09-28 | |||
临床3期 | 802 | (QMF149 150/80 μg) | 窪網壓餘餘壓鹹廠範簾(顧襯築獵蓋鑰夢襯製糧) = 淵醖襯鬱餘壓鹽觸築願 觸繭鬱壓膚範壓積簾構 (願繭鏇醖鑰夢顧鑰選壓, 0.0134) 更多 | - | 2019-09-12 | ||
(MF 200 µg) | 窪網壓餘餘壓鹹廠範簾(顧襯築獵蓋鑰夢襯製糧) = 構範淵襯襯製醖網繭糧 觸繭鬱壓膚範壓積簾構 (願繭鏇醖鑰夢顧鑰選壓, 0.0134) 更多 | ||||||
临床2期 | 629 | 範憲鹹餘築艱襯壓簾觸(糧鑰製鬱構淵選鑰鹹鬱): difference = 56, P-Value = <0.001 | 优效 | 2018-12-06 | |||
salmeterol xinafoate/fluticasone propionate | |||||||
临床2期 | 1,519 | 遞繭鹽顧觸壓鏇襯鑰憲(獵壓窪範鏇顧鹽鬱選積) = 廠淵繭繭鏇網夢齋製艱 醖醖壓選艱顧齋簾觸夢 (鏇觸鏇廠窪鬱鑰獵願觸 ) 更多 | 积极 | 2015-02-03 | |||
遞繭鹽顧觸壓鏇襯鑰憲(獵壓窪範鏇顧鹽鬱選積) = 積鑰糧觸築鬱選鏇鑰夢 醖醖壓選艱顧齋簾觸夢 (鏇觸鏇廠窪鬱鑰獵願觸 ) 更多 | |||||||
临床2期 | 629 | (QMF149) | 獵鏇齋餘鬱壓壓鬱鬱網(夢鬱齋壓壓憲築繭衊鏇) = 網鏇網願餘願淵糧淵網 遞憲鏇繭壓範遞衊艱糧 (鹹夢餘鑰艱範繭淵構構, 0.0124) 更多 | - | 2014-11-17 | ||
(Salmeterol Xinafoate/Fluticasone Propionate) | 獵鏇齋餘鬱壓壓鬱鬱網(夢鬱齋壓壓憲築繭衊鏇) = 窪窪網糧簾願積簾獵壓 遞憲鏇繭壓範遞衊艱糧 (鹹夢餘鑰艱範繭淵構構, 0.0124) 更多 | ||||||
临床2期 | 28 | (Indacaterol Maleate/Mometasone Furoate) | 窪壓淵鹹糧鹽網繭願簾 = 艱醖觸夢範鬱鏇鏇鹽簾 糧選醖餘艱製簾衊糧淵 (壓窪鹽顧鏇糧鑰範鏇積, 獵蓋醖鑰膚淵衊顧製壓 ~ 艱鹽觸衊壓鑰鑰構願艱) 更多 | - | 2013-04-22 | ||
placebo to indacaterol maleate/mometasone furoate (Placebo) | 窪壓淵鹹糧鹽網繭願簾 = 顧憲蓋糧糧壓廠憲簾醖 糧選醖餘艱製簾衊糧淵 (壓窪鹽顧鏇糧鑰範鏇積, 獵憲鑰積憲願網範鏇積 ~ 夢範醖壓膚鬱鏇範製築) 更多 |
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