主要试验目的：本试验以四川普锐特药业有限公司生产的茚达特罗格隆溴铵吸入粉雾剂[每粒含马来酸茚达特罗110μg（以C24H28N2O3计）和格隆溴铵50μg（以C19H28NO3计）]为受试制剂，原研Novartis Pharma Schweiz AG公司持证、Siegfried Barbera, S.L.生产的茚达特罗格隆溴铵吸入粉雾剂[杰润®，Ultibro®，规格：每粒含马来酸茚达特罗110μg（以C24H28N2O3计）和格隆溴铵50μg（以C19H28NO3计）]为参比制剂，评价受试制剂和参比制剂在空腹条件下给药时的生物等效性。次要试验目的：观察受试制剂和参比制剂在健康受试者中的安全性。

开始日期2025-08-08

申办/合作机构

四川普锐特药业有限公司

CTIS2024-514725-38-00

/ Recruiting临床1期

- 01INDA2024

开始日期2025-06-01

申办/合作机构

Celon Pharma SA

CTR20251262

/ CompletedN/A

茚达特罗格隆溴铵吸入粉雾剂在COPD受试者中的随机、盲法、两制剂、单次给药、两周期、双交叉的药效动力学研究

主要目的以山东京卫制药有限公司生产的茚达特罗格隆溴铵吸入粉雾剂为受试制剂，以Siegfried Barbera, S.L.生产的茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润® Ultirto®）为参比制剂，比较受试制剂（T）和参比制剂（R）在慢性阻塞性肺疾病（COPD）受试者体内的药效动力学特征，为正式试验提供参考依据。次要目的观察受试制剂和参比制剂在COPD受试者中的安全性。

开始日期2025-05-21

申办/合作机构

山东京卫制药有限公司

100 项与茚达特罗/格隆溴铵相关的临床结果

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100 项与茚达特罗/格隆溴铵相关的转化医学

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100 项与茚达特罗/格隆溴铵相关的专利（医药）

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项与茚达特罗/格隆溴铵相关的文献（医药）

2024-02-01·International journal of pharmaceutics

Mixing energy as an adjustment tool for aerodynamic behaviour of an inhaled product: In-vitro and in-vivo effects

Article

作者: Göransson, Stefan ; Lyberg, Ann-Marie ; Husman-Piirainen, Johanna ; Matilainen, Laura ; Kirjavainen, Merja ; Heinonen, Elina ; Lähelmä, Satu ; Autio, Maiju ; Eriksson, Patrik ; Thalberg, Kyrre

This paper describes the development of a fixed dose dry powder combination of indacaterol maleate (Inda) and glycopyrronium bromide (Glyco) in Easyhaler® inhaler for a comparative pharmacokinetic (PK) study, as well as the outcome of such a study. The development aim was to produce formulations with three different in vitro dispersibility profiles for both Inda and Glyco. This so-called 'rake' approach allows for quantitation of the candidate formulations relative to the reference product Ultibro® Breezhaler® in terms of the key PK parameters. Three formulations (A, B and C) were produced based on the mixing energy concept. For both APIs, formulation A (lowest mixing energy) displayed the highest fine particle fractions and formulation C (highest mixing energy) the lowest. GMP manufacturing confirmed the performance of the three formulations. The candidate formulations were tested against the reference product in a single dose PK study in healthy volunteers. Clear differences in Inda plasma concentration profiles were observed between the treatments when administered concomitantly with charcoal, with Easyhaler A showing the highest C_max value and Easyhaler C the lowest. Easyhaler B was bioequivalent to Ultibro Breezhaler with regard to the primary PK parameters of Inda, C_max and AUC_72h. For Glyco, Easyhaler formulations A, B and C provided lower peak concentrations than Ultibro Breezhaler. For AUC_72h of Glyco_, Easyhaler B was bioequivalent to the reference product. Additional measures for adjustment of formulation performance can be foreseen, whose effects can be predicted based on mixing energy theory.

2023-10-01·Respiratory 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).

2023-01-01·International journal of chronic obstructive pulmonary disease

Comparative Effectiveness of Umeclidinium/Vilanterol versus Indacaterol/Glycopyrronium on Moderate-to-Severe Exacerbations in Patients with Chronic Obstructive Pulmonary Disease in Clinical Practice in England.

Article

作者: Compton, Chris ; Herth, Felix J F ; Czira, Alexandrosz ; Requena, Gema ; Yeap, Jie ; Castillo, Catherine ; Tritton, Theo ; Ismaila, Afisi S ; Banks, Victoria ; Wild, Rosie ; Quint, Jennifer K ; Rothnie, Kieran J ; Wood, Robert

Purpose:

Chronic obstructive pulmonary disease (COPD) exacerbations are associated with significant morbidity and mortality and increased economic healthcare burden for patients with COPD. Long-acting muscarinic antagonist (LAMA)/long-acting β₂-agonist (LABA) dual therapy is recommended for patients receiving mono-bronchodilator therapy who experience exacerbations or ongoing breathlessness. This study compared two single-inhaler LAMA/LABA dual therapies, umeclidinium/vilanterol (UMEC/VI) and indacaterol/glycopyrronium (IND/GLY), on moderate-to-severe exacerbation rates in patients with COPD in England.

Patients and Methods:

This retrospective cohort study used linked primary care electronic health record data (Clinical Practice Research Datalink-Aurum) and secondary care data (Hospital Episode Statistics) to assess outcomes for patients with COPD who had a first prescription for single-inhaler UMEC/VI or IND/GLY (index date) between 1 January 2015 and 30 September 2019 (indexing period). Analyses compared UMEC/VI and IND/GLY on moderate-to-severe, moderate, and severe exacerbations, healthcare resource utilization (HCRU), and direct costs at 6, 12, 18, and 24 months, and time-to-first on-treatment exacerbation up to 24 months post-index date. Following inverse probability of treatment weighting (IPTW), non-inferiority and superiority of UMEC/VI versus IND/GLY were assessed.

Results:

In total, 12,031 patients were included, of whom 8753 (72.8%) were prescribed UMEC/VI and 3278 (27.2%) IND/GLY. After IPTW, for moderate-to-severe exacerbations, weighted rate ratios were <1 at 6, 12, and 18 months and equal to 1 at 24 months for UMEC/VI; around the null value for moderate exacerbations and <1 at all timepoints for severe exacerbations. UMEC/VI showed lower HCRU incidence rates than IND/GLY for all-cause Accident and Emergency visits and COPD-related inpatient stays and associated all-cause costs at 6 months post-indexing. Time-to-triple therapy was similar for both treatments.

Conclusion:

UMEC/VI demonstrated non-inferiority to IND/GLY in moderate-to-severe exacerbation reduction at 6, 12 and 18 months. These results support previous findings demonstrating similarity between UMEC/VI and IND/GLY on reduction of moderate-to-severe exacerbations.

项与茚达特罗/格隆溴铵相关的新闻（医药）

20 小时之前

·EndPoints

AeroRx closes $21M Series A in bid to capitalize on COPD momentum

A respiratory biotech that launched Tuesday morning aims to take advantage of excitement in COPD drug development spurred by two recent deals. AeroRx Therapeutics took the wraps off a $21 million Series A that it’s using to get its lead program through Phase 2b testing in chronic obstructive pulmonary disease, or COPD. It’s the same category that spurred Merck’s $10 billion acquisition of Verona Pharma and GSK’s partnership with Hengrui Pharma that could be worth $12 billion if everything pans out. The AeroRx drug, known as AERO-007, is a nebulized reformulation of two approved compounds — indacaterol and glycopyrrolate — that use different mechanisms of action. Indacaterol is a long-acting beta agonist (LABA), while glycopyrrolate is a long-acting muscarinic agonist (LAMA). Combining LABAs and LAMAs is common when treating COPD. AeroRx CEO Ahmet Tutuncu said the FDA has approved five such products. An inhaler combination of indacaterol and glycopyrrolate was approved in 2015 as Utibron, which was developed by Novartis and out-licensed to Sunovion Pharmaceuticals a year later. (Sunovion is now owned by Sumitomo Pharma.) All the approvals are for inhalers with dry powder, which is more difficult for older and sicker patients to use, Tutuncu said. AeroRx believes it can be the first company to offer a nebulized formulation as a first-line maintenance therapy in COPD. “It’s a different delivery technology, or full dose delivery, for those patients who need to be on nebulized medicines,” Tutuncu said. “A significant number of COPD patients who are typically getting older, they are on inhalers, but they are the ones who end up in hospitals with exacerbations for symptom control, and therefore they need to be on nebulized medicine.” So far, AeroRx has run a small Phase 2a study with 16 patients that suggested AERO-007 could be dosed once daily. In the Phase 2b trial, researchers plan to test once-daily and twice-daily doses. Most other details about the trial remain undisclosed until after discussions with the FDA, according to Tutuncu, including how long it’s expected to last. But because both components of AERO-007 are already approved, Tutuncu expects an “abbreviated” late-stage development process comprising the Phase 2b and Phase 3 trials. The trials will also enroll all COPD patients, and if AERO-007 wins approval, AeroRx plans to market it for patients older than 65 years old. The company also has another preclinical program called AERO-111, which is a triple combination nebulized COPD treatment. (There are two approved triple-combo inhalers.) In addition to a LABA and LAMA compound, AERO-111 also includes a corticosteroid. Tutuncu said the company is still figuring out which one to use. AeroRx’s Series A comes about 18 months after it closed a $6 million seed round in the spring of last year. With the new cash in hand, AeroRx is aiming to capitalize on the recent momentum in COPD following the Merck and GSK deals. “Those were two really important validation points for the interest from big pharma for nebulized delivery in the respiratory space, and particularly in the COPD space,” Tutuncu said. “We’re very excited about that potential for collaboration with pharma down the road.”

临床2期上市批准并购

23 小时之前

·Firstwordpharma

AeroRx raises $21M for mid-stage study of nebulised COPD treatment

Two months after posting proof-of-concept data supporting its nebulised approach to treating chronic obstructive pulmonary disease (COPD), AeroRx Therapeutics has bagged a $21-million series A to kick off a Phase IIb trial of AERO-007.The biotech's candidate is poised to become the first nebulised combination of a long-acting beta agonist (LABA) and a long-acting muscarinic antagonist (LAMA) for first-line maintenance treatment of COPD, CEO Ahmet Tutuncu told FirstWord. While dual LABA/LAMA bronchodilation delivered via handheld inhaler is the standard first-line therapy, a subset of patients with COPD can't effectively use the devices, or prefer nebulised treatments, he explained."Up to 75% of COPD patients, particularly older and sicker individuals, do not receive the optimal dose from inhalers, leading to poor symptom control, more frequent exacerbations, and hospitalisations," Tutuncu said. "By contrast, nebulised delivery is designed to provide the full intended dose regardless of disease severity or patient technique, using normal, passive breathing. This ensures more consistent drug delivery, improves adherence, and gives the patients and clinicians greater confidence that patients are receiving effective therapy."However, there are no approved nebulised LABA/LAMA combinations — and that's where AeroRx and AERO-007 come in. In July, the company reported results from a Phase IIa study showing that in 16 adults with moderate-to-severe COPD, both low- and high-doses of AERO-007 led to clinically meaningful, statistically significant improvements in forced expiratory volume in one second compared with placebo, with rapid-onset and sustained 24-hour bronchodilation.Additionally, the treatment was well tolerated, with a systemic drug exposure profile similar to that of other LABAs and LAMAs. With the proceeds from the series A — led by Avalon BioVentures, with participation from Correlation Ventures and Alexandria Venture — AeroRx plans to launch a Phase IIb dose-optimisation study in early 2026. The 14-day, placebo-controlled crossover study will randomise patients with COPD to evaluate once- versus twice-daily dosing, and to select the dosage of AERO-007 for Phase III testing. "Our goal has always been simple: ensure that every patient can receive the best-in-class treatment their condition demands, regardless of their ability to use an inhaler," Tutuncu said. "This financing moves us closer to that vision."

临床2期临床结果

2025-08-31

·信狐药迅

上海欣峰2.2类吡仑帕奈口溶膜提交上市申请|新受理（8.25-8.31）

本周药品注册受理数据，分门别类呈现，一目了然。(8.25-8.31）新药上市申请药品名称企业注册分类受理号吡仑帕奈口溶膜上海欣峰制药有限公司 2.2 CXHS2500105 吡仑帕奈口溶膜上海欣峰制药有限公司 2.2 CXHS2500104 新药临床申请药品名称企业注册分类受理号 HH101785片上海海和药物研究开发股份有限公司 1 CXHL2500933 HH101785片上海海和药物研究开发股份有限公司 1 CXHL2500932 JNJ-88998377口服片强生(中国)投资有限公司 1 CXHL2500927 JNJ-88998377口服片强生(中国)投资有限公司 1 CXHL2500926 JNJ-88998377口服片强生(中国)投资有限公司 1 CXHL2500925 ANS014004片北京鞍石生物科技股份有限公司 1 CXHL2500920 ANS014004片北京鞍石生物科技股份有限公司 1 CXHL2500918 PLB1004胶囊鞍石药业(宁波)有限责任公司 1 CXHL2500900 PLB1004胶囊鞍石药业(宁波)有限责任公司 1 CXHL2500899 JMKX000189片上海济煜医药科技股份有限公司 1 CXHL2500924 JMKX000189片上海济煜医药科技股份有限公司 1 CXHL2500923 JMKX000189片上海济煜医药科技股份有限公司 1 CXHL2500922 XNW34017片苏州信诺维医药科技股份有限公司 1 CXHL2500921 XNW34017片苏州信诺维医药科技股份有限公司 1 CXHL2500919 ST-01156胶囊万春宏基(大连)医药有限公司 1 CXHL2500917 ST-01156胶囊万春宏基(大连)医药有限公司 1 CXHL2500916 ST-01156胶囊万春宏基(大连)医药有限公司 1 CXHL2500915 ST-01156胶囊万春宏基(大连)医药有限公司 1 CXHL2500914 BIOS-0625片杭州百诚医药科技股份有限公司 1 CXHL2500908 BIOS-0625片杭州百诚医药科技股份有限公司 1 CXHL2500907 SAL0140片深圳信立泰药业股份有限公司 1 CXHL2500898 SAL0140片深圳信立泰药业股份有限公司 1 CXHL2500897 SAL0140片深圳信立泰药业股份有限公司 1 CXHL2500896 HBW-012462片成都海博为药业有限公司 1 CXHL2500889 HBW-012462片成都海博为药业有限公司 1 CXHL2500888 SBK008注射液成都施贝康生物医药科技有限公司 1 CXHL2500887 P-0264直服颗粒华益泰康药业股份有限公司 2.2 CXHL2500930 JL4083吸入溶液四川健林药业有限责任公司 2.2 CXHL2500911 JL4083吸入溶液四川健林药业有限责任公司 2.2 CXHL2500910 JL4083吸入溶液四川健林药业有限责任公司 2.2 CXHL2500909 BIOS2242口服溶液浙江赛默制药有限公司 2.2 CXHL2500895 司美格鲁肽注射液齐鲁制药有限公司 2.2 CXHL2500906 司美格鲁肽注射液齐鲁制药有限公司 2.2 CXHL2500905 司美格鲁肽注射液齐鲁制药有限公司 2.2 CXHL2500903 司美格鲁肽注射液齐鲁制药有限公司 2.2 CXHL2500904 司美格鲁肽注射液齐鲁制药有限公司 2.2 CXHL2500901 盐酸奥洛他定口服液北京尚修堂医药科技有限公司 2.2 CXHL2500892 盐酸奥洛他定口服液北京尚修堂医药科技有限公司 2.2 CXHL2500891 硫酸艾玛昔替尼片江苏恒瑞医药股份有限公司 2.4 CXHL2500931 富马酸泰吉利定注射液江苏恒瑞医药股份有限公司 2.4 CXHL2500913 富马酸泰吉利定注射液江苏恒瑞医药股份有限公司 2.4 CXHL2500912 瑞维鲁胺片江苏恒瑞医药股份有限公司 2.4 CXHL2500890 TTYP01片上海澳宗生物科技有限公司 2.4;2.2 CXHL2500902 KEM2408乳胶内蒙古科立雅药业有限公司 2.4;2.2 CXHL2500894 KEM2408乳胶内蒙古科立雅药业有限公司 2.4;2.2 CXHL2500893 重组带状疱疹疫苗(CHO细胞) 北京科兴中维生物技术有限公司 1.3 CXSL2500749 注射用ZG006 苏州泽璟生物制药股份有限公司 1 CXSL2500753 注射用戈氏梭菌芽孢冻干粉施慧达药业集团(吉林)有限公司 1 CXSL2500752 9MW3811注射液迈威(上海)生物科技股份有限公司 1 CXSL2500751 SCTC21C注射液神州细胞工程有限公司 1 CXSL2500750 ARC001滴鼻液羿旻生物医药科技(东阳)有限公司 1 CXSL2500748 ARC001注射液羿旻生物医药科技(东阳)有限公司 1 CXSL2500747 AK152注射液中山康方生物医药有限公司 1 CXSL2500746 PM8002注射液百欧恩泰(上海)医药有限公司 1 CXSL2500744 PM8002注射液百欧恩泰(上海)医药有限公司 1 CXSL2500743 GenSci134注射液长春金赛药业有限责任公司 1 CXSL2500738 GenSci134注射液长春金赛药业有限责任公司 1 CXSL2500737 WSK-V108E 北京威斯克生物医药有限公司 1 CXSL2500736 WGc-0201 注射液成都威斯津生物医药科技有限公司 1 CXSL2500735 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500742 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500741 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500740 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500739 QT-019B细胞注射液杭州启函生物科技有限公司 1 CXSL2500745 仿制药申请药品名称企业注册分类受理号中性低钙腹膜透析液(碳酸氢盐-G2.5%) 海南爱科制药有限公司 3 CYHS2503187 中性低钙腹膜透析液(碳酸氢盐-G1.5%) 海南爱科制药有限公司 3 CYHS2503186 中性腹膜透析液(碳酸氢盐-G2.5%) 海南爱科制药有限公司 3 CYHS2503185 中性腹膜透析液(碳酸氢盐-G1.5%) 海南爱科制药有限公司 3 CYHS2503184 盐酸二甲双胍口服液安徽四环科宝制药有限公司 3 CYHS2503201 盐酸二甲双胍口服液安徽四环科宝制药有限公司 3 CYHS2503200 磷酸奥司他韦颗粒山东朗诺制药有限公司 3 CYHS2503199 磷苯妥英钠注射液武汉华尔生物科技有限公司 3 CYHS2503195 磷苯妥英钠注射液武汉华尔生物科技有限公司 3 CYHS2503194 复方聚乙二醇(3350)电解质口服溶液河北华晨药业集团有限公司 3 CYHS2503175 盐酸米那普仑片白云山东泰商丘药业有限公司 3 CYHS2503173 盐酸地尔硫䓬控释胶囊广州绿十字制药股份有限公司 3 CYHS2503164 地氯雷他定口服溶液千海始德堂(鹤壁)制药有限公司 3 CYHS2503163 地氯雷他定口服溶液千海始德堂(鹤壁)制药有限公司 3 CYHS2503162 盐酸异丙肾上腺素注射液辰欣药业股份有限公司 3 CYHS2503147 盐酸异丙肾上腺素注射液辰欣药业股份有限公司 3 CYHS2503146 盐酸利多卡因胶浆广东君康药业有限公司 3 CYHS2503138 盐酸利多卡因注射液山西铭羽生物科技有限公司 3 CYHS2503129 碳酸司维拉姆干混悬剂国药集团致君(深圳)坪山制药有限公司 3 CYHS2503127 右酮洛芬氨丁三醇口服溶液北京柏雅联合药物研究所有限公司 3 CYHS2503126 舒林酸片苏州朗科生物技术股份有限公司 3 CYHS2503125 硫酸长春新碱注射液吉斯美(武汉)制药有限公司 3 CYHS2503117 西甲硅油咀嚼片浙江远力健药业有限责任公司 3 CYHS2503116 注射用磷霉素钠汇禹远和(海南)药业有限公司 3 CYHS2503131 注射用磷霉素钠汇禹远和(海南)药业有限公司 3 CYHS2503130 左羟丙哌嗪口服溶液合肥华威药业有限公司 3 CYHS2503113 酒石酸西尼必利片江苏永安制药有限公司 4 CYHS2503191 对乙酰氨基酚缓释片南京正大天晴制药有限公司 4 CYHS2503190 乌帕替尼缓释片江苏和晨药业有限公司 4 CYHS2503189 阿帕他胺片无锡紫杉药业股份有限公司 4 CYHS2503188 盐酸阿莫罗芬搽剂中山万汉制药有限公司 4 CYHS2503183 蔗糖羟基氧化铁咀嚼片湖南明瑞制药股份有限公司 4 CYHS2503182 硫酸氨基葡萄糖胶囊海南全星制药有限公司 4 CYHS2503181 莫匹罗星软膏浙江康润制药有限公司 4 CYHS2503180 盐酸达泊西汀片国大(吉林)制药集团有限公司 4 CYHS2503179 盐酸达泊西汀片国大(吉林)制药集团有限公司 4 CYHS2503178 注射用氯诺昔康北京四环科宝制药股份有限公司 4 CYHS2503203 地塞米松棕榈酸酯注射液河南利华制药有限公司 4 CYHS2503202 沙库巴曲缬沙坦钠片云鹏医药集团有限公司 4 CYHS2503198 沙库巴曲缬沙坦钠片云鹏医药集团有限公司 4 CYHS2503197 沙库巴曲缬沙坦钠片云鹏医药集团有限公司 4 CYHS2503196 达格列净二甲双胍缓释片(III) 陕西君可力医药科技有限公司 4 CYHS2503193 达格列净二甲双胍缓释片(I) 陕西君可力医药科技有限公司 4 CYHS2503192 吸入用复方异丙托溴铵溶液鲁南贝特制药有限公司 4 CYHS2503165 硫酸氨基葡萄糖胶囊四川梓橦宫药业股份有限公司 4 CYHS2503177 瑞维那新吸入溶液洋浦京泰药业有限公司 4 CYHS2503176 盐酸二甲双胍片石家庄市华新药业有限责任公司 4 CYHS2503174 醋酸阿托西班注射液北京双鹭药业股份有限公司 4 CYHS2503172 美阿沙坦钾片南京正科医药股份有限公司 4 CYHS2503171 美阿沙坦钾片南京正科医药股份有限公司 4 CYHS2503170 注射用硫酸艾沙康唑北京海步医药科技有限公司 4 CYHS2503169 吗啉硝唑氯化钠注射液石药银湖制药有限公司 4 CYHS2503168 帕拉米韦氯化钠注射液珠海同源药业有限公司 4 CYHS2503167 帕拉米韦氯化钠注射液珠海同源药业有限公司 4 CYHS2503166 溴芬酸钠滴眼液湖北美林药业有限公司 4 CYHS2503161 艾拉莫德片合肥华威药业有限公司 4 CYHS2503158 阿替卡因肾上腺素注射液华夏生生药业(北京)有限公司 4 CYHS2503157 枸橼酸西地那非片湘北威尔曼制药股份有限公司 4 CYHS2503156 枸橼酸西地那非片湘北威尔曼制药股份有限公司 4 CYHS2503155 钆喷酸葡胺注射液海南倍特药业有限公司 4 CYHS2503154 钆喷酸葡胺注射液海南倍特药业有限公司 4 CYHS2503153 甘油磷酸钠注射液湖北天圣药业有限公司 4 CYHS2503151 盐酸二甲双胍缓释片山东诚康药业有限公司 4 CYHS2503150 瑞维那新吸入溶液华润双鹤利民药业(济南)有限公司 4 CYHS2503160 瑞维那新吸入溶液九华华源药业(桂林)有限公司 4 CYHS2503159 甲磺酸溴隐亭片浙江泰利森药业有限公司 4 CYHS2503148 盐酸曲唑酮缓释片重庆锐恩医药有限公司 4 CYHS2503145 盐酸曲唑酮缓释片重庆锐恩医药有限公司 4 CYHS2503144 盐酸氨溴索注射液西洲医药科技(浙江)有限公司 4 CYHS2503143 盐酸氨溴索注射液西洲医药科技(浙江)有限公司 4 CYHS2503142 盐酸氨溴索注射液西洲医药科技(浙江)有限公司 4 CYHS2503140 伊曲康唑口服液湖北莱康医疗技术有限公司 4 CYHS2503139 玻璃酸钠滴眼液广州白云山天心制药股份有限公司 4 CYHS2503137 玻璃酸钠滴眼液广州白云山天心制药股份有限公司 4 CYHS2503136 阿达帕林凝胶北京京丰制药(河北)有限公司 4 CYHS2503135 莫匹罗星软膏遂成药业股份有限公司 4 CYHS2503134 阿帕他胺片海南卓泰制药有限公司 4 CYHS2503133 磷酸奥司他韦胶囊湖北远大永晟药业有限公司 4 CYHS2503149 艾拉莫德片宜昌东阳光长江药业股份有限公司 4 CYHS2503152 尼可地尔片山东新时代药业有限公司 4 CYHS2503128 阿达帕林过氧苯甲酰凝胶杭州和泽坤元药业有限公司 4 CYHS2503124 钆特酸葡胺注射液成都克莱蒙医药科技有限公司 4 CYHS2503123 甘油磷酸钠注射液浙江同伍生物医药有限公司 4 CYHS2503122 注射用磷酸左奥硝唑酯二钠仁合益康汇泽药业河北有限公司 4 CYHS2503121 聚多卡醇注射液成都倍特药业股份有限公司 4 CYHS2503120 聚多卡醇注射液成都倍特药业股份有限公司 4 CYHS2503119 聚多卡醇注射液成都倍特药业股份有限公司 4 CYHS2503118 腺苷注射液扬州中宝药业股份有限公司 4 CYHS2503115 腺苷注射液扬州中宝药业股份有限公司 4 CYHS2503114 聚乙二醇4000散武汉同济现代医药科技股份有限公司 4 CYHS2503132 阿帕他胺片郑州德迈药业有限公司 4 CYHS2503141 多替诺雷片天地恒一制药股份有限公司 4 CYHS2503112 注射用甲苯磺酸奥马环素海南卫康制药(潜山)有限公司 4 CYHS2503111 盐酸达利雷生片海南先声药业有限公司 4 CYHS2503110 盐酸达利雷生片海南先声药业有限公司 4 CYHS2503109 SHR0302碱凝胶瑞石生物医药有限公司 2.1;2.4;2.2 CXHL2500929 SHR0302碱凝胶瑞石生物医药有限公司 2.1;2.4;2.2 CXHL2500928 酮洛芬贴剂湖南华纳大药厂股份有限公司 3 CYHL2500157 注射用醋酸亮丙瑞林微球上海恒瑞医药有限公司 3 CYHL2500159 利多卡因丁卡因乳膏北京逸诚医药科技有限公司 3 CYHL2500154 利多卡因丁卡因乳膏北京逸诚医药科技有限公司 3 CYHL2500153 枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司 3 CYHL2500152 枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司 3 CYHL2500151 枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司 3 CYHL2500150 枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司 3 CYHL2500149 克霉唑阴道片浙江众延医药科技有限公司 4 CYHL2500158 茚达特罗格隆溴铵吸入粉雾剂广州呼吸药物工程技术有限公司 4 CYHL2500155 进口申请药品名称企业注册分类受理号维生素K1混合胶束注射液 CHEPLAPHARM Arzneimittel GmbH 5.1 JXHS2500091 注射用Rurioctocog alfa pegol Takeda Canada Inc 3.1 JXSS2500115 注射用Rurioctocog alfa pegol Takeda Canada Inc 3.1 JXSS2500114 注射用Rurioctocog alfa pegol Takeda Canada Inc 3.1 JXSS2500113 注射用Rurioctocog alfa pegol Takeda Canada Inc 3.1 JXSS2500112 注射用Rurioctocog alfa pegol Takeda Canada Inc 3.1 JXSS2500111 盐酸奥洛他定滴眼液 Teika Pharmaceutical Co., Ltd. 5.2 JYHS2500042 [111In]In-FL-020注射液 Full-Life Technologies GmbH 1 JXHL2500249 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500248 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500247 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500246 [225Ac]Ac-FL-020注射液 Full-Life Technologies GmbH 1 JXHL2500250 MK-0616 片 Merck Sharp & Dohme LLC 1 JXHL2500245 Orforglipron片 Eli Lilly and Company 1 JXHL2500243 Orforglipron片 Eli Lilly and Company 1 JXHL2500242 Orforglipron片 Eli Lilly and Company 1 JXHL2500241 Orforglipron片 Eli Lilly and Company 1 JXHL2500240 Orforglipron片 Eli Lilly and Company 1 JXHL2500239 Orforglipron片 Eli Lilly and Company 1 JXHL2500238 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500237 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500236 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500235 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500234 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500233 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500232 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500231 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500230 DS-3201b片 Daiichi Sankyo, Inc. 2.4 JXHL2500244 英克司兰钠注射液 Novartis Pharma AG 2.4 JXHL2500229 AZD0486 AstraZeneca AB 1 JXSL2500160 AZD0486 AstraZeneca AB 1 JXSL2500159 AZD0486 AstraZeneca AB 1 JXSL2500158 AZD0486 AstraZeneca AB 1 JXSL2500157 萨特利珠单抗注射液 F. Hoffmann-La Roche Ltd. 2.2 JXSL2500164 萨特利珠单抗注射液 F. Hoffmann-La Roche Ltd. 2.2 JXSL2500163 Amivantamab注射液(皮下注射) Janssen Research & Development, LLC 2.2 JXSL2500162 Amivantamab注射液(皮下注射) Janssen Research & Development, LLC 2.2 JXSL2500161 中药相关申请药品名称企业注册分类受理号保精片苏中药业集团股份有限公司 1.1 CXZL2500069 痰火丸上海凯宝药业股份有限公司 1.1 CXZL2500068 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

100 项与茚达特罗/格隆溴铵相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	茚达特罗/格隆溴铵	R03AL04	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
气道阻塞	美国	Novartis Pharmaceuticals Corp.	2015-10-29
慢性支气管炎	美国	Novartis Pharmaceuticals Corp.	2015-10-29
肺气肿	美国	Novartis Pharmaceuticals Corp.	2015-10-29
慢性阻塞性肺疾病	欧盟	Novartis Europharm Ltd.	2013-09-18
慢性阻塞性肺疾病	冰岛	Novartis Europharm Ltd.	2013-09-18
慢性阻塞性肺疾病	列支敦士登	Novartis Europharm Ltd.	2013-09-18
慢性阻塞性肺疾病	挪威	Novartis Europharm Ltd.	2013-09-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
呼吸困难	临床3期	比利时	Novartis Pharmaceuticals Corp.	2011-10-01
呼吸困难	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2011-10-01
呼吸困难	临床3期	德国	Novartis Pharmaceuticals Corp.	2011-10-01
呼吸困难	临床3期	西班牙	Novartis Pharmaceuticals Corp.	2011-10-01
呼吸困难	临床3期	英国	Novartis Pharmaceuticals Corp.	2011-10-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ATS2025	N/A	慢性阻塞性肺疾病	191	Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 µg	選鹽鏇選觸簾積鏇鬱窪(鑰積艱艱願齋齋廠遞鹹) = 窪觸觸襯鑰鏇憲築構鬱製製襯顧憲遞範蓋壓繭 (蓋繭繭願艱選糧選範膚, 105 ~ 180)	积极	2025-05-16
NCT02867761 (RETHINC, CTgov)	临床3期	慢性阻塞性肺疾病	780	Indacaterol/Glycopyrrolate (Indacaterol/Glycopyrrolate)	窪糧願壓製簾夢淵齋獵 = 鹹鏇範鹽觸淵窪鏇願簾網觸憲壓淵窪糧鏇壓膚 (廠製願構築鏇壓選顧繭, 壓夢餘鹹鏇壓製顧淵艱 ~ 膚積憲淵糧鏇遞選艱夢) 更多	-	2022-08-30
				Placebo (Placebo)	窪糧願壓製簾夢淵齋獵 = 襯壓窪網齋廠獵淵襯憲網觸憲壓淵窪糧鏇壓膚 (廠製願構築鏇壓選顧繭, 構膚選網鏇顧壓範夢範 ~ 淵窪繭遞餘衊艱鹽廠襯) 更多
NCT02566031 (CTgov)	临床4期	慢性阻塞性肺疾病	379	Indacaterol and glycopyrronium (QVA149) (Indacaterol and Glycopyrronium (QVA149))	衊餘憲鹹構獵衊餘艱壓(鬱壓範鹽壓顧窪選壓憲) = 膚餘鹽願鹽襯憲網廠醖鹽遞衊獵膚鹽壓鏇範構 (衊膚壓淵膚繭構願積窪, 0.18097) 更多	-	2019-09-23
				Tiotropium (Tiotropium)	衊餘憲鹹構獵衊餘艱壓(鬱壓範鹽壓顧窪選壓憲) = 繭襯齋廠夢選衊壓製餘鹽遞衊獵膚鹽壓鏇範構 (衊膚壓淵膚繭構願積窪, 0.18487) 更多
NCT02202616 (POWER, CTgov)	临床4期	慢性阻塞性肺疾病	401	Sal+Flu+QVA149 (QVA149 110/50 After Flu/Sal)	鬱壓蓋顧築糧顧選積選(壓構範觸鬱壓壓糧艱衊) = 鬱壓淵網衊網齋餘獵構憲選網蓋廠顧築積築鑰 (襯選遞願觸艱繭窪膚願, 0.397) 更多	-	2019-06-24
				QVA149 (QVA149 110/50 After Tio)	鬱壓蓋顧築糧顧選積選(壓構範觸鬱壓壓糧艱衊) = 遞鹹顧廠膚齋鹽衊獵艱憲選網蓋廠顧築積築鑰 (襯選遞願觸艱繭窪膚願, 0.321) 更多
NCT02634983 (CTgov)	临床4期	慢性阻塞性肺疾病	31	QVA149 (QVA149 110/50 mcg)	艱憲簾製艱襯顧願淵蓋(廠鑰顧網壓醖積鹹繭衊) = 構襯繭願窪製蓋鬱艱範願廠獵積簾繭願鏇獵襯 (廠廠艱憲顧遞鏇淵鹹築, 艱製繭廠壓繭膚鹽衊廠 ~ 糧醖蓋鑰鏇壓繭築網膚) 更多	-	2019-06-03
				placebo (Matching Placebo)	艱憲簾製艱襯顧願淵蓋(廠鑰顧網壓醖積鹹繭衊) = 淵齋獵壓廠獵壓衊壓顧願廠獵積簾繭願鏇獵襯 (廠廠艱憲顧遞鏇淵鹹築, 鹹壓鏇憲膚網夢壓壓鑰 ~ 窪築糧鹽製廠築網壓繭) 更多
NCT02442206 (CLAIM, Pubmed \| Am J Respir Crit Care Med)	临床4期	慢性阻塞性肺疾病	62	Indacaterol/Glycopyrronium	獵網鏇齋糧糧願餘壓窪(窪糧膚鏇獵遞齋簾觸憲) = 衊齋製築窪壓獵積鹽齋鹽壓憲艱糧鹽鹹餘鑰齋 (鹹蓋廠網淵選鬱鏇夢顧 )	-	2019-05-01
NCT02603393 (CTgov)	临床4期	慢性阻塞性肺疾病	1,053	QVA149 (QVA149)	襯艱繭網鏇窪顧遞範窪(獵憲獵餘獵鹹願簾餘鏇) = 夢壓願憲繭廠積鬱鬱遞夢壓蓋選選遞網製艱餘 (膚築築醖遞齋網範襯鏇, 0.0119) 更多	-	2019-04-29
				Tiotropium+Salmeterol/fluticasone (Tiotropium + Salmeterol/Fluticasone)	襯艱繭網鏇窪顧遞範窪(獵憲獵餘獵鹹願簾餘鏇) = 選齋鏇憲廠夢淵齋淵顧夢壓蓋選選遞網製艱餘 (膚築築醖遞齋網範襯鏇, 0.0115) 更多
NCT02516592 (FLASH, CTgov)	临床4期	慢性阻塞性肺疾病	500	QVA149 110/50 micrograms (QVA149 110/50 Micrograms)	鬱餘簾餘製網艱齋鑰壓(鏇齋繭夢簾願鬱鹹鏇壓) = 衊製構獵襯壓願淵鹽壓觸衊膚觸糧襯壓糧憲衊 (壓構遞製蓋範鬱衊鑰壓, 0.0151) 更多	-	2019-03-21
				Salmeterol/fluticasone 50/500 microgrammes (Salmeterol/Fluticasone 50/500 Micrograms)	鬱餘簾餘製網艱齋鑰壓(鏇齋繭夢簾願鬱鹹鏇壓) = 夢觸餘夢遞窪衊製襯蓋觸衊膚觸糧襯壓糧憲衊 (壓構遞製蓋範鬱衊鑰壓, 0.0152) 更多
NCT02233543 (CTgov)	临床4期	慢性阻塞性肺疾病	38	Indacaterol+Glycopyrronium+QVA149 (QVA149 (Indacaterol/Glycopyrronium))	衊廠構壓淵製顧觸衊夢(鬱糧蓋鑰廠鬱憲鏇網壓) = 鹹構鑰網鑰觸構齋膚艱獵鑰積膚齋範積顧醖選 (獵淵願醖鑰鹽糧簾顧繭, 0.30) 更多	-	2018-08-06
				QVA149 (Placebo)	衊廠構壓淵製顧觸衊夢(鬱糧蓋鑰廠鬱憲鏇網壓) = 製網範繭獵艱構餘築鹹獵鑰積膚齋範積顧醖選 (獵淵願醖鑰鹽糧簾顧繭, 0.28) 更多
NCT02487446 \| NCT02487498 (Pubmed \| Lung)	临床3期	慢性阻塞性肺疾病	-	Indacaterol Maleate/Glycopyrronium Bromide	願艱襯艱醖淵鏇襯願鹹(鏇衊鬱窪廠襯膚廠鏇鬱) = 簾積淵繭築鬱簾築淵積淵壓窪壓簾鹽製鹹範蓋 (壓積衊憲選顧鹹鹹窪範 )	-	2017-12-01
				Umeclidinium Bromide/Vilanterol	願艱襯艱醖淵鏇襯願鹹(鏇衊鬱窪廠襯膚廠鏇鬱) = 衊積繭網顧製窪繭製憲淵壓窪壓簾鹽製鹹範蓋 (壓積衊憲選顧鹹鹹窪範 )