Last update 21 Nov 2024

Umeclidinium Bromide/Vilanterol Trifenatate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GSK-573719/Vilanterol, LAMA/LABA, UMEC/VI
+ [13]
Mechanism
M1 receptor antagonists(Muscarinic acetylcholine receptor M1 antagonists), M2 receptor antagonists(Muscarinic acetylcholine receptor M2 antagonists), M3 receptor antagonists(Muscarinic acetylcholine receptor M3 antagonists)
+ [3]
Therapeutic Areas
Inactive Indication-
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationSpecial Review Project (CN), Priority Review (CN)
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Structure

Molecular FormulaC29H34BrNO2
InChIKeyPEJHHXHHNGORMP-UHFFFAOYSA-M
CAS Registry869113-09-7
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Disease, Chronic Obstructive
US
18 Dec 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Disease, Chronic ObstructiveDiscovery
UA
01 Mar 2011
Pulmonary Disease, Chronic ObstructiveDiscovery
PH
01 Mar 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
iehsgiolaa(wmfcxnikzw) = bebawyeiyn igspuzywqq (boflbrcogc )
-
19 May 2024
nuztfalatp(lazpojiecg) = irjxatscnp fbvvfpyfuw (slloadndsn )
Phase 3
760
ENHANCE-1 was a 24-week (+48-wk subset), multi-center, randomized, double-blind, placebo-controlled trial to evaluate nebulized ensifentrine-3mg twice-daily (randomized 5:3) in subjects 40-80 years with symptomatic moderate-to-severe COPD (post-bronchodilator FEV1 30–70% predicted, FEV1/FVC ratio <0.7, >2mMRC), and smoking history >10 pack-years. Primary endpoint was change from baseline to Week 12 average FEV1 AUC0-12h. Healthcare resource utilization (HRU) included all unscheduled visits to physician office, visits to emergency department and unplanned hospitalizations for any cause and/or related to COPD. Exacerbation rate and time to first event were assessed. 760 subjects were randomized and treated. Background LAMA or LABA medication was used in 69% of subjects, including 21% on ICS. Results: The primary endpoint was met. At 24 weeks, the ensifentrine group had fewer unscheduled physician’s office visits (6.5% vs 10.6%) and emergency room attendance resulting in hospital admission (3.6% vs 4.9%) vs placebo. Ensifentrine reduced moderate/severe exacerbation rate (36%, p=0.050) and instant risk, as assessed by time to first exacerbation (38%, p=0.038) vs placebo. Ensifentrine reduced moderate exacerbation rate (RR=0.59 [95% CI 0.36, 0.97], p=0.036) and instant risk (HR=0.57 [0.35, 0.93], p=0.025) vs placebo. Conclusion: Ensifentrine substantially reduced rate and instant risk of moderate exacerbations over 24 weeks. HRU was numerically reduced with ensifentrine vs placebo, which includes COPD and non-COPD-related HRU.
(isjhlmsyhc) = qqupjxojvl doxgpzhgne (jvpctfkvjo )
Positive
11 Sep 2023
Placebo
(isjhlmsyhc) = wjrsafhaew doxgpzhgne (jvpctfkvjo )
Phase 2
325
Placebo
wnkcwkaoyo(amygjulmma) = zluhagpknw zahprpabti (jvtthuombm, dhiidnwckb - ysbwrmnust)
-
24 Mar 2017
Phase 3
494
(sqqdsvjduk): difference = 88 (95% CI, 45 - 131), P-Value = <0.001
Superior
24 Feb 2017
Not Applicable
1,747
(phmttikiqy) = rmqddgioro bzdsnhisau (rpwxedfscz )
-
01 Jan 2017
(phmttikiqy) = dcxgqpkuwe bzdsnhisau (rpwxedfscz )
Phase 3
494
(iggixxrrvi) = Adverse events were similar for both treatments ftrwuicfcl (xerqaiforw )
Positive
01 Sep 2016
Phase 3
-
(yxebegluyx) = ouzvlwjbbz oksgkqpulu (wxfvhswisy )
Similar
01 Jun 2016
(yxebegluyx) = ylleufdcfc oksgkqpulu (wxfvhswisy )
Phase 3
496
(hfdutiujcp): difference = -4.03 (95% CI, -6.28 to -1.79), P-Value = <0.001
Positive
09 May 2016
Placebo
Phase 3
498
placebo+salbutamol
(Placebo)
kfgcxxybqp(xiaydxpcek) = sshehpssxw pyzbiuzvfs (hfpqyksoaj, kfktempixs - pkcfrefvoo)
-
25 Feb 2016
25mcg+UMEC/VI+albuterol
(UMEC/VI 62.5/25 mcg)
kfgcxxybqp(xiaydxpcek) = jncotzliap pyzbiuzvfs (hfpqyksoaj, wdkwqwvygy - rbjnaalrsf)
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