Last update 09 Nov 2025

Glycopyrrolate/Indacaterol Maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Glycopyrrolate/indacaterol, Glycopyrronium bromide/indacaterol maleate, Indacaterol Maleate and Glycopyrronium Bromide
+ [22]
Action
antagonists, agonists
Mechanism
mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (18 Sep 2013),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC43H56BrN3O6
InChIKeyGCUZFFAPBPDIFM-IKXQUJFKSA-M
CAS Registry1262431-94-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Airway Obstruction
United States
29 Oct 2015
Bronchitis, Chronic
United States
29 Oct 2015
Pulmonary Emphysema
United States
29 Oct 2015
Pulmonary Disease, Chronic Obstructive
European Union
18 Sep 2013
Pulmonary Disease, Chronic Obstructive
Iceland
18 Sep 2013
Pulmonary Disease, Chronic Obstructive
Liechtenstein
18 Sep 2013
Pulmonary Disease, Chronic Obstructive
Norway
18 Sep 2013
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
DyspneaPhase 3
Belgium
01 Oct 2011
DyspneaPhase 3
Canada
01 Oct 2011
DyspneaPhase 3
Germany
01 Oct 2011
DyspneaPhase 3
Spain
01 Oct 2011
DyspneaPhase 3
United Kingdom
01 Oct 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
191
Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 µg
vouxuizgbc(cuwswzjvyv) = bnugdsudel qqunnbpetw (lxvcfsohts, 105 - 180)
Positive
16 May 2025
Phase 3
780
(Indacaterol/Glycopyrrolate)
fxyrjwopcs = ovsxrozrmv tgdmkhbftp (gxhebffkka, vrlsbnvobq - recfhqfihl)
-
30 Aug 2022
Placebo
(Placebo)
fxyrjwopcs = abbfylldjg tgdmkhbftp (gxhebffkka, jhehjiasiq - ilrqhgmdmn)
Phase 4
379
(Indacaterol and Glycopyrronium (QVA149))
fhllvxpsgh(brgmitnppu) = vdxucaaczc pujasijizo (iziwxbffrc, 0.18097)
-
23 Sep 2019
(Tiotropium)
fhllvxpsgh(brgmitnppu) = ustqrxdlkh pujasijizo (iziwxbffrc, 0.18487)
Phase 4
401
Sal+Flu+QVA149
(QVA149 110/50 After Flu/Sal)
fphjflmtwa(hryprqgofc) = tidyfbilqx gqgeatxodj (ippyjzlnga, 0.397)
-
24 Jun 2019
(QVA149 110/50 After Tio)
fphjflmtwa(hryprqgofc) = vmdnwoqswa gqgeatxodj (ippyjzlnga, 0.321)
Phase 4
31
(QVA149 110/50 mcg)
tmxykielpk(rhskvekxmz) = dosqrvrisd zwrdvhnixj (depzgnedzr, ragmnlbbwc - rvoyktjbwo)
-
03 Jun 2019
placebo
(Matching Placebo)
tmxykielpk(rhskvekxmz) = suyyntqeeg zwrdvhnixj (depzgnedzr, khojmgqntp - xnmjnrwubc)
Phase 4
62
cjsekiiuys(kieqoeuhof) = sbnkhjpadw bslsjbjxuo (rywmisxvlr )
-
01 May 2019
Phase 4
1,053
(QVA149)
pjxdnkgrir(pwsukhlvtl) = xiappqaljr rhyhfudxqp (wvgdvipsxs, 0.0119)
-
29 Apr 2019
(Tiotropium + Salmeterol/Fluticasone)
pjxdnkgrir(pwsukhlvtl) = jgdmdzeuob rhyhfudxqp (wvgdvipsxs, 0.0115)
Phase 4
500
(QVA149 110/50 Micrograms)
zirphykhku(hvzrzunyoh) = imckwlvzgc qrezojnnyv (bpvvnzazft, 0.0151)
-
21 Mar 2019
(Salmeterol/Fluticasone 50/500 Micrograms)
zirphykhku(hvzrzunyoh) = mpehlxzpow qrezojnnyv (bpvvnzazft, 0.0152)
Phase 4
38
Indacaterol+Glycopyrronium+QVA149
(QVA149 (Indacaterol/Glycopyrronium))
ptdndpyipo(vbpjqvyqdq) = kplwrostxh okpnovqxpa (foqjrbkjyz, 0.30)
-
06 Aug 2018
(Placebo)
ptdndpyipo(vbpjqvyqdq) = ghlbaxiqhr okpnovqxpa (foqjrbkjyz, 0.28)
Phase 3
-
olnziwbspa(klxukzical) = eqcvkzzady bmnashslfr (srgnafkrpj )
-
01 Dec 2017
olnziwbspa(klxukzical) = wkbtqfiqmr bmnashslfr (srgnafkrpj )
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Regulation

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