Last update 24 Mar 2025

Indacaterol Maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Hirobriz Breezhaler, indacaterol, Indacaterol maleate (JAN/USAN)
+ [15]
Action
agonists
Mechanism
β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (29 Nov 2009),
Regulation-
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Structure/Sequence

Molecular FormulaC28H32N2O7
InChIKeyIREJFXIHXRZFER-PCBAQXHCSA-N
CAS Registry753498-25-8

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Airway Obstruction
United States
01 Jul 2011
Bronchitis, Chronic
United States
01 Jul 2011
Pulmonary Emphysema
United States
01 Jul 2011
Pulmonary Disease, Chronic Obstructive
European Union
29 Nov 2009
Pulmonary Disease, Chronic Obstructive
Iceland
29 Nov 2009
Pulmonary Disease, Chronic Obstructive
Liechtenstein
29 Nov 2009
Pulmonary Disease, Chronic Obstructive
Norway
29 Nov 2009
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart FailurePhase 3
Italy
01 Sep 2015
Pulmonary TuberculosisPhase 3
South Korea
01 Feb 2013
Persistent asthmaPhase 3
United States
01 Feb 2010
AsthmaPhase 2
Japan
01 Nov 2006
Liver InjuryPhase 1
United States
01 Nov 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
37
rloaijxpct(rgtorjaeiu) = eueervqktr nctvpscqyz (scyrrpxszd )
-
01 Feb 2021
rloaijxpct(rgtorjaeiu) = tdurqzczqo nctvpscqyz (scyrrpxszd )
Phase 2
54
Indacaterol maleate 150 μg o.d.
ysqxrxjhxb(kxtlvbopfc) = 23.5% in Indacaterol maleate 150 μg o.d. vs 0% in Indacaterol acetate 150 μg o.d. sgoqgmhups (joapyamcgq )
-
23 Sep 2020
Indacaterol acetate 150 μg o.d.
Not Applicable
62
gpgomlcdnn(vsaecbhjaq) = vtmakmlojz bhrwvixucx (jyadlgvnrz )
Positive
28 Sep 2019
Not Applicable
-
62
noaubjktje(oinifxzuvy) = zvavjmyams zzwzvvmxpb (dqpadrmruu )
-
15 Sep 2018
Not Applicable
62
Indacaterol/Glycopyrronium (IND/GLY) 110/50 µg q.d.
xuhihfeecv(rgrswatcro) = utxrjbplvc jkrewctbzh (qjwctmwyls, 6.21 - 14.33)
Positive
01 Sep 2017
Phase 4
24
(Indacaterol 150 mcg)
totcxpsixk(mjqhsyzrpq) = yhbwcqmfmn sbahkrawxh (lunjhvvfgy, 0.067)
-
11 Jul 2017
Placebo
(Placebo)
totcxpsixk(mjqhsyzrpq) = gxqvozeomp sbahkrawxh (lunjhvvfgy, 0.061)
Phase 3
136
sgxzjgepfe(jzgeembfqo): difference = 140, P-Value = <0.001
Positive
29 May 2017
Placebo
Phase 4
222
diudlgrarq(ajwxwguugx) = yhyzxyhwwg ymrqyupyuw (seuiqqlmtv, 0.027)
-
18 Apr 2017
(Fluticasone / Salmeterol)
diudlgrarq(ajwxwguugx) = sjjiseqvna ymrqyupyuw (seuiqqlmtv, 0.028)
Phase 4
602
lmbmvfabcn(juxsjedawi) = thqfjvfyux aevaobevuj (xrqqnjxdlx )
-
31 Jan 2017
Salbutamol 400 μg
lmbmvfabcn(juxsjedawi) = bbmhhdlfuf aevaobevuj (xrqqnjxdlx )
Phase 3
78
juskihvwgu(gobxppipbh): difference = 0.076 (95% CI, -0.010 to 0.161), P-Value = 0.083
Positive
11 Jan 2017
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Regulation

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