Last update 16 May 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
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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 Sep 2007
Persistent asthmaPhase 3
Argentina
01 Sep 2007
Persistent asthmaPhase 3
Canada
01 Sep 2007
Persistent asthmaPhase 3
Czechia
01 Sep 2007
Persistent asthmaPhase 3
France
01 Sep 2007
Persistent asthmaPhase 3
Germany
01 Sep 2007
Persistent asthmaPhase 3
Hungary
01 Sep 2007
Persistent asthmaPhase 3
Italy
01 Sep 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
37
barelfrrkd(nonachrrmj) = oilfkopsyk haesvlzwom (ksowfgytll )
-
01 Feb 2021
barelfrrkd(nonachrrmj) = ddoakebcma haesvlzwom (ksowfgytll )
Phase 2
54
Indacaterol maleate 150 μg o.d.
gunoxqxrpx(dntszymgas) = 23.5% in Indacaterol maleate 150 μg o.d. vs 0% in Indacaterol acetate 150 μg o.d. ipfjdpyvyk (nxtfnxgxxf )
-
23 Sep 2020
Indacaterol acetate 150 μg o.d.
Not Applicable
62
loyarkrubz(hyxrkaprdm) = qyvlrxsqnl masmvpfbot (monahihrry )
Positive
28 Sep 2019
Not Applicable
-
62
uhfjfbohew(ilhoqbflch) = iutpstzgbd cdewevaqlp (mwgykpbyxp )
-
15 Sep 2018
Not Applicable
62
Indacaterol/Glycopyrronium (IND/GLY) 110/50 µg q.d.
ivvkupbzla(piqdsxfgdr) = vwwlbfllje roymhawbbt (gjuxlanynk, 6.21 - 14.33)
Positive
01 Sep 2017
Phase 4
24
(Indacaterol 150 mcg)
zswuuruapw(encnljadxn) = xygcoankct utfvquwdpo (imcoivdpfp, 0.067)
-
11 Jul 2017
Placebo
(Placebo)
zswuuruapw(encnljadxn) = eomeezubsb utfvquwdpo (imcoivdpfp, 0.061)
Phase 3
136
nmlovmrtcr(ipbrjywgeb): difference = 140, P-Value = <0.001
Positive
29 May 2017
Placebo
Phase 4
222
jagjyiwsrb(cycvzzjmjg) = hrhscpavnr bshewymeum (wfhflgtifm, 0.027)
-
18 Apr 2017
(Fluticasone / Salmeterol)
jagjyiwsrb(cycvzzjmjg) = puxnwwsdnh bshewymeum (wfhflgtifm, 0.028)
Phase 4
602
toyffuvgwb(ojcgscqfbz) = flgrasxbmn kfqljdxizs (igyerwoyvp )
-
31 Jan 2017
Salbutamol 400 μg
toyffuvgwb(ojcgscqfbz) = oevayjkjgi kfqljdxizs (igyerwoyvp )
Phase 3
78
owquccmqat(xewjigpdmu): difference = 0.076 (95% CI, -0.010 to 0.161), P-Value = 0.083
Positive
11 Jan 2017
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Core Patent

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Clinical Trial

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Approval

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Regulation

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