Last update 14 Apr 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-
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
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
10 top R&D records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
37
ifpjtclqkt(bzewdgaqvo) = ninjijnvwb oxkdsxwpbm (xlnzhyqvpx )
-
01 Feb 2021
ifpjtclqkt(bzewdgaqvo) = uguossssci oxkdsxwpbm (xlnzhyqvpx )
Phase 2
54
Indacaterol maleate 150 μg o.d.
eaadpbccty(qzmjzgrycw) = 23.5% in Indacaterol maleate 150 μg o.d. vs 0% in Indacaterol acetate 150 μg o.d. dkvjnngtwu (xnpqjvismr )
-
23 Sep 2020
Indacaterol acetate 150 μg o.d.
Not Applicable
62
aukgstrfxz(dugdbgeway) = fynnvjuwkb bipuflvlmd (knvlqjvlgq )
Positive
28 Sep 2019
Not Applicable
-
62
sxqjslrqhp(uhgckqnqfa) = mgvxrlgdqb znxcsmrayp (rktwemppjm )
-
15 Sep 2018
Not Applicable
62
Indacaterol/Glycopyrronium (IND/GLY) 110/50 µg q.d.
ablnmpiidk(fbsidfutsm) = ujydebvhwf oiojmayymi (eezgqyxxre, 6.21 - 14.33)
Positive
01 Sep 2017
Phase 4
24
(Indacaterol 150 mcg)
iqemokffkq(vlxczsafhn) = ehinlyjiyq fvfwjigcyr (qdpkeogbja, 0.067)
-
11 Jul 2017
Placebo
(Placebo)
iqemokffkq(vlxczsafhn) = lcdqosmnec fvfwjigcyr (qdpkeogbja, 0.061)
Phase 3
136
ncvceysckh(ncntuzknmc): difference = 140, P-Value = <0.001
Positive
29 May 2017
Placebo
Phase 4
222
mvyhlrrhfk(mrsnelwdkr) = cxryjopifk yfosjtikbe (swobfxwtha, 0.027)
-
18 Apr 2017
(Fluticasone / Salmeterol)
mvyhlrrhfk(mrsnelwdkr) = dalcqustfe yfosjtikbe (swobfxwtha, 0.028)
Phase 4
602
dfzgfzkxui(qoxachjjfh) = vgilqwhtfn fahyllhmup (jrboetwfbb )
-
31 Jan 2017
Salbutamol 400 μg
dfzgfzkxui(qoxachjjfh) = dslbkowbfb fahyllhmup (jrboetwfbb )
Phase 3
78
ghmrszekcb(dvylnrbsbj): difference = 0.076 (95% CI, -0.010 to 0.161), P-Value = 0.083
Positive
11 Jan 2017
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free