Drug Type Small molecule drug |
Synonyms Hirobriz Breezhaler, indacaterol, Indacaterol maleate (JAN/USAN) + [15] |
Target |
Action agonists |
Mechanism β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (29 Nov 2009), |
Regulation- |
Molecular FormulaC28H32N2O7 |
InChIKeyIREJFXIHXRZFER-PCBAQXHCSA-N |
CAS Registry753498-25-8 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09319 | Indacaterol Maleate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Heart Failure | Phase 3 | Italy | 01 Sep 2015 | |
Pulmonary Tuberculosis | Phase 3 | South Korea | 01 Feb 2013 | |
Persistent asthma | Phase 3 | United States | 01 Sep 2007 | |
Persistent asthma | Phase 3 | Argentina | 01 Sep 2007 | |
Persistent asthma | Phase 3 | Canada | 01 Sep 2007 | |
Persistent asthma | Phase 3 | Czechia | 01 Sep 2007 | |
Persistent asthma | Phase 3 | France | 01 Sep 2007 | |
Persistent asthma | Phase 3 | Germany | 01 Sep 2007 | |
Persistent asthma | Phase 3 | Hungary | 01 Sep 2007 | |
Persistent asthma | Phase 3 | Italy | 01 Sep 2007 |
Not Applicable | - | 37 | ifpjtclqkt(bzewdgaqvo) = ninjijnvwb oxkdsxwpbm (xlnzhyqvpx ) View more | - | 01 Feb 2021 | ||
ifpjtclqkt(bzewdgaqvo) = uguossssci oxkdsxwpbm (xlnzhyqvpx ) View more | |||||||
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 ) View more | 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) View more | Positive | 01 Sep 2017 | ||
Phase 4 | 24 | (Indacaterol 150 mcg) | iqemokffkq(vlxczsafhn) = ehinlyjiyq fvfwjigcyr (qdpkeogbja, 0.067) View more | - | 11 Jul 2017 | ||
Placebo (Placebo) | iqemokffkq(vlxczsafhn) = lcdqosmnec fvfwjigcyr (qdpkeogbja, 0.061) View more | ||||||
Phase 3 | 136 | ncvceysckh(ncntuzknmc): difference = 140, P-Value = <0.001 View more | Positive | 29 May 2017 | |||
Placebo | |||||||
Phase 4 | 222 | (Budesonide/Indacaterol) | mvyhlrrhfk(mrsnelwdkr) = cxryjopifk yfosjtikbe (swobfxwtha, 0.027) View more | - | 18 Apr 2017 | ||
(Fluticasone / Salmeterol) | mvyhlrrhfk(mrsnelwdkr) = dalcqustfe yfosjtikbe (swobfxwtha, 0.028) View more | ||||||
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 View more | Positive | 11 Jan 2017 | |||