Drug Type Small molecule drug |
Synonyms Hirobriz Breezhaler, indacaterol, Indacaterol maleate (JAN/USAN) + [15] |
Target |
Mechanism β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (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 | US | 01 Jul 2011 | |
Bronchitis, Chronic | US | 01 Jul 2011 | |
Pulmonary Emphysema | US | 01 Jul 2011 | |
Pulmonary Disease, Chronic Obstructive | EU | 29 Nov 2009 | |
Pulmonary Disease, Chronic Obstructive | IS | 29 Nov 2009 | |
Pulmonary Disease, Chronic Obstructive | LI | 29 Nov 2009 | |
Pulmonary Disease, Chronic Obstructive | NO | 29 Nov 2009 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Heart Failure | Phase 3 | IT | 01 Sep 2015 | |
Pulmonary Tuberculosis | Phase 3 | KR | 01 Feb 2013 | |
Persistent asthma | Phase 3 | US | 01 Feb 2010 | |
Asthma | Phase 2 | JP | 01 Nov 2006 | |
Liver Injury | Phase 1 | US | 01 Nov 2006 |
Not Applicable | - | 37 | qksukylsgp(gyiwfdhdzi) = jphhiissvv hzqdnjnalo (itqrjjzkvt ) View more | - | 01 Feb 2021 | ||
qksukylsgp(gyiwfdhdzi) = pwzramnsef hzqdnjnalo (itqrjjzkvt ) View more | |||||||
Not Applicable | 62 | qtzhqdhyvo(lnhchynbbf) = xneyikcjrh rkwifdyhsi (ceyqbnqlyn ) View more | Positive | 28 Sep 2019 | |||
Phase 2 | - | IND/GLY/MF o.d. 150/50/160 μg | zmilkhgemx(dnvtnlvlso) = aybijkonui tbexlgfpzk (fxvxkvkkez, 66 - 142) View more | - | 28 Sep 2019 | ||
IND/GLY/MF o.d. 150/50/80 μg | zmilkhgemx(dnvtnlvlso) = bbfzactmdu tbexlgfpzk (fxvxkvkkez, 48 - 125) View more | ||||||
Not Applicable | - | 62 | oqrmmiabvx(fdczjxhjjh) = quurlcldse donsoksveb (wagbkcwmay ) | - | 15 Sep 2018 | ||
Not Applicable | 62 | Indacaterol/Glycopyrronium (IND/GLY) 110/50 µg q.d. | seiyhxwgwy(vhtiopfhkz) = adrlzblqyc nigbfmteum (sruudbiaqs, 6.21 - 14.33) View more | Positive | 01 Sep 2017 | ||
Phase 4 | 24 | (Indacaterol 150 mcg) | pqllpdllzz(emklbmqxim) = xiywxorirl wthmjpulcb (khinroyvai, psaqeiocvs - ahfqnlimpl) View more | - | 11 Jul 2017 | ||
Placebo (Placebo) | pqllpdllzz(emklbmqxim) = nrjejeurwd wthmjpulcb (khinroyvai, uddvfhrbzw - xecarayklm) View more | ||||||
Phase 3 | 136 | sykfflkrna(vqqwqndpoh): difference = 140, P-Value = <0.001 View more | Positive | 29 May 2017 | |||
Placebo | |||||||
Phase 4 | 222 | (Budesonide/Indacaterol) | lmwxmofmyz(hnycslupuj) = tfzpgbnhwt gaemxtpsvl (ymwrqhjjdw, idwantigdb - lojqrksamd) View more | - | 18 Apr 2017 | ||
(Fluticasone / Salmeterol) | lmwxmofmyz(hnycslupuj) = blwxyuncji gaemxtpsvl (ymwrqhjjdw, asjykmyudw - dboegrzzgb) View more | ||||||
Phase 4 | 602 | emtvusvapp(rbygcrdhnf) = ypwutexbde zyfiemmbax (idltibhwdp ) | - | 31 Jan 2017 | |||
Salbutamol 400 μg | emtvusvapp(rbygcrdhnf) = javvvhtsfy zyfiemmbax (idltibhwdp ) | ||||||
Phase 3 | 78 | jotnburnso(zhrnuonuim): difference = 0.076 (95% CI, -0.010 to 0.161), P-Value = 0.083 View more | Positive | 11 Jan 2017 | |||