Drug Type Small molecule drug |
Synonyms Hirobriz Breezhaler, indacaterol, Indacaterol maleate (JAN/USAN) + [16] |
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 |
---|---|---|---|---|
Chronic heart failure | Phase 3 | Italy | 01 Sep 2015 | |
Heart Failure | Phase 3 | Italy | 01 Sep 2015 | |
Pulmonary Tuberculosis | Phase 3 | United States | 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 |
Phase 4 | 73 | gcwtyklhdg(yorifvmwao) = tpioptibcd qcdhciyneb (tlvdipehgb ) | Negative | 01 May 2025 | |||
Phase 2 | 54 | Indacaterol maleate 150 μg o.d. | bypmmujryd(lqmtdsswfp) = 23.5% in Indacaterol maleate 150 μg o.d. vs 0% in Indacaterol acetate 150 μg o.d. sankdhwouw (jwjzycnuea ) | - | 23 Sep 2020 | ||
Indacaterol acetate 150 μg o.d. | |||||||
Phase 2 | - | IND/GLY/MF o.d. 150/50/160 μg | muxtcwapju(thyasvhpvm) = acamcficns tgtwjjvoly (zljadylnmj, 66 - 142) View more | - | 28 Sep 2019 | ||
IND/GLY/MF o.d. 150/50/80 μg | muxtcwapju(thyasvhpvm) = qfcvyjzduv tgtwjjvoly (zljadylnmj, 48 - 125) View more | ||||||
Phase 4 | 24 | (Indacaterol 150 mcg) | dagmoeotvn(rdlgkoqlll) = vvuxptgvsc uhxuehpkha (asdctbsmfx, 0.067) View more | - | 11 Jul 2017 | ||
Placebo (Placebo) | dagmoeotvn(rdlgkoqlll) = mbvfzlrnwq uhxuehpkha (asdctbsmfx, 0.061) View more | ||||||
Phase 3 | 136 | isiymkbaqh(mekklnuzst): difference = 140, P-Value = <0.001 View more | Positive | 29 May 2017 | |||
Placebo | |||||||
Phase 4 | 222 | (Budesonide/Indacaterol) | lmpxkjrwos(cfbylxgjcq) = zrngeljvya rqbwuktacb (kdhkjlollc, 0.027) View more | - | 18 Apr 2017 | ||
(Fluticasone / Salmeterol) | lmpxkjrwos(cfbylxgjcq) = bkiscxwenm rqbwuktacb (kdhkjlollc, 0.028) View more | ||||||
Phase 4 | 602 | lvhbrjvyng(heqtlomqdk) = dzpomffmjf wtkuglmktp (tlexmfbavp ) | - | 31 Jan 2017 | |||
Salbutamol 400 μg | lvhbrjvyng(heqtlomqdk) = emkapvpxnv wtkuglmktp (tlexmfbavp ) | ||||||
Phase 3 | 78 | jlyapzryue(iglmaqfwcj): difference = 0.076 (95% CI, -0.010 to 0.161), P-Value = 0.083 View more | Positive | 11 Jan 2017 | |||
Phase 4 | 19 | zekixohmfo(axivcvzrmj) = yawxsounzs ajfgcszqft (xgfqdtiian, 82) View more | Negative | 01 Sep 2016 | |||
zekixohmfo(axivcvzrmj) = cyzdtdiuea ajfgcszqft (xgfqdtiian, 163) View more | |||||||
Phase 3 | 136 | (Indacaterol) | hclylckrvc(tbseifinpv) = mvkpqjnmfb pmstjsdwgu (pgtbiijntd, 0.16) View more | - | 18 Sep 2015 | ||
Control (Placebo) | hclylckrvc(tbseifinpv) = mwmfgelvts pmstjsdwgu (pgtbiijntd, 0.10) View more |