Drugs / Indacaterol
Indacaterol
also known as
indacaterol maleate · QAB149 · Indacaterol acetate · IND · AERO-001 · Arcapta neohaler · Hirobriz breezhaler · Indacaterol (as maleate) · +10 more
Other / unclassified targets ADRB2 via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ARCAPTA NEOHALER | — | 2011-07-01 | fda.gov ↗ |
| Approved | EU (EMA) | Oslif Breezhaler | — | 2009-11-29 | europa.eu ↗ |
Trials 109 · started per year
today
EU approved 2009
US approved 2011
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 1 met primary | ||||||
| Phase 1 | NCT05288075 | Feb → Jun 2022 | — | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT04856098 | May → Sep 2021 | — | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02573155 | Oct 2015 → Aug 2016 | asthma, chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01263808 | Apr → Aug 2008 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00410501 | Dec 2006 → ? | — | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT00416702 | Nov 2006 → Mar 2008 | liver disorder | Novartis | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06841640 | Jan → May 2025 | chronic obstructive pulmonary disease | AeroRx Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00422552 | Sep 2006 → ? | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 225 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT06035393 | Jan 2024 → Feb 2025 | chronic obstructive pulmonary disease | Jiangsu HengRui Medicine Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06619210 | Jan 2022 → May 2023 | chronic obstructive pulmonary disease | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04589663 | Jun 2021 → Apr 2022 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03257995 | Sep 2017 → Jan 2018 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01959412 | Nov 2013 → Mar 2014 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01845623 | Aug → Dec 2013 | asthma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT01636076 | Nov 2012 → Sep 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01609478 | Aug 2012 → Jul 2013 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01484197 | Nov 2011 → May 2012 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01156844 | Mar → Jul 2010 | chronic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01012739 | Oct 2009 → Mar 2010 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00941798 | Jul 2009 → May 2011 | asthma | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00927901 | Jun → Nov 2009 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00636961 | Feb → Aug 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00605306 | Jan → Apr 2008 | asthma | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00557440 | Nov 2007 → Apr 2008 | asthma | Novartis | Completed | Met primary |
| Phase 2 | NCT00558285 | Nov 2007 → Jul 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00545272 | Oct 2007 → Apr 2008 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00556673 | Oct 2007 → Apr 2008 | asthma | Novartis | Completed | Met primary |
| Phase 2 | NCT00557466 | Oct 2007 → May 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00531050 | Aug 2007 → Jun 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00403845 | Dec 2006 → Oct 2007 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 2 | NCT00403754 | Nov 2006 → Nov 2007 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00129831 | Sep 2004 → Sep 2005 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00098228 | Jul → Dec 2004 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/34 trials · 2 met primary | ||||||
| Phase 2/3 | NCT02693769 | Jul → Oct 2016 | asthma | Mundipharma Research Limited | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT00463567 | Apr 2007 → Aug 2008 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 2/3 | NCT00403637 | Nov 2006 → Feb 2007 | asthma | Novartis | Completed | No outcome recorded |
| Phase 2/3 | NCT00396604 | Oct 2006 → Jan 2007 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 343 trials · 23 met primary · 2 missed | ||||||
| Phase 3 | NCT05776927 | Aug 2026 → Dec 2028 expected | asthma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06643078 | Dec 2023 → May 2025 | chronic obstructive pulmonary disease | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05562466 | May 2023 → Feb 2028 expected | asthma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT04206761 | Dec 2021 → Jul 2022 | asthma | Dr. Grace Parraga | Withdrawn | No outcome recorded |
| Phase 3 | NCT03158311 | Feb 2018 → Jul 2019 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02892344 | Jan 2017 → Nov 2018 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02554786 | Dec 2015 → Nov 2018 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02571777 | Dec 2015 → Jun 2019 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02598505 | Sep 2015 → Nov 2016 | heart failure | Centro Cardiologico Monzino | Completed | No outcome recorded |
| Phase 3 | NCT02487498 | Jul 2015 → Sep 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01782326 | Jul 2013 → Sep 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01778062 | Feb 2013 → Sep 2014 | pulmonary tuberculosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01709903 | Nov 2012 → Feb 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01315249 | Mar 2011 → Mar 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01232894 | Mar 2011 → May 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01294787 | Feb → Nov 2011 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01285492 | Jan 2011 → Sep 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01120717 | Apr 2010 → Dec 2011 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01120691 | Apr 2010 → Jul 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01089127 | Mar → Jul 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01079130 | Feb → Jul 2010 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01072448 | Jan → Jul 2010 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 3 | NCT01068600 | Jan → Jun 2010 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 3 | NCT01012765 | Nov 2009 → Jan 2011 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00999908 | Oct 2009 → Mar 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00900731 | Jun 2009 → Mar 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00877383 | Apr 2009 → Feb 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00846586 | Mar 2009 → Mar 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00845728 | Mar 2009 → Jul 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00876694 | Mar 2009 → Oct 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00821093 | Jan → Oct 2009 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00792805 | Nov 2008 → Feb 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00794157 | Nov 2008 → Oct 2009 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00677807 | May 2008 → Mar 2009 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00620022 | Apr 2008 → Jan 2009 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 3 | NCT00669617 | Apr → Aug 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00615459 | Feb → Dec 2008 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 3 | NCT00624286 | Feb → Jul 2008 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 3 | NCT00615030 | Jan → Jul 2008 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 3 | NCT00622635 | Jan → Jul 2008 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00567996 | Nov 2007 → Jan 2009 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00529529 | Sep 2007 → Aug 2008 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00393458 | Oct 2006 → Jul 2008 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 426 trials · 5 met primary · 3 missed | ||||||
| Phase 4 | NCT04509661 | Sep 2020 → Jun 2024 | idiopathic bronchiectasis | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 4 | NCT03662711 | Nov 2018 → Oct 2022 | chronic obstructive pulmonary disease | Università degli Studi di Ferrara | Terminated | No outcome recorded |
| Phase 4 | NCT02953041 | Oct 2016 → Jan 2017 | asthma | University of Saskatchewan | Completed | No outcome recorded |
| Phase 4 | NCT02567214 | Jun 2016 → Nov 2018 | chronic obstructive pulmonary disease | Laval University | Completed | No outcome recorded |
| Phase 4 | NCT02872090 | Mar 2016 → Jun 2021 | chronic obstructive pulmonary disease | Centre Hospitalier Universitaire de Besancon | Completed | No outcome recorded |
| Phase 4 | NCT02516592 | Oct 2015 → May 2017 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT02547558 | Oct 2015 | chronic obstructive pulmonary disease | Hospital Clinic of Barcelona | Unknown | No outcome recorded |
| Phase 4 | NCT02442206 | May 2015 → Apr 2017 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT02418468 | Apr 2015 → Apr 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT02233543 | Nov 2014 → Jun 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT02202616 | Aug 2014 → Apr 2017 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02055352 | May 2014 → Jan 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT01985334 | Feb 2014 → Apr 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT01996124 | Nov 2013 → Oct 2014 | chronic obstructive pulmonary disease, heart failure | University of Milan | Completed | No outcome recorded |
| Phase 4 | NCT01727024 | Apr 2013 → Nov 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02473237 | Apr 2013 → Jun 2015 | chronic obstructive pulmonary disease | National Institute of Respiratory Diseases, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT02566031 | Mar 2013 → Jun 2018 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT01693003 | Mar → Oct 2013 | chronic obstructive pulmonary disease | Irmandade Santa Casa de Misericórdia de Porto Alegre | Completed | Missed primary |
| Phase 4 | NCT01794780 | Feb 2013 → May 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01715311 | Nov 2012 → Sep 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05506865 | Sep 2012 → Jan 2016 | chronic obstructive pulmonary disease | National Institute of Respiratory Diseases, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT01555138 | Feb 2012 → Feb 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01543828 | Jan → Mar 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01377428 | Sep 2011 → Feb 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 4 | NCT01437748 | Aug 2011 → Sep 2014 | chronic obstructive pulmonary disease | University of Milan | Completed | No outcome recorded |
| Phase 4 | NCT01272362 | Apr 2010 → May 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07541378 | Mar 2024 → Feb 2025 | chronic obstructive pulmonary disease | Medical University of Bialystok | Suspended | No outcome recorded Stop: Enrollment |
| — | NCT06067100 | Jan 2024 → Jul 2026 overdue | — | Morten Hostrup, PhD | Recruiting | No outcome recorded |
| — | NCT06077019 | Oct 2023 → Jul 2026 overdue | — | Morten Hostrup, PhD | Recruiting | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 1 | NCT02059434 Comparator | Sep 2013 → Oct 2014 | asthma, chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT00624702 Comparator | Feb → Sep 2008 | asthma | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT02892019 Comparator | Apr 2017 → Jun 2019 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01498081 Comparator | Mar → Oct 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01425814 Comparator | Aug 2011 → Mar 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00570778 Comparator | Dec 2007 → Sep 2008 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04259164 Background | Sep 2020 → Dec 2022 | allergic asthma | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 3 | NCT03379233 Background | Jul 2018 → Jan 2019 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02867761 Comparator | Aug 2017 → Jul 2021 | chronic obstructive pulmonary disease | University of Michigan | Completed | No outcome recorded |
| Phase 3 | NCT02257385 Comparator | Oct 2014 → May 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02165826 Background | May 2014 → Sep 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT01996319 Comparator | Apr 2014 → Feb 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01712516 Comparator | Dec 2012 → Feb 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01699685 Comparator | Nov 2012 → Jun 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01727141 Comparator | Nov 2012 → Feb 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01697696 Comparator | Oct 2012 → Nov 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01682863 Comparator | Oct 2012 → Jun 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01604278 Comparator | May 2012 → Jan 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01529632 Comparator | May → Dec 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01202188 Comparator | Sep 2010 → Feb 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT06282861 Comparator | Feb 2024 → Jan 2025 | chronic obstructive pulmonary disease | Fundacio Privada Mon Clinic Barcelona | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02039011 Comparator | Feb 2014 → Jul 2016 | asthma | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT01377051 Comparator | May → Aug 2011 | cardiac rhythm disease, chronic obstructive pulmonary disease | University of Milan | Completed | No outcome recorded |
| — | NCT07058259 Background | Nov 2024 → Jun 2025 overdue | chronic obstructive pulmonary disease | Istanbul Medeniyet University | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2021-09-03 | Novartis Pharmaceuticals | Results Novartis presents new findings at ERS reinforcing the efficacy of Enerzair® Breezhaler®, highlighting its digital companion, as well as showcasing commitment to low carbon footprint asthma solutions novartis.com ↗ |
| 2020-09-07 | Novartis Pharmaceuticals | Results Novartis post hoc analysis shows high-dose Enerzair® Breezhaler® reduces asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings novartis.com ↗
High-dose, once-daily Enerzair ® Breezhaler ® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks |
| 2020-07-07 | Novartis Pharmaceuticals | Regulatory Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU novartis.com ↗
European Commission approves once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS |
| 2020-06-29 | Novartis Pharmaceuticals | Regulatory Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options novartis.com ↗ |
| 2020-06-05 | Novartis Pharmaceuticals | Results Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma novartis.com ↗
Once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma 1 . |
| 2020-05-01 | Novartis Pharmaceuticals | Regulatory Novartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma novartis.com ↗ |
| 2019-12-06 | Novartis Pharmaceuticals | Results Novartis Phase III data on new inhaled dual combination QMF149 show significant improvement across key asthma outcomes versus monotherapy novartis.com ↗
Once-daily QMF149 met primary endpoint of lung function improvement and key secondary endpoint of asthma control improvement versus mometasone furoate |
| 2019-09-30 | Novartis Pharmaceuticals | Results Novartis announces positive results from Phase III PALLADIUM study of inhaled combination QMF149 in patients with uncontrolled asthma novartis.com ↗
Novartis today announced that investigational, once-daily, fixed-dose inhaled QMF149 (indacaterol acetate and mometasone furoate or IND/MF) was superior to mometasone furoate (MF) in improving trough forced expiratory volume in one second (FEV 1 ) after 26 weeks |
| 2019-09-30 | Novartis Pharmaceuticals | Results Novartis announces positive results from Phase III IRIDIUM study of inhaled combination QVM149 in patients with uncontrolled asthma novartis.com ↗
Once-daily QVM149 demonstrated statistically significant improvement in lung function versus QMF149, meeting primary endpoint[1],[2] |
| 2017-11-28 | Nxera Pharma UK Limited | Results New data showed Ultibro Breezhaler significantly improved COPD patients’ lung function after direct switch from Seretide nxera.life ↗
The study met the primary endpoint demonstrating that switching patients to Ultibro ® Breezhaler® resulted in significantly improved lung function (trough FEV1)1. |
| 2017-11-27 | Novartis Pharmaceuticals | Results Novartis' Ultibro® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide® novartis.com ↗
Novartis today announced positive results from the FLASH** study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide ® (salmeterol/fluticasone) 50/500 mcg to Ultibro ® Breezhaler ® (indacaterol/glycopyrronium) 110/50 mcg[1]. |
| 2016-05-16 | Nxera Pharma UK Limited | Results Major study published in NEJM confirms Ultibro Breezhaler superiority over Seretide in preventing COPD exacerbations nxera.life ↗
In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes 1. |
| 2016-05-15 | Novartis Pharmaceuticals | Results Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations novartis.com ↗
In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes[1]. |
| 2015-11-17 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2015-11-17 | Nxera Pharma UK Limited | Results FLAME Study Shows Superiority of Ultibro Breezhaler over Seretide in Reducing COPD Exacerbations nxera.life ↗ |
| 2015-01-08 | Nxera Pharma UK Limited | Regulatory Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237 nxera.life ↗
Submissions to US FDA complete for QVA149 and NVA237 in Q4 2014 |
| 2014-04-30 | Nxera Pharma UK Limited | Results Once-daily Ultibro Breezhaler showed superior efficacy versus Seretide for COPD patients in second head-to-head study, and the anticipated timing of China filing nxera.life ↗
Ultibro Breezhaler met both the primary and key secondary objectives. |
| 2013-09-23 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) approved for the treatment of COPD in Europe nxera.life ↗
European Commission approved once-daily Ultibro ® Breezhaler® (indacaterol 85 mcg / glycopyrronium 43 mcg) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
| 2013-09-20 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Inhalation Capsules (QVA149) approved for the treatment of COPD in Japan nxera.life ↗
Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved once-daily Ultibro ® Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg) |
| 2013-07-27 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) gains positive CHMP opinion for the treatment of COPD nxera.life ↗
QVA149 (indacaterol/glycopyrronium) is the first once-daily fixed-dose combination of both a LABA and a LAMA bronchodilator to gain positive CHMP opinion |
| 2013-04-24 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2013-04-24 | Nxera Pharma UK Limited | Results Seebri Breezhaler GLOW 5 and GLOW 6 Phase III studies meet primary endpoint, and data from QVA149 SPARK Phase III study published in a medical journal nxera.life ↗
The Phase IIIb study GLOW 6 met its primary endpoint and demonstrated the superiority of treating moderate-to-severe COPD patients with both Seebri ® Breezhaler® 50 mcg and Onbrez® Breezhaler ® (indacaterol) 150 mcg administered once-daily, versus treating patients with indacaterol 150 mcg alone as measured by trough FEV 1 at week 12. |
| 2011-03-11 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2009-09-16 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2009-09-16 | Nxera Pharma UK Limited | Results QVA149 Phase II Data Presented at the European Respiratory Society Annual Meeting nxera.life ↗
Similar results were observed on Day 1 of the study and both QVA149 and QAB149 were well tolerated. |
All press releases naming this drug 27 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 140 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | indacaterol | “The GEM3 (Glycopyrrolate Effect on syMptoms and lung function) study assessed the long-term safety and efficacy of a LAMA, glycopyrrolate (GLY) 15.6 μg twice daily (b.i.d.),...” PMID 27215502 ↗ Mar 2016121“Dual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a...” NCT07058259 ↗ “The investigators will compare the reduction in Borg dyspnea score during the 3-min constant rate shuttle walking test after 3 weeks of indacaterol 110 µg/Glycopyrronium 50 µg...” NCT02567214 ↗ “QVA149 is an inhaled, once-daily fixed-dose dual bronchodilator combination of the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium...” PMID 23867808 ↗ Jul 2013 “We randomly assigned participants (1:1) to either receive a combined inhaled dual bronchodilator containing the LABA indacaterol (110 μg as maleate salt) plus the LAMA...” PMID 29477448 ↗ Feb 2018 “Seventy patients (aged ≥40 years, Global initiative for chronic Obstructive Lung Disease Stage II/III) were randomised (1:1:1:1:1:1) to single doses of abediterol 0.625, 2.5, 5...” PMID 27439370 ↗ Jul 2016 “AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) under development for...” NCT06841640 ↗ “HL231 Solution for Inhalation, 3ml:261 μg/141μg, once per day via PARI BOY nebulizer, consisting of a fixed dose combination of indacaterol 261µg and glycopyrronium 141µg,...” NCT06643078 ↗ “The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in...” NCT02233543 ↗ “Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled,...” PMID 27301417 ↗ Jun 2016 “Examples of LABA containing products are: Formoterol, Salmeterol, Indacaterol, Formoterol/Budesonide, Salmeterol/Fluticasone, Treatment including lon-acting anticholinergics:...” NCT02165826 ↗ |
| Known as | AERO-001 | “AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) under development for...” NCT06841640 ↗ |
| Known as | Arcapta neohaler | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | Hirobriz breezhaler | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | IND | “The GEM3 (Glycopyrrolate Effect on syMptoms and lung function) study assessed the long-term safety and efficacy of a LAMA, glycopyrrolate (GLY) 15.6 μg twice daily (b.i.d.),...” PMID 27215502 ↗ Mar 20163“GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium...” PMID 24596459 ↗ Feb 2014 “ICS with Indacaterol and Tiotropium (IND/TIO) vs ICS with Indacaterol (IND) over 4 weeks with challenge performed after first and last doses at trough.” PMID 28665534 ↗ Aug 2017 “free combination of indacaterol maleate (IND) and glycopyrronium bromide (GLY)” PMID 28077140 ↗ Jan 2017 |
| Known as | Indacaterol (as maleate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | Indacaterol acetate | “Single inhaled dose of QMF149 (75/40 µg indacaterol acetate/MF fixed dose combination) administered via Concept 1 device on Day 6-9” NCT04589663 ↗4“QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device” NCT02571777 ↗ “QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device” NCT01636076 ↗ “Indacaterol acetate/Mometasone furoate” NCT02892344 ↗ |
| Known as | indacaterol maleate | “This study aimed to establish optimal dosage of nebulized HL231 inhalation solution (HL231), comparable to Ultibro® (110 µg indacaterol maleate/50 µg glycopyrronium bromide),...” PMID 41229760 ↗ Oct 202510“Indacaterol maleate, long-acting beta2-agonist (LABA). Administered as 110 μg, 1 capsule inhaled once daily via Breezhaler device for 28 days in combination with glycopyrronium.” NCT07541378 ↗ “fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol maleate and inhaled corticosteroid (ICS) mometasone furoate (MF)” PMID 25649209 ↗ Feb 2015 “Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler” NCT03379233 ↗ “Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.” NCT01377051 ↗ “Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.” NCT01012739 ↗ “Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients” NCT02442206 ↗ “Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.” NCT01529632 ↗ “free combination of indacaterol maleate (IND) and glycopyrronium bromide (GLY)” PMID 28077140 ↗ Jan 2017 “Drug: Indacaterol maleate and glycopyrronium bromide” NCT04856098 ↗ “Drug: Indacaterol maleate” NCT01437748 ↗ |
| Known as | Indacaterol maleate component of qva-149 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | Indacaterol maleate component of ultibro | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | Indacaterol maleate component of utibron | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | Indacterol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | Indacterol maleate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | Onbrez | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06282861 ↗ |
| Known as | Onbrez Breezhaler | “Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD” NCT01272362 ↗ |
| Known as | Oslif breezhaler | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | QAB-149-AFA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Known as | QAB149 | “Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler” NCT03379233 ↗9“indacaterol (QAB149)” NCT01202188 ↗ “Indacaterol (QAB149)” NCT00422552 ↗ “Indacaterol (QAB149)” NCT00410501 ↗ |
| Known as | QABI49 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1095777 ↗ |
| Action | Activate | “Beta-2 adrenergic receptor agonist” CHEMBL1095777 ↗1“β2-adrenoceptor agonist” PMID 21184620 ↗ 2011 |
| Modality | Other / unclassified | “once-daily long-acting β2 agonist” PMID 27812637 ↗ Sep 2016 |
| Route | Inhaled | “delivery via a multiple dose inhaler” NCT00098228 ↗ |
| Target | ADRB2 | “Beta-2 adrenergic receptor agonist” CHEMBL1095777 ↗ |