Drugs / Indacaterol

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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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2004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
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 No outcome recorded
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
Phase 2 NCT06035393 Jan 2024 → Feb 2025 chronic obstructive pulmonary disease Jiangsu HengRui Medicine Co., Ltd. Terminated No outcome recorded
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 No outcome recorded
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Phase 2 NCT01845623 Aug → Dec 2013 asthma Novartis Pharmaceuticals Withdrawn No outcome recorded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 2/34 trials
Phase 2/3 NCT02693769 Jul → Oct 2016 asthma Mundipharma Research Limited Terminated No outcome recorded
Phase 2/3 NCT00463567 Apr 2007 → Aug 2008 chronic obstructive pulmonary disease Novartis Completed No outcome recorded
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 No outcome recorded
Phase 343 trials
Phase 3 NCT05776927 May 2026 → Dec 2028 expected asthma Novartis Pharmaceuticals Not yet 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 No outcome recorded
Phase 3 NCT02892344 Jan 2017 → Nov 2018 asthma Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02554786 Dec 2015 → Nov 2018 asthma Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02571777 Dec 2015 → Jun 2019 asthma Novartis Pharmaceuticals Completed No outcome recorded
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 No outcome recorded
Phase 426 trials
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 No outcome recorded
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 No outcome recorded
Phase 4 NCT02418468 Apr 2015 → Apr 2016 chronic obstructive pulmonary disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT02233543 Nov 2014 → Jun 2016 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
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
Also used as a comparator or background therapy in 24 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02059434 Comparator Sep 2013 → Oct 2014 asthma, chronic obstructive pulmonary disease AstraZeneca Completed No outcome recorded
Phase 1 NCT00624702 Comparator Feb → Sep 2008 asthma Novartis Completed No outcome recorded
Phase 24 trials
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 No outcome recorded
Phase 2 NCT00570778 Comparator Dec 2007 → Sep 2008 chronic obstructive pulmonary disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 314 trials
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 No outcome recorded
Phase 3 NCT02165826 Background May 2014 → Sep 2015 chronic obstructive pulmonary disease AstraZeneca Completed No outcome recorded
Phase 43 trials
Phase 4 NCT06282861 Comparator Feb 2024 → Jan 2025 chronic obstructive pulmonary disease Fundacio Privada Mon Clinic Barcelona Terminated No outcome recorded
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
Phase not applicable1 trial
NCT07058259 Background Nov 2024 → Jun 2025 overdue chronic obstructive pulmonary disease Istanbul Medeniyet University Active not recruiting No outcome recorded

Evidence & citations 23 cited values

Every value below carries the sentence it was read from. 140 sources stand behind the page.

FieldValueCited 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 2016
121

“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

“Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial.” PMID 30074294 Aug 2018

“PURPOSE: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI).” PMID 28993871 Oct 2017

“QVM149 is an investigational drug consisting of 150μg indacaterol acetate, 50μg glycopyrronium bromide and 160μg mometasone furoate.” NCT04206761

“once-daily QVA149 (fixed-dose combination of indacaterol 110 μg and glycopyrronium 50 μg), glycopyrronium 50 μg, or tiotropium 18 μg” PMID 24429126 Apr 2013

“Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler” NCT03379233

“QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg od delivered via Breezhaler®” NCT05776927

“HL231 261 µg/141 µg demonstrated peak concentration (Cmax) of indacaterol and glycopyrronium at 86% and 54% of Ultibro®” PMID 41229760 Oct 2025

“A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture” NCT01845623

“a fixed-dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg” NCT00941798

“Inhaled indacaterol/glycopyrronium fixed-dose combination (IND/GLY) is approved in over 80 countries” PMID 27715335 Aug 2016

“QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device” NCT01636076

“QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1” NCT01285492

“free combination of indacaterol maleate (IND) and glycopyrronium bromide (GLY)” PMID 28077140 Jan 2017

“the LABA indacaterol (110 μg) plus the LAMA glycopyrronium (50 μg) once daily” PMID 27181606 May 2016

Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.” NCT04509661

Indacaterol acetate / glycopyrronium bromide / mometasone furoate” NCT03158311

“QMF149 (Indacaterol Acetate / Mometasone Furoate)” NCT05562466

“a long-acting β2-agonist (indacaterol)” PMID 26177074 Nov 2015

“Mometasone / IndacaterolNCT04259164

IndacaterolNCT03662711

NCT01794780

NCT01012765

NCT01985334

NCT02892019

NCT00620022

NCT01778062

NCT02566031

NCT02418468

NCT01437748

NCT02202616

NCT02867761

NCT02547558

NCT00393458

NCT02257385

NCT01079130

NCT01315249

NCT02059434

NCT00792805

NCT00403754

NCT00622635

NCT01959412

NCT01012739

NCT00677807

NCT00876694

NCT01156844

NCT01072448

NCT00636961

NCT02039011

NCT05506865

NCT01555138

NCT01715311

NCT00556673

NCT01498081

NCT02872090

NCT01377051

NCT01693003

NCT00422552

NCT05288075

NCT00669617

NCT02473237

NCT00624702

NCT01272362

NCT00605306

NCT04856098

NCT00410501

NCT07541378

NCT00821093

NCT00570778

NCT01202188

NCT00403845

NCT02693769

NCT00846586

NCT02598505

NCT06067100

NCT00557466

NCT00545272

NCT06077019

NCT00615459

NCT00531050

NCT02573155

NCT01068600

NCT01609478

NCT01996124

NCT00900731

NCT00567996

NCT01484197

NCT01543828

NCT01727024

NCT02055352

NCT00999908

NCT06035393

NCT00403637

NCT00845728

NCT01377428

NCT00558285

NCT00463567

NCT03257995

NCT00557440

NCT00927901

NCT00396604

NCT00794157

NCT00877383

NCT02953041

NCT01294787

NCT01263808

NCT01089127

NCT01604278

NCT01232894

NCT00615030

NCT00529529

NCT00624286

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 2016
3

“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

NCT02554786

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 2025
10

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 maleateNCT01437748

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)” NCT00410501

“Indacaterol (QAB149)” NCT00422552

“indacaterol (QAB149)” NCT01202188

NCT00416702

NCT00098228

NCT01529632

NCT01682863

NCT01712516

NCT00129831

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