Indacaterol

Generic Name: Indacaterol

Brand Names: Hirobriz, Onbrez, Ultibro, Oslif Breezhaler, Hirobriz Breezhaler, Onbrez Breezhaler

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₈N_₂O_₃

CAS Number: 312753-06-3

Unique Ingredient Identifier: 8OR09251MQ

Background: Indacaterol is a novel, ultra-long-acting, rapid onset β(2)-adrenoceptor agonist developed for Novartis for the once-daily management of asthma and chronic obstructive pulmonary disease. It was approved by the European Medicines Agency (EMA) on 30 November 2009 and by the FDA on 1 July 2011. It is marketed in Europe as Onbrez and in America as Arcapta Neohaler. Indacaterol is provided as its maleate salt form. Indacaterol is also a chiral molecule but only the pure R-enantiomer is dispensed.

Indication: For the long term, once-daily-dosing maintenance of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Associated Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Associated Therapies: Maintenances

Clinical Trials

Efficacy in Walked Distance of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass (EMERALD)

Phase 4

Completed

Conditions: COPD

Interventions: Drug: indacaterol
Drug: Tiotropium

First Posted Date: 2015-06-16

Last Posted Date: 2015-10-16

Lead Sponsor: National Institute of Respiratory Diseases, Mexico

Target Recruit Count: 40

Registration Number: NCT02473237

Locations: 🇲🇽
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas", Mexico, City, Mexico

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol
Drug: Placebo

First Posted Date: 2015-04-16

Last Posted Date: 2017-07-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 24

Registration Number: NCT02418468

Locations: 🇭🇰
Novartis Investigative Site, Hong Kong, Hong Kong

Comparative Study of Umeclidinium/Vilanterol (UMEC/VI) in a Fixed Dose Combination With Indacaterol Plus Tiotropium

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium
Drug: UMEC/VI
Drug: UMEC/VI matching placebo
Drug: Tiotropium matching placebo
Drug: Albuterol/salbutamol Metered Dose Inhaler (MDI)
Drug: Indacaterol
Drug: Indacaterol matching placebo

First Posted Date: 2014-10-06

Last Posted Date: 2018-03-01

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 967

Registration Number: NCT02257385

Locations: 🇸🇰
GSK Investigational Site, Vrable, Slovakia

Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol (Onbrez®) /QAB149

First Posted Date: 2014-04-25

Last Posted Date: 2014-04-25

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 103

Registration Number: NCT02123199

Locations: 🇬🇧
Novartis Investigative Site, London, United Kingdom

Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD

Phase 1

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Asthma

Interventions: Drug: LAS190792 Dose 1
Drug: LAS190792 Dose 2
Drug: Placebo
Drug: LAS190792 Dose 2 (Part 2)
Drug: LAS190792 Dose 5
Drug: Tiotropium 18 μg
Drug: Indacaterol 150 μg
Drug: LAS190792 Dose 3
Drug: LAS190792 Dose 4
Drug: LAS190792 Dose 6
Drug: LAS190792 Dose 1 (Part 2)

First Posted Date: 2014-02-11

Last Posted Date: 2019-06-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 55

Registration Number: NCT02059434

Locations: 🇬🇧
Medicines Evaluation Unit Ltd (MEU), Manchester, United Kingdom
🇬🇧
Quintiles Drug Research Unit at Guy's Hospital, London, United Kingdom