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

Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol

Phase 1

Completed

Conditions: COPD

First Posted Date: 2007-01-17

Last Posted Date: 2007-06-22

Lead Sponsor: Novartis

Target Recruit Count: 30

Registration Number: NCT00422552

Locations: 🇬🇧
Novartis Investigative site, Horsham, United Kingdom

Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function

Phase 1

Completed

Conditions: Hepatic Insufficiency

Interventions: Drug: QAB149

First Posted Date: 2006-12-28

Last Posted Date: 2008-06-10

Lead Sponsor: Novartis

Target Recruit Count: 32

Registration Number: NCT00416702

Locations: 🇺🇸
Novartis Investigative Site, East Hanover, New Jersey, United States

Evaluation of Pharmacokinetic Interaction of Indacaterol With Ketoconazole in Healthy Adult Subjects

Phase 1

Completed

Conditions: Healthy

First Posted Date: 2006-12-13

Last Posted Date: 2007-06-19

Lead Sponsor: Novartis

Target Recruit Count: 20

Registration Number: NCT00410501

Locations: 🇮🇳
Novartis, Mumbai, India

Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol 150 μg
Drug: Indacaterol 300 μg
Drug: Placebo

First Posted Date: 2006-11-27

Last Posted Date: 2011-08-17

Lead Sponsor: Novartis

Target Recruit Count: 50

Registration Number: NCT00403845

Locations: 🇯🇵
Novartis Investigative site, Kasukabe, Japan
🇯🇵
Novartis Investigator Site, Tokyo, Japan
🇯🇵
Novartis Investigative Site, Wakayama, Japan

Dose Ranging Study for Indacaterol in Japanese Asthma Patients

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: Indacaterol
Drug: Placebo
Drug: Salmeterol

First Posted Date: 2006-11-27

Last Posted Date: 2011-08-17

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 41

Registration Number: NCT00403754

Locations: 🇯🇵
Novartis, Tokyo, Japan
🇯🇵
Novartis Investigator Site, Yokohama, Japan
🇯🇵
Novartis Investigative Site, Tokyo, Japan

Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

Phase 2

Completed

Conditions: Asthma

First Posted Date: 2006-11-27

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis

Target Recruit Count: 45

Registration Number: NCT00403637

Locations: 🇺🇸
North Carolina Clinical Research, Raleigh, North Carolina, United States
🇺🇸
Colorado Allergy and Asthma Centres, P.C., Denver, Colorado, United States
🇺🇸
Northeast Medical Research Associates, Inc., North Dartmouth, Massachusetts, United States

and more 2 locations

Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

Conditions: Pulmonary Disease, Chronic Obstructive
COPD
Lung Diseases, Obstructive

First Posted Date: 2006-11-07

Last Posted Date: 2011-10-25

Lead Sponsor: Novartis

Target Recruit Count: 51

Registration Number: NCT00396604

Locations: 🇧🇪
Novartis, Vilvoorde, Belgium

Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol
Drug: Formoterol
Drug: Placebo to formoterol
Drug: Placebo to indacaterol

First Posted Date: 2006-10-27

Last Posted Date: 2011-08-18

Lead Sponsor: Novartis

Target Recruit Count: 1732

Registration Number: NCT00393458

Locations: 🇬🇧
Novartis Investigator Site, Swansea, United Kingdom
🇪🇸
Novartis Investigative Site, Madrid, Spain
🇹🇷
Novartis, Istanbul, Turkey

Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

Conditions: COPD

First Posted Date: 2005-08-12

Last Posted Date: 2011-10-25

Lead Sponsor: Novartis

Target Recruit Count: 6

Registration Number: NCT00129831

Locations: 🇺🇸
Radiant Research, Boise, Idaho, United States

Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

Conditions: COPD

First Posted Date: 2004-12-06

Last Posted Date: 2011-10-25

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 686

Registration Number: NCT00098228

Locations: 🇺🇸
Allergy Research Foundation , Inc, Los Angeles, California, United States
🇺🇸
David Geffin UCLA School of Medicine, Los Angeles, California, United States
🇺🇸
UAB Pulmonary Research, Birmingham, Alabama, United States

and more 51 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy