Indacaterol
- Generic Name
- Indacaterol
- Brand Names
- Hirobriz, Onbrez, Ultibro, Oslif Breezhaler, Hirobriz Breezhaler, Onbrez Breezhaler
- Drug Type
- Small Molecule
- Chemical Formula
- C24H28N2O3
- 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
Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
- First Posted Date
- 2008-05-15
- Last Posted Date
- 2011-08-22
- Lead Sponsor
- Novartis
- Target Recruit Count
- 415
- Registration Number
- NCT00677807
- Locations
- 🇹🇷
Novartis Investigative Site, Kartal/Istanbul, Turkey
🇺🇸Novartis Investigative SIte, Fullerton, California, United States
🇹🇷Novartis Investigator Site, Yenisehir/Izmir, Turkey
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Salmeterol/fluticasone (50/500 μg)Drug: Placebo to Salmeterol/fluticasone
- First Posted Date
- 2008-04-30
- Last Posted Date
- 2011-09-12
- Lead Sponsor
- Novartis
- Target Recruit Count
- 89
- Registration Number
- NCT00669617
- Locations
- 🇭🇺
Novartis Investigative site, Deszk, Hungary
🇭🇺Novartis Investigative Site, Nyiregyhaza, Hungary
🇩🇪Novartis Investigator Site, Potsdam, Germany
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- First Posted Date
- 2008-03-17
- Last Posted Date
- 2011-08-30
- Lead Sponsor
- Novartis
- Target Recruit Count
- 27
- Registration Number
- NCT00636961
- Locations
- 🇩🇪
Novartis Investigator Site, Wiesbaden, Germany
Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
- First Posted Date
- 2008-02-27
- Last Posted Date
- 2020-12-19
- Lead Sponsor
- Novartis
- Target Recruit Count
- 98
- Registration Number
- NCT00624702
- Locations
- 🇨🇦
Novartis Investigator Site, Montreal, Quebec, Canada
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2008-02-27
- Last Posted Date
- 2011-08-18
- Lead Sponsor
- Novartis
- Target Recruit Count
- 416
- Registration Number
- NCT00624286
- Locations
- 🇧🇪
Novartis Investigative Site, Lanaken, Belgium
🇳🇿Novartis Investigator Site, Tauranga, New Zealand
A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2008-02-25
- Last Posted Date
- 2011-08-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 68
- Registration Number
- NCT00622635
- Locations
- 🇪🇸
Novartis Investigator site, Mataro, Spain
🇪🇸Novartis Investigator Site, Madrid, Spain
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- First Posted Date
- 2008-02-21
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis
- Target Recruit Count
- 90
- Registration Number
- NCT00620022
- Locations
- 🇪🇸
Novartis Investigative Site, Madrid, Spain
🇪🇸Novartis Investigator Site, Zaragoza, Spain
🇪🇸Novartis Investigative site, Seville, Spain
Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2008-02-14
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis
- Target Recruit Count
- 96
- Registration Number
- NCT00615030
- Locations
- 🇪🇸
Novartis Investigative Site, Barcelona, Spain
A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2008-02-14
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis
- Target Recruit Count
- 169
- Registration Number
- NCT00615459
- Locations
- 🇪🇸
Novartis Investigator Site, Orense, Spain
🇪🇸Novartis Investigative Site, Madrid, Spain
🇪🇸Novartis Investigative site, Alicante, Spain
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
- Conditions
- Asthma
- Interventions
- Drug: placebo to indacaterol maleate/mometasone furoate
- First Posted Date
- 2008-01-31
- Last Posted Date
- 2013-04-22
- Lead Sponsor
- Novartis
- Target Recruit Count
- 28
- Registration Number
- NCT00605306
- Locations
- 🇫🇷
Novartis Investigator Site, Poitiers, France
Drug Development Updates
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