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
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2009-10-22
- Last Posted Date
- 2016-02-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 54
- Registration Number
- NCT00999908
- Locations
- 🇮🇹
Novartis Investigative Site, Verona, Italy
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2009-06-25
- Last Posted Date
- 2013-09-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 30
- Registration Number
- NCT00927901
- Locations
- 🇮🇹
Novartis Investigative Site, Verona, Italy
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2009-05-13
- Last Posted Date
- 2011-08-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 1598
- Registration Number
- NCT00900731
- Locations
- 🇨🇦
Novartis Investigative SIte, Quebec, Canada
🇬🇧Novartis Investigator Site, Watford, United Kingdom
🇹🇷Novartis Investigative Site, Yenisehir/Izmir, Turkey
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2009-04-07
- Last Posted Date
- 2011-11-08
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 186
- Registration Number
- NCT00876694
- Locations
- 🇯🇵
Novartis Investigator site, Sapporo, Japan
🇯🇵Novartis Investigator Site, Yokohama, Japan
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2009-04-07
- Last Posted Date
- 2011-08-25
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 1142
- Registration Number
- NCT00877383
- Locations
- 🇺🇸
Novartis Investigative site, Philadelphia, Pennsylvania, United States
🇨🇿Novartis Investigative SIte, Liberec, Czech Republic
🇭🇺Novartis Investgative Site, Százhalombatta, Hungary
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2009-02-18
- Last Posted Date
- 2011-08-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 1134
- Registration Number
- NCT00846586
- Locations
- 🇺🇸
Novartis Investigative site, Omaha, Nebraska, United States
🇦🇷Novartis Investigative SIte, Mendoza, Argentina
🇪🇸Novartis Investigative Site, Jaén, Spain
Exacerbation Study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2009-02-18
- Last Posted Date
- 2013-11-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 3439
- Registration Number
- NCT00845728
- Locations
- 🇻🇪
Novartis Investigative Site, Maracaibo, Estado Zulia, Venezuela
Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2009-01-13
- Last Posted Date
- 2011-08-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 1123
- Registration Number
- NCT00821093
- Locations
- 🇺🇸
Novartis Investigative Center, Clearwater, Florida, United States
🇺🇸Novartis Investigative site, Spartanburg, South Carolina, United States
🇩🇪Novartis Investgative Site, Witten, Germany
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2008-11-19
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 347
- Registration Number
- NCT00794157
- Locations
- 🇯🇵
Novartis Investigative site, Tokyo, Japan
🇨🇳Novartis Investigator Site, Taipei, Taiwan
🇨🇳Novartis Investigative Site, Taipei, Taiwan
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2008-11-18
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 563
- Registration Number
- NCT00792805
- Locations
- 🇨🇳
Novartis Investigator Site, Fuzhou, China
🇮🇳Novartis Investigative Site, Trivandrum, India
Drug Development Updates
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