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
Cardiac Safety of Indacaterol
- Conditions
- Healthy VolunteersChronic Obstructive Pulmonary Disease
- Interventions
- Drug: PlaceboDrug: Placebo/moxifloxacin
- First Posted Date
- 2010-12-21
- Last Posted Date
- 2010-12-21
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 404
- Registration Number
- NCT01263808
- Locations
- 🇺🇸
Novartis investigative site, Miami, Florida, United States
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Long-acting beta2-agonist
- First Posted Date
- 2010-11-02
- Last Posted Date
- 2013-11-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 90
- Registration Number
- NCT01232894
- Locations
- 🇮🇱
Novartis Investigative Site, Tel Aviv, Israel
A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- First Posted Date
- 2010-09-15
- Last Posted Date
- 2013-09-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 2144
- Registration Number
- NCT01202188
- Locations
- 🇯🇵
Novartis Inverstigative Site, Iwata, Japan
🇭🇺Novartis INvestigative Site, Balassagyarmat, Hungary
🇦🇺Novartis Investigative site, New lambton, Australia
Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
- Conditions
- Persistent Asthma
- Interventions
- First Posted Date
- 2010-07-05
- Last Posted Date
- 2011-08-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 191
- Registration Number
- NCT01156844
- Locations
- 🇺🇸
Novartis Investigator Site, Oklahoma City, Oklahoma, United States
🇬🇧Novartis Investigative Site, Merthyr Tydfil, United Kingdom
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2010-03-18
- Last Posted Date
- 2011-08-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 552
- Registration Number
- NCT01089127
- Locations
- 🇺🇸
Novartis Investigative Site, Richmond, Virginia, United States
🇺🇸Novartis Investigator Site, Tacoma, Washington, United States
🇺🇸Novartis Investigative site, Newport News, Virginia, United States
Efficacy and Safety of Different Doses of Indacaterol
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2010-03-02
- Last Posted Date
- 2011-08-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 511
- Registration Number
- NCT01079130
- Locations
- 🇺🇸
Novartis Investigative site, North Charleston, South Carolina, United States
🇺🇸Novartis Investigator Site, Seattle, Washington, United States
🇺🇸Novartis Investigative Site, Charleston, South Carolina, United States
12-week Efficacy of Indacaterol
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2010-02-22
- Last Posted Date
- 2011-08-19
- Lead Sponsor
- Novartis
- Target Recruit Count
- 323
- Registration Number
- NCT01072448
- Locations
- 🇺🇸
Novartis Investigative site, Greer, South Carolina, United States
🇺🇸Novartis Investigator Site, Tacoma, Washington, United States
🇺🇸Novartis Investigative Site, Newport News, Virginia, United States
Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2010-02-15
- Last Posted Date
- 2011-08-19
- Lead Sponsor
- Novartis
- Target Recruit Count
- 318
- Registration Number
- NCT01068600
- Locations
- 🇺🇸
Novartis Investigator Site, McKinney, Texas, United States
🇺🇸Novartis Investigative Site, Richmond, Virginia, United States
🇺🇸Novartis Investigative site, Greenville, South Carolina, United States
Effect of Indacaterol on Inspiratory Capacity (IC)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- First Posted Date
- 2009-11-13
- Last Posted Date
- 2016-02-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 173
- Registration Number
- NCT01012765
- Locations
- 🇩🇪
Novartis Investigative site, Leipzig, Germany
🇩🇪Novartis Investigative Site, Zerbst, Germany
🇩🇪Novartis Investigator Site, Witten, Germany
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
- First Posted Date
- 2009-11-13
- Last Posted Date
- 2011-08-29
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 35
- Registration Number
- NCT01012739
- Locations
- 🇬🇧
Novartis Investigative Site, Manchester, United Kingdom
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.