MedPath

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
Clinical Trials
Related News

ANTES B+ Clinical Trial

Phase 4
Recruiting
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D
Drug: Brimica
Drug: Ulunar
Drug: Xoterna
Drug: Laventair
Drug: Yanimo
Drug: Broncoral
Drug: Oxis
Drug: Formatris
Drug: Striverdi
Drug: Beglan
Drug: Betamican
Drug: Inaspir
Drug: Soltel
Drug: Bretaris
Drug: Seebri
Drug: Tovanor
Drug: Enurev
Drug: Tavulus
Drug: Sirkava
Drug: Braltus
Drug: Gregal
Drug: Rolufta
First Posted Date
2024-02-28
Last Posted Date
2024-03-05
Lead Sponsor
Fundacio Privada Mon Clinic Barcelona
Target Recruit Count
1028
Registration Number
NCT06282861
Locations
🇪🇸

Hospital Clínic Barcelona, Barcelona, Catalunya, Spain

Role of Lung Function for Exercise Capacity in Well-trained Individuals

Not Applicable
Recruiting
Conditions
Exercise Performance
Interventions
Drug: Placebo
First Posted Date
2023-10-11
Last Posted Date
2025-04-09
Lead Sponsor
Morten Hostrup, PhD
Target Recruit Count
60
Registration Number
NCT06077019
Locations
🇩🇰

August Krogh Building, Copenhagen, Denmark

U-LABA/ICS Effects on Exercise Performance, Indacaterol

Not Applicable
Recruiting
Conditions
Exercise Performance
Interventions
Drug: Placebo
First Posted Date
2023-10-04
Last Posted Date
2025-04-09
Lead Sponsor
Morten Hostrup, PhD
Target Recruit Count
30
Registration Number
NCT06067100
Locations
🇩🇰

August Krogh Building, Copenhagen, Denmark

A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Phase 2
Recruiting
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Drug: HRG2005 inhalation
Drug: Placebo to match HRG2005 inhalation
First Posted Date
2023-09-13
Last Posted Date
2024-01-30
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
200
Registration Number
NCT06035393
Locations
🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

Phase 3
Recruiting
Conditions
Asthma
Interventions
First Posted Date
2022-09-30
Last Posted Date
2025-05-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT05562466
Locations
🇪🇸

Novartis Investigative Site, Madrid, Spain

Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure

Phase 4
Completed
Conditions
COPD
Interventions
First Posted Date
2022-08-18
Last Posted Date
2025-04-13
Lead Sponsor
National Institute of Respiratory Diseases, Mexico
Target Recruit Count
73
Registration Number
NCT05506865
Locations
🇲🇽

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas", Mexico, City, Mexico

Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

First Posted Date
2021-04-22
Last Posted Date
2021-09-28
Lead Sponsor
Orion Corporation, Orion Pharma
Target Recruit Count
34
Registration Number
NCT04856098
Locations
🇫🇮

CRST Helsinki Oy, Helsinki, Finland

Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma

Phase 2
Completed
Conditions
Asthma
Interventions
Drug: Standard of Care (Soc)
First Posted Date
2020-10-19
Last Posted Date
2023-10-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT04589663
Locations
🇿🇦

Novartis Investigative Site, Cape Town, South Africa

Anti-inflammatory Effects Glycopyrronium

Phase 3
Completed
Conditions
Asthma
Allergic Asthma
Interventions
First Posted Date
2020-02-06
Last Posted Date
2023-01-12
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
28
Registration Number
NCT04259164
Locations
🇳🇱

University Medical Center Groningen, Groningen, Netherlands

Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.

Phase 2
Completed
Conditions
Asthma
Interventions
Drug: Placebo
First Posted Date
2017-08-22
Last Posted Date
2021-01-05
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
54
Registration Number
NCT03257995
Locations
🇺🇸

Novartis Investigative Site, El Paso, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy