Overview
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.
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)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/28 | Phase 4 | Recruiting | |||
2023/10/11 | Not Applicable | Recruiting | Morten Hostrup, PhD | ||
2023/10/04 | Not Applicable | Recruiting | Morten Hostrup, PhD | ||
2023/09/13 | Phase 2 | Recruiting | |||
2022/09/30 | Phase 3 | Recruiting | |||
2022/08/18 | Phase 4 | Completed | |||
2021/04/22 | Phase 1 | Completed | |||
2020/10/19 | Phase 2 | Completed | |||
2020/02/06 | Phase 3 | Completed | |||
2017/08/22 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/29/2009 | ||
Authorised | 11/29/2009 | ||
Authorised | 11/30/2009 | ||
Authorised | 4/23/2014 | ||
Authorised | 9/19/2013 | ||
Authorised | 5/30/2020 | ||
Authorised | 5/30/2020 | ||
Authorised | 9/18/2013 | ||
Authorised | 7/3/2020 | ||
Authorised | 11/30/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /160 MCG | SIN16148P | POWDER, METERED | 150 mcg | 4/7/2021 | |
| ULTIBRO BREEZHALER INHALATION POWDER HARD CAPSULE 110/50 MCG | SIN14539P | CAPSULE | 110 mcg | 4/10/2014 | |
| ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /320 MCG | SIN16147P | POWDER, METERED | 150 mcg | 4/7/2021 | |
| ENERZAIR BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /50 MCG /160 MCG | SIN16153P | POWDER, METERED | 150 mcg | 4/14/2021 | |
| ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /80 MCG | SIN16149P | POWDER, METERED | 150 mcg | 4/7/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Indacaterol Maleate Powder for Inhalation | 国药准字HJ20160302 | 化学药品 | 吸入粉雾剂 | 12/3/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||