Overview
Zafirlukast is an oral leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma, often used in conjunction with an inhaled steroid and/or long-acting bronchodilator. It is available as a tablet and is usually dosed twice daily. Another leukotriene receptor antagonist is montelukast (Singulair), which is usually taken just once daily. Zafirlukast blocks the action of the cysteinyl leukotrienes on the CysLT1 receptors, thus reducing constriction of the airways, build-up of mucus in the lungs and inflammation of the breathing passages.
Background
Zafirlukast is an oral leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma, often used in conjunction with an inhaled steroid and/or long-acting bronchodilator. It is available as a tablet and is usually dosed twice daily. Another leukotriene receptor antagonist is montelukast (Singulair), which is usually taken just once daily. Zafirlukast blocks the action of the cysteinyl leukotrienes on the CysLT1 receptors, thus reducing constriction of the airways, build-up of mucus in the lungs and inflammation of the breathing passages.
Indication
For the prophylaxis and chronic treatment of asthma.
Associated Conditions
- Asthma
- Chronic Urticaria
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/05 | Phase 2 | Not yet recruiting | Allergy & Asthma Medical Group & Research Center | ||
2020/04/09 | Phase 2 | Completed | |||
2016/11/01 | Phase 2 | Terminated | |||
2011/01/25 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Reddys Laboratories Limited | 55111-625 | ORAL | 10 mg in 1 1 | 12/20/2016 | |
| Carilion Materials Management | 68151-1977 | ORAL | 20 mg in 1 1 | 10/21/2010 | |
| Aurobindo Pharma Limited | 59651-292 | ORAL | 20 mg in 1 1 | 12/1/2023 | |
| Par Pharmaceutical, Inc. | 49884-590 | ORAL | 20 mg in 1 1 | 9/28/2022 | |
| AvKARE | 42291-970 | ORAL | 10 mg in 1 1 | 4/25/2023 | |
| AvKARE | 42291-971 | ORAL | 20 mg in 1 1 | 4/25/2023 | |
| Par Pharmaceutical, Inc. | 49884-554 | ORAL | 20 mg in 1 1 | 10/25/2022 | |
| Camber Pharmaceuticals, Inc. | 31722-008 | ORAL | 20 mg in 1 1 | 9/17/2020 | |
| Par Pharmaceutical, Inc. | 49884-589 | ORAL | 10 mg in 1 1 | 9/28/2022 | |
| American Health Packaging | 68084-059 | ORAL | 20 mg in 1 1 | 10/4/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||