Zafirlukast

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.

Indication

For the prophylaxis and chronic treatment of asthma.

Associated Conditions

Asthma
Chronic Urticaria

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Crossover Study of Zafirlukast in Preventing Allergen-induced Signs and Symptoms in Response to Cat Dander Challenge	2023/10/05	NCT06069063	Phase 2	Not yet recruiting	Allergy & Asthma Medical Group & Research Center
Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer	2020/04/09	NCT04339140	Phase 2	Completed	Beth Israel Deaconess Medical Center
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial	2016/11/01	NCT02950480	Phase 2	Terminated	University of California, San Francisco
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition	2011/01/25	NCT01283061	Phase 1	Completed	Dr. Reddy's Laboratories Limited

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Zafirlukast	Dr. Reddys Laboratories Limited	55111-625	ORAL	10 mg in 1 1	12/20/2016
Zafirlukast	Carilion Materials Management	68151-1977	ORAL	20 mg in 1 1	10/21/2010
Zafirlukast	Aurobindo Pharma Limited	59651-292	ORAL	20 mg in 1 1	12/1/2023
Accolate	Par Pharmaceutical, Inc.	49884-590	ORAL	20 mg in 1 1	9/28/2022
Zafirlukast	AvKARE	42291-970	ORAL	10 mg in 1 1	7/31/2025
Zafirlukast	AvKARE	42291-971	ORAL	20 mg in 1 1	7/31/2025
Zafirlukast	Par Pharmaceutical, Inc.	49884-554	ORAL	20 mg in 1 1	10/25/2022
Zafirlukast	Camber Pharmaceuticals, Inc.	31722-008	ORAL	20 mg in 1 1	9/17/2020
Accolate	Par Pharmaceutical, Inc.	49884-589	ORAL	10 mg in 1 1	9/28/2022
Zafirlukast	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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ACCOLATE TAB 20 MG	astrazeneca canada inc	02236606	Tablet - Oral	20 MG	11/17/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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