Last reviewed · How we verify
Accolate (ZAFIRLUKAST)
Accolate (ZAFIRLUKAST) is a leukotriene receptor antagonist, a small molecule drug that targets the cysteinyl leukotriene receptor 1. It was originally developed by PAR PHARM INC and is now owned by Strides Pharma Intl. Accolate is used to treat asthma and asthma management, and was FDA approved in 1996. The drug is off-patent, with multiple generic manufacturers available. As an off-patent medication, it is no longer protected by active patents.
At a glance
| Generic name | ZAFIRLUKAST |
|---|---|
| Sponsor | Strides Pharma Intl |
| Drug class | Leukotriene Receptor Antagonist [EPC] |
| Target | Cysteinyl leukotriene receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Asthma
- Asthma management
Common side effects
- Headache
- Infection
- Nausea
- Diarrhea
- Pain (generalized)
- Asthenia
- Abdominal Pain
- Accidental Injury
- Dizziness
- Myalgia
- Fever
- Back Pain
Key clinical trials
- Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer (PHASE2)
- Crossover Study of Zafirlukast in Preventing Allergen-induced Signs and Symptoms in Response to Cat Dander Challenge (PHASE2)
- The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19) (PHASE3)
- Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial (PHASE2)
- A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy (PHASE4)
- Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Accolate CI brief — competitive landscape report
- Accolate updates RSS · CI watch RSS
- Strides Pharma Intl portfolio CI