ACCOLATE (zafirlukast)
ACCOLATE is indicated for the treatment of Asthma.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-09-26
- Routes
- ORAL
- Dosage Forms
- TABLET
ACCOLATE Approval History
What ACCOLATE Treats
1 indicationsACCOLATE is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
ACCOLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04339140 results posted | 19-814 1R21CA231000-01A1 | Ph 2 | completed | Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer |
| NCT06069063 | ACC001 | Ph 2 | not yet recruiting | Crossover Study of Zafirlukast in Preventing Allergen-induced Signs and Symptoms in Response to Cat Dander Challenge |
| NCT02950480 results posted | 15754 | Ph 2 | terminated | Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACCOLATE FDA Label Details
Indications & Usage
FDA Label (PDF)ACCOLATE is indicated for the treatment of Asthma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment