ZURAMPIC (lesinurad)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2015-12-22
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
ZURAMPIC Approval History
What ZURAMPIC Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03226899 results posted | RDEA594-401 | Ph 4 | terminated | A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment |
| NCT01808144 results posted | RDEA594-307 2012-004390-54 | Ph 3 | completed | Lesinurad and Febuxostat Combination Extension Study in Gout |
| NCT01808131 | RDEA594-306 2012-004389-16 | Ph 3 | completed | Lesinurad and Allopurinol Combination Extension Study in Gout |
| NCT01510158 CLEAR 1 results posted | RDEA594-301 | Ph 3 | completed | Combining Lesinurad With Allopurinol in Inadequate Responders |
| NCT01510769 CRYSTAL results posted | RDEA594-304 2011-003768-55 | Ph 3 | completed | Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat |
| NCT01650246 results posted | RDEA594-305 | Ph 3 | completed | Open-Label Lesinurad Monotherapy Extension Study in Gout |
| NCT01493531 CLEAR 2 results posted | RDEA594-302 2011-003767-29 | Ph 3 | completed | Combining Lesinurad With Allopurinol in Inadequate Responders |
| NCT01508702 LIGHT results posted | RDEA594-303 2011-003756-39 | Ph 3 | completed | Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors |
| NCT01744379 | RDEA594-125 | Ph 1 | completed | Single and Multiple Dose Study in Japanese |
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.
ZURAMPIC FDA Label Details
Pro Intelligence Preview
Deep insights for ZURAMPIC
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 11 active patents
Trial Analysis
- • 14 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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