BEVYXXA (betrixaban)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2017-06-23
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- CAPSULE
BEVYXXA Approval History
What BEVYXXA Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03346083 results posted | 16-021 2018-002562-40 | Ph 1 | terminated | Study Evaluating Betrixaban in Pediatric Participants |
| NCT00999336 results posted | 08-016 | Ph 1 | completed | A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment |
| NCT02596100 | 15-020 | Ph 1 | completed | A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations |
| NCT00742859 EXPLORE-Xa results posted | 08-015 | Ph 2 | completed | Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin |
| NCT01583218 APEX results posted | 11-019 | Ph 3 | completed | Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) |
| NCT03397888 | 17-022 | Ph 1 | completed | The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist |
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.
BEVYXXA FDA Label Details
Pro Intelligence Preview
Deep insights for BEVYXXA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 24 active patents
Trial Analysis
- • 6 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