LYNAVOY (linerixibat)
Development Insights
Details
- Status
- Prescription
- First Approved
- 2026-03-17
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
LYNAVOY Approval History
What LYNAVOY Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04167358 LLSAT | 212358 2019-003158-10 | Ph 3 | active not recruiting | Linerixibat Long-term Safety, and Tolerability Study |
| NCT04950127 results posted | 212620 | Ph 3 | completed | Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) |
| NCT05393076 | 214899 | Ph 1 | completed | Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls |
| NCT05435170 | 214656 | Ph 1 | completed | Food Effect Study of Linerixibat Tablets in Healthy Adult Participants |
| NCT05133830 | 213688 | Ph 1 | completed | Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants |
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.
LYNAVOY FDA Label Details
LYNAVOY Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LYNAVOY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 1 active patents
Trial Analysis
- • 5 total trials
- • Stage: Stable
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