XDEMVY (lotilaner)
XDEMVY is an anti-parasitic medication that treats Demodex blepharitis. It helps patients with this specific eyelid condition by targeting the microscopic mites that cause the inflammation. This medication is used for individuals who need to eliminate these parasites to improve their ocular health.
How XDEMVY Works
This drug works by blocking GABA-gated chloride channels specifically within mites. This inhibition causes a paralytic effect in the parasites, which leads to their death. The medication is designed to be selective for these mite channels and does not interfere with mammalian GABA-mediated processes.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-07-24
- Patent Cliff
- 2038
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
XDEMVY Approval History
What XDEMVY Treats
1 indicationsXDEMVY is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Demodex Blepharitis
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07561450 | BFS-Xdemvy-01 | Ph 4 | not yet recruiting | Demodex Blepharitis in Scleral Lens Wearers |
| NCT07443202 | TRS-030 | Ph 2 | enrolling by invitation | Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE) |
| NCT05629390 | LB4001-301 | Ph 3 | completed | Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study |
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.
XDEMVY FDA Label Details
Indications & Usage
FDA Label (PDF)XDEMVY is indicated for the treatment of Demodex Blepharitis.
XDEMVY Patents & Exclusivity
Patents (9 active)
Exclusivity
Pro Intelligence Preview
Deep insights for XDEMVY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 9 active patents
Trial Analysis
- • 3 total trials
- • Stage: Expansion
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