VARITHENA (polidocanol)
Varithena is an injectable foam used to manage incompetent great saphenous veins and accessory saphenous veins. It helps patients with visible varicosities in the great saphenous vein system, whether located above or below the knee. This treatment improves the physical appearance of these veins and relieves the symptoms associated with superficial venous incompetence.
How VARITHENA Works
This drug works by using a foam to displace blood from the target vein, allowing the polidocanol to directly contact and destroy the vein's inner lining. This process triggers a vasospasm and the formation of a clot, which blocks the vein and eventually leads to its replacement by fibrous connective tissue. The drug is deactivated upon contact with blood, which limits its effects to the specific area near the injection site.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-11-25
- Patent Cliff
- 2032
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
VARITHENA Approval History
What VARITHENA Treats
1 indicationsVARITHENA is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Varicose Veins
VARITHENA 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.
Drugs Similar to VARITHENA
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06132165 | 2023P002152 | Ph 1 | completed | Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas |
| NCT02154789 | 2013-005338-39 | Ph 4 | terminated | An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst |
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.
VARITHENA FDA Label Details
Indications & Usage
FDA Label (PDF)VARITHENA is indicated for the treatment of Varicose Veins.
Pro Intelligence Preview
Deep insights for VARITHENA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 4 active patents
Trial Analysis
- • 4 total trials
- • Stage: Mature
Competitive Landscape
- • 3 similar drugs
- • 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