ASCLERA (polidocanol)
Asclera is a sclerosing agent used for patients with small, uncomplicated varicose veins in the legs. It helps patients with spider veins that are 1 mm or less in diameter, as well as reticular veins between 1 and 3 mm. This medication is prescribed to close off these specific types of veins, though it has not been evaluated for use in veins larger than 3 mm.
How ASCLERA Works
This drug works by causing local damage to the lining of the blood vessels when injected into the vein. This damage triggers platelets to gather and stick to the vein wall, creating a network of debris and fibrin that blocks the vessel. Over time, the blocked vein is replaced by fibrous connective tissue.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-03-30
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
ASCLERA Approval History
What ASCLERA Treats
3 indicationsASCLERA is approved for 3 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Spider Veins
- Varicose Veins
- Reticular Veins
ASCLERA 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.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05020912 | CASE2621 | Ph 2 | recruiting | Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy |
| NCT06132165 | 2023P002152 | Ph 1 | completed | Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas |
| NCT06120036 | 2022P001946 | Ph 1 | completed | Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment 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 |
| NCT02632110 results posted | CP0112 | Ph 2 | completed | Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face |
| NCT03024060 | CP0114 | Ph 3 | withdrawn | Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp |
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.
ASCLERA FDA Label Details
Indications & Usage
FDA Label (PDF)ASCLERA is indicated for the treatment of Spider Veins; Varicose Veins; Reticular Veins.
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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