Overview
Polidocanol is a sclerosing agent indicated to treat uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. It is marketed under the brand names Asclera and Varithena. The formula for Polidocanol has the structural formula C12H25(OCH2CH2)nOH, a mean extent of polymerization (n) of approximately 9 and a mean molecular weight of approximately 600.
Indication
Polidocanol is a sclerosing agent indicated to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity.
Associated Conditions
- Pain caused by Teething
- Incompetent accessory saphenous veins
- Incompetent great saphenous veins
- Superficial venous incompetence
- Uncomplicated veins 1 to 3 mm in diameter reticular veins
- Uncomplicated veins <1 mm in diameter Spider Veins
- Varicosities of the great saphenous vein
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/08 | Phase 1 | Not yet recruiting | |||
2023/11/15 | Phase 1 | Recruiting | |||
2023/11/07 | Phase 1 | Completed | |||
2023/04/05 | Phase 4 | Not yet recruiting | |||
2022/04/06 | Phase 4 | Terminated | |||
2020/12/19 | Phase 2 | Completed | |||
2019/09/17 | Phase 2 | Completed | |||
2019/01/03 | Phase 2 | Completed | Societa Italiana di Chirurgia ColoRettale | ||
2018/11/27 | Phase 2 | Withdrawn | |||
2017/08/22 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Methapharm, Inc | 67850-140 | INTRAVENOUS | 0.00500 g in 1 mL | 12/10/2021 | |
| Methapharm, Inc | 67850-141 | INTRAVENOUS | 0.01000 g in 1 mL | 12/10/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VARITHENA POLIDOCANOL INJECTABLE FOAM 10MG/ML | SIN15433P | INJECTION | 10mg/ml | 2/15/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VARITHENA | 02444267 | Foam - Intravenous | 1.3 MG / ML | 11/30/2016 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.