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2018/11/27 | Phase 2 | Withdrawn | |||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 |
|---|---|---|---|---|---|
| Polidocanol Injection | 国药准字H20243818 | 化学药品 | 注射剂 | 5/28/2024 | |
| Polidocanol Injection | 国药准字H20233935 | 化学药品 | 注射剂 | 7/25/2023 | |
| Polidocanol Injection | 国药准字H20233936 | 化学药品 | 注射剂 | 7/25/2023 | |
| Polidocanol Injection | 国药准字HJ20160032 | 化学药品 | 注射剂 | 3/11/2021 | |
| Polidocanol Injection | 国药准字H20233934 | 化学药品 | 注射剂 | 7/25/2023 | |
| Polidocanol Injection | 国药准字HJ20160034 | 化学药品 | 注射剂 | 12/1/2020 | |
| Polidocanol Injection | 国药准字H20243817 | 化学药品 | 注射剂 | 5/28/2024 | |
| Polidocanol Injection | 国药准字HJ20160033 | 化学药品 | 注射剂 | 12/1/2020 |
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. | |||||
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