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Asclera (POLIDOCANOL)
Asclera works by causing inflammation and scarring in targeted veins, leading to their closure.
Asclera (polidocanol) is a sclerosing agent used to treat venous varices. It is a small molecule modality originally developed by Chemisch FBRK Krsslr and currently owned by Provensis. Asclera works by causing inflammation and scarring in the targeted veins, leading to their closure. It was FDA-approved in 2010 and remains a branded product. Key safety considerations include potential allergic reactions and nerve damage.
At a glance
| Generic name | POLIDOCANOL |
|---|---|
| Also known as | lauromacrogol 400, lauromacrogol |
| Sponsor | Provensis |
| Drug class | Sclerosing Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2010 |
Mechanism of action
The active ingredient of Asclera is polidocanol.Polidocanol is sclerosing agent that locally damages the endothelium of blood vessels. When injected intravenously, polidocanol induces endothelial damage. Platelets then aggregate at the site of damage and attach to the venous wall. Eventually, dense network of platelets, cellular debris, and fibrin occludes the vessel. Finally, the occluded vein is replaced with connective fibrous tissue.
Approved indications
- Venous varices
Common side effects
- Injection site haematoma
- Injection site irritation
- Injection site discoloration
- Injection site pain
- Injection site pruritus
- Injection site warmth
- Neovascularisation
- Injection site thrombosis
- Immune system disorders: Anaphylactic shock
- Immune system disorders: Angioedema
- Immune system disorders: Urticaria generalized
- Immune system disorders: Asthma
Key clinical trials
- Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (PHASE4)
- Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins (NA)
- Caprini Score in Venous Surgery: a Prospective Cohort Study
- Comparative Study Between Sclerosing Agents Used in Treatment of Vascular Malformation (NA)
- Furosemide-Digoxin vs. Polidocanol for Cutaneous Warts (PHASE2)
- Polidocanol Foam With or Without Transdermal Laser for Varicose Veins: Randomized Clinical Trial (NA)
- Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins (NA)
- Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Asclera CI brief — competitive landscape report
- Asclera updates RSS · CI watch RSS
- Provensis portfolio CI