{"id":"varithena","safety":{"commonSideEffects":[{"rate":"20-40","effect":"Injection site pain or bruising"},{"rate":"5-15","effect":"Thrombophlebitis"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Dizziness"},{"rate":"1-5","effect":"Dyspnea"},{"rate":"1-5","effect":"Chest pain"}]},"_chembl":null,"_dailymed":{"setId":"dfd6b4a0-b0dc-11e2-9e96-0800200c9a66","title":"VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Varithena delivers polidocanol, a sclerosing agent, as a stable microfoam that displaces blood within the vein and maximizes contact between the sclerosant and the vein wall. This contact causes endothelial injury, inflammation, and thrombosis, leading to vein fibrosis and permanent closure. The microfoam formulation allows for lower doses and improved efficacy compared to liquid sclerosants.","oneSentence":"Varithena is a microfoam formulation of polidocanol that destroys varicose veins by causing endothelial damage and subsequent vein closure.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:14:57.874Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Varicose veins of the great saphenous vein, accessory saphenous vein, and visible varicosities"}]},"trialDetails":[{"nctId":"NCT05312970","phase":"PHASE4","title":"Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)","status":"TERMINATED","sponsor":"Boston Scientific Corporation","startDate":"2023-02-10","conditions":"Varicose Veins","enrollment":43},{"nctId":"NCT06667570","phase":"NA","title":"Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins","status":"COMPLETED","sponsor":"Lidiane Rocha","startDate":"2024-10-25","conditions":"Varicose Veins","enrollment":35},{"nctId":"NCT07221695","phase":"NA","title":"Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils","status":"ENROLLING_BY_INVITATION","sponsor":"Kafrelsheikh University","startDate":"2025-08-25","conditions":"Pelvic Congestive Syndrome","enrollment":60},{"nctId":"NCT05468450","phase":"NA","title":"RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency","status":"COMPLETED","sponsor":"Societe Francaise de Phlebologie","startDate":"2015-07-01","conditions":"Varicose Veins of Lower Limb","enrollment":161},{"nctId":"NCT03257254","phase":"","title":"Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)","status":"COMPLETED","sponsor":"Boston Scientific Corporation","startDate":"2017-09-29","conditions":"Venous Leg Ulcer","enrollment":76},{"nctId":"NCT03791775","phase":"PHASE2","title":"Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease","status":"COMPLETED","sponsor":"Societa Italiana di Chirurgia ColoRettale","startDate":"2019-01-02","conditions":"Second-degree Hemorrhoids","enrollment":183},{"nctId":"NCT00928421","phase":"PHASE2","title":"An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins","status":"COMPLETED","sponsor":"Boston Scientific Corporation","startDate":"2009-06","conditions":"Varicose Veins","enrollment":16},{"nctId":"NCT00442364","phase":"PHASE2","title":"Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt","status":"COMPLETED","sponsor":"Boston Scientific Corporation","startDate":"2007-03","conditions":"Varicose Veins","enrollment":60},{"nctId":"NCT02462720","phase":"PHASE4","title":"COMFORT: A Multicenter, Open-label, Randomized, Crossover Study","status":"COMPLETED","sponsor":"Boston Scientific Corporation","startDate":"2015-05","conditions":"Varicose Veins","enrollment":35},{"nctId":"NCT04358497","phase":"PHASE4","title":"Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome","status":"UNKNOWN","sponsor":"Hospital de Clínicas Dr. Manuel Quintela","startDate":"2020-10-01","conditions":"Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":22,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Polidocanol Solution, 180 mg/18 mL (10 mg/mL)"],"phase":"marketed","status":"active","brandName":"Varithena®","genericName":"Varithena®","companyName":"Boston Scientific Corporation","companyId":"boston-scientific-corporation","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Varithena is a microfoam formulation of polidocanol that destroys varicose veins by causing endothelial damage and subsequent vein closure. Used for Varicose veins of the great saphenous vein, accessory saphenous vein, and visible varicosities.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}