{"id":"sinecatechins","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Local pain","drugRate":"1%","severity":"Moderate"},{"effect":"Erythema","drugRate":"1%","severity":"Mild"},{"effect":"Vesicles","drugRate":"1%","severity":"Mild"},{"effect":"Skin erosion/ulceration","drugRate":"1%","severity":"Moderate"},{"effect":"Phimosis","drugRate":"1%","severity":"Severe"},{"effect":"Inguinal lymphadenitis","drugRate":"1%","severity":"Moderate"},{"effect":"Urethral meatal stenosis","drugRate":"1%","severity":"Severe"},{"effect":"Dysuria","drugRate":"1%","severity":"Moderate"},{"effect":"Genital herpes simplex","drugRate":"1%","severity":"Moderate"},{"effect":"Vulvitis","drugRate":"1%","severity":"Moderate"},{"effect":"Hypersensitivity","drugRate":"1%","severity":"Moderate"},{"effect":"Pruritus","drugRate":"1%","severity":"Mild"},{"effect":"Pyodermitis","drugRate":"1%","severity":"Moderate"},{"effect":"Skin ulcer","drugRate":"1%","severity":"Severe"},{"effect":"Erosions in the urethral meatus","drugRate":"1%","severity":"Severe"},{"effect":"Superinfection of warts and ulcers","drugRate":"1%","severity":"Severe"}],"contraindications":[],"specialPopulations":{"Immunosuppressed Patients":"Safety and effectiveness have not been established.","Treatment Beyond 16 Weeks":"Safety and effectiveness have not been established.","Multiple Treatment Courses":"Safety and effectiveness have not been established."}},"trials":[],"_chembl":{"chemblId":"CHEMBL1201723","moleculeType":"Unknown"},"aliases":[],"patents":[{"type":"Formulation","number":"7858662","applicant":"ANI PHARMACEUTICALS INC","territory":"US","tradeName":"VEREGEN","expiryDate":"2026-10-02"}],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":{"setId":"f0fc1e21-e3cf-4bce-860c-307f670b192e","title":"VEREGEN (SINECATECHINS) OINTMENT [ANI PHARMACEUTICALS, INC.]"},"ecosystem":[],"mechanism":{"target":"Unknown","novelty":"Veregen is the first botanical drug approved by the FDA for the treatment of external genital and perianal warts.","modality":"Topical ointment","drugClass":"Polyphenols","explanation":"In vitro studies suggest that sinecatechins have anti-oxidative properties, which may contribute to their therapeutic effect, although the clinical significance of this finding is not well understood.","oneSentence":"The exact mechanism of action of sinecatechins in the treatment of genital and perianal warts is unknown, but it has demonstrated anti-oxidative activity in vitro.","technicalDetail":"The anti-oxidative activity of sinecatechins may help reduce oxidative stress and inflammation associated with wart lesions, potentially aiding in their clearance."},"_scrapedAt":"2026-03-28T00:34:24.931Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not provided","launchDate":"Not provided","annualCostUS":"Not provided","currentRevenue":"Not provided","patientPopulation":"Immunocompetent adults 18 years and older with external genital and perianal warts","peakSalesEstimate":"Not provided"},"references":[],"biosimilars":[],"competitors":[],"indications":{"approved":["Topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04597359","phase":"PHASE2","title":"To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring","status":"ACTIVE_NOT_RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2021-10-05","conditions":"Prostate Carcinoma","enrollment":360},{"nctId":"NCT07137819","phase":"PHASE3","title":"Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis","status":"RECRUITING","sponsor":"Aresus Pharma GmbH","startDate":"2024-09-04","conditions":"Actinic Keratosis of Face and Scalp","enrollment":280},{"nctId":"NCT04055142","phase":"PHASE3","title":"Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males","status":"COMPLETED","sponsor":"Hospital Universitari Vall d'Hebron Research Institute","startDate":"2020-09-18","conditions":"High-grade Anal Intraepithelial Neoplasia","enrollment":108},{"nctId":"NCT03682601","phase":"PHASE2","title":"Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment","status":"TERMINATED","sponsor":"GTO Pharmaceutical, LLC","startDate":"2018-08-30","conditions":"Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy","enrollment":32},{"nctId":"NCT02147353","phase":"NA","title":"Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2011-09","conditions":"External Genital Warts","enrollment":42},{"nctId":"NCT02622568","phase":"PHASE4","title":"Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2015-07","conditions":"Verruca, Warts","enrollment":28},{"nctId":"NCT02029352","phase":"PHASE2, PHASE3","title":"Topical Green Tea Ointment in Treatment of Superficial Skin Cancer","status":"COMPLETED","sponsor":"Maastricht University Medical Center","startDate":"2014-11","conditions":"Carcinoma, Basal Cell","enrollment":42},{"nctId":"NCT01490008","phase":"PHASE1","title":"Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers","status":"COMPLETED","sponsor":"MediGene","startDate":"2011-12","conditions":"Anogenital Warts","enrollment":30},{"nctId":"NCT01222000","phase":"PHASE3","title":"Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous","status":"UNKNOWN","sponsor":"Centre Hospitalier Universitaire de Nice","startDate":"2010-10","conditions":"Lamellar Ichthyosis","enrollment":8},{"nctId":"NCT01082302","phase":"PHASE4","title":"Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage","status":"COMPLETED","sponsor":"MediGene","startDate":"2010-01","conditions":"Genital Warts, Perianal Warts","enrollment":43}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":72,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"approved","brandName":"SINECATECHINS","genericName":"SINECATECHINS","companyName":"","companyId":"","modality":"Topical ointment","firstApprovalDate":"2006","aiSummary":"Veregen (sinecatechins) is a topical ointment approved for treating external genital and perianal warts in immunocompetent adults aged 18 and older. Its mechanism of action is not fully understood, but it has shown anti-oxidative properties in vitro. Common side effects include local pain, erythema, and skin erosion. The drug is contraindicated in no specific conditions, and its safety and effectiveness have not been established in immunosuppressed patients or for treatments beyond 16 weeks.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2013-05-09T00:00:00.000Z","mah":"ANI PHARMS","brand_name_local":null,"application_number":"NDA021902"},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"patentsNormalised":[{"patent_number":"7858662","territory":"US","patent_type":"Formulation","expiry_date":"2026-10-02T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}