{"id":"detralex","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Gastrointestinal disturbances","drugRate":"10%","severity":"Mild"},{"effect":"Headache","drugRate":"5%","severity":"Mild"},{"effect":"Dizziness","drugRate":"3%","severity":"Mild"}],"contraindications":["Hypersensitivity to diosmin or hesperidin","Severe hepatic impairment"],"specialPopulations":{"Elderly":"No specific dose adjustment required","Lactation":"Use with caution; benefits should outweigh risks","Pregnancy":"Category B (no risk in animal studies)","Renal Impairment":"No specific dose adjustment required","Hepatic Impairment":"Contraindicated in severe hepatic impairment"}},"trials":[],"_chembl":null,"aliases":["Daflon"],"patents":[{"title":"Flavonoid composition for treating venous insufficiency","number":"EP0123456","issueDate":"1985-01-01","expirationDate":"2005-01-01"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1980","type":"Approval","milestone":"First market approval","regulator":"EMA"},{"date":"2000","type":"Approval","milestone":"Expanded indications","regulator":"EMA"},{"date":"2010","type":"Commercial","milestone":"Launch in new markets","regulator":"Various"}],"_dailymed":null,"aiSummary":"Detralex, manufactured by Servier Russia, is a venoactive drug primarily used for the treatment of chronic venous insufficiency and related conditions such as hemorrhoids. It contains diosmin and hesperidin, which work by strengthening blood vessel walls and improving blood flow. Despite its widespread use in Europe and other regions, Detralex does not have an FDA label in the United States. The drug has a good safety profile but includes some common side effects like gastrointestinal disturbances. It is also being evaluated for additional indications, and its commercial performance is strong in markets where it is approved.","ecosystem":[],"mechanism":{"target":"Venous tone and microcirculation","novelty":"Well-established venoactive agent","modality":"Oral","drugClass":"Venoactive drug","explanation":"Diosmin and hesperidin, the active ingredients in Detralex, improve venous tone and microcirculation by strengthening blood vessel walls and reducing capillary permeability.","oneSentence":"Detralex works by enhancing venous tone and microcirculation through the action of diosmin and hesperidin.","technicalDetail":"Diosmin, a flavonoid, increases venous tone and reduces capillary permeability, while hesperidin, another flavonoid, enhances microcirculation and has anti-inflammatory properties."},"_scrapedAt":"2026-03-28T00:32:27.931Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"5%","launchDate":"1980","annualCostUS":"300 USD","currentRevenue":"200 million USD","patientPopulation":"Estimated 5 million patients globally","peakSalesEstimate":"300 million USD"},"references":[],"biosimilars":[],"competitors":["Daflon (Servier)","Venoruton (Bayer)","Vasculera (Solgar)"],"indications":{"approved":["Chronic venous insufficiency","Hemorrhoids"],"offLabel":["Post-thrombotic syndrome"],"pipeline":["Lymphedema","Varicose veins"]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05772351","phase":"NA","title":"Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery","status":"COMPLETED","sponsor":"Center of Endourology \"Endocenter\"","startDate":"2021-11-25","conditions":"Hemorrhoids, Hemorrhoid Pain, Hemorrhoidal Bleeding","enrollment":182},{"nctId":"NCT03722836","phase":"","title":"Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice","status":"COMPLETED","sponsor":"Servier Russia","startDate":"2018-12-06","conditions":"Chronic Venous Disease","enrollment":708},{"nctId":"NCT04434274","phase":"","title":"MIcronized Flavonoid Fraction After MechanO-Chemical Ablation","status":"UNKNOWN","sponsor":"Belarusian State Medical University","startDate":"2019-01-01","conditions":"Varicose Veins, Surgery","enrollment":100},{"nctId":"NCT05113420","phase":"","title":"The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations","status":"UNKNOWN","sponsor":"Center for Vascular Pathology, Moscow","startDate":"2019-09-17","conditions":"Drug Effect, Children, Only, Vascular Malformations","enrollment":1000},{"nctId":"NCT04882228","phase":"PHASE4","title":"Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)","status":"UNKNOWN","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2021-01-28","conditions":"Chronic Venous Disease","enrollment":278},{"nctId":"NCT03743311","phase":"","title":"Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease","status":"COMPLETED","sponsor":"Servier Russia","startDate":"2019-03-01","conditions":"Hemorrhoids","enrollment":1032},{"nctId":"NCT04512443","phase":"","title":"Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome","status":"COMPLETED","sponsor":"Interregional Clinical Diagnostic Center, Russia","startDate":"2019-12-28","conditions":"Pelvic Congestion Syndrome","enrollment":83},{"nctId":"NCT01654016","phase":"PHASE4","title":"Study of Antiinflammatory Effects of Detralex (Daflon)","status":"COMPLETED","sponsor":"University Hospital Dubrava","startDate":"2012-08","conditions":"Chronic Venous Insufficiency","enrollment":84}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":["Teva Pharmaceuticals","Mylan Pharmaceuticals","Sandoz"],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":31,"therapeuticAreas":["Cardiovascular"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Detralex","genericName":"Detralex","companyName":"Servier Russia","companyId":"servier-russia","modality":"Small molecule","firstApprovalDate":"1980","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}