{"id":"dutasteride","rwe":[],"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Ejaculation disorders","drugRate":"","severity":"common","organSystem":""},{"effect":"Impotence","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased libido","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Breast disorders","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Breastfeeding (mother)","Cataract surgery","Disease of liver","Dizziness","High-Grade Prostate Cancer","Intraoperative floppy iris syndrome","Oligozoospermia","Orthostatic hypotension","Pregnancy, function","Priapism","Syncope"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"High-grade prostate cancer (Gleason score 8-10)","drugRate":"1%","severity":"serious"},{"effect":"Cardiac failure","drugRate":"0.7%","severity":"serious"}]},"status":"approved","trials":["NCT00780754","NCT06677177","NCT01473030","NCT02014584","NCT00161421","NCT06001619","NCT02184585","NCT02159690","NCT07421804","NCT00690950","NCT06282731","NCT07444385","NCT06264414","NCT01653925","NCT02869971","NCT01254071","NCT00668642","NCT01004809","NCT01529086","NCT01777269","NCT01484808","NCT01351987","NCT07417449","NCT01435954","NCT01673490","NCT02509104","NCT01193855","NCT00309855","NCT01376284","NCT03240939","NCT00398281","NCT01390870","NCT00472251","NCT00985738","NCT01215292","NCT00853697","NCT00953576","NCT01376258","NCT01381510","NCT00399165","NCT01957189","NCT00431626","NCT01231607","NCT07420517","NCT01923090","NCT02839122","NCT00673127","NCT00490555","NCT05513365","NCT01337258"],"aliases":["Avodart"],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1922/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$70","description":"DUTASTERIDE 0.5 MG CAPSULE","retrievedDate":"2026-04-07"}],"allNames":"avodart","offLabel":[],"timeline":[],"aiSummary":"Dutasteride (Avodart) is a dual 5-alpha-reductase inhibitor developed by GSK, approved in 2001. More complete DHT suppression than finasteride. Available generically.","brandName":"Avodart","companyId":"gsk","ecosystem":[],"mechanism":{"target":"3-oxo-5-alpha-steroid 4-dehydrogenase 1, 3-oxo-5-alpha-steroid 4-dehydrogenase 2, Glycine receptor subunit alpha-1","novelty":"","modality":"Small molecule","drugClass":"5-alpha-reductase inhibitor (dual)","explanation":"Dutasteride inhibits both type I and type II 5-alpha-reductase, suppressing serum DHT by >90% compared to ~70% with finasteride. This more complete DHT suppression may provide greater prostate volume reduction in BPH. Very long half-life (5 weeks) means effects persist long after discontinuation.","oneSentence":"Dual 5-alpha-reductase inhibitor (types I and II) that more completely suppresses DHT than finasteride for BPH treatment.","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"GSK (GlaxoSmithKline)","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"dutasteride","indications":{"approved":[{"name":"Benign prostatic hyperplasia","diseaseId":"benign-prostatic-hyperplasia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00780754","phase":"Phase 3","title":"Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate","status":"COMPLETED","sponsor":"Kaunas University of Medicine","isPivotal":true,"enrollment":200,"indication":"Prostate Cancer","completionDate":"2010-12"},{"nctId":"NCT06677177","phase":"NA","title":"The Efficacy of Nano-water in Combination With Tamsulosin-Dutasteride for Alleviating Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia","status":"COMPLETED","sponsor":"ALI KAMAL M. 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