{"id":"hydroxy-urea","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Warfarin","effect":"Increased risk of bleeding"},{"drug":"Thiopurines","effect":"Increased myelosuppression"}],"commonSideEffects":[{"effect":"Bone marrow suppression","drugRate":"30%","severity":"Moderate"},{"effect":"Nausea and vomiting","drugRate":"25%","severity":"Mild"},{"effect":"Diarrhea","drugRate":"20%","severity":"Mild"},{"effect":"Skin rash","drugRate":"15%","severity":"Mild"},{"effect":"Fatigue","drugRate":"10%","severity":"Mild"}],"contraindications":["Severe bone marrow depression","Known hypersensitivity to hydroxyurea"],"specialPopulations":{"lactation":"Not recommended due to potential harm to the nursing infant","pregnancy":"Category D: Risk to the fetus has been demonstrated","renalImpairment":"Dose adjustment may be required","hepaticImpairment":"Dose adjustment may be required"}},"trials":[],"_chembl":null,"aliases":["Hydroxy Urea tablet medication 20mg/kg/day"],"patents":[{"number":"US3142680A","issueDate":"1964-07-28","expirationDate":"1981-07-28"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1967","type":"Approval","milestone":"First approved for chronic myeloid leukemia","regulator":"FDA"},{"date":"1998","type":"Approval","milestone":"Approved for sickle cell disease","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Hydroxyurea is an antineoplastic agent primarily used in the treatment of chronic myeloid leukemia and sickle cell disease. It works by inhibiting DNA synthesis, leading to cell cycle arrest and apoptosis in rapidly dividing cells. Despite its therapeutic benefits, hydroxyurea has several side effects, including bone marrow suppression, gastrointestinal disturbances, and skin reactions. The drug is not approved by the FDA but is widely used in clinical practice, particularly in regions like Bangladesh where it is produced by institutions such as Bangabandhu Sheikh Mujib Medical University. Hydroxyurea's efficacy and safety profile make it a valuable treatment option for specific hematological conditions.","ecosystem":[],"mechanism":{"target":"Ribonucleotide reductase","novelty":"Hydroxyurea is a well-established drug with a long history of use, but its application in sickle cell disease represents a novel therapeutic approach.","modality":"Small molecule","drugClass":"Antimetabolite","explanation":"By inhibiting ribonucleotide reductase, hydroxyurea reduces the pool of deoxyribonucleotides necessary for DNA replication, thereby slowing down or stopping the proliferation of cancer cells and other rapidly dividing cells.","oneSentence":"Hydroxyurea inhibits ribonucleotide reductase, an enzyme essential for DNA synthesis, leading to cell cycle arrest and apoptosis in rapidly dividing cells.","technicalDetail":"Hydroxyurea specifically targets the M1 subunit of ribonucleotide reductase, which is responsible for converting ribonucleotides into deoxyribonucleotides, a critical step in DNA synthesis."},"_scrapedAt":"2026-03-27T23:40:47.059Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"N/A","launchDate":"N/A","annualCostUS":"N/A","currentRevenue":"N/A","patientPopulation":"N/A","peakSalesEstimate":"N/A"},"references":[],"biosimilars":[],"competitors":[{"name":"Droxia","company":"Bristol Myers Squibb"},{"name":"Hydrea","company":"Teva Pharmaceuticals"}],"indications":{"approved":["Chronic myeloid leukemia","Sickle cell disease"],"offLabel":["Polycythemia vera","Essential thrombocythemia"],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06456346","phase":"PHASE3","title":"Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-07-16","conditions":"Essential Thrombocythemia","enrollment":300},{"nctId":"NCT06439082","phase":"PHASE3","title":"A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 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