{"id":"moderate-dose-hydroxyurea","safety":{"commonSideEffects":[{"rate":"20-50","effect":"Myelosuppression (anemia, leukopenia, thrombocytopenia)"},{"rate":"common","effect":"Macrocytosis"},{"rate":"10-20","effect":"Nausea and vomiting"},{"rate":"5-15","effect":"Headache"},{"rate":"10-20","effect":"Elevated uric acid/hyperuricemia"},{"rate":"5-10","effect":"Cutaneous reactions"}]},"_chembl":{"chemblId":"CHEMBL467","moleculeType":"Small molecule","molecularWeight":"76.05"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hydroxyurea is a ribonucleotide reductase inhibitor that decreases deoxyribonucleotide pools, slowing DNA replication in rapidly dividing cells. In sickle cell disease, it increases fetal hemoglobin (HbF) expression, which inhibits polymerization of sickle hemoglobin and reduces vaso-occlusive crises. The moderate dose regimen aims to balance efficacy with tolerability.","oneSentence":"Hydroxyurea inhibits ribonucleotide reductase to reduce DNA synthesis and increase fetal hemoglobin production, thereby reducing sickling and hemolysis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:50:04.980Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Sickle cell disease (reduction of vaso-occlusive crises and acute chest syndrome)"},{"name":"Polycythemia vera"},{"name":"Essential thrombocythemia"}]},"trialDetails":[{"nctId":"NCT06526117","phase":"PHASE4","title":"Stroke Prevention in Nigeria 2 Trial","status":"RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2024-08-05","conditions":"Sickle Cell Disease, Stroke","enrollment":220},{"nctId":"NCT03013998","phase":"PHASE1, PHASE2","title":"Study of Biomarker-Based Treatment of Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"Beat AML, LLC","startDate":"2016-11","conditions":"Previously Untreated Relapsed Refractory Acute Myeloid Leukemia","enrollment":3000},{"nctId":"NCT04808778","phase":"","title":"Stroke Prevention in Young Adults With Sickle Cell Anemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2021-05-17","conditions":"Sickle Cell Disease, Sickle Cell Anemia, Stroke, Ischemic","enrollment":250},{"nctId":"NCT03944915","phase":"PHASE2","title":"De-Escalation Therapy for Human Papillomavirus Negative Disease","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2019-08-26","conditions":"Human Papilloma Virus, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck","enrollment":35},{"nctId":"NCT06761560","phase":"PHASE2, PHASE3","title":"Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia","status":"NOT_YET_RECRUITING","sponsor":"Yves Pastore","startDate":"2025-01-15","conditions":"Sickle Cell Disease (SCD)","enrollment":29},{"nctId":"NCT02675790","phase":"PHASE3","title":"Moderate Dose Hydroxyurea for Secondary Stroke Prevention in Children With Sickle Cell Disease in Sub-Saharan Africa","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2017-01","conditions":"Sickle Cell Disease, Sickle Cell Anemia, Stroke","enrollment":120},{"nctId":"NCT02560935","phase":"PHASE3","title":"Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2016-07-19","conditions":"Sickle Cell Disease, Stroke","enrollment":440}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Hydrea"],"phase":"phase_3","status":"active","brandName":"Moderate Dose Hydroxyurea","genericName":"Moderate Dose Hydroxyurea","companyName":"Vanderbilt University Medical Center","companyId":"vanderbilt-university-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Hydroxyurea inhibits ribonucleotide reductase to reduce DNA synthesis and increase fetal hemoglobin production, thereby reducing sickling and hemolysis. Used for Sickle cell disease (reduction of vaso-occlusive crises and acute chest syndrome), Polycythemia vera, Essential thrombocythemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}