{"id":"hydroxyurea-low-dose","safety":{"commonSideEffects":[{"rate":null,"effect":"Myelosuppression (anemia, leukopenia, thrombocytopenia)"},{"rate":null,"effect":"Macrocytosis"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Elevated uric acid/hyperuricemia"}]},"_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 promotes the production of fetal hemoglobin (HbF), which does not polymerize like sickle hemoglobin (HbS). By increasing HbF levels and reducing the proportion of HbS, low-dose hydroxyurea decreases hemolysis, vaso-occlusive crises, and organ damage in sickle cell disease. It also has anti-inflammatory and anti-proliferative effects that contribute to its therapeutic benefit.","oneSentence":"Low-dose hydroxyurea increases fetal hemoglobin (HbF) production and reduces sickling of red blood cells by inhibiting ribonucleotide reductase.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:55:20.992Z","_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":"NCT03165734","phase":"PHASE3","title":"A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2017-06-26","conditions":"Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis","enrollment":399},{"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":"NCT04229979","phase":"PHASE3","title":"Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sellas Life Sciences Group","startDate":"2021-02-08","conditions":"Acute Myeloid Leukemia","enrollment":127},{"nctId":"NCT04808778","phase":"","title":"Stroke Prevention in Young Adults With Sickle Cell 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Mutation","status":"COMPLETED","sponsor":"Celgene","startDate":"2015-12-30","conditions":"Leukemia, Myeloid, Isocitrate Dehydrogenase","enrollment":319},{"nctId":"NCT03107182","phase":"PHASE2","title":"Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2017-06-27","conditions":"HPV-Related Squamous Cell Carcinoma, HNSCC","enrollment":72},{"nctId":"NCT01499888","phase":"PHASE1, PHASE2","title":"Ph I/II Study of Allogeneic SCT for Clinically Aggressive Sickle Cell Disease (SCD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Illinois at Chicago","startDate":"2011-11-11","conditions":"Sickle Cell Disease","enrollment":45},{"nctId":"NCT02258659","phase":"PHASE2","title":"Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2014-09-22","conditions":"Human Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx","enrollment":62},{"nctId":"NCT06503458","phase":"","title":"A Low-Interventional Study of an Electronic Sickle Cell Disease Patient Reported Outcomes in Sickle Cell Participants","status":"TERMINATED","sponsor":"Sanguine Biosciences","startDate":"2022-01-19","conditions":"Sickle Cell Disease, Sickle Cell Anemia","enrollment":52},{"nctId":"NCT05407805","phase":"","title":"A Study to Learn About Sickle Cell Disease In Adult Patients","status":"COMPLETED","sponsor":"Pfizer","startDate":"2022-02-10","conditions":"Sickle Cell Disease","enrollment":98},{"nctId":"NCT06239389","phase":"PHASE2","title":"Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.","status":"COMPLETED","sponsor":"National Institute of Blood and Marrow Transplant (NIBMT), Pakistan","startDate":"2021-09-01","conditions":"Beta-Thalassemia","enrollment":24},{"nctId":"NCT01387763","phase":"PHASE3","title":"A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms","status":"COMPLETED","sponsor":"Thomas Stauffer Larsen","startDate":"2012-01","conditions":"Polycythemia Vera, Essential Thrombocythemia, Primary Myelofibrosis","enrollment":202},{"nctId":"NCT03651102","phase":"PHASE2, PHASE3","title":"Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia","status":"COMPLETED","sponsor":"Blood Diseases Clinic","startDate":"2018-01-01","conditions":"Thalassemia","enrollment":654},{"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":"NCT05132270","phase":"PHASE2, PHASE3","title":"Clinical Experience of Thalidomide in Thalassemic Patients","status":"COMPLETED","sponsor":"Children's Hospital Karachi","startDate":"2020-01-01","conditions":"Thalassemia, Beta","enrollment":135},{"nctId":"NCT01597401","phase":"PHASE1","title":"A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2012-05-12","conditions":"Sickle Cell Disease","enrollment":19},{"nctId":"NCT01801423","phase":"NA","title":"Sickle Cell Disease - Stroke Prevention in Nigeria Trial","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2013-04-24","conditions":"Sickle Cell Anemia, Sickle Cell Disease, Stroke","enrollment":29},{"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},{"nctId":"NCT01895361","phase":"PHASE2","title":"Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises","status":"COMPLETED","sponsor":"Reprixys Pharmaceutical Corporation","startDate":"2013-07","conditions":"Sickle Cell Disease","enrollment":198},{"nctId":"NCT00055874","phase":"PHASE3","title":"Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia","status":"COMPLETED","sponsor":"Heidelberg University","startDate":"2002-06","conditions":"Leukemia","enrollment":1551},{"nctId":"NCT00152113","phase":"PHASE1","title":"Haploidentical Stem Cell Transplant for Patients With Sickle Cell Disease and Prior Stroke or Abnormal Transcranial Ultrasound","status":"COMPLETED","sponsor":"St. Jude Children's Research Hospital","startDate":"2005-04","conditions":"Sickle Cell Disease","enrollment":5},{"nctId":"NCT00940784","phase":"PHASE2","title":"Clopidogrel and Aspirin for the Treatment of Polycythemia Vera","status":"WITHDRAWN","sponsor":"Ronald Hoffman","startDate":"2009-06","conditions":"Polycythemia Vera","enrollment":""},{"nctId":"NCT00002869","phase":"PHASE3","title":"Interferon Alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia","status":"UNKNOWN","sponsor":"Medical Research Council","startDate":"1995-04","conditions":"Leukemia","enrollment":800},{"nctId":"NCT00615927","phase":"PHASE2","title":"Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)","status":"COMPLETED","sponsor":"Duke University","startDate":"2006-02","conditions":"Glioblastoma, Gliosarcoma","enrollment":64},{"nctId":"NCT01645124","phase":"PHASE3","title":"Large-scale Trial Testing the Intensity of CYTOreductive Therapy in Polycythemia Vera (PV)","status":"TERMINATED","sponsor":"Consorzio Mario Negri Sud","startDate":"2008-05","conditions":"Polycythemia Vera","enrollment":365},{"nctId":"NCT00040677","phase":"PHASE2","title":"A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia.","status":"COMPLETED","sponsor":"Icagen","startDate":"2002-02","conditions":"Sickle Cell Disease, Sickle Cell 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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}}