Hydroxyurea Clinical Trials

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50mg	USD 147
200mg	USD 270

Clinical Trials

Numerous clinical trials evaluate hydroxyurea across various hematologic disorders and malignant neoplasms. Spanning Early Phase 1 through Phase 3, these studies assess its safety and efficacy in pediatric and adult patients with conditions such as sickle cell disease, vaso-occlusive crises, polycythemia vera, thalassemia intermedia, acute myeloid leukemia, myelodysplastic syndromes, glioblastoma, and advanced head and neck carcinomas. Supported by academic medical centers, government institutes, and pharmaceutical sponsors, these trials encompass recruiting, active, and completed statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07616154	RECRUITING	Sickle Cell Disease	St. Jude Children's Research Hospital	2026-09	PHASE2
NCT07722611	NOT_YET_RECRUITING	Polycythemia Vera	Merck Sharp & Dohme LLC	2026-09-21	PHASE2; PHASE3
NCT07708714	RECRUITING	Sickle Cell Disease; Sickle Cell Anemia in Children	Children's Hospital Medical Center, Cincinnati	2026-05-13	PHASE1; PHASE2
NCT06526117	RECRUITING	Sickle Cell Disease; Stroke	Vanderbilt University Medical Center	2024-08-05	PHASE4
NCT06439082	RECRUITING	Sickle Cell Disease	Novartis Pharmaceuticals	2024-10-24	PHASE3
NCT07766850	NOT_YET_RECRUITING	R/R AML	Christer C Nilsson	2026-10	PHASE1; PHASE2
NCT07507760	RECRUITING	Acute Myeloid Leukemia With Gene Mutations	PETHEMA Foundation	2026-06-12	PHASE2
NCT07190833	RECRUITING	Treatment-Refractory Solid Tumors	Bionoxx Inc.	2026-03-09	PHASE1
NCT07170592	NOT_YET_RECRUITING	Treatment-Refractory Solid Tumors	Bionoxx Inc.	2027-01	PHASE1
NCT06761560	RECRUITING	Sickle Cell Disease (SCD)	Yves Pastore	2026-02-03	PHASE2; PHASE3
NCT03653338	RECRUITING	Sickle Cell Anemia; Beta-thalassemia Major; Diamond-blackfan Anemia	Paul Szabolcs	2018-08-02	PHASE1; PHASE2
NCT07033598	RECRUITING	Leukemia, Myelomonocytic, Chronic	Theradex	2026-01-01	PHASE2
NCT06871410	RECRUITING	Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	Roswell Park Cancer Institute	2026-02-02	PHASE1
NCT05870475	RECRUITING	Polycythemia Vera	Institute of Hematology & Blood Diseases Hospital, China	2023-06-30	PHASE2
NCT05526924	RECRUITING	Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma; Head and Neck Cancer Stage IV; Head and Neck Cancers - Throat	University of Chicago	2023-03-07	PHASE1
NCT06930352	RECRUITING	Acute Myeloid Leukemia	Uma Borate	2026-10-01	PHASE2
NCT03500731	RECRUITING	Idiopathic Pulmonary Fibrosis; Emphysema or COPD	Paul Szabolcs	2018-04-19	PHASE1; PHASE2
NCT06171217	ACTIVE_NOT_RECRUITING	Sickle Cell Disease; Children	Children's Hospital Medical Center, Cincinnati	2023-10-27	PHASE2
NCT06456346	ACTIVE_NOT_RECRUITING	Essential Thrombocythemia	Merck Sharp & Dohme LLC	2024-07-16	PHASE3
NCT05953584	RECRUITING	Sickle Cell Disease	Forma Therapeutics, Inc.	2023-06-20	PHASE2
NCT06079879	ACTIVE_NOT_RECRUITING	Essential Thrombocythemia	Merck Sharp & Dohme LLC	2023-12-31	PHASE3
NCT07232290	RECRUITING	Polycythemia Vera (PV)	Chengdu Zenitar Biomedical Technology Co., Ltd	2025-09-23	PHASE2
NCT06318143	RECRUITING	Sickle Cell Disease	New York University	2024-07-01
NCT07673302	RECRUITING	Thalassemia	Riphah International University	2026-06-20
NCT05662098	ACTIVE_NOT_RECRUITING	Sickle Cell Disease	Children's Hospital Medical Center, Cincinnati	2022-06-16	EARLY_PHASE1
NCT07177300	RECRUITING	Sickle Cell Anemia (HbSS); Sickle-β0-thalassemia (HbSβ0)	Children's Hospital Medical Center, Cincinnati	2024-12-19	PHASE4
NCT02286154	ACTIVE_NOT_RECRUITING	Anemia, Sickle Cell	Children's Hospital Medical Center, Cincinnati	2014-10
NCT01962415	RECRUITING	Primary Immunodeficiency (PID); Congenital Bone Marrow Failure Syndromes; Inherited Metabolic Disorders (IMD); Hereditary Anemias; Inflammatory Conditions; Systemic Juvenile Idiopathic Arthritis (sJIA); Juvenile Rheumatoid Arthritis (JRA)	Paul Szabolcs	2014-02-04	PHASE2
NCT05285917	RECRUITING	Sickle Cell Anemia in Children; Sickle Cell Disease	Brown University	2023-11-15	PHASE3
NCT06264700	COMPLETED	Sickle Cell Disease	Nationwide Children's Hospital	2024-07-11
NCT06093672	RECRUITING	Polycythemia Vera	Italfarmaco	2024-03-26	PHASE3
NCT04362293	ACTIVE_NOT_RECRUITING	Sickle Cell Disease	St. Jude Children's Research Hospital	2020-04-30	PHASE2
NCT05853458	TERMINATED	Polycythemia Vera	Novartis Pharmaceuticals	2023-07-28	PHASE4
NCT06606886	COMPLETED	Transfusion Dependent Beta-thalassemia	Bahria University	2024-09-16	PHASE4
NCT06063317	TERMINATED	Solid Tumor, Adult	Imugene Limited	2023-10-02	PHASE1
NCT05357482	ACTIVE_NOT_RECRUITING	Sickle Cell Anemia; Beta Thalassemia	National Heart, Lung, and Blood Institute (NHLBI)	2022-05-12	PHASE1; PHASE2
NCT06299670	COMPLETED	Transfusion-dependent Thalassemia	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	2023-11-01	PHASE4
NCT06881056	RECRUITING	Respiratory Syncytial Virus (RSV)	West China Second University Hospital	2024-07-17
NCT07292259	COMPLETED	Transfusion Dependent Beta Thalassemia	Pakistan Blood and Marrow Transplant (PBMT) Group	2024-01-01	PHASE2
NCT06199557	RECRUITING	Acute Myeloid Leukemia, Adult; Myelodysplastic Syndromes, Adult	Haukeland University Hospital	2024-05-23	PHASE1; PHASE2
NCT06552429	RECRUITING	Essential Thrombocythemia	Xiamen Amoytop Biotech Co., Ltd.	2024-08-29	PHASE2
NCT06464458	UNKNOWN	Sickle Cell Disease	University Hospital, Strasbourg, France	2023-02-08
NCT05434000	UNKNOWN	Sickle Cell Disease; Stroke	Barau Dikko Teaching Hospital	2021-01-06
NCT05405114	COMPLETED	Sickle Cell Disease	Novo Nordisk A/S	2022-07-07	PHASE2
NCT05062278	UNKNOWN	AML; Hyperleukocytosis	Hospital Universitario Dr. Jose E. Gonzalez	2021-07-26	PHASE2
NCT03789591	COMPLETED	Sickle Cell Disease; Sickle Cell Anemia	Lifespan	2019-01-17	PHASE3
NCT04750707	COMPLETED	Sickle Cell Anemia in Children	Global Health Uganda LTD	2021-03-09	PHASE3
NCT03263559	COMPLETED	Sickle Cell Disease	Medical College of Wisconsin	2017-10-03	PHASE2
NCT07066072	COMPLETED	the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients	Cairo University	2022-12-01
NCT05451940	COMPLETED	Anemia, Sickle Cell; Sickle Cell Disease	Julia Xu	2023-05-25	PHASE1; PHASE2
NCT03474965	COMPLETED	Sickle Cell Disease (SCD)	Novartis Pharmaceuticals	2018-10-01	PHASE2
NCT03107182	COMPLETED	HPV-Related Squamous Cell Carcinoma; HNSCC	University of Chicago	2017-06-27	PHASE2
NCT02258659	COMPLETED	Human Papilloma Virus Infection; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Oropharynx	University of Chicago	2014-09-22	PHASE2
NCT04126681	COMPLETED	Chronic Myeloid Leukemia, Chronic Phase	Ascentage Pharma Group Inc.	2019-10-21	PHASE2
NCT04691323	COMPLETED	Sickle Cell Disease; Sickle B+ Thalassemia; Sickle Beta Zero Thalassemia; Sickle Cell Hemoglobin C	Ann & Robert H Lurie Children's Hospital of Chicago	2021-03-02
NCT06490601	ACTIVE_NOT_RECRUITING	Fetal Hemoglobin; Beta-Thalassemia; Hemoglobinopathies	National Institute of Blood and Marrow Transplant (NIBMT), Pakistan	2022-04-01	PHASE2
NCT04662931	COMPLETED	Sickle Cell Disease (SCD)	Novartis Pharmaceuticals	2021-07-14	PHASE4
NCT01847326	COMPLETED	Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Tongue Cancer	University of Chicago	2013-03-26	PHASE1
NCT03944915	COMPLETED	Human Papilloma Virus; Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Head and Neck; HPV-Related Squamous Cell Carcinoma; HNSCC	University of Chicago	2019-08-26	PHASE2
NCT05020652	COMPLETED	Moderate and High Risk Myelofibrosis	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	2021-11-11	PHASE2
NCT06171217	Recruiting	Sickle Cell Disease\|Children	Children''s Hospital Medical Center Cincinnati\|National Heart Lung and Blood Institute (NHLBI)	2023-10-27	Phase 2
NCT06153784	COMPLETED	Thalassemia, Beta	Children's Hospital Karachi	2020-07-07	PHASE2; PHASE3
NCT03077542	ACTIVE_NOT_RECRUITING	Sickle Cell Disease	National Heart, Lung, and Blood Institute (NHLBI)	2017-04-06	PHASE1; PHASE2
NCT05142254	COMPLETED	Priapism Due to Sickle Cell Disease	Vanderbilt University Medical Center	2022-04-01	PHASE2
NCT05909657	Recruiting	Sickle Cell Disease	The University of The West Indies	2023-07-01	--
NCT03264989	COMPLETED	Sickle Cell Disease (SCD)	Novartis Pharmaceuticals	2017-12-19	PHASE2
NCT05005182	TERMINATED	Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified; Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified	Mayo Clinic	2023-02-20	PHASE2
NCT02493530	COMPLETED	Myelofibrosis; Polycythemia Vera	Vanderbilt-Ingram Cancer Center	2015-07	PHASE1
NCT05548062	Recruiting	Polycythemia Vera	Novartis Pharmaceuticals\|Novartis	2023-03-02	--
NCT02556099	COMPLETED	Sickle Cell Anemia	Children's Hospital Medical Center, Cincinnati	2014-08	PHASE2
NCT03634488	COMPLETED	Sickle Cell Anemia; Severe Acute Malnutrition	Vanderbilt University Medical Center	2021-08-18	PHASE2
NCT03860844	TERMINATED	Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia	Sanofi	2019-08-06	PHASE2
NCT05485948	ACTIVE_NOT_RECRUITING	Polycythemia Vera	PharmaEssentia	2021-10-08	PHASE2
NCT03948867	ACTIVE_NOT_RECRUITING	Sickle Cell Anemia in Children	Children's Hospital Medical Center, Cincinnati	2019-04-24	PHASE2
NCT02899169	UNKNOWN	Acute Promyelocytic Leukemia	First Affiliated Hospital Xi'an Jiaotong University	2016-09-01	PHASE3
NCT03814746	ACTIVE_NOT_RECRUITING	Sickle Cell Disease (SCD)	Novartis Pharmaceuticals	2019-07-26	PHASE3
NCT05662098	Recruiting	Sickle Cell Disease	Children''s Hospital Medical Center Cincinnati\|Jinja Regional Referral Hospital (JRRH) Sickle Cell Clinic Jinja Uganda	2022-06-16	Early Phase 1
NCT01389024	COMPLETED	Sickle Cell Disease; Stroke	Johns Hopkins University	2012-08-16	PHASE2
NCT04080167	COMPLETED	Sickle Cell Disease	St. Jude Children's Research Hospital	2019-11-11
NCT03442114	COMPLETED	Sickle Cell Anemia; Children, Only	Children's Hospital Medical Center, Cincinnati	2018-07-12
NCT03825341	TERMINATED	Sickle Cell Disease; Thalassemia	St. Jude Children's Research Hospital	2019-06-10	PHASE2
NCT03462511	COMPLETED	Sickle Cell Disease	Columbia University	2018-08-15
NCT02757885	COMPLETED	Sickle Cell Disease	Emory University	2019-07-10	PHASE2
NCT06239389	COMPLETED	Beta-Thalassemia	National Institute of Blood and Marrow Transplant (NIBMT), Pakistan	2021-09-01	PHASE2
NCT03651102	COMPLETED	Thalassemia	Blood Diseases Clinic	2018-01-01	PHASE2; PHASE3
NCT02214407	COMPLETED	MDS	Groupe Francophone des Myelodysplasies	2014-10-14	PHASE3
NCT03644953	COMPLETED	Sickle Cell Disease	Children's National Research Institute	2018-10-30	PHASE2
NCT02962388	TERMINATED	Essential Thrombocythemia	French Innovative Leukemia Organisation	2017-01-03	PHASE2; PHASE3
NCT03463733	UNKNOWN	Glioma; Glioblastoma	M.E. van Linde	2018-03-02	PHASE1
NCT03763656	COMPLETED	Sickle Cell Disease; Sickle-Cell; Hemoglobin Disease, Thalassemia; Sickle Cell-beta-thalassemia; Sickle Cell Hemoglobin C	Nova Laboratories Limited	2019-01-03	PHASE1; PHASE2
NCT05132270	COMPLETED	Thalassemia, Beta	Children's Hospital Karachi	2020-01-01	PHASE2; PHASE3
NCT04292314	COMPLETED	Iron Overload; Oxidative Stress; Thalassemia Major	Beni-Suef University	2019-11-01	PHASE2; PHASE3
NCT04301336	COMPLETED	Vaso-occlusive Crisis; Sickle Cell Disease; Sickle Cell Anemia in Children	Beni-Suef University	2019-11-01	PHASE2; PHASE3
NCT03123588	TERMINATED	MPN (Myeloproliferative Neoplasms)	Incyte Corporation	2017-11-14	PHASE2
NCT02042222	COMPLETED	Sickle Cell Disease	Baylor College of Medicine	2013-10	EARLY_PHASE1
NCT04675645	COMPLETED	Sickle Cell Disease; Sickle B+ Thalassemia; Sickle Beta Zero Thalassemia; Sickle Cell Hemoglobin C	Ann & Robert H Lurie Children's Hospital of Chicago	2018-05-15
NCT03020615	COMPLETED	Sickle Cell Anemia	St. Jude Children's Research Hospital	2017-05-12	PHASE2
NCT01387763	COMPLETED	Polycythemia Vera; Essential Thrombocythemia; Primary Myelofibrosis	Thomas Stauffer Larsen	2012-01	PHASE3
NCT05681598	COMPLETED	Sickle-Cell Anaemia	University of Kinshasa	2017-08-30
NCT03515018	UNKNOWN	Leukemia, Chronic Myeloid	First Affiliated Hospital of Harbin Medical University	2018-05-01	PHASE3
NCT02675790	COMPLETED	Sickle Cell Disease; Sickle Cell Anemia; Stroke	Vanderbilt University Medical Center	2017-01	PHASE3
NCT03287245	TERMINATED	Polycythemia Vera	Hoffmann-La Roche	2018-02-21	PHASE2
NCT02560935	COMPLETED	Sickle Cell Disease; Stroke	Vanderbilt University Medical Center	2016-07-19	PHASE3
NCT02611973	UNKNOWN	MPN; Essential Thrombocythemia	Assistance Publique - Hôpitaux de Paris	2016-03-10	PHASE3
NCT03577691	TERMINATED	Sickle Cell Disease	Emory University	2018-08-03
NCT02769845	COMPLETED	Sickle Cell Anemia	Children's Hospital Medical Center, Cincinnati	2016-03-16
NCT02578017	COMPLETED	Sickle Cell Disease	Nationwide Children's Hospital	2014-07
NCT03128515	COMPLETED	Sickle Cell Anemia; Sickle Cell Disease; Malaria	Indiana University	2017-07-26	PHASE3
NCT01801423	COMPLETED	Sickle Cell Anemia; Sickle Cell Disease; Stroke	Vanderbilt University Medical Center	2013-04-24
NCT02371720	COMPLETED	Sickle Cell Disease	Emory University	2014-06-01
NCT02197845	COMPLETED	Sickle Cell Disease	Virginia Commonwealth University	2012-10
NCT01966731	ACTIVE_NOT_RECRUITING	Sickle Cell Disease	Children's Hospital Medical Center, Cincinnati	2014-06	PHASE1; PHASE2
NCT01185171	COMPLETED	Head and Neck Cancer	University of Chicago	2003-01-27	PHASE2
NCT01964755	TERMINATED	Epstein Barr Virus Associated Non Hodgkin's Lymphoma; Epstein Barr Virus Associated Hodgkin's Lymphoma; Post-Transplant Lymphoproliferative Disease	University of Miami	2009-04-21	PHASE2
NCT02225132	COMPLETED	Sickle Cell Disease	National Heart, Lung, and Blood Institute (NHLBI)	2014-08-23	PHASE1; PHASE2
NCT03183375	UNKNOWN	Thalassemia, Beta	Dr.Saqib Hussain Ansari	2017-08-21	PHASE2
NCT01960413	COMPLETED	Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)	Vanderbilt University Medical Center	2013-11	PHASE2
NCT01711541	COMPLETED	Head and Neck Squamous Cell Carcinoma; Stage IVA Oropharyngeal Carcinoma AJCC v7; Stage IVB Oropharyngeal Carcinoma AJCC v7	National Cancer Institute (NCI)	2012-10-22	PHASE1; PHASE2
NCT02844673	COMPLETED	Sickle Cell Anaemia	Muhimbili University of Health and Allied Sciences	2017-04-28	PHASE2
NCT02088541	COMPLETED	Acute Myeloid Leukemia (AML)	Karyopharm Therapeutics Inc	2014-03	PHASE2
NCT02292446	COMPLETED	Polycythemia Vera	Novartis Pharmaceuticals	2014-11-21	PHASE3
NCT02640573	TERMINATED	Hemoglobin SC Disease	Baylor College of Medicine	2015-10-12	PHASE2
NCT02149537	COMPLETED	Sickle Cell Disease; Sickle Cell Anemia	Loyola University	2014-12	PHASE4
NCT01259856	COMPLETED	High Risk Polycythemia Vera; High Risk Essential Thrombocythemia	Ronald Hoffman	2011-09	PHASE3
NCT03062501	UNKNOWN	Anemia, Sickle Cell; Anemia; Sickle-Cell, With Crisis	Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti	2016-11	PHASE2
NCT02336373	TERMINATED	Hemoglobin SC Disease	Baylor College of Medicine	2014-12	PHASE2
NCT00117572	COMPLETED	Cancer of the Pharynx; Cancer of the Larynx; Cancer of the Nasal Cavity; Paranasal Sinus Neoplasms; Cancer of the Oral Cavity	University of Chicago	2004-11	PHASE3
NCT01259817	COMPLETED	High Risk Polycythemia Vera; High Risk Essential Thrombocythemia	Ronald Hoffman	2011-09	PHASE2
NCT02522104	COMPLETED	Sickle Cell Disease; Renal Function Disorder	Theravia	2015-09-03	PHASE4
NCT00175838	COMPLETED	Thrombocythemia; Myeloproliferative Disorder	University of Cambridge	1997-07
NCT01976416	COMPLETED	Sickle Cell Anemia; Sickle Cell Disease; Malaria	Indiana University	2014-09	PHASE3
NCT02114203	COMPLETED	Phase 1 Sickle Cell	Pfizer	2014-12	PHASE1
NCT01949805	COMPLETED	Polycythemia Vera	AOP Orphan Pharmaceuticals AG	2013-09	PHASE3
NCT01895361	COMPLETED	Sickle Cell Disease	Reprixys Pharmaceutical Corporation	2013-07	PHASE2
NCT00202644	COMPLETED	Thrombocythemia, Hemorrhagic	Shire	2006-01-13	PHASE4
NCT02029742	COMPLETED	Sickle Cell Disease	Columbia University	2013-09
NCT02038036	COMPLETED	Polycythemia Vera	Novartis Pharmaceuticals	2014-03-25	PHASE3
NCT00706810	COMPLETED	Cancer; Brain Cancer; Meningioma	University of Utah	2007-12	PHASE2
NCT02090296	WITHDRAWN	Sickle Cell Anemia	Children's National Research Institute	2014-02	PHASE2
NCT01425307	TERMINATED	Sickle Cell Anemia	Children's Hospital Medical Center, Cincinnati	2011-08	PHASE3
NCT00978146	WITHDRAWN	Desmoid Tumors; Fibromatosis	Children's Hospital of Philadelphia	2009-10	PHASE2
NCT01950585	WITHDRAWN	Pulmonary Hypertension	National Heart, Lung, and Blood Institute (NHLBI)	2013-09-06	EARLY_PHASE1
NCT00383448	COMPLETED	Adrenoleukodystrophy; Metachromatic Leukodystrophy; Globoid Cell Leukodystrophy; Tay Sachs Disease; Sandhoffs Disease; Wolman Disease; I-Cell Disease; Sanfilippo Syndrome; GM1 Gangliosidosis	Masonic Cancer Center, University of Minnesota	2006-09	PHASE2
NCT01848925	COMPLETED	Sickle Cell Disease	Prolong Pharmaceuticals	2013-05	PHASE1
NCT01632904	COMPLETED	Polycythemia Vera	Incyte Corporation	2012-06	PHASE3
NCT01243944	COMPLETED	Polycythemia Vera	Incyte Corporation	2010-10-27	PHASE3
NCT01531387	TERMINATED	Sickle Cell Anemia	Children's Hospital Medical Center, Cincinnati	2012-05	PHASE3
NCT01103583	TERMINATED	Multiple Sclerosis	S. Andrea Hospital	2011-07	PHASE2; PHASE3
NCT01506544	COMPLETED	Sickle Cell Anemia	Children's Mercy Hospital Kansas City	2011-12	PHASE1
NCT01521299	WITHDRAWN	Advanced Solid Tumors	Dartmouth-Hitchcock Medical Center	2012-03	PHASE1
NCT01609192	COMPLETED	Drepanocytic Men Treated by Hydroxyurea for the First Time	Assistance Publique - Hôpitaux de Paris	2010-04	PHASE4
NCT01624038	UNKNOWN	Thalassemia Intermedia	Ain Shams University	2012-06	PHASE2; PHASE3
NCT00672789	COMPLETED	Sickle Cell Anemia	Duke University	2008-04
NCT01420783	COMPLETED	Hematopoietic Neoplasm	Bristol-Myers Squibb	2011-10	PHASE2
NCT00468169	COMPLETED	Head and Neck Cancer	University of Chicago	2006-07	PHASE2
NCT01645124	TERMINATED	Polycythemia Vera	Consorzio Mario Negri Sud	2008-05	PHASE3
NCT00055874	COMPLETED	Leukemia	Heidelberg University	2002-06	PHASE3
NCT00568698	COMPLETED	Muscular Atrophy, Spinal	Stanford University	2004-01	PHASE1; PHASE2
NCT02480608	COMPLETED	Leukemia, Myelogenous, Chronic, BCR-ABL Positive	University of Leipzig	2004-04	PHASE1; PHASE2
NCT00928707	COMPLETED	Polycythemia Vera	Italfarmaco	2009-06	PHASE2
NCT00462735	COMPLETED	Head and Neck Cancer; Cancer of the Pharynx; Cancer of the Larynx; Nose Neoplasms; Paranasal Sinus Neoplasms; Cancer of the Oral Cavity	Johnny Kao	2007-02	PHASE2
NCT00336362	COMPLETED	Beta-Thalassemia	University of Washington	2006-07
NCT00726232	TERMINATED	Myeloproliferative Neoplasm (MPN)	Incyte Corporation	2008-08-20	PHASE2
NCT00122980	TERMINATED	Hemochromatosis; Cerebrovascular Accident; Anemia, Sickle Cell; Hematologic Diseases	St. Jude Children's Research Hospital	2006-10	PHASE3
NCT00568802	COMPLETED	Muscular Atrophy, Spinal	Stanford University	2004-01	PHASE1; PHASE2
NCT00023959	COMPLETED	Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Recurrent Basal Cell Carcinoma of the Lip; Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity; Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity; Recurrent Lymphoepithelioma of the Nasopharynx; Recurrent Lymphoepithelioma of the Oropharynx; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity; Recurrent Mucoepidermoid Carcinoma of the Oral Cavity; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage III Adenoid Cystic Carcinoma of the Oral Cavity; Stage III Basal Cell Carcinoma of the Lip; Stage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity; Stage III Inverted Papilloma of the Paranasal Sinus and Nasal Cavity; Stage III Lymphoepithelioma of the Nasopharynx; Stage III Lymphoepithelioma of the Oropharynx; Stage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity; Stage III Mucoepidermoid Carcinoma of the Oral Cavity; Stage III Salivary Gland Cancer; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage III Verrucous Carcinoma of the Larynx; Stage III Verrucous Carcinoma of the Oral Cavity; Stage IV Adenoid Cystic Carcinoma of the Oral Cavity; Stage IV Basal Cell Carcinoma of the Lip; Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity; Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity; Stage IV Lymphoepithelioma of the Nasopharynx; Stage IV Lymphoepithelioma of the Oropharynx; Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity; Stage IV Mucoepidermoid Carcinoma of the Oral Cavity; Stage IV Salivary Gland Cancer; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral Cavity; Untreated Metastatic Squamous Neck Cancer With Occult Primary	National Cancer Institute (NCI)	2001-07	PHASE1
NCT00006400	COMPLETED	Hematologic Diseases; Anemia, Sickle Cell	National Heart, Lung, and Blood Institute (NHLBI)	2000-08	PHASE3
NCT00270478	COMPLETED	Sickle Cell Disease; Chronic Kidney Disease; Pulmonary Hypertension	National Heart, Lung, and Blood Institute (NHLBI)	2005-12-21	PHASE1
NCT00485511	COMPLETED	Spinal Muscular Atrophy	Kaohsiung Medical University Chung-Ho Memorial Hospital	2007-06	PHASE2; PHASE3
NCT00615927	COMPLETED	Glioblastoma; Gliosarcoma	Duke University	2006-02	PHASE2
NCT00354913	COMPLETED	Glioblastoma; Gliosarcoma	Duke University	2005-05	PHASE2
NCT00532883	TERMINATED	Hemoglobin SC Disease	St. Jude Children's Research Hospital	2007-01	PHASE2
NCT00613054	COMPLETED	Glioblastoma; Gliosarcoma	Annick Desjardins	2007-11	PHASE1
NCT00387933	COMPLETED	Brain and Central Nervous System Tumors	Duke University	2005-07	PHASE1
NCT00003590	COMPLETED	Adult Meningioma	SWOG Cancer Research Network	1998-11	PHASE2
NCT00613132	COMPLETED	Glioblastoma; Gliosarcoma	Annick Desjardins	2005-05	PHASE1
NCT00154375	COMPLETED	Glioblastoma Multiforme; Astrocytoma	Novartis Pharmaceuticals	2004-10	PHASE3
NCT00290771	TERMINATED	Recurrent Glioblastoma Multiforme (GBM)	Novartis	2006-02	PHASE2
NCT00350844	TERMINATED	Sickle Cell Disease; Pulmonary Hypertension	Ann & Robert H Lurie Children's Hospital of Chicago	2006-07	PHASE1; PHASE2
NCT00143572	COMPLETED	Anemia, Sickle Cell	St. Jude Children's Research Hospital	2004-11	PHASE1
NCT00203905	COMPLETED	Head and Neck Cancer	University of Chicago	2004-01	PHASE2
NCT00809042	COMPLETED	β-Thalassemia Intermedia	Shiraz University of Medical Sciences	2007-06	PHASE2
NCT00004897	TERMINATED	Esophageal Cancer	Northwestern University	1999-10	PHASE2
NCT00083187	COMPLETED	Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms	Vion Pharmaceuticals	2005-11	PHASE2
NCT00056433	COMPLETED	Sickle Cell Anemia	National Institutes of Health Clinical Center (CC)	2003-03-10	PHASE1
NCT00344981	COMPLETED	HIV Infections; AIDS	University of Maryland, Baltimore	2003-06
NCT00006119	COMPLETED	Brain and Central Nervous System Tumors	UNICANCER	1999-07	PHASE2
NCT00002951	COMPLETED	Esophageal Cancer; Head and Neck Cancer	University of Chicago	1996-06	PHASE2
NCT00002868	COMPLETED	Leukemia	Eastern Cooperative Oncology Group	1997-11-20	PHASE3
NCT00001197	COMPLETED	Sickle Cell Anemia	National Heart, Lung, and Blood Institute (NHLBI)	1984-02-07	PHASE2
NCT00040677	COMPLETED	Sickle Cell Disease; Sickle Cell Anemia	Icagen	2002-02	PHASE2
NCT01693718	COMPLETED	Head and Neck	University of Chicago	2003-03	PHASE2
NCT00004089	COMPLETED	Head and Neck Cancer	National Cancer Institute (NCI)	1999-08	PHASE2
NCT00002940	COMPLETED	Lymphoma	St. Jude Children's Research Hospital	1996-10	PHASE2
NCT00004933	TERMINATED	Leukemia	Alliance for Clinical Trials in Oncology	2000-01	PHASE3
NCT00019474	COMPLETED	Extrahepatic Bile Duct Cancer; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Liver Cancer; Pancreatic Cancer; Small Intestine Cancer	Montefiore Medical Center	1998-03	PHASE2
NCT00002674	COMPLETED	Leukemia	Fred Hutchinson Cancer Center	1994-10	PHASE2
NCT00002177	COMPLETED	HIV Infections	Bristol-Myers Squibb	1997-05
NCT00002176	COMPLETED	HIV Infections	Bristol-Myers Squibb	1997-05
NCT00000586	COMPLETED	Anemia, Sickle Cell; Hematologic Diseases; Hemoglobinopathies	National Heart, Lung, and Blood Institute (NHLBI)	1992-01	PHASE3
NCT00005823	COMPLETED	Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms	Leukemia Research Fund	1998-12	PHASE3
NCT00002427	COMPLETED	HIV Infections	Research Institute for Genetic and Human Therapy	1999-05	PHASE1
NCT00519701	COMPLETED	Sickle Cell Anemia	Duke University	2002-04
NCT00001958	COMPLETED	Beta Thalassemia; Hemoglobinopathy	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1999-12	PHASE2
NCT00402480	COMPLETED	Stroke	Duke University	2003-04	PHASE2
NCT00002771	UNKNOWN	Leukemia	German CML Study Group	1995-01	PHASE3
NCT00004404	COMPLETED	Sickle Cell Anemia	Boston Children's Hospital	1997-04
NCT00180973	UNKNOWN	LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT	Gustave Roussy, Cancer Campus, Grand Paris	1995-02	PHASE3
NCT00093990	COMPLETED	Acute Myeloid Leukemia	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2004-01	PHASE3
NCT00001074	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE1
NCT00025402	UNKNOWN	Leukemia	III. Medizinische Klinik Mannheim	1997-07	PHASE3
NCT00003172	COMPLETED	Gastric Cancer	Eastern Cooperative Oncology Group	1997-12	PHASE2
NCT00004094	UNKNOWN	Head and Neck Cancer	National Cancer Institute (NCI)	1999-08	PHASE2
NCT00002869	UNKNOWN	Leukemia	Medical Research Council	1995-04	PHASE3
NCT00000916	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE2
NCT00000939	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE2
NCT00000919	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00004901	COMPLETED	Head and Neck Cancer	Robert H. Lurie Cancer Center	1999-10	PHASE1; PHASE2
NCT00002230	COMPLETED	HIV Infections	Northwestern University		PHASE3
NCT00019058	COMPLETED	Brain and Central Nervous System Tumors	National Cancer Institute (NCI)	1995-04	PHASE1
NCT00496535	COMPLETED	Head and Neck Cancer; Head and Neck Neoplasms	GenVec		PHASE1; PHASE2
NCT00002418	TERMINATED	HIV Infections	Bristol-Myers Squibb		PHASE2
NCT00006339	WITHDRAWN	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE2
NCT00001818	COMPLETED	HIV Infection	National Cancer Institute (NCI)	1999-06	PHASE1
NCT00904735	UNKNOWN	Brain and Central Nervous System Tumors	Istituto Scientifico H. San Raffaele	2009-06	PHASE2
NCT00008866	WITHDRAWN	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE2
NCT00002887	UNKNOWN	Lung Cancer	Ottawa Regional Cancer Centre	1995-07	PHASE1
NCT00004492	COMPLETED	Sickle Cell Anemia	University of North Carolina	1999-10	PHASE1; PHASE2
NCT01065038	COMPLETED	Essential Thrombocythaemia	AOP Orphan Pharmaceuticals AG	2002-09	PHASE3
NCT00294541	TERMINATED	Sickle Cell Disease; Sickle Cell Anemia	Icagen	2006-02	PHASE3
NCT00002412	COMPLETED	HIV Infections	Triangle Pharmaceuticals		PHASE2
NCT00005018	COMPLETED	HIV Infections	Glaxo Wellcome	1999-07	PHASE4
NCT00002420	TERMINATED	HIV Infections	Bristol-Myers Squibb		PHASE2
NCT00008047	UNKNOWN	Esophageal Cancer	GERCOR - Multidisciplinary Oncology Cooperative Group	1999-08	PHASE1; PHASE2
NCT00000602	COMPLETED	Anemia, Sickle Cell; Hematologic Diseases; Hemoglobinopathies	National Heart, Lung, and Blood Institute (NHLBI)	1994-04	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-23)

Check the Hydroxyurea product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydroxyurea quenches the tyrosyl free radical within the M2 subunit of ribonucleotide reductase, inactivating the enzyme complex and selectively inhibiting DNA synthesis to induce S-phase cell cycle arrest and apoptosis. By halting cellular proliferation and stimulating fetal hemoglobin production via soluble guanylyl cyclase activation, this targeted activity directly mitigates vaso-occlusive crises in sickle cell disease and suppresses pathologic cell expansion in myeloproliferative neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).