Drug
Hydroxyurea clinical trials
Also written Hydrea, Hydroxycarbamide and Droxia.
How each study uses Hydroxyurea is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- 7 Dec 1967 · DROXIA · NDA 016295 (FDA, Drugs@FDA)
- European Union
- 29 Jun 2007 · Siklos · EMEA/H/C/000689 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
122 studies that test it; most in 2014 (10); 1 more planned to start later
| Year | Studies |
|---|---|
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 5 |
| 1998 | 2 |
| 1999 | 8 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 5 |
| 2005 | 2 |
| 2006 | 6 |
| 2007 | 6 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 3 |
| 2014 | 10 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 8 |
| 2018 | 6 |
| 2019 | 7 |
| 2020 | 3 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 5 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 15 · Other 117
Children's Hospital Medical Center, Cincinnati (10) · St. Jude Children's Research Hospital (8) · National Heart, Lung, and Blood Institute (NHLBI) (8) · Theravia (5) · Vanderbilt University Medical Center (5) · National Institute of Allergy and Infectious Diseases (NIAID) (4) · National Cancer Institute (NCI) (4) · Duke University (4)
Often tested with
Tested in the same studies.
Didanosine (9) · Thiotepa (7) · Stavudine (7) · Alemtuzumab (6) · Cyclophosphamide (6) · Thalidomide (6) · Fludarabine (6) · Fluorouracil (6)
Related medicines
As reviewed, each with the page that says it.
- One of Antimetabolites source
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Tested against it · 3 phase 3 studies under way
Hydroxyurea is the comparator. A study of two new drugs counts under both.
- 1Bomedemstat · Merck Sharp & Dohme LLC · next primary completion Sep 2027
- 1Ruxolitinib · University of Birmingham · next primary completion Oct 2028
- 1Givinostat · Italfarmaco
Reaching primary completion within a year · 5
Studies that test Hydroxyurea.
- Nov 2026Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCTPhase 2 · Paul Szabolcs
- Dec 2026Therapeutic Response Evaluation and Adherence Trial (TREAT)Not applicable · Children's Hospital Medical Center, Cincinnati
- Dec 2026Alternative Dosing And Prevention of Transfusions (ADAPT)Early Phase 1 · Children's Hospital Medical Center, Cincinnati
- Jun 2027Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta ThalassemiaNot applicable · Riphah International University
- Oct 2027Realizing Effectiveness Across Continents With HydroxyureaPhase 2 · Children's Hospital Medical Center, Cincinnati
Studies
Open first, then newest update. How each study uses Hydroxyurea is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 132
- Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell DiseaseRecruitingPhase 2St. Jude Children's Research HospitalNCT07616154Written as Hydroxyurea
- Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid LeukemiaRecruitingPhase 1Roswell Park Cancer InstituteNCT06871410Written as Hydroxyurea
- Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell DiseaseRecruitingPhase 2TheraviaNCT06578507Written as Hydroxycarbamid
- A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor PatientsNot yet recruitingPhase 1Bionoxx Inc.NCT07170592Written as Hydroxyurea (HU)
- Promoting Utilization and Safety of Hydroxyurea Using Precision in AfricaRecruitingPhase 3Brown UniversityNCT05285917Written as Hydroxyurea
- Addition of Hydroxyurea to Fludarabine, Cytarabine, Idarubicin and Venetoclax Salvage Therapy for Adults With Relapsed or Refractory Acute Myeloid LeukemiaNot yet recruitingPhase 1/2Christer C NilssonNCT07766850Written as Hydroxycarbamid
- T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other AnemiasRecruitingPhase 1/2Paul SzabolcsNCT03653338Written as Hydroxyurea
- Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta ThalassemiaRecruitingNot applicableRiphah International UniversityNCT07673302Written as Hydroxy Urea
- Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) StudyRecruitingPhase 1/2Children's Hospital Medical Center, CincinnatiNCT07708714Written as hydroxycarbamide
- Stroke Prevention in Nigeria 2 TrialRecruitingPhase 4Vanderbilt University Medical CenterNCT06526117Written as Hydroxyurea
- Lung and Bone Marrow Transplantation for Lung and Bone Marrow FailureRecruitingPhase 1/2Paul SzabolcsNCT03500731Written as Hydroxyurea
- Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCTRecruitingPhase 2Paul SzabolcsNCT01962415Written as Hydroxyurea
- Primary Prevention of Stroke in Children With Sickle Cell Anaemia in Nigeria in the CommunityRecruitingNot applicableBarau Dikko Teaching HospitalNCT05434000Written as Hydroxyurea
- Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)Active, not recruitingPhase 2Children's Hospital Medical Center, CincinnatiNCT03948867Written as Hydroxyurea
- A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Hydroxycarbamide in Healthy VolunteersCompletedPhase 1TheraviaNCT05025072Written as Hydroxycarbamide film-coated tablet
- Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary HypertensionTerminatedPhase 1/2Ann & Robert H Lurie Children's Hospital of ChicagoNCT00350844Written as Hydroxyurea
- Reduced Intensity Transplantation for Severe Sickle Cell DiseaseActive, not recruitingPhase 2St. Jude Children's Research HospitalNCT04362293Written as hydroxyurea, azathioprine, alemtuzumab, thiotepa, plerixafor, low dose total body irradiation, cyclophosphamide and sirolimus
- Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM PredictorsTerminatedPhase 4Novartis PharmaceuticalsNCT05853458Written as Hydroxyurea
- Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)CompletedPhase 2Medical College of WisconsinNCT03263559Written as Hydroxyurea
- Realizing Effectiveness Across Continents With Hydroxyurea (REACH)Active, not recruitingPhase 1/2Children's Hospital Medical Center, CincinnatiNCT01966731Written as Hydroxyurea
See all 132 studies that test Hydroxyurea →
Given beside what is tested · 23 — Hydroxyurea is usual care or a partner of the new treatment
- Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard TherapyRecruitingPhase 2Uma BorateNCT06930352Written as Hydroxyurea
- A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea)RecruitingPhase 1Bionoxx Inc.NCT07190833Written as Hydroxyurea (HU)
- Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML PatientsRecruitingPhase 2PETHEMA FoundationNCT07507760Written as Hydroxyurea
- A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary StrokeRecruitingPhase 2Forma Therapeutics, Inc.NCT05953584Written as Hydroxyurea
- Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck CancerRecruitingPhase 1University of ChicagoNCT05526924Written as Hydroxyurea
- A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS PatientsRecruitingPhase 1/2Haukeland University HospitalNCT06199557Written as Hydroxyurea, Hydroxycarbamide
- Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-ThalassemiaActive, not recruitingPhase 1/2National Heart, Lung, and Blood Institute (NHLBI)NCT05357482Written as Hydroxyurea
- A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)TerminatedPhase 1Imugene LimitedNCT06063317Written as Hydroxyurea
- Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid LeukemiaTerminatedPhase 2SanofiNCT03860844Written as Hydroxyurea
- Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck CancerCompletedPhase 2University of ChicagoNCT03107182Written as Hydroxyurea
- Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal CancerCompletedPhase 2University of ChicagoNCT02258659Written as hydroxyurea
- A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot StudyCompletedPhase 2Vanderbilt University Medical CenterNCT05142254Written as Hydroxyurea
- Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring SideroblastsTerminatedPhase 2Mayo ClinicNCT05005182Written as Hydroxyurea
- Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck CancerCompletedPhase 1University of ChicagoNCT01847326Written as hydroxyurea
- Mobile-Directly Observed Therapy on Adherence to HydroxyureaCompletedPhase 2Muhimbili University of Health and Allied SciencesNCT02844673Written as Hydroxyurea
- Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck CancerCompletedPhase 1/2National Cancer Institute (NCI)NCT01711541Written as Hydroxyurea
- Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)Status unknownPhase 3First Affiliated Hospital Xi'an Jiaotong UniversityNCT02899169Written as Hydroxyurea
- Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell AnemiaCompletedPhase 2/3Beni-Suef UniversityNCT04301336Written as Hydroxy Urea
- HSCT for High Risk Inherited Inborn ErrorsCompletedPhase 2Masonic Cancer Center, University of MinnesotaNCT00383448Written as Hydroxyurea
- Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)CompletedPhase 3University of ChicagoNCT00117572Written as hydroxyurea
Showing 20 of 23.
As the comparator · 15 — what is tested is compared with Hydroxyurea
- MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia VeraRecruitingPhase 3University of BirminghamNCT04116502Written as Hydroxycarbamide
- Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic LeukemiaRecruitingPhase 2TheradexNCT07033598Written as Hydroxyurea
- Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia VeraRecruitingPhase 3ItalfarmacoNCT06093672Written as Hydroxyurea
- Vinblastine for Leukoreduction in Newly Diagnosed AML and HyperleukocytosisRecruitingPhase 2Hospital Universitario Dr. Jose E. GonzalezNCT05062278Written as Hydroxyurea capsules
- Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)Active, not recruitingPhase 3Merck Sharp & Dohme LLCNCT06456346Written as Hydroxyurea
- A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk MyelofibrosisCompletedPhase 2Chia Tai Tianqing Pharmaceutical Group Co., Ltd.NCT05020652Written as Hydroxycarbamide tablets
- Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk MyelofibrosisCompletedPhase 3Suzhou Zelgen Biopharmaceuticals Co.,LtdNCT04617028Written as Hydroxycarbamide Tablets
- Selinexor (KPT-330) in Older Patients With Relapsed AMLCompletedPhase 2Karyopharm Therapeutics IncNCT02088541Written as Hydroxyurea
- A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia PatientsCompletedPhase 4ShireNCT00202644Written as Hydroxyurea
- Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)CompletedPhase 3Ronald HoffmanNCT01259856Written as Hydroxyurea
- Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief StudyCompletedPhase 3Incyte CorporationNCT01632904Written as Hydroxyurea (HU)
- Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia VeraCompletedPhase 3AOP Orphan Pharmaceuticals AGNCT01949805Written as Hydroxyurea
- Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon AlfaTerminatedPhase 3Alliance for Clinical Trials in OncologyNCT00004933Written as hydroxyurea
- Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) PatientsCompletedPhase 1Prolong PharmaceuticalsNCT01848925Written as Hydroxyurea
- Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential ThrombocythaemiaCompletedPhase 3AOP Orphan Pharmaceuticals AGNCT01065038Written as Hydroxyurea
Codes
What other systems call Hydroxyurea · ClinicalTrials.gg INT007637
- MeSH (NLM) D006918HydroxyureaConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) X6Q56QN5QCHYDROXYCARBAMIDEConfirmed FDA, NLM
- RxNorm 5552One source FDA
- NCI Thesaurus C560HydroxyureaOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D006918 | Hydroxyurea | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | X6Q56QN5QC | HYDROXYCARBAMIDE | Confirmed FDA, NLM |
| RxNorm | 5552 | — | One source FDA |
| NCI Thesaurus | C560 | Hydroxyurea | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.