TheraRadar
Data updated: May 26, 2026

HYDROXYUREA

Oncology Approved 1995-08-18

HYDROXYUREA is indicated for the treatment of Chronic Myeloid Leukemia; Squamous Cell Carcinoma.

Source: FDA Label • QILU
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
7
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1995-08-18
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

QILU Teva LEADING ROXANE PH HEALTH
Active Ingredient: HYDROXYUREA

HYDROXYUREA Approval History

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Original
New Indication
New Form
Label Update
74 FDA actions from 1995 to 2024
Sep 2024 SUPPL
Label · Labeling
Apr 2024 SUPPL
Label · Labeling
Mar 2024 ORIGINAL
Update

What HYDROXYUREA Treats

2 indications

HYDROXYUREA is approved for 2 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Myeloid Leukemia
  • Squamous Cell Carcinoma
Source: FDA Label

HYDROXYUREA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

FAVLYXA
AVYXA HOLDINGS
2026 3 indic.
KOMZIFTI
KURA
2025 1 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in HYDROXYUREA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HYDROXYUREA treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials

Drugs Similar to HYDROXYUREA

3 of 9

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

HYDREA
HYDROXYUREA
2 shared
WAYLIS THERAP
Shared indications:
Chronic Myeloid LeukemiaSquamous Cell Carcinoma
DANZITEN
NILOTINIB TARTRATE
1 shared
AZURITY
Shared indications:
Chronic Myeloid Leukemia
DASATINIB
DASATINIB
1 shared
BIOCON PHARMA
Shared indications:
Chronic Myeloid Leukemia
View all 9 similar drugs Pro
📋

Clinical Trial Registry

60 trials
Trial Sponsor ID Phase Status Title
NCT06456346 3543-007 2023-505232-36-00, MK-3543-007 Ph 3 recruiting Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
NCT05853458 HU-F-AIM CINC424BDE15 2022-502338-20-00 Ph 4 terminated Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors
NCT03263559 results posted BMTCTN1507 2U10HL069294-11, 5U24CA076518 Ph 2 completed Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)
NCT03077542 results posted 170069 17-H-0069 Ph 1, Ph 2 active not recruiting Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease
NCT06171217 REACH 2013-4221b U01HL133883 Ph 2 active not recruiting Realizing Effectiveness Across Continents With Hydroxyurea
NCT07507760 DECISIVO DECISIVO Ph 2 not yet recruiting Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients
NCT06093672 GIV-IN-PV DSC/08/2357/32 2022-502276-23-00 Ph 3 recruiting Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
NCT06871410 I-3916824 NCI-2025-01523, I-3916824 Ph 1 recruiting Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
NCT06930352 OSU-24309 NCI-2025-02414 Ph 2 not yet recruiting Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy
NCT05357482 10000539 000539-H Ph 1, Ph 2 active not recruiting Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia
NCT06063317 OASIS CF33-CD19-101 Ph 1 terminated A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)
NCT07033598 PROSPERA PROSPERA ABNL-MARRO 002 Ph 2 recruiting Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
NCT06526117 SPRING-2 231110 U01NS129143 Ph 4 recruiting Stroke Prevention in Nigeria 2 Trial
NCT05526924 IRB22-0578 Ph 1 recruiting Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
NCT03500731 STUDY19110120 Ph 1, Ph 2 recruiting Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
NCT05451940 ACHiEvE-SCD results posted STUDY21120027 Ph 1, Ph 2 completed Hydroxyurea and EPO in Sickle Cell Disease
NCT01962415 HSCT+RIC STUDY19060337 Ph 2 recruiting Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
NCT05953584 HIBISCUS 3 4202-HEM-204 PACTR202301655446404 Ph 2 recruiting 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 Stroke
NCT03860844 ISAKIDS results posted ACT15378 PIP - 2018-002697-45, U1111-1202-1096 Ph 2 terminated Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
NCT02556099 2014-2875 EXTEND Ph 2 completed EXTEND EXpanding Treatment for Existing Neurological Disease
NCT03653338 STUDY19050050 Ph 1, Ph 2 recruiting T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias
NCT03948867 SPHERE Ph 2 enrolling by invitation Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
NCT03789591 HOPS CCHMC_HOPS Ph 3 completed Hydroxyurea Optimization Through Precision Study
NCT01966731 REACH results posted 2013-4221 Ph 1, Ph 2 active not recruiting Realizing Effectiveness Across Continents With Hydroxyurea (REACH)
NCT03107182 OPTIMA-II results posted IRB17-0104 Ph 2 completed Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer
NCT04750707 BRAINSAFEII REC REF 2019-147 R01HD096559 Ph 3 completed Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II )
NCT05285917 PUSHUP BrUOG 419 U01HL157872 Ph 3 recruiting Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa
NCT02258659 OPTIMA results posted IRB14-0639 NCI-2014-01867, IRB14-0639 Ph 2 completed Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer
NCT05142254 PIN 202504 Ph 2 completed A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study
NCT05005182 results posted MC200805 NCI-2021-08519, 20-013021 Ph 2 terminated Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts
NCT01847326 12-1554 NCI-2012-02179 Ph 1 completed Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
NCT01389024 HUPrevent results posted NA_00041623 3UL1RR025005 Ph 2 completed Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease
NCT02844673 mDOT MUPI-001 Ph 2 completed Mobile-Directly Observed Therapy on Adherence to Hydroxyurea
NCT06239389 NIBD/IRB-236/21-2021. Ph 2 completed Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.
NCT02757885 TRANSFORM results posted IRB00080955 Ph 2 completed Transplantation for Patients With Sickle Cell Disease From Mismatched Family Donors of Bone Marrow
NCT01711541 results posted NCI-2012-02009 NCI-2012-02009, A091101 Ph 1, Ph 2 completed Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer
NCT02149537 205449 Ph 4 completed Risk Clinical Stratification of Sickle Cell Disease in Nigeria, Assessment of Efficacy/Safety of Hydroxyurea Treatment
NCT02088541 SOPRA results posted KCP-330-008 Ph 2 completed Selinexor (KPT-330) in Older Patients With Relapsed AML
NCT03825341 results posted HOPE18 Ph 2 terminated Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere
NCT02214407 GFM-DAC-CMML GFM-DAC-CMML Ph 3 completed Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML
NCT03644953 HAT Pro00010541 Ph 2 completed Hydroxyurea and Transfusion
NCT03020615 results posted HUGKISS R34HL127162 Ph 2 completed Hydroxyurea Management in Kids: Intensive Versus Stable Dosage Strategies
NCT04292314 TQ/Omega-3 on Thalassemia Ph 2, Ph 3 completed Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia
NCT02336373 SCYTHE results posted H-35010 SCYTHE Ph 2 terminated Treatment of Hemoglobin SC Disease With Hydroxyurea
NCT01425307 TWiTCH results posted H-28572 TWiTCH R01HL095647 Ph 3 terminated Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea
NCT03128515 NOHARM-MTD 00456728 Ph 3 completed Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas
NCT02640573 results posted 37290 IM-SCYTHE Ph 2 terminated Treatment of Adult Patients With Hemoglobin SC Disease (SCYTHE)
NCT01964755 results posted 20090166 Ph 2 terminated Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma
NCT02225132 results posted 140172 14-H-0172 Ph 1, Ph 2 completed Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease
NCT01259856 results posted GCO 09-1300-00002 P01CA108671, MPD-RC 112 Ph 3 completed Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)

Showing 50 of 60 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

HYDROXYUREA FDA Label Details

Indications & Usage

HYDROXYUREA is indicated for the treatment of Chronic Myeloid Leukemia; Squamous Cell Carcinoma.

Looking for the branded version?

XROMI

Full clinical data, patents, trials, and competitive landscape for hydroxyurea.

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Data Sources

FDA Approval: ANDA218021 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.