Data updated: May 26, 2026
HYDREA (hydroxyurea)
Oncology
Approved 1967-12-07
HYDREA is indicated for the treatment of Chronic Myeloid Leukemia; Squamous Cell Carcinoma.
3
Indications
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Phase 3 Trials
2
Priority Reviews
58
Years on Market
Details
- Status
- Prescription
- First Approved
- 1967-12-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE
HYDREA Approval History
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Original
New Indication
New Form
Label Update
44 FDA actions from 1967 to 2024 · 1 indication expansions
Feb 2001 SUPPL
Label
Jan 2000 SUPPL
Label
Aug 1999 SUPPL
Label
Nov 1998 SUPPL Priority
Mfg
Feb 1998 SUPPL Priority
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May 1997 SUPPL Priority
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Apr 1997 SUPPL Priority
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Nov 1996 SUPPL Priority
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Oct 1996 SUPPL Priority
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Sep 1996 SUPPL
Label
Sep 1995 SUPPL Priority
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Mar 1993 SUPPL Priority
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Jul 1992 SUPPL Priority
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Aug 1988 SUPPL Priority
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May 1988 SUPPL Priority
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Mar 1987 SUPPL Priority
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Jul 1985 SUPPL Priority
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Feb 1980 SUPPL Priority
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May 1977 SUPPL Priority
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Dec 1967 ORIGINAL Priority
New Drug
What HYDREA Treats
2 indicationsHYDREA is approved for 2 conditions since its original approval in 1967. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
- Squamous Cell Carcinoma
Source: FDA Label
HYDREA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
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Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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What's emerging in HYDREA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HYDREA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to HYDREA
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
61 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 |
| NCT01387763 DALIAH | daliah2011 | Ph 3 | completed | A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms |
| 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 |
Showing 50 of 61 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
HYDREA FDA Label Details
Indications & Usage
FDA Label (PDF)HYDREA is indicated for the treatment of Chronic Myeloid Leukemia; Squamous Cell Carcinoma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.