How many clinical trials are studying Hydroxyurea?

7 recruiting trials in our tracked data involve Hydroxyurea.

What conditions is Hydroxyurea being studied for?

In our tracked recruiting trials, Hydroxyurea is being studied in trials for Sickle Cell Disease, Beta-thalassemia Major, COPD.

Hydroxyurea: clinical trials recruiting now

Q: Is Hydroxyurea FDA-approved?

Yes. According to the FDA drug label available through openFDA, Hydroxyurea is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Hydroxyurea appears in the FDA drug-label database. Marketed as DROXIA.
Drug class: Antimetabolite (FDA established pharmacologic class)
Boxed warning: The FDA label for Hydroxyurea carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. DROXIA is an antimetabolite indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. ( 1 )

FDA label via openFDA

Phase breakdown

Phase 1 2 Phase 2 5 Phase 3 1 Phase 4 1

Conditions being studied

Condition	Trials
Sickle Cell Disease · Hydroxyurea for Sickle Cell Disease	6
Beta-thalassemia Major	1
COPD	1
Congenital Bone Marrow Failure Syndromes	1
Crohn's disease	1
Diamond-blackfan Anemia	1
Emphysema or COPD	1
Hereditary Anemias	1
Idiopathic Pulmonary Fibrosis	1
Inflammatory Conditions	1
Inherited Metabolic Disorders (IMD)	1
Juvenile Rheumatoid Arthritis (JRA)	1
Primary Immunodeficiency (PID)	1
Rheumatoid arthritis	1
Sickle Cell Anemia	1

Recruiting trials involving 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 Stroke
NCT05953584 · Phase: Phase 2 · Ages: 12 Years to 16 Years · Sex: All (male and female) · 9 locations
Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease
NCT07616154 · Phase: Phase 2 · Ages: Up to 22 Years · Sex: All (male and female) · 1 location
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
NCT03500731 · Phase: Phase 1, Phase 2 · Ages: 18 Years to 60 Years · Sex: All (male and female) · 2 locations
Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa
NCT05285917 · Phase: Phase 3 · Ages: 6 Months to 12 Years · Sex: All (male and female) · 1 location
Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
NCT01962415 · Phase: Phase 2 · Ages: 2 Months to 55 Years · Sex: All (male and female) · 2 locations
Stroke Prevention in Nigeria 2 Trial
NCT06526117 · Phase: Phase 4 · Ages: 5 Years to 12 Years · Sex: All (male and female) · 2 locations
T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias
NCT03653338 · Phase: Phase 1, Phase 2 · Ages: 5 Years to 40 Years · Sex: All (male and female) · 1 location

Common questions

Is Hydroxyurea FDA-approved?

Yes, marketed as DROXIA. Its FDA label carries a boxed warning.

How many recruiting trials involve Hydroxyurea?

7 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.