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Hydrea® (hydroxyurea )
Hydroxyurea inhibits ribonucleotide reductase, reducing deoxyribonucleotide synthesis and slowing DNA replication in rapidly dividing cells.
Hydroxyurea inhibits ribonucleotide reductase, reducing deoxyribonucleotide synthesis and slowing DNA replication in rapidly dividing cells. Used for Chronic myeloid leukemia (CML), Polycythemia vera, Essential thrombocythemia.
At a glance
| Generic name | Hydrea® (hydroxyurea ) |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Antimetabolite; ribonucleotide reductase inhibitor |
| Target | Ribonucleotide reductase |
| Modality | Small molecule |
| Therapeutic area | Oncology; Hematology |
| Phase | FDA-approved |
Mechanism of action
By blocking the enzyme ribonucleotide reductase, hydroxyurea depletes the deoxyribonucleotide pool needed for DNA synthesis, thereby slowing or halting cell division. This mechanism makes it effective against rapidly proliferating cancer cells and also increases fetal hemoglobin production in sickle cell disease, reducing sickling episodes. The drug is a non-selective cytotoxic agent that affects both malignant and normal dividing cells.
Approved indications
- Chronic myeloid leukemia (CML)
- Polycythemia vera
- Essential thrombocythemia
- Sickle cell disease (to reduce vaso-occlusive crises)
Common side effects
- Myelosuppression (anemia, leukopenia, thrombocytopenia)
- Nausea and vomiting
- Elevated uric acid (hyperuricemia)
- Megaloblastic anemia
- Skin ulceration and atrophy
- Hepatotoxicity
Key clinical trials
- A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE) (PHASE3)
- PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]
- Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure (PHASE1, PHASE2)
- 177Lu-DOTATATE for Recurrent Meningioma (PHASE2)
- T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias (PHASE1, PHASE2)
- SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial) (PHASE2)
- Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507) (PHASE2)
- Optimizing the Management of Sickle Cell Patients on Hydroxyurea: The Value of Therapeutic Pharmacological Monitoring (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydrea® (hydroxyurea ) CI brief — competitive landscape report
- Hydrea® (hydroxyurea ) updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI