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Hydroxyurea (Moderate Dose)
Hydroxyurea inhibits ribonucleotide reductase to reduce DNA synthesis and promote fetal hemoglobin production.
Hydroxyurea inhibits ribonucleotide reductase to reduce DNA synthesis and promote fetal hemoglobin production. Used for Sickle cell disease (to reduce vaso-occlusive crises), Polycythemia vera, Essential thrombocythemia.
At a glance
| Generic name | Hydroxyurea (Moderate Dose) |
|---|---|
| Also known as | Hydrea |
| Sponsor | Vanderbilt University Medical Center |
| Drug class | Ribonucleotide reductase inhibitor |
| Target | Ribonucleotide reductase |
| Modality | Small molecule |
| Therapeutic area | Hematology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Hydroxyurea is a ribonucleotide reductase inhibitor that decreases deoxynucleotide pools, slowing DNA replication in rapidly dividing cells. In sickle cell disease, it increases fetal hemoglobin (HbF) production, which inhibits polymerization of sickle hemoglobin and reduces vaso-occlusive crises. The moderate dose regimen aims to balance efficacy with tolerability.
Approved indications
- Sickle cell disease (to reduce vaso-occlusive crises)
- Polycythemia vera
- Essential thrombocythemia
Common side effects
- Myelosuppression (anemia, leukopenia, thrombocytopenia)
- Nausea and vomiting
- Macrocytosis
- Elevated uric acid
- Cutaneous reactions
Key clinical trials
- Stroke Prevention in Nigeria 2 Trial (PHASE4)
- Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (PHASE1, PHASE2)
- Stroke Prevention in Young Adults With Sickle Cell Anemia
- De-Escalation Therapy for Human Papillomavirus Negative Disease (PHASE2)
- Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia (PHASE2, PHASE3)
- Moderate Dose Hydroxyurea for Secondary Stroke Prevention in Children With Sickle Cell Disease in Sub-Saharan Africa (PHASE3)
- Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II (PHASE3)
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:
- Hydroxyurea (Moderate Dose) CI brief — competitive landscape report
- Hydroxyurea (Moderate Dose) updates RSS · CI watch RSS
- Vanderbilt University Medical Center portfolio CI