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Hydroxycarbamide Tablets
Hydroxycarbamide inhibits ribonucleotide reductase, reducing deoxynucleotide synthesis and promoting fetal hemoglobin production while decreasing sickling and hemolysis.
Hydroxycarbamide inhibits ribonucleotide reductase, reducing deoxynucleotide synthesis and promoting fetal hemoglobin production while decreasing sickling and hemolysis. Used for Sickle cell disease, Chronic myeloid leukemia, Polycythemia vera.
At a glance
| Generic name | Hydroxycarbamide Tablets |
|---|---|
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| Drug class | Ribonucleotide reductase inhibitor |
| Target | Ribonucleotide reductase |
| Modality | Small molecule |
| Therapeutic area | Oncology; Hematology |
| Phase | Phase 3 |
Mechanism of action
Hydroxycarbamide (hydroxyurea) is a ribonucleotide reductase inhibitor that decreases DNA synthesis and cell proliferation. In sickle cell disease, it increases fetal hemoglobin (HbF) production, which inhibits polymerization of sickle hemoglobin and reduces vaso-occlusive crises. It also has cytoreductive effects useful in myeloproliferative disorders.
Approved indications
- Sickle cell disease
- Chronic myeloid leukemia
- Polycythemia vera
- Essential thrombocythemia
Common side effects
- Myelosuppression (anemia, leukopenia, thrombocytopenia)
- Nausea and vomiting
- Elevated uric acid levels
- Skin hyperpigmentation
- Peripheral neuropathy
Key clinical trials
- A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006) (PHASE3)
- Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia (PHASE2)
- Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera (PHASE2)
- A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis (PHASE2)
- Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (PHASE1, PHASE2)
- Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia (PHASE2)
- A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis (PHASE2)
- Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (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:
- Hydroxycarbamide Tablets CI brief — competitive landscape report
- Hydroxycarbamide Tablets updates RSS · CI watch RSS
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd portfolio CI