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Hydroxy Urea
Hydroxyurea inhibits ribonucleotide reductase, an enzyme essential for DNA synthesis, leading to cell cycle arrest and apoptosis in rapidly dividing cells.
Hydroxyurea is an antineoplastic agent primarily used in the treatment of chronic myeloid leukemia and sickle cell disease. It works by inhibiting DNA synthesis, leading to cell cycle arrest and apoptosis in rapidly dividing cells. Despite its therapeutic benefits, hydroxyurea has several side effects, including bone marrow suppression, gastrointestinal disturbances, and skin reactions. The drug is not approved by the FDA but is widely used in clinical practice, particularly in regions like Bangladesh where it is produced by institutions such as Bangabandhu Sheikh Mujib Medical University. Hydroxyurea's efficacy and safety profile make it a valuable treatment option for specific hematological conditions.
At a glance
| Generic name | Hydroxy Urea |
|---|---|
| Also known as | Hydroxy Urea tablet medication 20mg/kg/day |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Drug class | Antimetabolite |
| Target | Ribonucleotide reductase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
By inhibiting ribonucleotide reductase, hydroxyurea reduces the pool of deoxyribonucleotides necessary for DNA replication, thereby slowing down or stopping the proliferation of cancer cells and other rapidly dividing cells.
Approved indications
Common side effects
- Bone marrow suppression
- Nausea and vomiting
- Diarrhea
- Skin rash
- Fatigue
Drug interactions
- Warfarin
- Thiopurines
Key clinical trials
- Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) (PHASE3)
- 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)
- Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma (PHASE1)
- Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1, PHASE2)
- Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera (PHASE3)
- Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma (PHASE2)
- Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| US3142680A |
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 |
| FDA Orange Book | Patents + exclusivity |