Overview
An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.
Indication
Hydroxyurea is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises.
Associated Conditions
- Chronic Myelogenous Leukemia (CML)
- Essential Thrombocythemia (ET)
- Head and Neck Primary Squamous Cell Carcinoma
- Hypereosinophilic Syndrome (HES)
- Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
- Meningiomas
- Polycythemia Vera (PV)
- Sickle Cell Crisis
- Vaso-occlusive Crisis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 2 | Not yet recruiting | Theradex | ||
2025/04/16 | Phase 2 | Not yet recruiting | Uma Borate | ||
2025/04/11 | N/A | Recruiting | |||
2025/03/12 | Phase 1 | Not yet recruiting | |||
2024/08/29 | Phase 2 | Recruiting | |||
2024/07/29 | Phase 4 | Recruiting | |||
2024/06/13 | Phase 3 | Recruiting | |||
2024/02/02 | Phase 2 | Completed | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | ||
2024/01/10 | Phase 1 | Recruiting | Haukeland University Hospital | ||
2023/12/14 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Par Pharmaceutical, Inc. | 49884-724 | ORAL | 500 mg in 1 1 | 11/22/2021 | |
| E.R. Squibb & Sons, L.L.C. | 0003-6336 | ORAL | 300 mg in 1 1 | 11/21/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0555-0882 | ORAL | 500 mg in 1 1 | 3/7/2022 | |
| REMEDYREPACK INC. | 70518-3615 | ORAL | 500 mg in 1 1 | 3/26/2024 | |
| E.R. Squibb & Sons, L.L.C. | 0003-6337 | ORAL | 400 mg in 1 1 | 11/21/2022 | |
| Medunik | 71770-105 | ORAL | 100 mg in 1 1 | 11/4/2023 | |
| Leading Pharma, LLC | 69315-164 | ORAL | 500 mg in 1 1 | 2/8/2023 | |
| American Health Packaging | 68084-284 | ORAL | 500 mg in 1 1 | 10/2/2023 | |
| Major Pharmaceuticals | 0904-6939 | ORAL | 500 mg in 1 1 | 4/10/2019 | |
| Golden State Medical Supply, Inc. | 60429-265 | ORAL | 500 mg in 1 1 | 8/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/29/2007 | ||
Authorised | 7/1/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HYDRINE CAPSULES 500 mg | SIN11083P | CAPSULE | 500 mg | 8/25/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hydroxycarbamide Tablets | 国药准字H14020411 | 化学药品 | 片剂 | 6/22/2020 | |
| Hydroxycarbamide Tablets | 国药准字H20013389 | 化学药品 | 片剂 | 2/19/2020 | |
| Hydroxycarbamide Tablets | 国药准字H42022293 | 化学药品 | 片剂 | 7/13/2020 | |
| Hydroxycarbamide Tablets | 国药准字H11020569 | 化学药品 | 片剂 | 9/14/2021 | |
| Hydroxycarbamide Tablets | 国药准字H45020227 | 化学药品 | 片剂 | 8/13/2020 | |
| Hydroxycarbamide Tablets | 国药准字H37021289 | 化学药品 | 片剂 | 5/11/2024 | |
| Hydroxycarbamide Capsules | 国药准字H14023012 | 化学药品 | 胶囊剂 | 6/22/2020 | |
| Hydroxycarbamide Capsules | 国药准字H20174046 | 化学药品 | 胶囊剂 | 6/12/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| HYDROXYCARBAMIDE TEVA CAPSULES 500MG | N/A | N/A | N/A | 7/28/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| HYDREA hydroxycarbamide (hydroxyurea) 500 mg capsule bottle | 47486 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 1/18/1994 |
| HYDROXYCARBAMIDE MEDSURGE hydroxycarbamide (hydroxyurea) 500 mg capsule blister | 313761 | Medicine | A | 6/3/2020 | |
| HYDROXYCARBAMIDE MEDICIANZ hydroxycarbamide (hydroxyurea) 500 mg capsule blister | 313760 | Medicine | A | 6/3/2020 |
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