Hydrea, Xromi(hydroxyurea)
Hydrea, Hydroxyurea, Siklos, Xromi (hydroxyurea) is a small molecule pharmaceutical. Hydroxyurea was first approved as Hydrea on 1982-01-01. It is used to treat BCR-ABL positive chronic myelogenous leukemia, brain neoplasms, essential thrombocythemia, head and neck neoplasms, and hypereosinophilic syndrome amongst others in the USA. The pharmaceutical is active against ribonucleoside-diphosphate reductase subunit M2 and ribonucleoside-diphosphate reductase large subunit.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Droxia, Hydroxyurea, Xromi (discontinued: Droxia, Hydroxyurea)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydroxyurea
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYDREA | CHEPLAPHARM Arzneimittel | N-016295 RX | 1982-01-01 | 1 products, RLD, RS |
| XROMI | Nova Laboratories | N-216593 RX | 2024-04-04 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| droxia | New Drug Application | 2025-09-12 |
| hydrea | New Drug Application | 2025-09-15 |
| hydroxyurea | ANDA | 2025-09-11 |
| siklos | New Drug Application | 2025-02-05 |
| xromi | New Drug Application | 2025-08-20 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
HYDROXYUREA, SIKLOS, ADDMEDICA SAS | |||
| 2024-12-21 | ODE-177 | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| S0176 | Hydroxyurea, oral, 500 mg |
Clinical
Clinical Trials
396 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 24 | 45 | 21 | 9 | 58 | 144 |
| Polycythemia vera | D011087 | — | D45 | 1 | 10 | 11 | 1 | 6 | 29 |
| Thalassemia | D013789 | EFO_1001996 | D56 | 3 | 13 | 5 | 2 | 7 | 25 |
| Thrombocytosis | D013922 | — | D75.83 | 3 | 10 | 8 | 1 | 3 | 23 |
| Essential thrombocythemia | D013920 | — | D47.3 | 2 | 9 | 9 | 1 | 3 | 22 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 8 | 1 | 1 | 5 | 18 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 3 | 12 | 5 | 1 | 3 | 17 |
| Hemoglobin sc disease | D006450 | EFO_1001797 | D57.2 | 1 | 4 | — | 1 | 4 | 9 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | 3 | 1 | 3 | 9 |
| Vaso-occlusive crises | D000098644 | — | — | — | 2 | 3 | 1 | — | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 7 | 16 | 13 | — | 5 | 35 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 5 | 12 | 8 | — | 9 | 31 |
| Myeloid leukemia | D007951 | — | C92 | 6 | 12 | 9 | — | 4 | 26 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 9 | 13 | 5 | — | 4 | 25 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | 9 | 11 | — | 4 | 25 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 2 | 7 | 8 | — | 2 | 17 |
| Neoplasms | D009369 | — | C80 | 7 | 6 | 3 | — | 2 | 16 |
| Primary myelofibrosis | D055728 | — | D47.4 | 3 | 5 | 6 | — | 1 | 13 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 2 | 6 | 2 | — | 3 | 12 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 3 | 2 | 6 | — | 1 | 11 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 11 | 20 | — | — | 1 | 24 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 8 | 12 | — | — | — | 15 |
| B-cell lymphoma | D016393 | — | — | 6 | 11 | — | — | — | 13 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 5 | 8 | — | — | 1 | 12 |
| Head and neck neoplasms | D006258 | — | — | 3 | 11 | — | — | — | 12 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | 7 | — | — | 1 | 9 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 4 | 5 | — | — | — | 8 |
| Burkitt lymphoma | D002051 | — | C83.7 | 2 | 6 | — | — | — | 7 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | — | 7 | — | — | — | 7 |
| Hodgkin disease | D006689 | — | C81 | 4 | 4 | — | — | — | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 1 | — | — | — | 3 | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | — | — | 3 | 4 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | 2 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | — | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 3 | — | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | — | 2 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 2 | — | — | — | — | 2 |
| Verrucous carcinoma | D018289 | — | — | 2 | — | — | — | — | 2 |
| Pancreatic ductal carcinoma | D021441 | — | — | 2 | — | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | — | 2 |
Show 24 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Iron deficiencies | D000090463 | — | E61.1 | — | — | — | — | 1 | 1 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 1 | 1 |
| Cerebral infarction | D002544 | — | I63 | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 1 | 1 |
| Bone marrow neoplasms | D019046 | — | — | — | — | — | — | 1 | 1 |
| Only child | D009863 | — | — | — | — | — | — | 1 | 1 |
| Yin deficiency | D016710 | — | — | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hydroxyurea |
| INN | hydroxycarbamide |
| Description | Hydroxyurea is a member of the class of ureas that is urea in which one of the hydrogens is replaced by a hydroxy group. An antineoplastic used in the treatment of chronic myeloid leukaemia as well as for sickle-cell disease. It has a role as a DNA synthesis inhibitor, an EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor, an antineoplastic agent, a genotoxin, an antimetabolite, a teratogenic agent, a radical scavenger, an immunomodulator and an antimitotic. It is a member of ureas and a one-carbon compound. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)NO |
Identifiers
| PDB | — |
| CAS-ID | 127-07-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL467 |
| ChEBI ID | 44423 |
| PubChem CID | 3657 |
| DrugBank | DB01005 |
| UNII ID | X6Q56QN5QC (ChemIDplus, GSRS) |
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Hydroxyurea
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Droxia, Siklos, Xromi
Adverse Events
Top Adverse Reactions
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8,036 adverse events reported
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