Hydroxyurea
Droxia, Hydrea, Siklos (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, Hydrea, Siklos (generic drugs available since 1998-10-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bcr-abl positive chronic myelogenous leukemia | EFO_0000340 | D015464 | — |
| brain neoplasms | EFO_0003833 | D001932 | C71 |
| essential thrombocythemia | — | D013920 | D47.3 |
| head and neck neoplasms | — | D006258 | — |
| hypereosinophilic syndrome | EFO_1001467 | D017681 | D72.11 |
| leukocytosis | HP_0001974 | D007964 | D72.829 |
| melanoma | — | D008545 | — |
| non-small-cell lung carcinoma | — | D002289 | — |
| ovarian neoplasms | EFO_0003893 | D010051 | C56 |
| polycythemia vera | — | D011087 | D45 |
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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
182 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 | 15 | 29 | 13 | 4 | 16 | 68 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 7 | 1 | 1 | 4 | 16 |
| Essential thrombocythemia | D013920 | D47.3 | — | — | 3 | 1 | — | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 2 | 8 | 3 | — | 1 | 9 |
| Leukemia | D007938 | C95 | — | 2 | 7 | — | — | 9 | |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | 3 | — | 3 | 8 |
| Polycythemia vera | D011087 | D45 | — | 1 | 5 | — | 1 | 7 | |
| Glioblastoma | D005909 | EFO_0000515 | 3 | 3 | 1 | — | — | 7 | |
| Neoplasms | D009369 | C80 | 1 | 2 | 1 | — | — | 4 | |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 1 | 3 | — | — | 4 |
| Primary myelofibrosis | D055728 | D47.4 | — | — | 2 | — | 1 | 3 | |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | 2 | 1 | — | 1 | 3 |
| Spinal muscular atrophy | D009134 | EFO_0008525 | G12.1 | 2 | 3 | 1 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | 2 | 7 | — | — | — | 8 | ||
| Squamous cell carcinoma of head and neck | D000077195 | 4 | 3 | — | — | — | 6 | ||
| Gliosarcoma | D018316 | 2 | 2 | — | — | — | 4 | ||
| Hemoglobin sc disease | D006450 | EFO_1001797 | D57.2 | — | 4 | — | — | — | 4 |
| Central nervous system neoplasms | D016543 | 2 | 2 | — | — | — | 4 | ||
| Squamous cell carcinoma | D002294 | 2 | 1 | — | — | — | 3 | ||
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 3 | 1 | — | — | — | 3 |
| Esophageal neoplasms | D004938 | C15 | 1 | 3 | — | — | — | 3 | |
| Myeloid leukemia acute | D015470 | C92.0 | — | 2 | — | — | — | 2 | |
| Thrombocytosis | D013922 | D75.83 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 2 | — | — | — | — | 2 |
| Verrucous carcinoma | D018289 | 2 | — | — | — | — | 2 | ||
| Basal cell carcinoma | D002280 | 1 | — | — | — | — | 1 | ||
| Adenoid cystic carcinoma | D003528 | 1 | — | — | — | — | 1 | ||
| Inverted papilloma | D018308 | 1 | — | — | — | — | 1 | ||
| Olfactory esthesioneuroblastoma | D018304 | EFO_1000407 | 1 | — | — | — | — | 1 | |
| Mucoepidermoid carcinoma | D018277 | 1 | — | — | — | — | 1 | ||
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Tongue neoplasms | D014062 | EFO_0003871 | C02.9 | 1 | — | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | N18 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | D47.1 | — | — | — | — | 1 | 1 | |
| Ischemic stroke | D000083242 | — | — | — | — | 1 | 1 | ||
| Bone marrow neoplasms | D019046 | — | — | — | — | 1 | 1 | ||
| Only child | D009863 | — | — | — | — | 1 | 1 | ||
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
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 |
Target
Agency Approved
RRM2
RRM2
RRM1
RRM1
Organism
Homo sapiens
Gene name
RRM2
Gene synonyms
RR2
NCBI Gene ID
Protein name
ribonucleoside-diphosphate reductase subunit M2
Protein synonyms
ribonucleotide reductase M2 polypeptide, Ribonucleotide reductase small chain, Ribonucleotide reductase small subunit, uncharacterized protein C2orf48
Uniprot ID
Mouse ortholog
Rrm2 (20135)
ribonucleoside-diphosphate reductase subunit M2 (Q542E2)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 27,153 documents
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Safety
Black-box Warning
Black-box warning for: Droxia, Siklos
Adverse Events
Top Adverse Reactions
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1,224 adverse events reported
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