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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 2024-08-15 |
| hydrea | New Drug Application | 2024-08-15 |
| hydroxyurea | ANDA | 2025-03-04 |
| siklos | New Drug Application | 2025-02-05 |
| xromi | New Drug Application | 2025-01-03 |
Indications
FDA
EMA
Show 5 more
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
333 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 44 | 21 | 7 | 55 | 138 |
| Polycythemia vera | D011087 | — | D45 | 1 | 11 | 13 | 1 | 6 | 31 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | 11 | 13 | 1 | 6 | 31 |
| Thalassemia | D013789 | EFO_1001996 | D56 | 5 | 16 | 6 | 2 | 8 | 29 |
| Thrombocytosis | D013922 | — | D75.83 | 2 | 11 | 11 | 1 | 3 | 25 |
| Essential thrombocythemia | D013920 | — | D47.3 | 2 | 10 | 11 | 1 | 3 | 24 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 3 | 12 | 5 | 1 | 3 | 17 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 7 | 1 | 1 | 5 | 17 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | 3 | 1 | 3 | 9 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 6 | 17 | 16 | — | 5 | 38 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 5 | 13 | 8 | — | 11 | 33 |
| Myeloid leukemia | D007951 | — | C92 | 6 | 15 | 12 | — | 5 | 32 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 5 | 11 | 5 | — | 4 | 20 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 2 | 6 | 8 | — | 2 | 16 |
| Head and neck neoplasms | D006258 | — | — | 4 | 11 | 1 | — | — | 14 |
| Primary myelofibrosis | D055728 | — | D47.4 | 2 | 5 | 6 | — | 1 | 12 |
| Carcinoma | D002277 | — | C80.0 | 5 | 6 | 2 | — | — | 11 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | 6 | 1 | — | 3 | 10 |
| Squamous cell carcinoma | D002294 | — | — | 5 | 6 | 1 | — | — | 10 |
Show 28 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 3 | 2 | — | — | 5 | 10 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 3 | 1 | — | — | 5 | 9 |
| Hemoglobin sc disease | D006450 | EFO_1001797 | D57.2 | 1 | 4 | — | — | 4 | 8 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 4 | 4 | — | — | — | 7 |
| Communicable diseases | D003141 | — | — | 1 | 1 | — | — | 4 | 6 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | — | 6 | — | — | — | 6 |
| Gliosarcoma | D018316 | — | — | 2 | 2 | — | — | — | 4 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 2 | 3 | — | — | 1 | 4 |
| Metabolic brain diseases | D001928 | — | G93.41 | 2 | 3 | — | — | 1 | 4 |
| Pancytopenia | D010198 | — | D61.81 | 2 | 3 | — | — | 1 | 4 |
Show 78 more
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 |
| Laryngeal diseases | D007818 | — | J38.7 | 2 | — | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | — | 2 |
| Basal cell carcinoma | D002280 | — | — | 1 | — | — | — | — | 1 |
| Adenoid cystic carcinoma | D003528 | — | — | 1 | — | — | — | — | 1 |
| Unknown primary neoplasms | D009382 | — | — | 1 | — | — | — | — | 1 |
| Inverted papilloma | D018308 | — | — | 1 | — | — | — | — | 1 |
| Granuloma | D006099 | — | — | 1 | — | — | — | — | 1 |
| Olfactory esthesioneuroblastoma | D018304 | EFO_1000407 | — | 1 | — | — | — | — | 1 |
Show 13 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-deficiency anemia | D018798 | — | D50 | — | — | — | — | 1 | 1 |
| Iron deficiencies | D000090463 | — | E61.1 | — | — | — | — | 1 | 1 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 1 | 1 |
| Cerebral infarction | D002544 | — | I63 | — | — | — | — | 1 | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 1 | 1 |
| Bone marrow neoplasms | D019046 | — | — | — | — | — | — | 1 | 1 |
| Leukoencephalopathies | D056784 | — | R90.82 | — | — | — | — | 1 | 1 |
Show 13 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Hydroxyurea
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 31,102 documents
View more details
Safety
Black-box Warning
Black-box warning for: Droxia, Siklos, Xromi
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
7,711 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use