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Drug ReportsHydroxyurea
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
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
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
nervous system diseasesD009422
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
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
XROMINova LaboratoriesN-216593 RX2024-04-04
1 products, RLD, RS
HYDREAWaylis TherapeuticsN-016295 RX1982-01-01
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
droxiaNew Drug Application2025-09-12
hydreaNew Drug Application2025-09-15
hydroxyureaANDA2025-09-11
siklosNew Drug Application2025-02-05
xromiNew Drug Application2025-08-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
renal cell carcinomaEFO_0000376D002292—
brain neoplasmsEFO_0003833D001932C71
ovarian neoplasmsEFO_0003893D010051C56
psoriasisEFO_0000676D011565L40
non-small-cell lung carcinoma—D002289—
head and neck neoplasms—D006258—
essential thrombocythemia—D013920D47.3
polycythemia vera—D011087D45
bcr-abl positive chronic myelogenous leukemiaEFO_0000340D015464—
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Agency Specific
FDA
EMA
Expiration
Code
HYDROXYUREA, SIKLOS, ADDMEDICA SAS
2024-12-21ODE-177
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XX: Other antineoplastic agents in atc
— L01XX05: Hydroxycarbamide
HCPCS
Code
Description
S0176
Hydroxyurea, oral, 500 mg
Clinical
Clinical Trials
397 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sickle cell anemiaD000755EFO_0000697D5711——12
Beta-thalassemiaD017086Orphanet_848D56.111———1
ThalassemiaD013789EFO_1001996D5611———1
Hemoglobin sc diseaseD006450EFO_1001797D57.211———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydroxyurea
INNhydroxycarbamide
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)Loading
Structure (InChI/SMILES or Protein Sequence)
NC(=O)NO
Identifiers
PDB—
CAS-ID127-07-1
RxCUI—
ChEMBL IDCHEMBL467
ChEBI ID44423
PubChem CID3657
DrugBankDB01005
UNII IDX6Q56QN5QC (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)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 32,504 documents
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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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