Skip to content
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.
Download report
Favorite
BMS
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, 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)
Hydroxyurea
Tradename
Company
Number
Date
Products
SIKLOSaddmedicaN-208843 RX2017-12-21
2 products, RLD, RS
DROXIACHEPLAPHARM ArzneimittelN-016295 RX1998-02-25
3 products, RLD
HYDREACHEPLAPHARM ArzneimittelN-016295 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
droxiaNew Drug Application2023-03-06
hydreaNew Drug Application2022-11-15
siklosNew Drug Application2020-10-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bcr-abl positive chronic myelogenous leukemiaEFO_0000340D015464
brain neoplasmsEFO_0003833D001932C71
essential thrombocythemiaD013920D47.3
head and neck neoplasmsD006258
hypereosinophilic syndromeEFO_1001467D017681D72.11
leukocytosisHP_0001974D007964D72.829
melanomaD008545
non-small-cell lung carcinomaD002289
ovarian neoplasmsEFO_0003893D010051C56
polycythemia veraD011087D45
Show 5 more
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
182 clinical trials
View more details
Mock 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 anemiaD000755EFO_0000697D5715291341668
Hiv infectionsD015658EFO_0000764B203711416
Essential thrombocythemiaD013920D47.3314
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Beta-thalassemiaD017086Orphanet_848D56.128319
LeukemiaD007938C95279
StrokeD020521EFO_0000712I63.92338
Polycythemia veraD011087D451517
GlioblastomaD005909EFO_00005153317
NeoplasmsD009369C801214
Hematologic diseasesD006402EFO_0005803D75.9134
Primary myelofibrosisD055728D47.4213
ThalassemiaD013789EFO_1001996D562113
Spinal muscular atrophyD009134EFO_0008525G12.12313
Show 15 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Head and neck neoplasmsD006258278
Squamous cell carcinoma of head and neckD000077195436
GliosarcomaD018316224
Hemoglobin sc diseaseD006450EFO_1001797D57.244
Central nervous system neoplasmsD016543224
Squamous cell carcinomaD002294213
Pulmonary hypertensionD006976EFO_0001361I27.20313
Esophageal neoplasmsD004938C15133
Myeloid leukemia acuteD015470C92.022
ThrombocytosisD013922D75.83112
Show 32 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Salivary gland neoplasmsD012468EFO_0003826D1122
Verrucous carcinomaD01828922
Basal cell carcinomaD00228011
Adenoid cystic carcinomaD00352811
Inverted papillomaD01830811
Olfactory esthesioneuroblastomaD018304EFO_100040711
Mucoepidermoid carcinomaD01827711
GliomaD005910EFO_000052011
Tongue neoplasmsD014062EFO_0003871C02.911
Chronic renal insufficiencyD051436N1811
Show 2 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloproliferative disordersD009196D47.111
Ischemic strokeD00008324211
Bone marrow neoplasmsD01904611
Only childD00986311
Acquired immunodeficiency syndromeD000163EFO_0000765B2011
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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)
Structure (InChI/SMILES or Protein Sequence)
NC(=O)NO
Identifiers
PDB3UB9
CAS-ID127-07-1
RxCUI5552
ChEMBL IDCHEMBL467
ChEBI ID44423
PubChem CID3657
DrugBankDB01005
UNII IDX6Q56QN5QC (ChemIDplus, GSRS)
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:
Mock data
Subscribe for the real data
Additional graphs summarizing 27,153 documents
View more details
Safety
Black-box Warning
Black-box warning for: Droxia, Siklos
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
1,224 adverse events reported
View more details