Hydroxyurea

Highest phase reached

Approved

www.ebi.ac.uk

Drug type

Small molecule

www.ebi.ac.uk

First approval year

1967

www.ebi.ac.uk

First approval year: 1967
www.ebi.ac.uk

Listing at source: Listed

Highest phase reached: Approved
www.ebi.ac.uk

Drug type: Small molecule
www.ebi.ac.uk

Drug name: Hydroxyurea
www.ebi.ac.uk

Molecular weight: 76.05
www.ebi.ac.uk

Structure (SMILES): NC(=O)NO
www.ebi.ac.uk

droxia
Droxia
hydrea
Hydrea
hydroxyurea
Hydroxyurea
siklos
Siklos
xromi
Xromi

hidroxicarbamida
Hidroxicarbamida
hydrea
Hydrea
Hydrea® (hydroxyurea )
hydroxycarbamide
Hydroxycarbamide
HYDROXYCARBAMIDE [EMA EPAR]
HYDROXYCARBAMIDE [EP MONOGRAPH]
hydroxycarbamide [INN]
HYDROXYCARBAMIDE [JAN]
HYDROXYCARBAMIDE [MART.]
Hydroxycarbamide [WHO-DD]
Hydroxycarbamide 500 Mg Oral Capsule
hydroxycarbamide ema epar
hydroxycarbamide ep monograph
Hydroxycarbamide film-coated tablet
hydroxycarbamide inn
hydroxycarbamide jan
hydroxycarbamide mart
Hydroxycarbamide tablets
Hydroxycarbamide Tablets
hydroxycarbamide who dd
hydroxyurea
Hydroxyurea

And 31 more, listed on the interactive page.

ATC classification codes

L01XX05

Sources for recorded values

www.ebi.ac.uk

CAS registry numbers

127-07-1

ChEMBL ID: CHEMBL467
www.ebi.ac.uk

InChIKey: VSNHCAURESNICA-UHFFFAOYSA-N
www.ebi.ac.uk

PubChem compound IDs

3657

RxNorm IDs (RxCUI)

5552

FDA ingredient codes (UNII)

X6Q56QN5QC

Applicant: WAYLIS THERAP
Approval date: 7 Dec 1967
Application number: NDA016295

Patents: 1
Designations: 3
Earliest recorded loss of exclusivity: 23 Dec 2041
First in class: No
Fast track: No
Breakthrough designation: No
Orphan designation: No
Priority review: No
Orphan exclusivity: No
Accelerated approval: No
Availability: Prescription only
Boxed warning: Yes

Pharmacology name: hydroxyurea
Type: Synthetic organic
Approval recorded by Guide to Pharmacology: Yes

Administration routes

Oral

Action
Inhibition
Action type
Inhibitor
Target
ribonucleotide reductase catalytic subunit M1
Gene symbol
RRM1
Protein identifier
P23921
Median affinity
3.83
Affinity units
pIC50
Primary target
Yes
Action
Inhibition
Action type
Inhibitor
Target
ribonucleotide reductase regulatory subunit M2
Gene symbol
RRM2
Protein identifier
P31350
Median affinity
3.83
Affinity units
pIC50
Primary target
Yes
Mechanism
Ribonucleoside-diphosphate reductase RR1 inhibitor
Action type
Inhibitor
Target
Ribonucleoside-diphosphate reductase RR1
Protein identifier
P23921
Mechanism
Ribonucleoside-diphosphate reductase RR1 inhibitor
Action type
Inhibitor
Target
Ribonucleoside-diphosphate reductase RR1
Protein identifier
P31350
Mechanism
Ribonucleoside-diphosphate reductase RR1 inhibitor
Action type
Inhibitor
Target
Ribonucleoside-diphosphate reductase RR1
Protein identifier
Q7LG56

Open Targets mechanisms

Mechanism
Ribonucleoside-diphosphate reductase RR1 inhibitor
Action type
Inhibitor
Target
Ribonucleoside-diphosphate reductase RR1

Action type
Inhibitor
Gene symbol
RRM1
Protein identifier
P23921
Organism
Homo sapiens
Target development level
Clinical
Action type
Inhibitor
Gene symbol
RRM2
Protein identifier
P31350
Organism
Homo sapiens
Target development level
Clinical

Condition
Carcinoma, Squamous Cell
Highest recorded phase
4
Condition identifier
EFO:0000181
Subject identifier
D002294
Condition
Myelodysplastic Syndromes
Highest recorded phase
3
Condition identifier
EFO:0000198
Subject identifier
D009190
Condition
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Highest recorded phase
2
Condition identifier
EFO:0000220
Subject identifier
D054198
Condition
Leukemia, Myeloid, Acute
Highest recorded phase
2
Condition identifier
EFO:0000222
Subject identifier
D015470
Condition
Leukemia, Promyelocytic, Acute
Highest recorded phase
3
Condition identifier
EFO:0000224
Subject identifier
D015473
Condition
Astrocytoma
Highest recorded phase
3
Condition identifier
EFO:0000272
Subject identifier
D001254
Condition
Carcinoma
Highest recorded phase
3
Condition identifier
EFO:0000313
Subject identifier
D002277
Condition
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Highest recorded phase
4
Condition identifier
EFO:0000339
Subject identifier
D015464
Condition
Thrombocythemia, Essential
Highest recorded phase
3
Condition identifier
EFO:0000479
Subject identifier
D013920
Condition
Fibroma
Highest recorded phase
2
Condition identifier
EFO:0000497
Subject identifier
D005350
Condition
Glioblastoma
Highest recorded phase
3
Condition identifier
EFO:0000519
Subject identifier
D005909
Condition
Leukemia
Highest recorded phase
3
Condition identifier
EFO:0000565
Subject identifier
D007938
Condition
Lymphoma
Highest recorded phase
2
Condition identifier
EFO:0000574
Subject identifier
D008223
Condition
Neoplasms
Highest recorded phase
4
Condition identifier
EFO:0000616
Subject identifier
D009369
Condition
Carcinoma, Squamous Cell
Highest recorded phase
4
Condition identifier
EFO:0000707
Subject identifier
D002294
Condition
Stroke
Highest recorded phase
3
Condition identifier
EFO:0000712
Subject identifier
D020521
Condition
Melanoma
Highest recorded phase
4
Condition identifier
EFO:0000756
Subject identifier
D008545
Condition
HIV Infections
Highest recorded phase
3
Condition identifier
EFO:0000764
Subject identifier
D015658
Condition
Polycythemia Vera
Highest recorded phase
3
Condition identifier
EFO:0002429
Subject identifier
D011087
Condition
Primary Myelofibrosis
Highest recorded phase
3
Condition identifier
EFO:0002430
Subject identifier
D055728
Condition
Laryngeal Neoplasms
Highest recorded phase
3
Condition identifier
EFO:0003817
Subject identifier
D007822
Condition
Paranasal Sinus Neoplasms
Highest recorded phase
3
Condition identifier
EFO:0003866
Subject identifier
D010255
Condition
Myeloproliferative Disorders
Highest recorded phase
3
Condition identifier
EFO:0004251
Subject identifier
D009196
Condition
Mouth Neoplasms
Highest recorded phase
3
Condition identifier
EFO:0005570
Subject identifier
D009062
Condition
Pharyngeal Neoplasms
Highest recorded phase
3
Condition identifier
EFO:0005577
Subject identifier
D010610

And 22 more, listed on the interactive page.

Condition identifier
EFO_0000198
Highest recorded phase
3
Condition identifier
EFO_0000224
Highest recorded phase
3
Condition identifier
EFO_0000313
Highest recorded phase
3
Condition identifier
EFO_0000339
Condition identifier
EFO_0000479
Highest recorded phase
3
Condition identifier
EFO_0000497
Highest recorded phase
2
Condition identifier
EFO_0000519
Highest recorded phase
1
Condition identifier
EFO_0000574
Highest recorded phase
2
Condition identifier
EFO_0000616
Condition identifier
EFO_0000707
Condition identifier
EFO_0000712
Highest recorded phase
3
Condition identifier
EFO_0000756
Condition identifier
EFO_0000764
Highest recorded phase
3
Condition identifier
EFO_0000768
Highest recorded phase
1
Condition identifier
EFO_0002429
Highest recorded phase
3
Condition identifier
EFO_0004285
Highest recorded phase
2
Condition identifier
EFO_0008525
Condition identifier
EFO_0009907
Highest recorded phase
2
Condition identifier
EFO_1000158
Highest recorded phase
2
Condition identifier
EFO_1000642
Highest recorded phase
3
Condition identifier
EFO_1001465
Highest recorded phase
1
Condition identifier
EFO_1001797
Highest recorded phase
2
Condition identifier
EFO_1001996
Condition identifier
HP_0001297
Highest recorded phase
3
Condition identifier
HP_0001871
Highest recorded phase
3

And 81 more, listed on the interactive page.

Warning
Black Box Warning
Effect
carcinogenicity
Warning
Black Box Warning
Effect
hematological toxicity
Warning
Black Box Warning
Effect
infectious disease

Warning
Black Box Warning
Effect
carcinogenicity
Country
United States
Warning
Black Box Warning
Effect
hematological toxicity
Country
United States
Warning
Black Box Warning
Effect
infectious disease
Country
United States

Event
actinic keratosis
Reports
34
Reporting signal score
97.8746
Event
acute chest syndrome
Reports
13
Reporting signal score
48.7913
Event
acute myeloid leukaemia
Reports
39
Reporting signal score
76.96
Event
anaemia
Reports
146
Reporting signal score
78.3376
Event
aquagenic pruritus
Reports
7
Reporting signal score
39.9762
Event
bowen's disease
Reports
19
Reporting signal score
55.7448
Event
cytogenetic analysis abnormal
Reports
18
Reporting signal score
64.3568
Event
differentiation syndrome
Reports
12
Reporting signal score
42.313
Event
endocarditis noninfective
Reports
10
Reporting signal score
49.0644
Event
erythromelalgia
Reports
14
Reporting signal score
60.0436
Event
essential thrombocythaemia
Reports
10
Reporting signal score
39.1476
Event
febrile neutropenia
Reports
63
Reporting signal score
43.5254
Event
granulomatous rosacea
Reports
13
Reporting signal score
72.0555
Event
idiopathic intracranial hypertension
Reports
17
Reporting signal score
49.8346
Event
myelofibrosis
Reports
33
Reporting signal score
106.913
Event
nail pigmentation
Reports
16
Reporting signal score
69.7651
Event
pancytopenia
Reports
79
Reporting signal score
80.8173
Event
platelet count increased
Reports
54
Reporting signal score
112.944
Event
pyrexia
Reports
150
Reporting signal score
41.9036
Event
sickle cell anaemia with crisis
Reports
24
Reporting signal score
61.5323
Event
skin ulcer
Reports
100
Reporting signal score
211.806
Event
splenomegaly
Reports
52
Reporting signal score
112.504
Event
squamous cell carcinoma
Reports
45
Reporting signal score
92.2596
Event
squamous cell carcinoma of skin
Reports
28
Reporting signal score
57.1333
Event
thrombocytopenia
Reports
133
Reporting signal score
101.907

And 2 more, listed on the interactive page.

NCT00000586
clinicaltrials.gov
NCT00000602
clinicaltrials.gov
NCT00001197
clinicaltrials.gov
NCT00004492
clinicaltrials.gov
NCT00006400
clinicaltrials.gov
NCT00056433
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NCT00143572
clinicaltrials.gov
NCT01425307
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NCT01506544
clinicaltrials.gov
NCT01531387
clinicaltrials.gov
NCT01565954
clinicaltrials.gov
NCT01848925
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NCT01960413
clinicaltrials.gov
NCT01966731
clinicaltrials.gov
NCT02042222
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NCT02090296
clinicaltrials.gov
NCT02149537
clinicaltrials.gov
NCT02225132
clinicaltrials.gov
NCT02522104
clinicaltrials.gov
NCT02556099
clinicaltrials.gov
NCT02757885
clinicaltrials.gov
NCT02844673
clinicaltrials.gov
NCT03020615
clinicaltrials.gov
NCT03077542
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NCT03263559
clinicaltrials.gov

And 102 more, listed on the interactive page.

Hydrogen bond acceptors: 2
Hydrogen bond donors: 3
Polar surface area: 75.35
Calculated partition coefficient (ALogP): -0.96
Calculated partition coefficient (XLogP): -1.8
Prodrug: No
Chirality: Achiral
Inorganic: No
Rule-of-five violations: 0
Rotatable bonds: 0
Heavy atoms: 5
Molecular formula: CH4N2O2
Monoisotopic mass: 76.027277375
Natural product: Yes

0555-0882
0904-6939
42291-321
49884-724
51407-909
61269-402
61269-403
61269-404
61269-835
68084-284
69315-164
70069-820
71770-105
71770-120
80725-810
80725-820
80725-830
80725-840
62484-0015
67046-1619
67184-0607

Recorded assays: 6,361
Active assays: 465

Confirmatory
Other
Screening

Antineoplastic Agents
id.nlm.nih.gov
Antisickling Agents
id.nlm.nih.gov
Enzyme Inhibitors
id.nlm.nih.gov
Nucleic Acid Synthesis Inhibitors
id.nlm.nih.gov

Distribution coefficient (LogD)

Median: -1.27
Mean: -1.27
Minimum: -1.27
Maximum: -1.27
Unit: unitless
Assays: 1
Standard deviation: 0
Summary method: median
Censored results excluded: 0
Other units excluded: 0
Unknown units excluded: 0

Measurement types

LogD

Related records

Trials (306)

A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers
A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis
A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
A Dose Escalation Study of Hydroxyurea in Combination With SCH900776 in Advanced Malignant Solid Tumors
A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea)
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke
A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection
A Pilot Therapeutic Trial Using Hydroxyurea in Type I Spinal Muscular Atrophy Patients
A Pilot Therapeutic Trial Using Hydroxyurea in Type II and Type III Spinal Muscular Atrophy Patients
A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients
A Randomized, Self-controlled Post-marketing Clinical Study on the Comparison of Shengbai Oral Liquid and Leucogen Tablets in the Treatment of Moderate Neutropenia Caused by Anti-tumor Drugs in Breast Cancer Patients
A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)

Approved for (6)

Chronic myeloid leukemia
Head and neck squamous cell carcinoma
Melanoma
Neoplasm
Sickle cell disease
Squamous cell carcinoma

In development for (41)

Acquired polycythemia vera Phase 3
Acute lymphoblastic leukemia Phase 2
Acute myeloid leukemia Phase 2
Acute promyelocytic leukemia Phase 3
Astrocytoma (excluding glioblastoma) Phase 3
Beta thalassemia Phase 2
Beta-thalassemia intermedia Phase 2
Bone marrow neoplasm Phase 3
Carcinoma Phase 3
Central nervous system neoplasm Phase 2
Desmoid tumor Phase 2
Esophageal cancer Phase 2
Essential thrombocythemia Phase 3
Fibromatosis Phase 2
Gastric cancer Phase 2
Glioblastoma Phase 3
Gliosarcoma Phase 2
Head and neck cancer Phase 2
Hematologic disorder Phase 3
Hemoglobinopathy Phase 3

Targets (3)

RRM1 Ribonucleoside-diphosphate reductase RR1 inhibitor
RRM2 Ribonucleoside-diphosphate reductase RR1 inhibitor
RRM2B Ribonucleoside-diphosphate reductase RR1 inhibitor

Hydroxyurea

Development status

Names and chemistry

Brand names (10)

Other names (56)

Identifiers

Regulatory information

United States

Other regulatory facts

Pharmacology

Drug classification

Administration routes

Mechanisms of action (5)

Open Targets mechanisms

DrugCentral mechanisms (2)

Investigated indications (47)

Open Targets indications (106)

Warnings (3)

Open Targets warnings (3)

Reported adverse events (27)

Trial references (127)

Chemical properties

National Drug Codes

Evidence counts

Active assay types (3)

Pharmacologic actions

Biological measurements

Observed measurements

Distribution coefficient (LogD)

Measurement types

Related records

Trials (306)

Approved for (6)

In development for (41)

Targets (3)