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AboutPricing
Drug ReportsAzacitidine
Vidaza(azacitidine)
Azacitidine, Onureg, Vidaza (azacitidine) is a small molecule pharmaceutical. Azacitidine was first approved as Vidaza on 2004-05-19. It is used to treat myelomonocytic leukemia chronic, refractory anemia, and sideroblastic anemia in the USA. It has been approved in Europe to treat myelodysplastic syndromes, myeloid leukemia acute, and myelomonocytic leukemia chronic.
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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
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Azacitidine, Onureg, Vidaza (discontinued: Azacitidine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azacitidine
Tradename
Company
Number
Date
Products
AZACITIDINEAllerganN-208216 RX2016-04-29
1 products
ONUREGBristol Myers SquibbN-214120 RX2020-09-01
2 products, RLD, RS
VIDAZABristol Myers SquibbN-050794 RX2004-05-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
azacitidineANDA2024-10-24
azacitidine forANDA2022-09-14
onuregNew Drug Application2022-10-26
vidazaNew Drug Application2024-01-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myelomonocytic leukemia chronic—D015477C93.1
sideroblastic anemiaHP_0001924D000756D64.3
refractory anemia—D000753—
Agency Specific
FDA
EMA
Expiration
Code
AZACITIDINE, VIDAZA, BRISTOL-MYERS
2029-05-20ODE-399
2025-05-20I-889
AZACITIDINE, ONUREG, BRISTOL
2027-09-01ODE-320
Patent Expiration
Patent
Expires
Flag
FDA Information
Azacitidine, Onureg, Bristol
88466282030-06-03DPU-2950
115714362029-05-14DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BC: Pyrimidine analogues, antineoplastic antimetabolites
— L01BC07: Azacitidine
HCPCS
Code
Description
J9025
Injection, azacitidine, 1 mg
Clinical
Clinical Trials
831 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C9519725450340458
Myeloid leukemia acuteD015470—C92.018923952343443
Myeloid leukemiaD007951—C9216220448337384
Myelodysplastic syndromesD009190—D4615119430420329
PreleukemiaD011289——12716027215272
SyndromeD013577——981311929211
Myelomonocytic leukemia chronicD015477—C93.1495571491
Myelomonocytic leukemia juvenileD054429—C93.3475571387
Cocaine-related disordersD019970—F14———1—1
Addictive behaviorD016739EFO_0004347————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8056342—170
LymphomaD008223—C85.938336—364
Myelomonocytic leukemia acuteD015479—C92.519272——35
Hematologic neoplasmsD019337——22121—127
T-cell lymphoma peripheralD016411——10154—225
T-cell lymphomaD016399——11134—224
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1081—117
Refractory anemia with excess of blastsD000754—D46.25103—115
B-cell lymphomaD016393——752—112
Large b-cell lymphoma diffuseD016403—C83.3652——11
Show 20 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——3626——352
Precursor cell lymphoblastic leukemia-lymphomaD054198——1816——131
Myeloproliferative disordersD009196—D47.11921———31
Non-hodgkin lymphomaD008228—C85.9207——124
Lymphoid leukemiaD007945—C911311——122
Myelodysplastic-myeloproliferative diseasesD054437——1210———17
Multiple myelomaD009101—C90.0126——116
Non-small-cell lung carcinomaD002289——88——116
CarcinomaD002277—C80.099———15
Lung neoplasmsD008175HP_0100526C34.9088——115
Show 94 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpendymomaD004806——5————5
Squamous cell carcinoma of head and neckD000077195——4————4
Squamous cell carcinomaD002294——4————4
Extranodal nk-t-cell lymphomaD054391—C86.03————3
Adult t-cell leukemia-lymphomaD015459—C91.52————2
T-cell lymphoma cutaneousD016410——2————2
Renal insufficiencyD051437HP_0000083N192————2
NeuroblastomaD009447EFO_0000621—2————2
Central nervous system neoplasmsD016543——2————2
Burkitt lymphomaD002051—C83.72————2
Show 31 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.0————11
MethylationD008745——————11
InfectionsD007239EFO_0000544—————11
Gastrointestinal microbiomeD000069196——————11
Congenital abnormalitiesD000013EFO_0003915Q89.9————11
Eye abnormalitiesD005124HP_0000478Q15.9————11
Stomach neoplasmsD013274EFO_0003897C16————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAzacitidine
INNazacitidine
Description
5-azacytidine is an N-glycosyl-1,3,5-triazine that is 4-amino-1,3,5-triazin-2(1H)-one substituted by a beta-D-ribofuranosyl residue via an N-glycosidic linkage. An antineoplastic agent, it is used in the treatment of myeloid leukaemia. It has a role as an antineoplastic agent. It is a N-glycosyl-1,3,5-triazine and a nucleoside analogue. It is functionally related to a beta-D-ribose.
Classification
Small molecule
Drug classH2-receptor antagonists (cimetidine type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c(=O)n1
Identifiers
PDB—
CAS-ID320-67-2
RxCUI—
ChEMBL IDCHEMBL1489
ChEBI ID2038
PubChem CID9444
DrugBankDB00928
UNII IDM801H13NRU (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Azacitidine – Celgene
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Vidaza – Bristol Myers Squibb
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Vidaza – Celgene
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Onureg – Bristol Myers Squibb
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 24,255 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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22,047 adverse events reported
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