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Vidaza(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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SARS-CoV-2 Interaction
BMS
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Onureg, Vidaza (generic drugs available since 2013-09-16)
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
azacitidineANDA2023-02-01
onuregNew Drug Application2020-11-12
vidazaNew Drug Application2020-03-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myelomonocytic leukemia chronic—D015477C93.1
refractory anemia—D000753D46.4
sideroblastic anemia—D000756D64.3
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
2023-09-01NP
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
546 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.01161453216242
Myelodysplastic syndromesD009190D46981261726205
Myelomonocytic leukemia chronicD015477C93.1383631—61
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C9518302—142
NeoplasmsD009369C802292——25
Hodgkin diseaseD006689C81741——10
T-cell lymphoma peripheralD016411C84.9561——9
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340451——9
Hematologic neoplasmsD019337641——8
Large b-cell lymphoma diffuseD016403C83.3432——7
Myeloid leukemiaD007951C92511—17
Follicular lymphomaD008224C82321——5
T-cell lymphomaD016399222——5
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01310———19
Non-hodgkin lymphomaD008228C85.9136———16
Multiple myelomaD009101C90.094——112
Non-small-cell lung carcinomaD00228965——111
LymphomaD008223C85.995———10
Primary myelofibrosisD055728D47.464———8
B-cell chronic lymphocytic leukemiaD015451C91.152———7
Breast neoplasmsD001943EFO_0003869C5035——17
Erythroblastic leukemia acuteD004915EFO_1001257C94.034———6
Megakaryoblastic leukemia acuteD007947C94.244———6
Show 49 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Extranodal nk-t-cell lymphomaD054391C86.03————3
Adult t-cell leukemia-lymphomaD015459C91.52————2
Mantle-cell lymphomaD020522C83.12————2
EpendymomaD0048062————2
Squamous cell carcinoma of head and neckD0000771952————2
RecurrenceD0120082————2
B-cell lymphoma marginal zoneD018442C88.41————1
Hairy cell leukemiaD007943C91.41————1
T-cell lymphoma cutaneousD016410C84.A1————1
Liver diseasesD008107EFO_0001421K70-K771————1
Show 25 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.0————11
Skin neoplasmsD012878EFO_0004198C44————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)
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
RxCUI1251
ChEMBL IDCHEMBL1489
ChEBI ID2038
PubChem CID9444
DrugBankDB00928
UNII IDM801H13NRU (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Onureg - Bristol Myers Squibb
$
€
£
₣
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Vidaza - Bristol Myers Squibb
$
€
£
₣
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Vidaza - Celgene
$
€
£
₣
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Azacitidine - Celgene
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 10,648 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,419 adverse events reported
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