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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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Events Timeline
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
azacitidineANDA2025-04-08
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 anemia—D000756D64.3
refractory anemia—D000753D46.4
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
860 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D46231—15
PreleukemiaD011289——231—15
SyndromeD013577——221—14
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C9525——39
Myeloid leukemia acuteD015470—C92.023——38
Myeloid leukemiaD007951—C9213——37
Non-small-cell lung carcinomaD002289———2———2
Pathologic complete responseD000095384———2———2
MelanomaD008545———1———1
TuberculosisD014376EFO_0000774A15-A1911———1
Pulmonary tuberculosisD014397EFO_1000049A1511———1
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.011———1
CarcinomaD002277—C80.011———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——1————1
SarcomaD012509——1————1
OsteosarcomaD012516——1————1
Liver failureD017093—K72.91————1
NeoplasmsD009369—C801————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelomonocytic leukemia chronicD015477—C93.1————11
Myelomonocytic leukemia juvenileD054429—C93.3————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‚£
Vidaza – Bristol Myers Squibb
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Vidaza – Celgene
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Azacitidine – 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 25,471 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,129 adverse events reported
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