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AboutPricing
Drug ReportsDecitabine
Dacogen(decitabine)
Dacogen, Decitabine, Inaqovi, Inqovi (decitabine) is a small molecule pharmaceutical. Decitabine was first approved as Dacogen on 2006-05-02. It is used to treat myelodysplastic syndromes in the USA. It has been approved in Europe to treat myeloid leukemia. It is known to target cytidine deaminase.
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FDA Novel Drug Approvals 2020
SARS-CoV-2 Interaction
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
Trade Name
FDA
EMA
Decitabine (discontinued: Dacogen, Decitabine)
Combinations
Inqovi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Decitabine
Tradename
Company
Number
Date
Products
DACOGENOtsukaN-021790 DISCN2006-05-02
1 products, RLD
DECITABINESun Pharmaceutical IndustriesN-205582 DISCN2014-01-28
1 products, RLD
Hide discontinued
Cedazuridine
+
Decitabine
Tradename
Company
Number
Date
Products
INQOVITaiho OncologyN-212576 RX2020-07-07
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w...Biologic Licensing Application2011-03-11
center-al - acacia longifolia pollen center-al - acer negundo pollen center-al - acer saccharum pollen center-al - agrostis gigantea center-al - al...Biologic Licensing Application2009-06-12
coditussin dacOTC monograph final2016-05-10
dacarbazineANDA2025-09-22
dactinomycinANDA2024-06-18
decitabineANDA2025-09-29
inqoviNew Drug Application2024-11-29
standardized bermuda grass pollen standardized kentucky bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass pollen ...Biologic Licensing Application2010-03-27
standardized bermuda grass standardized kentucky blue (june) grass standardized meadow fescue grass standardized orchard grass standardized perenni...Biologic Licensing Application2025-06-03
vizimproNew Drug Application2025-08-15
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myelodysplastic syndromes—D009190D46
Agency Specific
FDA
EMA
Expiration
Code
CEDAZURIDINE / DECITABINE, INQOVI, OTSUKA
2027-07-07ODE-316
2025-07-07NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Cedazuridine / Decitabine, Inqovi, Otsuka
82688002030-08-22DPU-2864, U-2865, U-2866, U-2867
86180752028-10-16U-2864, U-2867
95673632028-10-16DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BC: Pyrimidine analogues, antineoplastic antimetabolites
— L01BC08: Decitabine
HCPCS
Code
Description
J0893
Injection, decitabine (sun pharma) not therapeutically equivalent to j0894, 1 mg
J0894
Injection, decitabine, 1 mg
Clinical
Clinical Trials
597 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
LeukemiaD007938—C95132——4
Myeloid leukemia acuteD015470—C92.0132——4
Myeloid leukemiaD007951—C92131——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D46—1———1
PreleukemiaD011289———1———1
SyndromeD013577———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDecitabine
INNdecitabine
Description
5-aza-2'-deoxycytidine is a 2'-deoxyribonucleoside.
Classification
Small molecule
Drug classnucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1
Identifiers
PDB—
CAS-ID2353-33-5
RxCUI—
ChEMBL IDCHEMBL1201129
ChEBI ID50131
PubChem CID451668
DrugBankDB01262
UNII ID776B62CQ27 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CDA
CDA
Organism
Homo sapiens
Gene name
CDA
Gene synonyms
CDD
NCBI Gene ID
978
Protein name
cytidine deaminase
Protein synonyms
Cytidine aminohydrolase, cytosine nucleoside deaminase, small cytidine deaminase
Uniprot ID
P32320
Mouse ortholog
Cda (72269)
cytidine deaminase (Q9D7V3)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 33,393 documents
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Safety
Black-box Warning
Black-box warning for: 2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w..., Center-al - acacia longifolia pollen center-al - acer negundo pollen center-al - acer saccharum pollen center-al - agrostis gigantea center-al - al..., Dacarbazine, Standardized bermuda grass pollen standardized kentucky bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass pollen ..., Standardized bermuda grass standardized kentucky blue (june) grass standardized meadow fescue grass standardized orchard grass standardized perenni...
Adverse Events
Top Adverse Reactions
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110,589 adverse events reported
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