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Dacogen(decitabine)
Dacogen, 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
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Combinations
Inqovi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cedazuridine
+
Decitabine
Tradename
Company
Number
Date
Products
INQOVIOtsukaN-212576 RX2020-07-07
1 products, RLD, RS
Decitabine
Tradename
Company
Number
Date
Products
DECITABINEsparcN-205582 RX2014-01-28
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
dacogenNew Drug Application2020-06-24
decitabineANDA2023-05-26
inqoviNew Drug Application2021-04-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myelodysplastic syndromesD009190D46
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
J0894
Injection, decitabine, 1 mg
Clinical
Clinical Trials
371 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 acuteD015470C92.076872422157
Myelodysplastic syndromesD009190D4645701324108
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.083110
Large b-cell lymphoma diffuseD016403C83.343118
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelomonocytic leukemia chronicD015477C93.114161128
LeukemiaD007938C951417326
NeoplasmsD009369C801663120
Myeloid leukemiaD007951C922215
Hodgkin diseaseD006689C811415
Monocytic leukemia acuteD007948314
Myelomonocytic leukemia acuteD015479C92.5314
Hematologic diseasesD006402EFO_0005803D75.91113
ThrombocytopeniaD013921HP_0001873D69.61213
Megakaryoblastic leukemia acuteD007947C94.2213
Show 8 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340178
MelanomaD008545848
Primary myelofibrosisD055728D47.4426
Breast neoplasmsD001943EFO_0003869C50436
Non-hodgkin lymphomaD008228C85.9525
Non-small-cell lung carcinomaD002289435
AnemiaD000740EFO_0004272D64.9324
Ovarian neoplasmsD010051EFO_0003893C56334
Fallopian tube neoplasmsD005185324
Sickle cell anemiaD000755EFO_0000697D57123
Show 39 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.122
Mantle-cell lymphomaD020522C83.122
Burkitt lymphomaD002051C83.722
Leukemia myeloid chronic atypical bcr-abl negativeD054438C92.222
SarcomaD01250922
Gata2 deficiencyD00007742811
Hematopoietic stem cell transplantationD01838011
EpendymomaD00480611
PreleukemiaD01128911
Bone marrow diseasesD00185511
Show 16 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colonic neoplasmsD003110C1811
Pulmonary hypertensionD006976EFO_0001361I27.2011
OsteoporosisD010024EFO_0003882M81.011
Beta-thalassemiaD017086Orphanet_848D56.111
Iron overloadD01919011
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)
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
RxCUI15657
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
Protein name
cytidine deaminase
Protein synonyms
Cytidine aminohydrolase, cytosine nucleoside deaminase, small cytidine deaminase
Uniprot ID
Mouse ortholog
Cda (72269)
cytidine deaminase (Q9D7V3)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 12,252 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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