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Drug ReportsCedazuridine
Cedazuridine
Inaqovi, Inqovi (cedazuridine) is a small molecule pharmaceutical. Cedazuridine was first approved as Inqovi on 2020-07-07. 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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
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3M
6M
YTD
1Y
2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Results first post date
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Commercial
Therapeutic Areas
No data
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
Labels
FDA
EMA
Brand Name
Status
Last Update
inqoviNew Drug Application2022-05-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myelodysplastic syndromes—D009190D46
myeloid leukemia—D007951C92
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
No data
HCPCS
No data
Clinical
Clinical Trials
65 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—D4621193——31
LeukemiaD007938—C9518173——29
Myeloid leukemia acuteD015470—C92.019153——28
PreleukemiaD011289——17173——26
Myeloid leukemiaD007951—C9216143——25
SyndromeD013577——14163——22
Myelomonocytic leukemia chronicD015477—C93.1642——11
Myelomonocytic leukemia juvenileD054429—C93.3642——11
Myelomonocytic leukemia acuteD015479—C92.5131——4
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340——21——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8044———7
Myeloproliferative disordersD009196—D47.123———4
RecurrenceD012008——32———4
Prostatic neoplasmsD011471—C6131———3
Castration-resistant prostatic neoplasmsD064129——31———3
Hematopoietic stem cell transplantationD018380——11———2
LymphomaD008223—C85.921———2
Hematologic neoplasmsD019337——11———2
ChondrosarcomaD002813———1———1
Residual neoplasmD018365——11———1
Show 16 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C502————2
Triple negative breast neoplasmsD064726——2————2
CarcinomaD002277—C80.02————2
Urologic neoplasmsD014571—C64-C681————1
Central nervous system neoplasmsD016543——1————1
Non-small-cell lung carcinomaD002289——1————1
T-cell leukemiaD015458——1————1
Healthy volunteers/patients———1————1
Non-hodgkin lymphomaD008228—C85.91————1
Hodgkin diseaseD006689—C811————1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCedazuridine
INNcedazuridine
Description
Decitabine/cedazuridine, sold under the brand name Inqovi among others, is a fixed-dose combination anticancer medication used for the treatment of adults with myelodysplastic syndromes and chronic myelomonocytic leukemia (CMML). It is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor.
Classification
Small molecule
Drug classantivirals; antineoplastics (uridine derivatives)
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Structure (InChI/SMILES or Protein Sequence)
O=C1N[C@H](O)CCN1[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Identifiers
PDB—
CAS-ID1141397-80-9
RxCUI—
ChEMBL IDCHEMBL3237547
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID39IS23Q1EW (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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 327 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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915 adverse events reported
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