All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

cedazuridine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
uridine derivatives used as antiviral agents and as antineoplastics	5402	1141397-80-9

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: cedazuridine inqovi C-DEC ASTX 727 ASTX727 LD

Cedazuridine inhibits cytidine deaminase (CDA), an enzyme that catalyzes the degradation of cytidine, including the cytidine analog decitabine (a nucleoside metabolic inhibitor). Because high levels of CDA in the gastrointestinal tract and liver degrade decitabine and limit its oral bioavailability, administration of cedazuridine with decitabine increases systemic exposure of decitabine. Inqovi is a combination of decitabine and cedazuridine for treatment of adult patients with myelodysplastic syndromes (MDS). Molecular weight: 268.22 Formula: C9H14F2N2O5 CLOGP: -0.07 LIPINSKI: 0 HAC: 7 HDO: 4 TPSA: 102.26 ALOGS: -0.17 ROTB: 2 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
S (Water solubility)	47.20 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2B,CAMK2D,CDK5,DYRK1B,EIF2AK3,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK	16
kinase-selectivity-class	ACVRL1,CHUK,DYRK1A,MAP2K6,PDK1	5
pfas-class	PFAS structural alert (1 = True, 0 = False)	1

Approvals:

Date	Agency	Company	Orphan
July 7, 2020	FDA	OTSUKA

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
MeSH PA	D000963	Antimetabolites
MeSH PA	D000964	Antimetabolites, Antineoplastic
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D009676	Noxae
CHEBI has role	CHEBI:35610	antineoplastic agent

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Myelodysplastic syndrome	indication	109995007
Chronic myelomonocytic leukemia	indication	127225006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	8618075	Oct. 16, 2028	METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	8618075	Oct. 16, 2028	METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	8268800	Aug. 22, 2030	METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	8268800	Aug. 22, 2030	METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	8268800	Aug. 22, 2030	TREATMENT OF CHRONIC MYELOMONOCYTIC LEUKEMIA
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	8268800	Aug. 22, 2030	TREATMENT OF MYELODYSPLASTIC SYNDROME
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	12239653	Feb. 24, 2041	TREATMENT OF CHRONIC MYELOMONOCYTIC LEUKEMIA
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	12239653	Feb. 24, 2041	TREATMENT OF MYELODYSPLASTIC SYNDROME

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	July 7, 2027	TREATMENT OF ADULT PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS), INCLUDING PREVIOUSLY TREATED AND UNTREATED, DE NOVO AND SECONDARY MDS WITH THE FOLLOWING FRENCH-AMERICAN-BRITISH SUBTYPES (REFRACTORY ANEMIA, REFRACTORY ANEMIA WITH RINGED SIDEROBLASTS, REFRACTORY ANEMIA WITH EXCESS BLASTS, AND CHRONIC MYELOMONOCYTIC LEUKEMIA [CMML]) AND INTERMEDIATE-1, INTERMEDIATE-2, AND HIGH-RISK INTERNATIONAL PROGNOSTIC SCORING SYSTEM GROUPS.
100MG;35MG	INQOVI	TAIHO ONCOLOGY	N212576	July 7, 2020	RX	TABLET	ORAL	May 13, 2029	IN COMBINATION WITH VENETOCLAX FOR THE TREATMENT OF NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Cytidine deaminase	Enzyme	P32320	CDD_HUMAN	INHIBITOR	IC50	6.39		SCIENTIFIC LITERATURE	DRUG LABEL

External reference:

ID	Source
D11848	KEGG_DRUG
39IS23Q1EW	UNII
4039620	VANDF
C5226860	UMLSCUI
CHEBI:755235	CHEBI
CHEMBL3237547	ChEMBL_ID
25267009	PUBCHEM_CID
DB15694	DRUGBANK_ID
10741	INN_ID
C000633944	MESH_SUPPLEMENTAL_RECORD_UI
C000723076	MESH_SUPPLEMENTAL_RECORD_UI
C016122	MESH_SUPPLEMENTAL_RECORD_UI
11101	IUPHAR_LIGAND_ID
890332002	SNOMEDCT_US
336381	MMSL
38637	MMSL
d09593	MMSL
018439	NDDF
2384449	RXNORM
39IS23Q1EW	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
INQOVI	HUMAN PRESCRIPTION DRUG LABEL	2	64842-0727	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections