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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 |
|---|---|
|
Synonyms:
|
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).
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 |
|---|---|---|---|---|---|
| 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 | 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 |