Cedazuridine
Inqovi (cedazuridine) is a small molecule pharmaceutical. Cedazuridine was first approved as Inqovi on 2020-07-07. It is known to target cytidine deaminase.
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FDA Novel Drug Approvals 2020
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 |
|---|---|---|---|---|
| INQOVI | Otsuka | N-212576 RX | 2020-07-07 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| inqovi | New Drug Application | 2021-04-26 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CEDAZURIDINE / DECITABINE, INQOVI, OTSUKA | |||
| 2027-07-07 | ODE-316 | ||
| 2025-07-07 | NCE | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
84 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | 1 | 1 | 2 | 14 | 4 | 21 | |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | — | 7 | 1 | — | 9 |
| Helicobacter pylori | D016480 | NCBITaxon_210 | B96.81 | 2 | — | 1 | 2 | 1 | 6 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 3 | 1 | — | 1 | 1 | 6 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | — | — | 1 | 1 | 2 | |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | — | 1 | 1 | — | 2 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 1 | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peptic ulcer | D010437 | HP_0004398 | K27 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CEDAZURIDINE |
| INN | cedazuridine |
| Description | Decitabine/cedazuridine, sold under the brand name Inqovi, is a fixed-dose combination medication for the treatment of adults with myelodysplastic syndromes (MDS) 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 class | antivirals; antineoplastics (uridine derivatives) |
| Image (chem structure or protein) | |
| 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-ID | 1141397-80-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3237547 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 39IS23Q1EW (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 183 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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313 adverse events reported
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