Zepatier(grazoprevir)
Zepatier (grazoprevir) is a small molecule pharmaceutical. Grazoprevir was first approved as Zepatier on 2016-01-28. It is used to treat chronic hepatitis c and hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Commercial
Trade Name
FDA
EMA
Combinations
Zepatier
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Elbasvir
+
Grazoprevir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZEPATIER | Merck Sharp & Dohme | N-208261 RX | 2016-01-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zepatier | New Drug Application | 2019-12-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
| hepatitis c | — | D006526 | B19.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ELBASVIR / GRAZOPREVIR, ZEPATIER, MSD SUB MERCK | |||
| 2024-12-09 | NPP | ||
HCPCS
No data
Clinical
Clinical Trials
81 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | B19.2 | 5 | 11 | 11 | 15 | 9 | 50 | |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 2 | 4 | 9 | 5 | — | 19 |
| Hiv | D006678 | O98.7 | — | 1 | 3 | 1 | 1 | 6 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | 1 | 2 | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | 1 | — | 2 | — | 3 |
| Chronic renal insufficiency | D051436 | N18 | — | — | — | 2 | 1 | 3 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | 1 | — | 2 |
| Intravenous substance abuse | D015819 | — | — | — | 1 | — | 1 | ||
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | 1 | — | 1 |
| Cross infection | D003428 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatocellular carcinoma | D006528 | C22.0 | — | 1 | 1 | — | — | 2 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | 1 | — | — | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 2 | — | — | 2 |
| Hepacivirus | D016174 | — | 2 | 1 | — | — | 2 | ||
| Liver transplantation | D016031 | EFO_0010682 | — | — | 1 | — | — | 1 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 1 | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | — | — | — | 1 | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GRAZOPREVIR |
| INN | grazoprevir |
| Description | Grazoprevir is an azamacrocyclic compound that is a hepatitis C protease inhibitor used in combination with elbasvir (under the brand name Zepatier) for treatment of chronic HCV genotypes 1 or 4 infection in adults. It has a role as an antiviral drug, a hepatoprotective agent and a hepatitis C protease inhibitor. It is an azamacrocycle, a carbamate ester, a lactam, an aromatic ether, a member of cyclopropanes, a N-sulfonylcarboxamide and a quinoxaline derivative. |
| Classification | Small molecule |
| Drug class | antivirals: serine protease inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C=C[C@@H]1C[C@]1(NC(=O)[C@@H]1C[C@@H]2CN1C(=O)[C@H](C(C)(C)C)NC(=O)O[C@@H]1C[C@H]1CCCCCc1nc3ccc(OC)cc3nc1O2)C(=O)NS(=O)(=O)C1CC1 |
Identifiers
| PDB | — |
| CAS-ID | 1350514-68-9 |
| RxCUI | 1734630 |
| ChEMBL ID | CHEMBL2063090 |
| ChEBI ID | — |
| PubChem CID | 44603531 |
| DrugBank | DB11575 |
| UNII ID | 8YE81R1X1J (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
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Financial
Zepatier - Merck Sharp & Dohme
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Zepatier
Adverse Events
Top Adverse Reactions
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2,933 adverse events reported
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