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
Therapeutic Areas
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 & Co | N-208261 RX | 2016-01-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zepatier | New Drug Application | 2024-07-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatitis c | — | D006526 | B19.2 |
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ELBASVIR / GRAZOPREVIR, ZEPATIER, MSD SUB MERCK | |||
| 2024-12-09 | NPP | ||
HCPCS
No data
Clinical
Clinical Trials
95 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 | 11 | 23 | 21 | 24 | 17 | 90 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 7 | 20 | 19 | 19 | 14 | 73 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 4 | 16 | 14 | 16 | 9 | 56 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 2 | 10 | 12 | 8 | 8 | 37 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | 3 | 5 | 2 | 3 | 12 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 1 | 4 | 1 | 8 |
| Hiv | D006678 | — | — | — | 1 | 3 | 2 | 2 | 8 |
| Communicable diseases | D003141 | — | — | — | 2 | 1 | 3 | — | 6 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | 2 | 2 | 5 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | — | — | 3 | — | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | — | 1 | 1 | — | — | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | 1 | 1 | — | — | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | 1 | — | — | 2 |
| Hepacivirus | D016174 | — | — | — | 2 | 1 | — | — | 2 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | 1 | 1 | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 1 | 1 | 1 | — | — | 2 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | 1 | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 1 | — | — | — | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | 1 | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 1 | — | — | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | 1 | — | — | — | 1 |
| Virus diseases | D014777 | — | B34 | — | 1 | — | — | — | 1 |
| Rna virus infections | D012327 | — | — | — | 1 | — | — | — | 1 |
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | — | 1 | — | — | — | 1 |
| Viral hepatitis human | D006525 | EFO_0004196 | — | — | 1 | — | — | — | 1 |
| Flaviviridae infections | D018178 | EFO_0007274 | — | — | 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_0004239 | B18.1 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | — | — | 1 | 1 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Alcohol-related disorders | D019973 | — | F10 | — | — | — | — | 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 | — |
| ChEMBL ID | CHEMBL2063090 |
| ChEBI ID | — |
| PubChem CID | 44603531 |
| DrugBank | DB11575 |
| UNII ID | 8YE81R1X1J (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
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Zepatier – Merck & Co
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Estimated US medical usage
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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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4,476 adverse events reported
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