Zepatier(elbasvir)
Zepatier (elbasvir) is a small molecule pharmaceutical. Elbasvir 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
87 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 | 7 | 19 | 21 | 24 | 14 | 79 |
| Hepatitis | D006505 | — | K75.9 | 5 | 15 | 18 | 17 | 8 | 57 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 2 | 11 | 13 | 14 | 5 | 42 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | 6 | 12 | 7 | 6 | 29 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 2 | 5 | 2 | 2 | 9 |
| Hiv | D006678 | — | O98.7 | — | 1 | 3 | 2 | 2 | 8 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 1 | 4 | — | 7 |
| Communicable diseases | D003141 | — | — | — | 2 | 1 | 3 | — | 6 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 2 | 1 | 1 | 2 | 5 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | 1 | 3 | 1 | 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 | — | 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 | — | D84.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Viral hepatitis human | D006525 | EFO_0004196 | — | 1 | 1 | — | — | — | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 1 | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | 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 | EFO_0000405 | K92.9 | — | 1 | — | — | — | 1 |
| Flaviviridae infections | D018178 | EFO_0007274 | — | — | 1 | — | — | — | 1 |
| Recreational drug use | D000084783 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Deglutition disorders | D003680 | — | 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 | — | H35.9 | — | — | — | — | 1 | 1 |
| Glomerulonephritis | D005921 | — | 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 | Elbasvir |
| INN | elbasvir |
| Description | Elbasvir is a complex organic heterotetracyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with grazoprevir (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 virus nonstructural protein 5A inhibitor. It is a L-valine derivative, a member of imidazoles, a carbamate ester, a N-acylpyrrolidine, an organic heterotetracyclic compound and a ring assembly. |
| Classification | Small molecule |
| Drug class | antivirals: nonstructural protein 5A (NS5A) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc(-c2ccc3c(c2)O[C@@H](c2ccccc2)n2c-3cc3cc(-c4c[nH]c([C@@H]5CCCN5C(=O)[C@@H](NC(=O)OC)C(C)C)n4)ccc32)c[nH]1)C(C)C |
Identifiers
| PDB | — |
| CAS-ID | 1370468-36-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3039514 |
| ChEBI ID | — |
| PubChem CID | 71661251 |
| DrugBank | DB11574 |
| UNII ID | 632L571YDK (ChemIDplus, GSRS) |
Target
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Variants
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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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Additional graphs summarizing 2,131 documents
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Safety
Black-box Warning
Black-box warning for: Zepatier
Adverse Events
Top Adverse Reactions
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4,594 adverse events reported
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