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AboutPricing
Drug ReportsElbasvir
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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5D
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YTD
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
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
ZEPATIERMerck & CoN-208261 RX2016-01-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zepatierNew Drug Application2024-07-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatitis c—D006526B19.2
chronic hepatitis cEFO_0004220D019698B18.2
Agency Specific
FDA
EMA
Expiration
Code
ELBASVIR / GRAZOPREVIR, ZEPATIER, MSD SUB MERCK
2024-12-09NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Elbasvir / Grazoprevir, Zepatier, Msd Sub Merck
88717592031-05-04DS, DPU-1813
79730402029-07-24DS, DPU-1813
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AP: Antivirals for treatment of hcv infections
— J05AP10: Elbasvir
— J05AP54: Elbasvir and grazoprevir
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 cD006526—B19.271921241681
HepatitisD006505HP_0012115K75.951619191366
Hepatitis aD006506EFO_0007305B152121416849
Chronic hepatitis cD019698EFO_0004220B18.216128731
Chronic hepatitisD006521—K73.9—252310
InfectionsD007239EFO_0000544——21418
HivD006678———13228
Communicable diseasesD003141———213—6
Hiv infectionsD015658EFO_0000764B20——1225
Substance-related disordersD019966EFO_0003890F13———134
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0—11——2
Hepatocellular carcinomaD006528—C22.0—11——2
Liver neoplasmsD008113EFO_1001513C22.0—11——2
HepacivirusD016174———21——2
Liver failureD017093HP_0001399K72.9111——2
Hepatic insufficiencyD048550——111——2
Liver transplantationD016031EFO_0010682———1——1
Metabolic syndromeD024821EFO_0000195E88.810——1——1
SyndromeD013577————1——1
Immunologic deficiency syndromesD007153HP_0002721D84.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Viral hepatitis humanD006525EFO_0004196—11———2
Lung diseasesD008171HP_0002088J98.411———1
Heart failureD006333HP_0001635I5011———1
Liver diseasesD008107HP_0002910K70-K77—1———1
Gastrointestinal diseasesD005767———1———1
Virus diseasesD014777—B34—1———1
Rna virus infectionsD012327———1———1
Digestive system diseasesD004066HP_0011024K92.9—1———1
Flaviviridae infectionsD018178EFO_0007274——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Deglutition disordersD003680HP_0002015R13.11————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis bD019694EFO_0004239B18.1————11
Retinal diseasesD012164HP_0000479H35.9————11
GlomerulonephritisD005921HP_0000099N05————11
Drug interactionsD004347——————11
Medication adherenceD055118EFO_0006344—————11
Alcohol-related disordersD019973—F10————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameElbasvir
INNelbasvir
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 classantivirals: nonstructural protein 5A (NS5A) inhibitors
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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-ID1370468-36-2
RxCUI—
ChEMBL IDCHEMBL3039514
ChEBI ID—
PubChem CID71661251
DrugBankDB11574
UNII ID632L571YDK (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Zepatier – Merck & Co
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,992 documents
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Safety
Black-box Warning
Black-box warning for: Zepatier
Adverse Events
Top Adverse Reactions
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4,507 adverse events reported
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