NDAORALTABLETPriority Review
Approved
Jan 2016
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
5/8 — Partial
Priority Review
ZEPATIER (elbasvir and grazoprevir) by Merck & Co. is breast cancer resistance protein inhibitors [moa]. First approved in 2016.
Drug data last refreshed 21m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEPATIER is an oral fixed-dose combination of elbasvir (NS5A inhibitor) and grazoprevir (NS3/4A protease inhibitor) approved by the FDA in January 2016 for the treatment of chronic hepatitis C virus (HCV) infection. It works by inhibiting viral proteins essential for HCV replication, enabling direct-acting antiviral therapy. The combination targets both NS5A and protease pathways to achieve high cure rates across multiple HCV genotypes.
$0.468MPart D
PeakDeclining
4.9 years to LOEProduct is in mature peak phase with modest Part D claims; commercial teams are likely focused on defending against newer DAA competition rather than expansion.
Mechanism of Action
Breast Cancer Resistance Protein Inhibitors
Pharmacologic Class:
Hepatitis C Virus NS5A Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
Started Sep 2019
6 enrolled
Hepatitis CHemodialysisNosocomial Infection
Zepatier in Patients with Substance Use
Started Sep 2019
25 enrolled
Hepatitis CHivCoinfection, HIV+1 more
Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant
Started Aug 2018
0Cardiac Transplant DisorderHepatitis C
The Dublin Zepatier Study
Started Mar 2018
3 enrolled
Hepatitis C
Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
Started Nov 2017
11 enrolled
Hepatitis CMedication Adherence
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.