NDAORALTABLETPriority Review
Approved
Jan 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
6/8 — Strong
Priority Review
ZEPATIER (elbasvir and grazoprevir) by Merck & Co. is breast cancer resistance protein inhibitors [moa]. Approved for hepatitis c. First approved in 2016.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEPATIER is an oral fixed-dose combination of elbasvir (NS5A inhibitor) and grazoprevir (protease inhibitor) approved by FDA in January 2016 for the treatment of chronic hepatitis C virus (HCV) infection. The combination works through dual viral enzyme inhibition, with grazoprevir blocking the NS3/4A protease and elbasvir inhibiting the NS5A protein, achieving high cure rates across multiple HCV genotypes. It represents a significant advancement in HCV therapy by offering a pan-genotypic, interferon-free, and ribavirin-free treatment option.
$468KPart D
PeakDeclining
5.0 years to LOEZEPATIER is in peak commercialization with minimal part D spending and declining claims, indicating market maturation and potential team consolidation ahead of patent expiration.
Mechanism of Action
Breast Cancer Resistance Protein Inhibitors
Pharmacologic Class:
Hepatitis C Virus NS5A Inhibitor
Indications (1)
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.