TheraRadar
Data updated: May 26, 2026

ZEPATIER (elbasvir)

Trial Activity: Declining
Breakthrough Therapy Priority Review Fast Track
Infectious Disease Approved 2016-01-28
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Merck Sharp & Dohme LLC conducting 11 trials (61%)
11 indications explored (Broad Platform)
→ hepatitis c (10 trials)
→ chronic hepatitis c (2 trials)
→ end stage renal disease (1 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
10
Years on Market

Details

Status
Discontinued
First Approved
2016-01-28
Patent Cliff
2031
Revenue
$296M (Q4-2017)

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
ORAL
Dosage Forms
TABLET

Companies

Merck
Active Ingredient: ELBASVIR , GRAZOPREVIR

ZEPATIER Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2016 to 2021 · 1 indication expansions
Dec 2021 SUPPL
Efficacy
FDA Letter Label
Dec 2019 SUPPL
Label · Labeling
FDA Letter Label
Jun 2018 SUPPL
Label · Labeling
FDA Letter Label

What ZEPATIER Treats

2 FDA approvals

Originally approved for its first indication in 2016 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

18 trials
Trial Sponsor ID Phase Status Title
NCT02743897 THINKER results posted 823833 Ph 1, Ph 2 completed Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients
NCT03724149 SHELTER results posted 829397 Ph 1, Ph 2 completed Transplanting Hepatitis C Lungs Into Negative Lung Recipients
NCT03146741 USHER results posted 826708 Ph 1, Ph 2 completed Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV)
NCT01717326 C-WORTHy results posted 5172-035 2012-003354-89 Ph 2 completed A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)
NCT01932762 results posted 5172-047 2013-002169-21 Ph 2 completed Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)
NCT03791814 MATCH-D MATCH-D study Ph 4 withdrawn A Prospective Cohort Study to Improve HCV Care in Dialysis Patients
NCT02895958 ZEP-HEPC-001 Ph 4 terminated The Dublin Zepatier Study
NCT02601573 results posted 5172-083 2015-003187-37, MK-5172-083 Ph 2 completed Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)
NCT02332720 results posted 3682-012 2014-003347-35 Ph 2 completed Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012)
NCT02332707 results posted 3682-011 2014-003304-73, MK-3682-011 Ph 2 completed Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011)
NCT02115321 results posted 5172-059 2014-000672-25 Ph 2, Ph 3 completed Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
NCT01937975 results posted 5172-050 Ph 1 completed The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
NCT03093740 2017P000301 Ph 4 withdrawn Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
NCT01797536 results posted 8742-009 Ph 1 completed The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
NCT02092350 C-SURFER results posted 5172-052 2013-003858-25 Ph 2, Ph 3 completed Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
NCT02203149 results posted 5172-058 142638 Ph 2, Ph 3 completed Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
NCT02781649 EXPANDER-1 results posted IRB00089751 Ph 4 completed Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients
NCT01532973 results posted 8742-002 2011-005190-23 Ph 1 completed Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZEPATIER FDA Label Details

View full patent landscape →
2 OB patents · 2 families · 149 international docs across 47 countries

ZEPATIER Patents & Exclusivity

Latest Patent: May 2031

Patents (2 active)

US8871759 Expires May 4, 2031
US7973040 Expires Jul 24, 2029
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for ZEPATIER

Revenue Insights

  • • Q4-2017: $296M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2031
  • • 2 active patents

Trial Analysis

  • • 18 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA208261 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment