MAVYRET (glecaprevir)
MAVYRET is indicated for the treatment of Hepatitis C.
How MAVYRET Works
Mavyret consists of two direct-acting antiviral agents with distinct mechanisms of action. Glecaprevir is an NS3/4A protease inhibitor necessary for the proteolytic cleavage of the HCV encoded polyprotein into mature forms. Pibrentasvir is an NS5A inhibitor which targets a protein essential for viral RNA replication and virion assembly. Together, these agents inhibit the life cycle of the hepatitis C virus.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-08-03
- Patent Cliff
- 2036
- Revenue
- $351M (Q1-2026)
- Routes
- ORAL
- Dosage Forms
- PELLETS, TABLET
MAVYRET Approval History
What MAVYRET Treats
1 indicationsMAVYRET is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatitis C
MAVYRET Boxed Warning
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfect...
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions ( 5.1 )] . WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )
MAVYRET Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MAVYRET
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04508907 | 20-001964 | Ph 4 | active not recruiting | A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients |
| NCT02743897 THINKER results posted | 823833 | Ph 1, Ph 2 | completed | Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients |
| NCT02946034 results posted | 2016P001822 | Ph 4 | completed | Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C |
| NCT03523871 results posted | 18-00091 | Ph 2 | completed | A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
MAVYRET FDA Label Details
Indications & Usage
FDA Label (PDF)MAVYRET is indicated for the treatment of Hepatitis C.
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing...
MAVYRET Patents & Exclusivity
Patents (20 active)
Exclusivity
Pro Intelligence Preview
Deep insights for MAVYRET
Revenue Insights
- • Q1-2026: $351M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 51 active patents
Trial Analysis
- • 4 total trials
- • Stage: Mature
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
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