Data updated: May 26, 2026
VICTRELIS (boceprevir)
Trial Activity: Declining
Infectious Disease
Approved 2011-05-13
Development Insights
Merck Sharp & Dohme LLC conducting 21 trials (58%)
16 indications explored (Broad Platform)
→ hepatitis c (13 trials)
→ hepatitis c, chronic (13 trials)
→ hiv infections (3 trials)
4
Indications
--
Phase 3 Trials
1
Priority Reviews
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-05-13
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- CAPSULE
VICTRELIS Approval History
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
16 FDA actions from 2011 to 2017 · 3 indication expansions
Jul 2013 SUPPL Priority
Mfg
What VICTRELIS Treats
4 FDA approvalsOriginally approved for its first indication in 2011 . Covers 4 distinct patient populations.
- Other (4)
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Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01463956 | ANRS HC 29 BOCEPRETRANSPLANT 2011-001089-17 | Ph 2 | completed | Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation |
| NCT01718301 BOC-HIV results posted | BOC-HIV 2012-003984-23 | Ph 3 | terminated | HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin |
| NCT01353911 results posted | 5172-003 2011-000759-18 | Ph 2 | completed | Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003) |
| NCT01023035 results posted | P06086 2009-012782-63 | Ph 3 | completed | Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2) |
| NCT01425203 results posted | P08160 MK-3034-046 | Ph 3 | completed | The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160) |
| NCT00910624 PROVIDE results posted | P05514 | Ph 3 | completed | Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514) |
| NCT01590225 | P08034 2010-024260-17 | Ph 3 | withdrawn | Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034) |
| NCT01470690 PROMO | UMCN-AKF 10.06 | Ph 1 | completed | Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO) |
| NCT01288417 OPAL | UMCN-AKF 10.05 | Ph 1 | completed | Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir |
| NCT01544920 results posted | P07755 2011-001345-32, MK-3034-040 | Ph 3 | completed | Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755) |
| NCT01425190 results posted | P07614 2010-023498-20, MK-3034-063 | Ph 1 | terminated | Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614) |
| NCT01756079 results posted | 3034-105 2012-002772-13 | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105) |
| NCT01945294 results posted | 3034-107 | Ph 3 | completed | Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107) |
| NCT01657552 | 116010 | Ph 1 | completed | Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects |
| NCT00959699 results posted | P05411 MK-3034-025 | Ph 2 | completed | A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4) |
| NCT01181804 results posted | P06992 | Ph 1 | completed | Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED) |
| NCT01396005 results posted | P08123 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123) |
| NCT00845065 results posted | P05685 | Ph 3 | completed | Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED) |
| NCT00705432 SPRINT-2 results posted | P05216 EUDRACT # 2007-005508-42 | Ph 3 | completed | Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED) |
| NCT01770223 | 3034-113 2012-002771-33 | Ph 4 | withdrawn | A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113) |
| NCT01925183 HIVCOBOC-RGT results posted | HIVCOBOC-RGT 2012-005591-33 | Ph 4 | completed | Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C |
| NCT01446250 results posted | CDEB025A2307 | Ph 3 | terminated | Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1 |
| NCT01591460 results posted | MV28073 2011-004810-41 | Ph 4 | completed | A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C |
| NCT01482403 | NV27780 2011-002714-37 | Ph 2 | completed | A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C |
| NCT01912495 DAHHS results posted | NL44825.078.13 | Ph 2 | completed | Dutch Acute HCV in HIV Study (DAHHS) |
| NCT02204475 | 5172-066 2014-001841-25 | Ph 3 | withdrawn | Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066) |
| NCT01585584 LeeG3 results posted | MISP #39897 24411 | Ph 3 | completed | Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment |
| NCT01641666 | P08599 | Ph 3 | withdrawn | Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599) |
| NCT01443923 results posted | 110253 11-I-0253 | Ph 4 | terminated | Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV |
| NCT01663922 results posted | SSAT 045 | Ph 1 | completed | Boceprevir and Ucalm (St John&Apos;s Wort) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
VICTRELIS FDA Label Details
View full patent landscape →
2 OB patents · 2 families ·
38 international docs across 18 countries
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Deep insights for VICTRELIS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 2 active patents
Trial Analysis
- • 36 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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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