Victrelis

(Boceprevir)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Victrelis is a small molecule that works as a Hepatitis C Virus Serine Protease, NS3/NS4A Inhibitor.[2] It is being used across 4 indications, with its most advanced program in Approved.[1]

Victrelis is one of 119 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

Total Trials

Active Trials

118

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Insulin ResistanceWithdrawn

Viral DiseaseActive, not recruiting

Chronic Hepatitis C Virus InfectionActive, not recruiting

Hepatitis C Virus InfectionActive, not recruiting

Insulin ResistanceApproved

Withdrawn

Viral DiseaseApproved

Active, not recruiting

Chronic Hepatitis C Virus InfectionApproved

Active, not recruiting

Hepatitis C Virus InfectionApproved

Active, not recruiting

Competition

Competitive Landscape

65 competitors in Insulin Resistance

#DrugCompanyPhaseTrials

Glucophage

EMD Serono

Approved

17 2

Niacor

AbbVie

Approved

1 3

Victoza

Novo Nordisk

Approved

1 4

Crestor

AstraZeneca

Approved

1 5

Isordil

AstraZeneca

Approved

1 6

Plaquenil

Calciferol

Tradjenta

1 9

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 10

Victrelis

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Chronic Hepatitis26 trials

Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01023035·687 enrolled

Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01353911·368 enrolled

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)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 3·NCT01641666

Show 23 more trials

Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 3·NCT02204475

Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 3·NCT01590225

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

Terminated· Roche logo

Roche··NCT02118597·19 enrolled

HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin

Terminated·AAnna Cruceta·Phase 3·NCT01718301·108 enrolled

The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01425203·238 enrolled

Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2/3·NCT00689390·1,954 enrolled

A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

Completed· Roche logo

Roche·Phase 2·NCT01482403·58 enrolled

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)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01756079·58 enrolled

Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00910624·168 enrolled

Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

Terminated·DDebiopharm International SA·Phase 3·NCT01446250·8 enrolled

An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

Completed· Roche logo

Roche··NCT01447446·4,442 enrolled

Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01390844·282 enrolled

Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00708500·404 enrolled

Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00160251·357 enrolled

Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00423670·765 enrolled

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)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01181804·177 enrolled

Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

Unknown status·TTheodor Bilharz Research Institute·Phase 3·NCT01653236·40 enrolled

Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT01425190·16 enrolled

A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

Completed· Roche logo

Roche·Phase 4·NCT01591460·165 enrolled

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)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00845065·202 enrolled

Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00705432·1,472 enrolled

Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01544920·737 enrolled

A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)

Unknown status·—·Phase 4·NCT01731301·20 enrolled

Hepatitis C5 trials

A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00959699·99 enrolled

Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT01443923·4 enrolled

Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir

Terminated·—··NCT01465516·105 enrolled

Show 2 more trials

Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT01482767·262 enrolled

Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C

Completed·MMarkus Peck-Radosavljevic·Phase 4·NCT01925183·6 enrolled

Liver Transplant2 trials

Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT01463956·58 enrolled

Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation

Completed·IIndiana University·Phase 1·NCT01909401·1 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

Completed·VValme University Hospital··NCT02333292·1,128 enrolled

Insulin resistance1 trial

A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 4·NCT01770223

11 more indications

Buprenorphine1 trial

A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01396005·21 enrolled

HCV1 trial

Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)

Completed·RRadboud University Medical Center·Phase 1·NCT01470690·24 enrolled

Adult Subject1 trial

Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT01657552·56 enrolled

Chronic1 trial

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)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01945294·257 enrolled

Acute1 trial

Dutch Acute HCV in HIV Study (DAHHS)

Completed·EErasmus Medical Center·Phase 2·NCT01912495·65 enrolled

T Cell1 trial

Effect of Boceprevir on HCV-specific T Cell Responses

Completed·AAzienda Ospedaliero-Universitaria di Parma··NCT01403181·30 enrolled

Treatment1 trial

Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment

Completed·UUniversity of Calgary·Phase 3·NCT01585584·11 enrolled

HIV1 trial

Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir

Completed·RRadboud University Medical Center·Phase 1·NCT01288417·24 enrolled

End Stage Renal Disease (ESRD)1 trial

Boceprevir in End Stage Renal Disease (ESRD)

Withdrawn·—·N/A·NCT02112630

Effectiveness1 trial

Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

Completed·—·N/A·NCT02113631·50 enrolled

Unspecified1 trial

Boceprevir and Ucalm (St John&Apos;s Wort)

Completed·SSt Stephens Aids Trust·Phase 1·NCT01663922·17 enrolled

Regulatory

FDA Approval Timeline[4]

May 13, 2011

VICTRELIS

NDA NDA202258

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for Boceprevir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Boceprevir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Boceprevir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202258). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Victrelis. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Hepatitis C Virus Serine Protease, NS3/NS4A Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[5]

Patent Cliff

Mar 17, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8119602Mar 17, 2027

7772178Nov 11, 2027

Victrelis

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Hepatitis26 trials

Hepatitis C5 trials

Liver Transplant2 trials

Efficacy and Safety1 trial

Insulin resistance1 trial

Buprenorphine1 trial

HCV1 trial

Adult Subject1 trial

Chronic1 trial

Acute1 trial

T Cell1 trial

Treatment1 trial

HIV1 trial

End Stage Renal Disease (ESRD)1 trial

Effectiveness1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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