Asunaprevir

Generic Name: Asunaprevir

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₄₆ClN_₅O_₉S

CAS Number: 630420-16-5

Unique Ingredient Identifier: S9X0KRJ00S

Background: Asunaprevir, also named BMS-650032, is a potent hepatitis C virus (HCV) NS3 protease inhibitor. It has been shown to have a very high efficacy in dual-combination regimens with daclatasvir in patients chronically infected with HCV genotype 1b. It was developed by Bristol-Myers Squibb Canada and approved by Health Canada on April 22, 2016. The commercialization of asunaprevir was cancelled one year later on October 16, 2017.

Indication: Asunaprevir is indicated in combination with other agents for the treatment of chronic hepatitis C in adult patients with hepatitis C virus genotypes 1 or 4 and compensated liver cirrhosis.

Hepatitis C is a liver disease caused by the hepatitis C virus. The chronic state of this condition accounts for 60-80% of the cases from which the risk of cirrhosis of the liver within 20 years is of around 15-30%. The genotype 1 is the most common type of hepatitis C in the United States and the most difficult to treat.

Associated Conditions: Chronic Hepatitis C Genotype 1, Genotype 4 Chronic Hepatitis C

Clinical Trials

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

Phase 3

Completed

Conditions: Hepatitis C

Interventions: Drug: Daclatasvir
Drug: Asunaprevir
Drug: BMS-791325
Drug: Placebo matching Ribavirin
Drug: Ribavirin

First Posted Date: 2013-10-31

Last Posted Date: 2015-10-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 202

Registration Number: NCT01973049

Locations: 🇺🇸
Scripps Clinic, La Jolla, California, United States
🇺🇸
Binghamton Gastroenterology Associates, Binghamton, New York, United States
🇺🇸
Weill Cornell Medical College, New York, New York, United States

and more 24 locations

Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease

Phase 1

Completed

Conditions: Hepatitis C

Interventions: Drug: Asunaprevir

First Posted Date: 2013-06-26

Last Posted Date: 2013-11-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 48

Registration Number: NCT01886599

Locations: 🇺🇸
Davita Clinical Research, Minneapolis, Minnesota, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States
🇺🇸
New Orleans Center For Clinical Research, Knoxville, Tennessee, United States

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

Phase 3

Completed

Conditions: Hepatitis C Virus Infection

Interventions: Drug: Daclatasvir
Drug: Ribavirin
Biological: pegIFNα-2b
Drug: Asunaprevir
Drug: Telaprevir

First Posted Date: 2012-10-31

Last Posted Date: 2015-10-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 258

Registration Number: NCT01718145

Locations: 🇯🇵
Local Institution, Saitama, Japan

Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)

Phase 3

Completed

Conditions: Hepatitis C Virus

Interventions: Drug: Asunaprevir (ASV)
Drug: Daclatasvir (DCV)
Drug: Pegylated-interferon alfa 2a (PegIFN)
Drug: Ribavirin (RBV)

First Posted Date: 2012-04-20

Last Posted Date: 2015-10-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 748

Registration Number: NCT01581203

Locations: 🇺🇸
The Health Care Authority For Baptist Health, Montgomery, Alabama, United States
🇺🇸
Scpmg/ Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
🇺🇸
University Of Colorado Denver And Hospital, Aurora, Colorado, United States

and more 24 locations

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

Phase 3

Completed

Conditions: Hepatitis C Virus

Interventions: Drug: Asunaprevir
Drug: Daclatasvir
Drug: Peg-interferon Alfa-2a
Drug: Ribavirin

First Posted Date: 2012-04-09

Last Posted Date: 2015-10-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 398

Registration Number: NCT01573351

Locations: 🇺🇸
University Of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Gastro One, Germantown, Tennessee, United States
🇨🇳
Local Institution, Taipei, Taiwan

and more 18 locations

Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

Completed

Conditions: Hepatitis C

Interventions: Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

First Posted Date: 2011-12-15

Last Posted Date: 2019-11-27

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 1850

Registration Number: NCT01492504

Locations: 🇺🇸
Yale New Haven Hospital, New Haven, Connecticut, United States
🇺🇸
Orlando Immunology Center, Orlando, Florida, United States
🇺🇸
Nashville Medical Research Institute, Nashville, Tennessee, United States

and more 60 locations

Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

Phase 2

Completed

Conditions: Chronic Hepatitis C

Interventions: Drug: BMS-650032
Drug: BMS-790052
Drug: BMS-791325
Drug: Ribavirin

First Posted Date: 2011-10-19

Last Posted Date: 2017-04-27

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 320

Registration Number: NCT01455090

Locations: 🇵🇷
Fundacion De Investigacion De Diego, San Juan, Puerto Rico
🇺🇸
James J Peters Vamc, The Bronx, New York, United States
🇺🇸
Inova Fairfax Hospital, Falls Church, Virginia, United States

and more 25 locations

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

Phase 2

Completed

Conditions: Hepatitis C Virus Infection

Interventions: Drug: Daclatasvir
Drug: Asunaprevir
Drug: Pegylated interferon alfa-2a
Drug: Ribavirin

First Posted Date: 2011-09-02

Last Posted Date: 2016-05-27

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 276

Registration Number: NCT01428063

Locations: 🇺🇸
Scpmg/ Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
🇺🇸
Mercy Medical Center, Baltimore, Maryland, United States
🇺🇸
University Of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 18 locations