MedPath

Asunaprevir

Generic Name
Asunaprevir
Drug Type
Small Molecule
Chemical Formula
C35H46ClN5O9S
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

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Phase 2
Completed
Conditions
Hepatitis C Virus
Interventions
First Posted Date
2009-12-11
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
285
Registration Number
NCT01030432
Locations
🇺🇸

Umass Memorial Medical Center, Worcester, Massachusetts, United States

🇺🇸

Hospital Of The University Of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Alabama Liver & Digestive Specialists (Alds), Montgomery, Alabama, United States

and more 13 locations

Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032

Phase 1
Completed
Conditions
Hepatic Insufficiency
Interventions
First Posted Date
2009-11-25
Last Posted Date
2011-10-26
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
28
Registration Number
NCT01019070
Locations
🇺🇸

Advanced Clinical Res Inst, Anaheim, California, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: Pegylated-interferon alfa-2a
First Posted Date
2009-11-13
Last Posted Date
2015-10-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
215
Registration Number
NCT01012895
Locations
🇺🇸

Advanced Clinical Research Institute, Anaheim, California, United States

🇺🇸

Mercy Medical Center, Baltimore, Maryland, United States

🇺🇸

Carolinas Center For Liver Disease, Statesville, North Carolina, United States

and more 8 locations

Drug-Drug Interaction Study in Healthy Subjects

Phase 1
Completed
Conditions
Hepatitis C
Interventions
First Posted Date
2009-05-19
Last Posted Date
2011-01-07
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
28
Registration Number
NCT00904059
Locations
🇺🇸

Ppd Development, Lp, Austin, Texas, United States

A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: Placebo
First Posted Date
2008-07-25
Last Posted Date
2011-06-27
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
15
Registration Number
NCT00722358
Locations
🇺🇸

Advanced Clinical Res Inst, Anaheim, California, United States

🇵🇷

Local Institution, Santurce, Puerto Rico

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

and more 2 locations
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