Drugs / Asunaprevir
last change Oct 2024 re-read 2 minutes ago

Asunaprevir

also known as ASV · BMS-650032 · Sunvepra

Small molecule

Developed for
hepatitis C virus infection · chronic hepatitis C virus infection · acute hepatitis C virus infection
Investigated by
Bristol-Myers Squibb · ANRS, Emerging Infectious Diseases · Beijing 302 Hospital · Humanity and Health Research Centre · Chang Gung Memorial Hospital · Cheongju St. Mary's Hospital, Cheongju, Korea
+28 more · China Medical University Hospital · Chungnam National University Hospital · Dankook University · Emory University · Eulji General Hospital · Eulji University Hospital · Foundation for Liver Research · Humanity & Health Medical Group Limited · Kaohsiung Medical University Chung-Ho Memorial Hospital · Kirby Institute · Konkuk University Hospital · Konyang University Hospital · Korea University Guro Hospital · Myeong Jun Song · Nanfang Hospital, Southern Medical University · National Cancer Institute (NCI) · National Cheng-Kung University Hospital · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health Clinical Center (CC) · National Taiwan University Hospital · Pusan National University Hospital · Saint Vincent's Hospital, Korea · Severance Hospital · Soonchunhyang University Hospital · Taipei Veterans General Hospital, Taiwan · Timothy Morgan, MD · VA Long Beach Healthcare System

Trials 37 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT02175602 Jun → Aug 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT02103569 Apr → Jul 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT02108639 Apr → Jun 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT02104843 Apr → May 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT02095860 Apr → May 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT01886599 Nov 2012 → Feb 2013 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT00904059 May → Jul 2009 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00559247 Jan → Jul 2008 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 215 trials
Phase 2 NCT03794258 May 2019 → Apr 2020 hepatitis C virus infection Humanity & Health Medical Group Limited Withdrawn No outcome recorded
Phase 2 NCT02583685 May 2015 → Oct 2024 chronic hepatitis C virus infection Humanity and Health Research Centre Completed No outcome recorded
Phase 2 NCT02470858 Jan → Dec 2015 chronic hepatitis C virus infection Humanity and Health Research Centre Completed No outcome recorded
Phase 2 NCT02309450 Dec 2014 → Nov 2015 hepatitis C virus infection ANRS, Emerging Infectious Diseases Withdrawn No outcome recorded
Phase 2 NCT02175966 Jul 2014 → Jan 2015 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 2 NCT02124044 Feb 2014 → Mar 2016 hepatitis C virus infection National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 2 NCT02107365 Nov 2013 → Feb 2015 hepatitis C virus infection ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 2 NCT01888900 May 2013 → Nov 2015 chronic hepatitis C virus infection, cirrhosis of liver National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 2 NCT01725542 Dec 2012 → Apr 2014 acute hepatitis C virus infection ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 2 NCT01455090 Nov 2011 → Mar 2014 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 310 trials
Phase 3 NCT03004625 Nov 2016 → Apr 2018 hepatitis C virus infection Kaohsiung Medical University Chung-Ho Memorial Hospital Completed No outcome recorded
Phase 3 NCT02170727 Jun 2014 → Jun 2015 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT01995266 Feb 2014 → Jul 2015 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT02282709 Feb 2014 → Jul 2015 chronic hepatitis C virus infection Foundation for Liver Research Completed No outcome recorded
Phase 3 NCT01979939 Dec 2013 → Aug 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT01973049 Dec 2013 → Aug 2014 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT01718145 Nov 2012 → Dec 2013 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT01573351 May 2012 → Sep 2013 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT01581203 May 2012 → Oct 2013 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT01497834 Jan 2012 → Apr 2013 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 43 trials
Phase 4 NCT02580474 Feb 2016 → Apr 2018 hepatitis C virus infection Myeong Jun Song Completed No outcome recorded
Phase 4 NCT02639585 Dec 2015 → Feb 2017 chronic hepatitis C virus infection Pusan National University Hospital Unknown No outcome recorded
Phase 4 NCT02292966 Jul 2015 → Jun 2016 chronic hepatitis C virus infection Kirby Institute Withdrawn No outcome recorded
Phase not applicable1 trial
NCT02098616 Jul 2014 → Feb 2016 chronic hepatitis C virus infection Timothy Morgan, MD Completed No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT02045693 Background Feb → Apr 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT01063023 Comparator Jan → Jun 2010 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT01019070 Comparator Dec 2009 → Aug 2011 liver disorder Bristol-Myers Squibb Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00722358 Comparator Dec 2008 → Dec 2009 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 32 trials
Phase 3 NCT02496078 Comparator Aug 2015 → Aug 2016 chronic hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT02123654 Comparator Apr 2014 → Jan 2015 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2012-04-19 Bristol-Myers Squibb All-Oral Hepatitis C Virus Treatment with Bristol-Myers Squibb’s Investigational Compounds Daclatasvir and Asunaprevir Achieved Sustained Virologic Response in 77% of Difficult-to-Treat Patients bms.com

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 49 sources stand behind the page.

FieldValueCited text
Known as Asunaprevir “Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 Jul 2016
32

“All participants will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food.” NCT02292966

“To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet” NCT02108639

“Fixed dose combination (daclatasvir \[DCV\] 30 milligrams, asunaprevir \[ASV\] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily” NCT02175602

“DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily” NCT02045693

“Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C.” PMID 25038486 Jul 2014

“Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks” NCT01979939

“DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks” NCT02170727

“Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.” NCT02175966

“Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day” NCT02098616

“Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325” NCT02095860

Asunaprevir (ASV) 200mg administered orally twice daily” NCT03794258

Asunaprevir (ASV) 200mg administered orally twice daily” NCT02583685

Asunaprevir and Daclatsvir” NCT01888900

NCT01428063

NCT02309450

NCT01497834

NCT01718145

NCT03004625

NCT02123654

NCT02282709

NCT01581203

NCT02124044

NCT02580474

NCT02104843

NCT01573351

NCT02496078

NCT01725542

NCT02107365

NCT02103569

NCT01995266

NCT01973049

NCT01886599

Known as ASV “To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet” NCT02108639
16

“We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis.” PMID 30400729 Mar 2019

“The efficacy of daclatasvir (DCV), asunaprevir (ASV), pegylated interferon and ribavirin (Peg-IFN/RBV) association was investigated in these patients.” PMID 29271782 Mar 2018

“Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients” NCT02124044

“UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination” NCT01979939

“whether a rapid reduction in viremia by daclatasvir (DCV) and asunaprevir (ASV) improves the response to pegylated interferon” PMID 26733671 Jan 2016

“DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks” NCT02170727

“Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.” NCT02175966

“The combination of daclatasvir (DCV, pan-genotypic NS5A inhibitor) plus asunaprevir (ASV; NS3 protease inhibitor)” PMID 27287851 Jun 2016

“Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325” NCT02095860

“Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy” NCT01718145

“Asunaprevir (ASV) 200mg, administered orally twice daily.” NCT02470858

“Asunaprevir (ASV) 200mg administered orally twice daily” NCT03794258

“Asunaprevir (ASV) 200mg administered orally twice daily” NCT02583685

“Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325” NCT02123654

“asunaprevir \[ASV\]” NCT02175602

“Asunaprevir (ASV)” NCT01581203

Known as BMS-650032 BMS-650032 (Asunaprevir)” NCT01497834
9

NCT01012895

NCT01309932

NCT00904059

NCT01019070

NCT01051414

NCT01455090

NCT00722358

NCT01063023

NCT00559247

Known as Sunvepra ClinicalTrials.gov intervention name — accepted as the source's own label NCT02639585
Action Inhibit “Asunaprevir is a selective HCV NS3 protease inhibitor” PMID 25038486 Jul 2014
Modality Small molecule CHEMBL2105735
Route Oral “single oral doses of BMS-650032” NCT00559247