Beclabuvir

also known as BMS 791325 · BECLABUVIR HYDROCHLORIDE · BMS-791325 HYDROCHLORIDE · BMS-791325-08

Developed for: hepatitis C virus infection · chronic hepatitis C virus infection
Investigated by: Bristol-Myers Squibb · ANRS, Emerging Infectious Diseases · Kirby Institute · National Cancer Institute (NCI) · National Institute of Allergy and Infectious Diseases (NIAID) · National Institutes of Health Clinical Center (CC)
+2 more
· Timothy Morgan, MD · VA Long Beach Healthcare System

Trials 21

today NCT02292966 · Ph 4 NCT02309450 · Ph 2 NCT00947245 · Ph 1 NCT02175966 · Ph 2 NCT02098616 · not/applicable NCT02170727 · Ph 3 NCT02175602 · Ph 1 NCT02104843 · Ph 1 NCT02095860 · Ph 1 NCT02112110 · Ph 1 NCT02108639 · Ph 1 NCT02103569 · Ph 1 NCT02084953 · Ph 1 NCT02045966 · Ph 1 NCT02124044 · Ph 2 NCT01973049 · Ph 3 NCT01979939 · Ph 3 NCT00996879 · Ph 1 NCT01455090 · Ph 2 NCT01193361 · Ph 2 NCT00664625 · Ph 1/2

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 110 trials
Phase 1	NCT00947245	Oct 2014 → Feb 2015	hepatitis C virus infection	Bristol-Myers Squibb	Withdrawn	No outcome recorded
Phase 1	NCT02175602	Jun → Aug 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	NCT02112110	Apr → May 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	NCT02103569	Apr → Jul 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02084953	Apr → May 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02045966	Feb → Apr 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT00996879	May → Sep 2013	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT00664625	May 2008 → Jun 2009	chronic hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 25 trials
Phase 2	NCT02309450	Dec 2014 → Nov 2015	hepatitis C virus infection	ANRS, Emerging Infectious Diseases	Withdrawn	No outcome recorded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	NCT01455090	Nov 2011 → Mar 2014	chronic hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 2	NCT01193361	Oct 2010 → Jun 2011	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 33 trials
Phase 3	NCT02170727	Jun 2014 → Jun 2015	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	NCT01979939	Dec 2013 → Aug 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 41 trial
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
Comparator or background therapy1 trial
Phase 1	NCT02045693 Background	Feb → Apr 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2014-11-08	Bristol-Myers Squibb	Results Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients, Including Those with Cirrhosis bms.com ↗ Daclatasvir TRIO achieves 98% cure rate in treatment-naïve and 93% cure rate in treatment-experienced genotype 1 patients with cirrhosis when used with ribavirin, as shown in UNITY 2
2013-04-23	Bristol-Myers Squibb	Results High Rates of SVR Demonstrated in Phase II Study with Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection bms.com ↗
2012-11-12	Bristol-Myers Squibb	Results Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 Achieved SVR12 of 94% in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection in Phase II Trial bms.com ↗ The remaining one patient had undetectable viral load at the end of treatment and was lost to follow-up until approximately 24 weeks post-treatment; in preliminary data, this patient has achieved SVR 24 .
2012-10-16	Bristol-Myers Squibb	Results Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting bms.com ↗

All press releases naming this drug 4 releases

Date	Issuer	Release
2014-11-08	Bristol-Myers Squibb	Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients, Including Those with Cirrhosis bms.com ↗
2013-04-23	Bristol-Myers Squibb	High Rates of SVR Demonstrated in Phase II Study with Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection bms.com ↗
2012-11-12	Bristol-Myers Squibb	Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 Achieved SVR12 of 94% in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection in Phase II Trial bms.com ↗
2012-10-16	Bristol-Myers Squibb	Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting bms.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

Field	Value	Cited text
Known as	Beclabuvir	“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 ↗ 1 “Asunaprevir (ASV) and Daclatasvir (DCV) and BMS-791325 (Beclabuvir)” NCT02124044 ↗
Known as	BECLABUVIR HYDROCHLORIDE	ChEMBL registry synonym — accepted as the source's own label CHEMBL4105584 ↗
Known as	BMS 791325	“All patients will receive an all-oral HCV tritherapy with Asunaprevir (200mg), Daclatasvir (30mg) and BMS-791325 (75mg) in a fixed-dose combination (FDC) tablet, twice a day (1...” NCT02309450 ↗ 21 “Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325” NCT02095860 ↗ “BMS 791325 75 mg table by mouth twice daily for 24 Weeks” NCT01455090 ↗ NCT02170727 ↗ NCT02124044 ↗ NCT02104843 ↗ NCT00664625 ↗ NCT02084953 ↗ NCT01455090 ↗ NCT02098616 ↗ NCT02112110 ↗ Show 11 more sources
Known as	BMS-791325 HYDROCHLORIDE	ChEMBL registry synonym — accepted as the source's own label CHEMBL4105584 ↗
Known as	BMS-791325-08	ChEMBL registry synonym — accepted as the source's own label CHEMBL4105584 ↗
Action	Inhibit	“BMS-791325 is a nonnucleoside inhibitor of hepatitis C virus (HCV) NS5B polymerase” PMID 24733462 ↗ Apr 2014
Modality	Small molecule	“BMS-791325 is a nonnucleoside inhibitor of hepatitis C virus (HCV) NS5B polymerase” PMID 24733462 ↗ Apr 2014
Route	Oral	“Capsules, Oral, Once Daily, Single Dose” NCT00664625 ↗