Drugs / Vaniprevir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | chronic hepatitis C virus infection | 2014-01-13 | “Filed vaniprevir (MK-7009), an investigational protease inhibitor for the treatment of chronic HCV infection, in Japan.” merck.com ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 2 met primary | ||||||
| Phase 1 | NCT01678131 | Oct 2012 → Aug 2013 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1 | NCT00954993 | Jan 2010 → Mar 2011 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01010906 | Jul 2009 → Jun 2010 | hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00518622 | Jul 2007 → Sep 2008 | hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 25 trials · 3 met primary | ||||||
| Phase 2 | NCT00895882 | Nov 2010 → Jan 2013 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT00943761 | Oct 2009 → May 2013 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00880763 | Apr 2009 → Jun 2010 | hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00704405 | Mar 2009 → Mar 2012 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00704184 | Jul → Dec 2008 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT01405560 | Sep 2011 → Mar 2013 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01405937 | Aug 2011 → Feb 2013 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01370642 | Jun 2011 → Jul 2013 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2013-04-08 | Merck Sharp & Dohme LLC | Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver CongressTM / 2013 EASL Annual Meeting merck.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vaniprevir | “Vaniprevir is a competitive inhibitor of the hepatitis C virus (HCV) NS3/4A protease that has potent anti-HCV activity in preclinical models.” PMID 23747481 ↗ Jun 2013 |
| Known as | MK-7009 | “Vaniprevir (MK-7009) is a hepatitis C virus (HCV) non-structural 3/4a protease inhibitor which significantly increases virologic response rates in HCV genotype (GT) 1-infected...” PMID 25115901 ↗ Aug 20143“A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)” NCT00943761 ↗ “Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)” NCT00704184 ↗ “vaniprevir (MK7009)” NCT00895882 ↗ |
| Action | Inhibit | “competitive inhibitor of the hepatitis C virus (HCV) NS3/4A protease” PMID 23747481 ↗ Jun 2013 |
| Modality | Small molecule | “Vaniprevir is a macrocyclic hepatitis C virus (HCV) non-structural (NS)3/4A protease inhibitor.” PMID 26936417 ↗ Oct 2016 |
| Route | Oral | “Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only),...” NCT00704405 ↗ |