Boceprevir
Small molecule targets CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Victrelis | — | 2018-06-29 | europa.eu ↗ |
| Label expansions (3) | US (FDA) | VICTRELIS | — | 2013-02-13 – 2014-04-09 | fda.gov ↗ |
| Approved | EU (EMA) | Victrelis | — | 2011-07-18 | europa.eu ↗ |
| Approved | US (FDA) | VICTRELIS | — | 2011-05-13 | fda.gov ↗ |
Trials 40 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01471717 Comparator | Oct → Nov 2011 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01949168 Comparator | Sep 2013 → Sep 2015 | chronic hepatitis C virus infection | St Vincent's Hospital Melbourne | Unknown | No outcome recorded |
| Phase 2 | NCT01482403 Comparator | Nov 2011 → Jan 2014 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01353911 Comparator | Jun 2011 → Jan 2013 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00959699 Comparator | Nov 2009 → May 2012 | HIV infectious disease, hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00689390 Background | Feb 2007 → Oct 2014 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02204475 Comparator | Nov 2014 → Jun 2016 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT01446250 Comparator | Dec 2011 → May 2013 | chronic hepatitis C virus infection | Debiopharm International SA | Terminated | No outcome recorded |
| Phase 3 | NCT01023035 Background | Dec 2009 → Oct 2011 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01443923 Comparator | Sep 2011 → Sep 2013 | HIV infectious disease, hepatitis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02113631 Comparator | Sep 2011 → Apr 2013 | chronic hepatitis C virus infection, cirrhosis of liver | Louis Stokes VA Medical Center | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Boceprevir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00705432 ↗49 |
| Known as | BOC | “On day 15 the participants will attend for their 2nd long visit (10 hours) when they will be administered boceprevir (BOC) 800mg (4 capsules) with a standardised meal then have...” NCT01499498 ↗9“This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African...” NCT01446250 ↗ “Recent data show that adding an HCV serine protease inhibitor (such as boceprevir \[BOC\]) to peg-IFN and RBV results in HCV eradication rates of 70% to 80% among...” NCT01443923 ↗ “Boceprevir (BOC) is an Hepatitis C (HCV) NS3 serine protease inhibitor that has recently received FDA approval for the treatment of chronic HCV infection.” NCT01470690 ↗ “The addition of boceprevir(BOC) on atazanavir (ATV) or raltegravir (RAL) pharmacokinetic parameters in a subgroup of patients.” PMID 27077673 ↗ Feb 2016 “triple therapy with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver transplantation(LT)” NCT02160080 ↗ “Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.” NCT02204475 ↗ “Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400” NCT00160251 ↗ “Boceprevir (BOC)” NCT01390844 ↗ “Boceprevir (BOC)” NCT01482767 ↗ |
| Known as | Boceprevir: Victrelis | “Boceprevir: Victrelis” NCT01457937 ↗ |
| Known as | EBP 520 | ChEMBL registry synonym — accepted as the source's own label CHEMBL218394 ↗ |
| Known as | SCH 503034 | “Boceprevir (SCH 503034)” NCT00708500 ↗ |
| Known as | Sch 50304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL218394 ↗ |
| Known as | Victrelis | “Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets)” NCT01949168 ↗ |
| Known as | Victrelis (Boceprevir) | “Victrelis (Boceprevir)” NCT02160080 ↗ |
| Known as | Victrelis(r) | “Boceprevir as Victrelis(r) 200mg capsules” NCT01663922 ↗ |
| Action | Inhibit | “boceprevir, an NS3 protease inhibitor” PMID 20692693 ↗ Aug 2010 |
| Modality | Small molecule | — CHEMBL218394 ↗ |
| Route | Oral | “100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID” NCT00160251 ↗ |
| Target | CYP3A4 | “Boceprevir is a strong inhibitor of CYP3A4/5.” NCT01663922 ↗ |