Telaprevir
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Incivo | — | 2016-09-22 | europa.eu ↗ |
| Label expansion | US (FDA) | INCIVEK | — | 2013-10-28 | fda.gov ↗ |
| Approved | EU (EMA) | Incivo | — | 2011-09-19 | europa.eu ↗ |
| Approved | US (FDA) | INCIVEK | — | 2011-05-23 | fda.gov ↗ |
Trials 72 · started per year
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01704521 Comparator | Dec 2012 → Oct 2014 | chronic hepatitis C virus infection, hemophilia | Kenneth Sherman | Completed | No outcome recorded |
| Phase 1 | NCT01646489 Comparator | Jun → Sep 2012 | chronic hepatitis C virus infection | Santaris Pharma A/S | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01872936 Background | Jun 2013 → Jan 2015 | chronic hepatitis C virus infection | Santaris Pharma A/S | Unknown | No outcome recorded |
| Phase 2 | NCT01648140 Comparator | Aug 2012 → Jul 2014 | chronic hepatitis C virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01355289 Background | Nov 2011 → Feb 2014 | thrombocytopenia | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01080222 Background | Aug 2010 → Oct 2013 | chronic hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01890772 Comparator | Aug 2013 → Oct 2015 | chronic hepatitis C virus infection | Timothy Morgan, MD | Withdrawn | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01854528 Comparator | Jun 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01854697 Comparator | Mar 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01718145 Comparator | Nov 2012 → Dec 2013 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT01598090 Background | Jun 2012 → Feb 2015 | chronic hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT01485991 Comparator | Feb 2012 → Apr 2014 | chronic hepatitis C virus infection | Janssen R&D Ireland | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01415141 Comparator | Jul 2011 | chronic hepatitis C virus infection | University of Vermont | Withdrawn | 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 |
Press releases naming this drug 87 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-11-20 | Vertex Pharmaceuticals Incorporated | Vertex Sells INCIVO ® Product Royalty Rights for $152 Million vrtx.com ↗ |
| 2013-10-29 | Vertex Pharmaceuticals Incorporated | Vertex Focuses Investment on Future Opportunities in Cystic Fibrosis and Other Key Research and Development Programs and Reduces Workforce Related to INCIVEK vrtx.com ↗ |
| 2013-04-24 | Vertex Pharmaceuticals Incorporated | Vertex Announces New Data that Showed High Viral Cure Rates with a Total of 12 and 24 Weeks of Telaprevir Combination Treatment Among People with Genotype 1 Hepatitis C Who Have the IL28B CC Genotype vrtx.com ↗ |
| 2012-12-19 | Vertex Pharmaceuticals Incorporated | Vertex Announces Update to U.S. Prescribing Information for INCIVEK® (telaprevir) vrtx.com ↗ |
| 2012-11-15 | Vertex Pharmaceuticals Incorporated | INCIVEK™ (telaprevir) Now Funded in Alberta and New Brunswick for People with Hepatitis C vrtx.com ↗ |
| 2012-11-10 | Vertex Pharmaceuticals Incorporated | Vertex Presents New Phase 3 Data that Showed People with Hepatitis C Treated with Twice-Daily Telaprevir Achieved Viral Cure (SVR12) Rates Similar to Those Treated Three Times Daily vrtx.com ↗ |
| 2012-04-24 | Vertex Pharmaceuticals Incorporated | INCIVEK™ (telaprevir) Now Funded for People With Hepatitis C in Quebec and Saskatchewan vrtx.com ↗ |
| 2012-04-18 | Vertex Pharmaceuticals Incorporated | Vertex Advances INCIVEK™ (telaprevir) and Broad Portfolio of Medicines in Development With Goal of Further Expanding and Improving Treatment for People With Hepatitis C vrtx.com ↗ |
| 2012-03-06 | Vertex Pharmaceuticals Incorporated | Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12) vrtx.com ↗ |
| 2012-02-23 | Vertex Pharmaceuticals Incorporated | Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C vrtx.com ↗ |
| 2011-11-05 | Vertex Pharmaceuticals Incorporated | Positive Interim Data From a Phase 2 Study of INCIVEK™ (telaprevir) Combination Therapy in People Co-Infected with Hepatitis C and HIV Presented at The Liver Meeting® vrtx.com ↗ |
| 2011-11-05 | Vertex Pharmaceuticals Incorporated | Interim Data from Phase 2 Study Showed 93% of People with Hepatitis C Who Received a Total of 12 Weeks of a Combination Regimen Including INCIVEK™ (telaprevir) and VX-222 (400mg) Achieved a Viral Cure (SVR) vrtx.com ↗ |
| 2011-10-27 | Vertex Pharmaceuticals Incorporated | Vertex Reports Profitable Third Quarter and Provides Updates on INCIVEKTM (telaprevir) Launch and Medicines in Development vrtx.com ↗ |
| 2011-10-24 | Vertex Pharmaceuticals Incorporated | Vertex Starts Global Phase 3b Study to Evaluate the Potential for People with Hepatitis C to Achieve a Viral Cure (SVR) with a Total Treatment Duration of 12 Weeks of INCIVEK™ Combination Therapy vrtx.com ↗ |
| 2011-10-11 | Vertex Pharmaceuticals Incorporated | INCIVEK™ (telaprevir) Now Available in Canada for People with Hepatitis C vrtx.com ↗ |
| 2011-09-14 | Vertex Pharmaceuticals Incorporated | New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK™ (telaprevir) in Hepatitis C vrtx.com ↗ |
| 2011-08-22 | Vertex Pharmaceuticals Incorporated | Health Canada Approves INCIVEK™ (telaprevir) for People With Hepatitis C vrtx.com ↗ |
| 2011-07-28 | Vertex Pharmaceuticals Incorporated | Vertex Reports Second Quarter 2011 Financial Results and Provides Updates on Launch of INCIVEKTM (telaprevir) and Development Programs vrtx.com ↗ |
| 2011-07-26 | Vertex Pharmaceuticals Incorporated | Interim Data from Phase 2 Study of Combination Regimen Including VX-222 and INCIVEK™ Suggest Potential to Treat Genotype 1 Hepatitis C in as few as 12 Weeks and No More Than 24 Weeks vrtx.com ↗ |
| 2011-06-22 | Vertex Pharmaceuticals Incorporated | New England Journal of Medicine Publishes Data From Two Phase 3 Studies of INCIVEK™ (telaprevir) in Hepatitis C vrtx.com ↗ |
| 2011-05-23 | Vertex Pharmaceuticals Incorporated | FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C vrtx.com ↗ |
| 2011-04-28 | Vertex Pharmaceuticals Incorporated | FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C vrtx.com ↗ |
| 2011-03-31 | Vertex Pharmaceuticals Incorporated | Results From Phase 3 REALIZE Study Showed Telaprevir-Based Therapy Significantly Improved SVR (Viral Cure) Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful vrtx.com ↗ |
| 2011-03-31 | Vertex Pharmaceuticals Incorporated | Interim Phase 2 Data Showed Rapid Viral Response to VX-222 in Combination with Telaprevir, Pegylated-Interferon and Ribavirin Among People With Hepatitis C vrtx.com ↗ |
| 2011-03-31 | Vertex Pharmaceuticals Incorporated | Data From Phase 3 Studies Showed Substantial Improvements in SVR (Viral Cure) Rates With Telaprevir-Based Therapy Compared to Currently Available Medicines in People With Hepatitis C, Regardless of Their IL28B Genotype Status vrtx.com ↗ |
| 2011-03-07 | Vertex Pharmaceuticals Incorporated | New Data on Telaprevir and VX-222 for the Treatment of Hepatitis C Accepted For Presentation at EASL Annual Meeting vrtx.com ↗ |
| 2011-03-02 | Vertex Pharmaceuticals Incorporated | Positive Phase 2 Interim Data from First Study of Telaprevir in People Co-Infected with Hepatitis C and HIV Presented at CROI Conference vrtx.com ↗ |
| 2011-01-20 | Vertex Pharmaceuticals Incorporated | U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C vrtx.com ↗ |
| 2011-01-09 | Vertex Pharmaceuticals Incorporated | Vertex Announces Key Business Objectives To Support Planned Launch of Telaprevir in Hepatitis C and Continued Progress in Other Serious Diseases vrtx.com ↗ |
| 2010-12-21 | Vertex Pharmaceuticals Incorporated | Vertex Provides Update to Ongoing Phase 2 Study Evaluating Combinations of Telaprevir and VX-222 for the Treatment of Hepatitis C vrtx.com ↗ |
| 2010-11-23 | Vertex Pharmaceuticals Incorporated | Vertex Completes New Drug Application for Telaprevir for Hepatitis C vrtx.com ↗ |
| 2010-11-10 | Vertex Pharmaceuticals Incorporated | Vertex Announces Plans to Enroll Additional Treatment Arm in Ongoing Phase 2 Combination Study of Telaprevir and VX-222 for the Treatment of People with Hepatitis C vrtx.com ↗ |
| 2010-10-30 | Vertex Pharmaceuticals Incorporated | New Data From Phase 3 Studies Showed Superior SVR (Viral Cure) Rates Achieved with Telaprevir-Based Combination Therapy in People with Hepatitis C, Regardless of Race or Stage of Liver Disease vrtx.com ↗ |
| 2010-10-25 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Start of a Phase 3b Study of Twice-Daily Telaprevir in People Not Treated Previously for Hepatitis C vrtx.com ↗ |
| 2010-09-07 | Vertex Pharmaceuticals Incorporated | 65% of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy in Phase 3 REALIZE Study vrtx.com ↗ |
| 2010-08-10 | Vertex Pharmaceuticals Incorporated | Phase 3 ILLUMINATE Study Supports 24-Week Telaprevir-Based Therapy Within a Response-Guided Regimen for People with Hepatitis C Who Had Not Received Prior Treatment vrtx.com ↗ |
| 2010-05-25 | Vertex Pharmaceuticals Incorporated | 75% of Treatment-Naïve Patients with Chronic Hepatitis C Achieve SVR (Viral Cure) with Telaprevir-Based Treatment in Phase 3 Trial vrtx.com ↗ |
| 2010-04-15 | Vertex Pharmaceuticals Incorporated | 59 Percent of Patients Overall Achieved SVR with Telaprevir-Based Regimens in Study 107 After Not Achieving SVR with at Least One Prior Course of Treatment for Hepatitis C Virus Infection vrtx.com ↗ |
| 2010-04-07 | Vertex Pharmaceuticals Incorporated | New England Journal of Medicine Publishes PROVE 3 Trial Showing Telaprevir-Based Regimens Significantly Increased Sustained Viral Response (SVR) Rates in Patients Who Did Not Achieve SVR with Prior HCV Therapy vrtx.com ↗ |
| 2010-03-16 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Acceptance of Telaprevir and VX-222 Abstracts for Presentation at EASL Annual Meeting vrtx.com ↗ |
| 2009-10-31 | Vertex Pharmaceuticals Incorporated | More than 80% of Hepatitis C Patients Treated in Study C208 Achieved an SVR with Telaprevir-Based Regimens vrtx.com ↗ |
| 2009-10-28 | Vertex Pharmaceuticals Incorporated | Interim Results from Study 107 Highlight the Potential Role of Telaprevir-Based Regimens in HCV Patients Who Failed Prior Treatment vrtx.com ↗ |
| 2009-09-30 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals to Receive $155 Million in Cash Related to Future Telaprevir Milestone Payments vrtx.com ↗ |
| 2009-09-24 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Publication of Telaprevir Abstracts for Presentation at the 60th AASLD Meeting vrtx.com ↗ |
| 2009-07-30 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals and Mitsubishi Tanabe Pharma Corporation Amend Agreement to Develop and Commercialize Telaprevir in Asia vrtx.com ↗ |
| 2009-07-10 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Intention to Sell Its Rights to European Milestone Payments for Telaprevir vrtx.com ↗ |
| 2009-04-29 | Vertex Pharmaceuticals Incorporated | New England Journal of Medicine Publishes Landmark Clinical Studies of the Investigational Hepatitis C Virus Protease Inhibitor Telaprevir vrtx.com ↗ |
| 2009-04-25 | Vertex Pharmaceuticals Incorporated | Telaprevir Data Presented at EASL Show Unprecedented SVR Rates in HCV Treatment-Failure Patients in PROVE 3 Study vrtx.com ↗ |
| 2009-04-21 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals to Present Data at EASL Suggesting Telaprevir's Potential for Use in a Broad Range of HCV Patients and Highlighting the Company's Expanded STAT-C Portfolio vrtx.com ↗ |
| 2009-03-18 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Acceptance of Telaprevir and VCH-222 Abstracts for Presentation at EASL Annual Meeting vrtx.com ↗ |
| 2009-03-03 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Strengthens HCV Drug Development Portfolio, Adds Novel Polymerase Inhibitors to Shape New Combinations with Telaprevir vrtx.com ↗ |
| 2008-11-01 | Vertex Pharmaceuticals Incorporated | New Clinical Data Support Broad Profile for Telaprevir in Patients with Genotype 1 Hepatitis C Virus (HCV) Infection vrtx.com ↗ |
| 2008-09-24 | Vertex Pharmaceuticals Incorporated | Telaprevir Presentations at the 59th AASLD Meeting to Feature SVR Data in Treatment-Naïve and Treatment-Failure Genotype 1 HCV Patients, and Clinical Data Exploring Twice-Daily Dosing Regimens vrtx.com ↗ |
| 2008-08-19 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals to Start Phase 3 'REALIZE' Trial with Telaprevir in Treatment-Failure HCV Patients vrtx.com ↗ |
| 2008-07-31 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Highlights Telaprevir Progress and Reports Second Quarter 2008 Results vrtx.com ↗ |
| 2008-06-09 | Vertex Pharmaceuticals Incorporated | Vertex Reports 52% SVR 12 Rate for a 24-week Telaprevir-based Regimen in Genotype 1 Hepatitis C Patients Who Failed Prior Treatment vrtx.com ↗ |
| 2008-04-24 | Vertex Pharmaceuticals Incorporated | Vertex Announces Positive Interim Results with Telaprevir-based Therapy in Genotype 1 Chronic Hepatitis C Patients who Failed to Achieve SVR with Previous Pegylated Interferon & Ribavirin Treatment vrtx.com ↗ |
| 2008-04-23 | Vertex Pharmaceuticals Incorporated | Telaprevir-Based PROVE Studies Show Significantly Higher SVR Rates in Treatment-Naive Genotype 1 Hepatitis C Patients in Half the Time of Current Treatments vrtx.com ↗ |
| 2008-03-31 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Acceptance of Late-Breaker Abstract on Telaprevir, Investigational HCV Protease Inhibitor, for Presentation at EASL Annual Meeting vrtx.com ↗ |
| 2008-03-13 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals and Tibotec Announce Start of Phase 3 'ADVANCE' Study with Telaprevir in Treatment-Naive, Genotype 1 HCV Patients vrtx.com ↗ |
| 2008-01-23 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Protease Inhibitor vrtx.com ↗ |
| 2008-01-07 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Reports Progress in Development of Investigational HCV Drug Telaprevir and Provides Business Update vrtx.com ↗ |
| 2007-04-14 | Vertex Pharmaceuticals Incorporated | Interim Results Presented at EASL from PROVE 1 Clinical Trial of Investigational Drug Telaprevir in Patients with Genotype 1 Hepatitis C vrtx.com ↗ |
| 2007-04-11 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces New Data for Investigational HCV Protease Inhibitor Telaprevir to be Presented at 42nd Annual Meeting of the European Association for the Study of the Liver (EASL) vrtx.com ↗ |
| 2006-12-13 | Vertex Pharmaceuticals Incorporated | Pharmaceuticals Announces Results of First Interim Safety and Antiviral Analysis of the PROVE 1 Clinical Trial of Investigational HCV Protease Inhibitor Telaprevir (VX-950) vrtx.com ↗ |
| 2006-10-27 | Vertex Pharmaceuticals Incorporated | New Data for Investigational Hepatitis C Drug Telaprevir (VX-950) to be Presented at AASLD Meeting vrtx.com ↗ |
| 2006-06-30 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals and Janssen Pharmaceutica, a Johnson & Johnson Company, Form Collaboration to Develop and Commercialize VX-950 for Treatment of Hepatitis C vrtx.com ↗ |
| 2006-05-23 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Initiates the First of Two Major Phase II Studies of VX-950 in Treatment-Naïve HCV Patients vrtx.com ↗ |
| 2006-05-21 | Vertex Pharmaceuticals Incorporated | Researchers Report Results for 28-day Phase II Study of VX-950 in Combination with Pegylated Interferon and Ribavirin in Hepatitis C Patients vrtx.com ↗ |
| 2006-04-29 | Vertex Pharmaceuticals Incorporated | Researchers Report Initial Results for 14-day Phase Ib Study of VX-950, and Pegylated Interferon, Showing Anti-HCV Activity in Combination in Hepatitis C Patients vrtx.com ↗ |
| 2006-04-26 | Vertex Pharmaceuticals Incorporated | New Data Highlight Anti-HCV Activity of Investigational Oral Hepatitis C Protease Inhibitor VX-950 vrtx.com ↗ |
| 2006-02-07 | Vertex Pharmaceuticals Incorporated | Vertex Successfully Completes Key Studies with VX-950 to Prepare for Next Steps in Clinical Program vrtx.com ↗ |
| 2006-01-09 | Vertex Pharmaceuticals Incorporated | VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid and Dramatic Reduction in Viral Levels in Combination with Pegylated Interferon vrtx.com ↗ |
| 2005-12-08 | Vertex Pharmaceuticals Incorporated | FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 vrtx.com ↗ |
| 2005-12-08 | Vertex Pharmaceuticals Incorporated | FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 vrtx.com ↗ |
| 2005-12-05 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Start of Phase II Clinical Development for Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 vrtx.com ↗ |
| 2005-12-05 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Start of Phase II Clinical Development for Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 vrtx.com ↗ |
| 2005-11-11 | Vertex Pharmaceuticals Incorporated | AASLD Presentations Support the Initiation of a Broad Phase II Program with VX-950, an Investigational Oral HCV Protease Inhibitor vrtx.com ↗ |
| 2005-11-09 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces a Conference Call and Webcast to Review VX-950 Presentations at the Upcoming AASLD Meeting vrtx.com ↗ |
| 2005-10-03 | Vertex Pharmaceuticals Incorporated | New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track vrtx.com ↗ |
| 2005-05-17 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Reports that Oral Hepatitis C Protease Inhibitor, VX-950, Dramatically Reduces Viral Levels in Phase Ib Clinical Study vrtx.com ↗ |
| 2005-05-10 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Reports that VX-950, an Investigational Oral Hepatitis C Protease Inhibitor, Displays Potent Antiviral Activity in Early Clinical Study vrtx.com ↗ |
| 2004-11-08 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Advancement to Phase Ib Clinical Trial for VX-950, an Investigational Oral Protease Inhibitor for the Treatment of Hepatitis C vrtx.com ↗ |
| 2004-11-01 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Reports Positive Results from First-in-Human Study for VX-950, an Investigational Oral Protease Inhibitor for the Treatment of Hepatitis C vrtx.com ↗ |
| 2004-09-07 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Reports Completion of Dosing in the Phase Ia Clinical Study of VX-950, an Oral HCV Protease Inhibitor for the Treatment of Hepatitis C vrtx.com ↗ |
| 2004-06-14 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals and Mitsubishi Pharma Sign Agreement for Development and Commercialization of the Oral HCV Protease Inhibitor VX-950 in Japan and Far East Countries vrtx.com ↗ |
| 2004-06-08 | Vertex Pharmaceuticals Incorporated | Vertex Pharmaceuticals Announces Initiation of First Human Clinical Trial for VX-950, an Investigational Oral Protease Inhibitor for the Treatment of Hepatitis C vrtx.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | telaprevir | “Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the...” NCT01743521 ↗75“Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised,...” PMID 25482330 ↗ Dec 2014 “A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection” NCT01241760 ↗ “Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection” NCT01253551 ↗ “telaprevir (TVR) is given as oral tablets” NCT01582035 ↗ “MP-424 (generic name:Telaprevir)” NCT01468584 ↗ “MP-424 (Telaprevir)” NCT00591214 ↗ |
| Known as | Incivek | “This study is for people who have been diagnosed with chronic hepatitis C, specifically those who have a certain type of the virus, genotype 1, and who have not yet received...” NCT01890772 ↗1“telaprevir 750 mg tid (Incivek®)” NCT01592006 ↗ |
| Known as | Incivek (telaprevir) | “Incivek (telaprevir)” NCT01532908 ↗ |
| Known as | Incivo | ChEMBL registry synonym — accepted as the source's own label CHEMBL231813 ↗ |
| Known as | LY 570310 | ChEMBL registry synonym — accepted as the source's own label CHEMBL231813 ↗ |
| Known as | MP-424 | “MP-424 (generic name:Telaprevir)” NCT01466192 ↗ |
| Known as | TPV | “Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the...” NCT01743521 ↗2“Telaprevir plus pegylated interferon/ribavirin (TPV+PegIFN/RBV)” PMID 26321288 ↗ Aug 2015 “ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV)” NCT02006745 ↗ |
| Known as | TVR | “This study aimed to characterize the pharmacokinetic parameters of telaprevir (TVR) in patients with moderate and severe hepatic impairment, measure the unbound...” PMID 25975934 ↗ Jul 201510“We evaluated the association between baseline HOMA-IR and pretreatment factors on sustained virologic response (SVR) to telaprevir (TVR) in genotype 1 patients with hepatitis C...” PMID 24382638 ↗ Oct 2013 “The purpose of this study is to investigate the effect of steady-state telaprevir (TVR 750 mg q8h (3 times a day, every 8 hours) on the steady-state pharmacokinetics of...” NCT00933894 ↗ “750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon dose only on day 18 and 200 mg ETR will be given twice a day from...” NCT01336829 ↗ “Telaprevir (TVR) plus peginterferon-α2a (PEG-IFN-α2a) and ribavirin substantially increases treatment efficacy for genotype 1 chronic hepatitis C virus (HCV) infection versus...” PMID 23685940 ↗ Jul 2013 “We studied 15 patients chronically infected with genotype 1 HCV treated with telaprevir (TVR)/pegylated-interferon alpha/ribavirin.” PMID 24811404 ↗ Jul 2014 “All participants will receive a single 750-mg dose of telaprevir (TVR) given by mouth as 2 tablets of 375 mg.” NCT00903773 ↗ “Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy” NCT01718145 ↗ “TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use.” NCT01485991 ↗ “TVR (Telaprevir)” NCT00828789 ↗ |
| Known as | VRT 111950 | ChEMBL registry synonym — accepted as the source's own label CHEMBL231813 ↗ |
| Known as | VX-950 | “A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection” NCT00580801 ↗4“Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours” NCT00528528 ↗ “telaprevir (VX-950)” NCT00509210 ↗ |
| Action | Inhibit | “Telaprevir, a protease inhibitor specific to the HCV nonstructural 3/4A serine protease, rapidly reduced HCV RNA levels in early studies.” PMID 19403902 ↗ Apr 2009 |
| Modality | Small molecule | “an orally available small molecule inhibitor of the HCV-1 protease” NCT01415141 ↗ |
| Route | Oral | “Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks” NCT00336479 ↗ |