Drugs / Telaprevir

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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Withdrawn EU (EMA) Incivo 2016-09-22 europa.eu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

today
US approved 2011
EU approved 2011
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2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 124 trials
Phase 1 NCT01786382 Feb → Mar 2013 Presidio Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01766167 Feb → Apr 2013 chronic hepatitis C virus infection Tanabe Pharma Corporation Completed No outcome recorded
Phase 1 NCT01818856 Dec 2012 → Apr 2013 HIV infectious disease, chronic hepatitis C virus infection Hospitales Universitarios Virgen del Rocío Completed No outcome recorded
Phase 1 NCT01657552 Aug → Oct 2012 thrombocytopenia GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01597895 Jul → Aug 2012 ViiV Healthcare Completed No outcome recorded
Phase 1 NCT01600976 Jun → Oct 2012 Janssen Infectious Diseases BVBA Completed No outcome recorded
Phase 1 NCT01635829 May → Aug 2012 Janssen Infectious Diseases BVBA Completed No outcome recorded
Phase 1 NCT01582035 Apr 2012 → Nov 2013 hepatitis C virus infection Janssen R&D Ireland Completed No outcome recorded
Phase 1 NCT01511432 Jan → Jun 2012 chronic hepatitis C virus infection Vertex Pharmaceuticals Incorporated Completed No outcome recorded
Phase 1 NCT01336829 Mar → Sep 2011 HIV infectious disease, hepatitis C virus infection Tibotec Pharmaceuticals, Ireland Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01701063 Jan 2013 → Apr 2015 hepatitis C virus infection Vertex Pharmaceuticals Incorporated Terminated No outcome recorded
Phase 218 trials
Phase 2 NCT01994486 Dec 2013 → Apr 2014 chronic hepatitis C virus infection University of Florida Completed No outcome recorded
Phase 2 NCT01841502 May 2013 → Sep 2014 depressive disorder, hepatitis C virus infection Radboud University Medical Center Terminated No outcome recorded
Phase 2 NCT01532908 Nov 2012 → Aug 2015 chronic hepatitis C virus infection MassBiologics Terminated No outcome recorded
Phase 2 NCT01581138 Jul 2012 → Jun 2013 chronic hepatitis C virus infection Vertex Pharmaceuticals Incorporated Completed No outcome recorded
Phase 2 NCT01467505 Feb 2012 → Apr 2014 hepatitis C virus infection Vertex Pharmaceuticals Incorporated Terminated No outcome recorded
Phase 2 NCT01516918 Feb 2012 → Sep 2013 chronic hepatitis C virus infection Vertex Pharmaceuticals Incorporated Completed No outcome recorded
Phase 2 NCT01332955 Apr 2011 → Sep 2013 HIV infectious disease, chronic hepatitis C virus infection ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 2 NCT00983853 Oct 2009 → Mar 2012 HIV infectious disease, hepatitis C virus infection Vertex Pharmaceuticals Incorporated Completed No outcome recorded
Phase 2 NCT00892697 May 2009 → Dec 2012 hepatitis C virus infection Weill Medical College of Cornell University Completed No outcome recorded
Phase 2 NCT00621296 Jan 2008 → Feb 2009 chronic hepatitis C virus infection Tanabe Pharma Corporation Completed No outcome recorded
Phase 323 trials
Phase 3 NCT02006745 Jan 2014 → Feb 2016 HIV infectious disease St Stephens Aids Trust Completed No outcome recorded
Phase 3 NCT01858961 May 2013 → Jul 2016 chronic hepatitis C virus infection Boehringer Ingelheim Withdrawn No outcome recorded
Phase 3 NCT01821963 Apr 2013 → Feb 2014 infectious disease M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 3 NCT01718158 Jan 2013 → Oct 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT01753557 Dec 2012 → Nov 2014 chronic hepatitis C virus infection Tanabe Pharma Corporation Completed No outcome recorded
Phase 3 NCT01753570 Dec 2012 → Oct 2015 chronic hepatitis C virus infection Tanabe Pharma Corporation Completed No outcome recorded
Phase 3 NCT01500616 Jun 2012 → Aug 2014 chronic hepatitis C virus infection Janssen-Cilag International NV Completed No outcome recorded
Phase 3 NCT01466192 May 2012 → Aug 2013 chronic hepatitis C virus infection Tanabe Pharma Corporation Completed No outcome recorded
Phase 3 NCT01513941 Apr 2012 → Mar 2014 chronic hepatitis C virus infection Janssen-Cilag International NV Completed No outcome recorded
Phase 3 NCT01571583 Feb 2012 → Apr 2014 chronic hepatitis C virus infection Janssen-Cilag International NV Completed No outcome recorded
Phase 45 trials
Phase 4 NCT02087111 Apr 2014 → Nov 2016 hepatitis C virus infection Queen Mary University of London Completed No outcome recorded
Phase 4 NCT01766115 Apr 2013 → May 2014 hepatitis C virus infection Massachusetts General Hospital Withdrawn No outcome recorded
Phase 4 NCT01743521 Jan 2013 → Nov 2015 chronic hepatitis C virus infection Kirby Institute Completed No outcome recorded
Phase 4 NCT01592006 Apr 2012 → Sep 2014 hepatitis C virus infection University of Chicago Terminated No outcome recorded
Phase 4 NCT01467492 Jan 2012 → May 2014 chronic hepatitis C virus infection Vertex Pharmaceuticals Incorporated Terminated No outcome recorded
Phase not stated1 trial
NCT01508286 hepatitis C virus infection Janssen-Cilag International NV No longer available No outcome recorded
Also used as a comparator or background therapy in 14 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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

DateIssuerRelease
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

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 94 sources stand behind the page.

FieldValueCited 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

NCT01657552

NCT01841502

NCT01592006

NCT00372385

NCT00892697

NCT01818856

NCT00703118

NCT00580801

NCT00420784

NCT01492426

NCT01821963

NCT01532908

NCT01872936

NCT01704521

NCT00509210

NCT00561015

NCT00535847

NCT02113631

NCT00336479

NCT01466192

NCT01275599

NCT01854528

NCT01336829

NCT00775125

NCT01038167

NCT01080222

NCT01701063

NCT01571583

NCT01648140

NCT01854697

NCT02087111

NCT01994486

NCT01597895

NCT01516918

NCT01598090

NCT00627926

NCT01581138

NCT00973388

NCT01054573

NCT00528528

NCT01332955

NCT02006745

NCT01635829

NCT01718158

NCT00933283

NCT01718145

NCT01890772

NCT00933894

NCT01355289

NCT01513941

NCT01498068

NCT00903773

NCT01786382

NCT01600976

NCT00983853

NCT01646489

NCT01459913

NCT01858961

NCT00958152

NCT01415141

NCT01511432

NCT00828789

NCT00758043

NCT01766115

NCT01467505

NCT01467492

NCT01508286

NCT01500616

NCT01467479

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
10

NCT00780416

NCT01753570

NCT00780910

NCT00781274

NCT01753557

NCT01468584

NCT00630058

NCT00591214

NCT01766167

NCT00621296

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 2015
10

“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

NCT01582035

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

NCT00262483

NCT00251199

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