Drugs / paritaprevir

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Viekirax 2024-09-25 europa.eu
Approved EU (EMA) Viekirax 2015-01-14 europa.eu
Approved US (FDA) VIEKIRA PAK (COPACKAGED) 2014-12-19 fda.gov

Trials 56 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT03341988 Nov 2017 → Jan 2018 chronic hepatitis C virus infection Assiut University Completed No outcome recorded
Phase 1 NCT02534870 Sep 2015 AbbVie Completed No outcome recorded
Phase 1 NCT02052362 Jan → Feb 2014 AbbVie Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04378608 Jan → Sep 2017 chronic hepatitis C virus infection Beni-Suef University Completed No outcome recorded
Phase 214 trials
Phase 2 NCT03067883 Nov 2016 → Jan 2018 chronic hepatitis C virus infection Ain Shams University Unknown No outcome recorded
Phase 2 NCT02194998 Sep 2015 → May 2018 HIV infectious disease, chronic hepatitis C virus infection National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 2 NCT02356562 Feb 2015 → Oct 2016 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT02292719 Dec 2014 → Jul 2017 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT01911845 Apr → Dec 2013 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT01782495 Feb 2013 → Nov 2016 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT01609933 Dec 2012 → May 2017 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT01685203 Aug 2012 → Jun 2014 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT01672983 Jul 2012 → May 2014 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT01464827 Oct 2011 → Mar 2013 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT02486406 Oct 2015 → Nov 2020 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2/3 NCT02555943 Feb 2015 → May 2021 chronic hepatitis C virus infection, hepatitis B virus infection Humanity and Health Research Centre Completed No outcome recorded
Phase 328 trials
Phase 3 NCT02806362 Sep 2016 → Jun 2018 chronic hepatitis C virus infection AbbVie Withdrawn No outcome recorded
Phase 3 NCT02634008 Jun 2016 → Apr 2021 acute hepatitis C virus infection Kirby Institute Completed No outcome recorded
Phase 3 NCT02646111 Jan 2016 → Jan 2018 chronic hepatitis C virus infection Tel-Aviv Sourasky Medical Center Unknown No outcome recorded
Phase 3 NCT02582632 Nov 2015 → Aug 2016 hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 3 NCT02609659 Oct 2015 → Oct 2016 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 3 NCT02487199 Sep 2015 → Dec 2016 hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 3 NCT02517528 Jul 2015 → Sep 2016 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 3 NCT02517515 Jul 2015 → Oct 2016 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 3 NCT02504099 Jul 2015 → Sep 2016 chronic hepatitis C virus infection AbbVie Terminated No outcome recorded
Phase 3 NCT02476617 Jun 2015 → Aug 2016 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 48 trials
Phase 4 NCT03499639 May → Aug 2018 end stage renal failure, hepatitis C virus infection Assiut University Completed No outcome recorded
Phase 4 NCT03003338 Oct 2017 → Oct 2018 chronic hepatitis C virus infection Hannover Medical School Terminated No outcome recorded
Phase 4 NCT03050905 Jun → Nov 2017 hepatitis C virus infection HaEmek Medical Center, Israel Completed No outcome recorded
Phase 4 NCT02874066 Mar 2017 → Oct 2018 viral hepatitis National Taiwan University Hospital Completed No outcome recorded
Phase 4 NCT02950870 Dec 2016 → Dec 2017 chronic hepatitis C virus infection University of Modena and Reggio Emilia Unknown No outcome recorded
Phase 4 NCT02498015 Aug 2016 → Aug 2017 chronic hepatitis C virus infection Kirby Institute Completed No outcome recorded
Phase 4 NCT03710252 Mar 2016 → Sep 2017 chronic hepatitis C virus infection American Research Corporation Completed No outcome recorded
Phase 4 NCT02460133 Jul 2015 → Oct 2025 overdue hepatitis C virus infection Nova Scotia Health Authority Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT01091649 Comparator Feb → Apr 2010 Abbott Completed No outcome recorded
Phase 1 NCT00931281 Comparator Jun → Sep 2009 hepatitis C virus infection Abbott Completed No outcome recorded
Phase 1 NCT00909311 Comparator May → Jul 2009 hepatitis C virus infection Abbott Completed No outcome recorded
Phase 1 NCT00850044 Comparator Feb → Jul 2009 hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04391985 Comparator Mar → Oct 2017 chronic hepatitis C virus infection Beni-Suef University Completed No outcome recorded
Phase 23 trials
Phase 2 NCT02493855 Background Jun 2015 → Apr 2016 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 2 NCT01995071 Background Nov 2013 → Jun 2015 chronic hepatitis C virus infection, cirrhosis of liver AbbVie Completed No outcome recorded
Phase 2 NCT01563536 Background Feb → Apr 2012 chronic hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 32 trials
Phase 3 NCT02247401 Comparator Nov 2014 → Aug 2016 hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 3 NCT01773070 Background Jun 2013 → Oct 2016 hepatitis C virus infection AbbVie Completed No outcome recorded
Phase 45 trials
Phase 4 NCT03296930 Comparator Oct 2017 → Sep 2018 poisoning Assiut University Unknown No outcome recorded
Phase 4 NCT02786537 Comparator Jun 2016 → Jun 2019 chronic hepatitis C virus infection University of Florida Completed No outcome recorded
Phase 4 NCT02461745 Comparator Jun 2015 → May 2017 chronic hepatitis C virus infection Kaiser Permanente Completed No outcome recorded
Phase 4 NCT02992457 Comparator Jan 2015 → Dec 2018 hepatitis C virus infection Tanta University Completed No outcome recorded
Phase 4 NCT03133065 Comparator Sep 2014 → Dec 2016 Ain Shams University Completed No outcome recorded

Press releases naming this drug 20 releases

DateIssuerRelease
2017-02-27 AbbVie AbbVie Receives CHMP Positive Opinion for Eight-Week Treatment Option with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for Patients with Genotype 1b Chronic Hepatitis C abbvie.com
2016-09-23 AbbVie AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C abbvie.com
2016-07-25 AbbVie CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A) abbvie.com
2016-07-25 AbbVie AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com
2016-04-25 AbbVie AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis abbvie.com
2016-04-15 AbbVie AbbVie Announces Real-World Data with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) from Large German Hepatitis C-Registry abbvie.com
2016-04-14 AbbVie AbbVie Announces High SVR Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Regardless of the Presence of Resistance-Associated Variants Prior to Treatment in Genotype 1 Chronic Hepatitis C Patients abbvie.com
2016-03-30 AbbVie AbbVie to Present Data on VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) and Investigational, Pan-Genotypic Regimen at The International Liver Congress™ 2016 abbvie.com
2016-02-26 AbbVie AbbVie Receives CHMP Positive Opinion for VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Without Ribavirin for the Treatment of Chronic Hepatitis C in Genotype 1b Patients with Compensated Cirrhosis (Child-Pugh A) in abbvie.com
2016-01-07 AbbVie FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis abbvie.com
2015-12-02 AbbVie AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection abbvie.com
2015-11-14 AbbVie AbbVie Announces New Data on VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Patients with Chronic Hepatitis C Virus Infection With or Without Compensated Cirrhosis abbvie.com

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 75 sources stand behind the page.

FieldValueCited text
Known as paritaprevir “GIFT-I is a phase 3 trial evaluating the efficacy and safety of a 12-week regimen of coformulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) for treatment of Japanese...” PMID 26147154 Aug 2015
45

“The combination of ombitasvir (an NS5A inhibitor), paritaprevir (an NS3/4A inhibitor) coadministered with ritonavir (r), and dasabuvir (an NS5B nonnucleoside polymerase...” PMID 26596948 Nov 2015

“one recipient is treated with fixed-dose combination of ombitasvir (12.5 mg), paritaprevir (75 mg) and ritonavir (50 mg) + weight based ribavirin due to having persistent renal...” NCT03133065

“A Monocenter Randomized Double-blind Placebo-controlled Study to Investigate Neuropsychiatric Manifestations of HCV-infection During and After Treatment With...” NCT03003338

“Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.” PMID 29909549 Feb 2019

“12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.” NCT02646111

“Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection.” NCT04378608

“Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients” NCT04391985

“A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection” NCT02498015

Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day” NCT02874066

“ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent” NCT02247401

“All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (Viekirax).” NCT03050905

“ABT-450 also known as paritaprevir and r is also know as ritonavir” NCT01609933

“ABT-450 also known as paritaprevirNCT01833533

“ABT-450 also known as paritaprevirNCT02167945

“ABT-450 also known as paritaprevirNCT01704755

NCT02582632

NCT02219477

NCT03296930

NCT02207088

NCT03341988

NCT02517515

NCT02634008

NCT03067883

NCT02609659

NCT03499639

NCT02356562

NCT02950870

NCT02806362

NCT02216422

NCT03710252

NCT02486406

NCT02992457

NCT02786537

NCT02399345

NCT02460133

NCT02476617

NCT02442284

NCT02504099

NCT02442271

NCT02487199

NCT02265237

NCT02461745

NCT02555943

NCT01782495

NCT02194998

Known as ABT-450 ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent” NCT02247401
29

“Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease” NCT04378608

“paritaprevir also known as ABT-450NCT02517515

NCT01609933

NCT02493855

NCT01716585

NCT02219490

NCT01464827

NCT01563536

NCT01767116

NCT01074008

NCT01773070

NCT01911845

NCT01674725

NCT01458535

NCT01221298

NCT01833533

NCT01995071

NCT00931281

NCT01306617

NCT01715415

NCT01854528

NCT01685203

NCT00850044

NCT01672983

NCT01854697

NCT01091649

NCT02167945

NCT02052362

NCT00909311

Known as ABT-450 also known as paritaprevir ABT-450 also known as paritaprevirNCT01674725
13

ABT-450 also known as paritaprevirNCT02219490

ABT-450 also known as paritaprevirNCT02216422

ABT-450 also known as paritaprevirNCT01685203

ABT-450 also known as paritaprevirNCT02023099

ABT-450 also known as paritaprevirNCT01672983

ABT-450 also known as paritaprevirNCT01715415

ABT-450 also known as paritaprevirNCT01716585

ABT-450 also known as paritaprevirNCT02219477

ABT-450 also known as paritaprevirNCT01995071

ABT-450 also known as paritaprevirNCT01854697

ABT-450 also known as paritaprevirNCT01773070

ABT-450 also known as paritaprevirNCT01767116

ABT-450 also known as paritaprevirNCT01854528

Known as paritaprevir (ABT-450) paritaprevir (ABT-450)NCT02265237
Known as paritaprevir also known as ABT-450 paritaprevir also known as ABT-450NCT02442284
7

paritaprevir also known as ABT-450NCT01782495

paritaprevir also known as ABT-450NCT02399345

paritaprevir also known as ABT-450NCT02442271

paritaprevir also known as ABT-450NCT02582632

paritaprevir also known as ABT-450NCT02609659

paritaprevir also known as ABT-450NCT02207088

paritaprevir also known as ABT-450NCT02504099

Known as Paritaprevir component of technivie ChEMBL registry synonym — accepted as the source's own label CHEMBL3391662
Known as Paritaprevir component of viekirax ChEMBL registry synonym — accepted as the source's own label CHEMBL3391662
Known as PTV “GIFT-I is a phase 3 trial evaluating the efficacy and safety of a 12-week regimen of coformulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) for treatment of Japanese...” PMID 26147154 Aug 2015
6

“mini-tablet formulations of ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) with or without ribavirin for 12 weeks in children infected with chronic...” PMID 32451952 May 2020

“Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection.” NCT04378608

“Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day” NCT02874066

“ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r)” PMID 29546644 Mar 2018

“paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)” NCT02194998

“paritaprevir (PTV; 150mg)” NCT03499639

Known as Veruprevir ChEMBL registry synonym — accepted as the source's own label CHEMBL3391662
Known as Veruprevir anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL3391662
Action Inhibit “experimental HCV protease inhibitor” NCT00850044
Modality Small molecule CHEMBL3391662
Route Oral “all-oral ombitasvir/paritaprevir/ritonavir and dasabuvir±ribavirin” PMID 26321288 Aug 2015