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paritaprevir

Trade name: viekira pak

Small moleculeapprovedFast Track FDABreakthrough Therapy FDA

Approved

Dec 19, 2014

Paritaprevir is a potent inhibitor of the NS3/4A protease that rapidly and consistently suppresses HCV. Paritaprevir is metabolized by the Cytochrome P450 isoform 3A (CYP3A); therefore, ritonavir was used concurrently to increase plasma concentrations and to prolong the half-life of this agent allowing for once-daily dosing. Several antiviral regimens combining paritaprevir with other agents have shown impressive results, tolerable side effects, and importantly, provided support of ‘all-oral’ interferon-free regimens against HCV. Paritaprevir monotherapy is discontinued now but paritaprevir is used as a component of Viekira Pak and Technivie for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection. — NCATS

Clinical trial activity

76 trials · 29 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
54
Phase 3
35
Phase 4
13

Earliest trial started Feb 1, 2009 (NCT00850044)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    AbbVie — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2012

    AbbVie — Earliest Phase 3 Sponsor(trial)

  3. Dec 19, 2014

    AbbVie — Earliest FDA Approval

  4. Dec 19, 2014

    AbbVie — NDA Organization

  5. Dec 19, 2014

    AbbVie — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • technivie

    with ritonavir, ombitasvir

    Also known as ombitasvir, paritaprevir, ritonavir

  • viekira pak (copackaged)

    with ritonavir, ombitasvir, dasabuvir

    Also known as dasabuvir, ombitasvir, paritaprevir, and ritonavir, ombitasvir and paritaprevir and ritonavir and dasabuvir, viekira xr

Approval history

  • approvedPriority reviewFast trackBreakthroughDec 19, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CC1=NC=C(N=C1)C(=O)N[C@H]2CCCCCC=C[C@@H]3C[C@]3(NC(=O)[C@@H]4C[C@H](CN4C2=O)OC5=NC6=CC=CC=C6C7=CC=CC=C57)C(=O)NS(=O)(=O)C8CC8
Mol. weight
765.877 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (2r,6s,12z,13ar,14ar,16as)-n-(cyclopropanesulfonyl)-6-[(5-methylpyrazine-2-carbonyl)amino]-5,16-dioxo-2-[(phenanthridin-6-yl)oxy]-1,2,3,6,7,8,9,10,11,13a,14,15,16,16a-tetradecahydrocyclopropa[e]pyrrolo[1,2-a][1,4]diazacyclopentadecine-14a(5h)-carboxamide
  • (2r,6s,12z,13ar,14ar,16as)-n-(cyclopropanesulfonyl)-6-[(5-methylpyrazine-2-carbonyl)amino]-5,16-dioxo-2-[(phenanthridin-6-yl)oxy]-1,2,3,6,7,8,9,10,11,13a,14,15,16,16a-tetradecahydrocyclopropa[e]pyrrolo[1,2-a][1,4]diazacyclopentadecine-14a(5h)-carboxamide
  • abt-450
  • abt-450
  • abt-450
  • abt-450
  • abt-450
  • ombitasvir / paritaprevir / ritonavir
  • paritapravir
  • paritaprevir
  • paritaprevir
  • paritaprevir
  • paritaprevir
  • paritaprevir
  • paritaprevir
  • paritaprevir
  • paritaprevir
  • paritaprevir
  • paritaprevir dihydrate
  • paritaprevir dihydrate
  • paritaprevir dihydrate
  • paritaprevir dihydrate
  • paritaprevir dihydrate
  • veruprevir
  • veruprevir
  • veruprevir
  • viekira pak
  • viekira pak

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03499639Phase 4May 1, 2018Assiut University, Sohag University, South Valley University
NCT03549832N/AJan 1, 2018Assiut University, Sohag University, South Valley University
NCT03341988Phase 1Nov 22, 2017Assiut University
NCT03296930Phase 4Oct 1, 2017Assiut University
NCT02874066Phase 4Mar 13, 2017AbbVie, National Taiwan University
NCT04391985Phase 1/Phase 2 (Phase 2)Mar 1, 2017Beni Suef University
NCT03050905Phase 4Mar 1, 2017AbbVie, Emek Medical Center
NCT02946034Phase 4Feb 1, 2017AbbVie, Harvard University
NCT04378608Phase 1/Phase 2 (Phase 2)Jan 5, 2017Beni Suef University
NCT02950870Phase 4Dec 1, 2016University of Modena and Reggio Emilia
NCT03067883Phase 2Nov 9, 2016Ain Shams University
NCT02806362Phase 3Sep 1, 2016AbbVie
NCT02786537Phase 4Jun 1, 2016AbbVie, Cancer Research Network, Merck, University of Florida
NCT02498015Phase 4Jun 1, 2016University of New South Wales
NCT02634008Phase 3Jun 1, 2016AbbVie, University of New South Wales
NCT03003338Phase 4May 1, 2016AbbVie, Gottfried Wilhelm Leibniz Universität Hannover, Hannover Clinical Trial Center GmbH
NCT03710252Phase 4Mar 31, 2016AbbVie, American Research Corporation (ARC)
NCT02707952Phase 3Feb 1, 2016AbbVie
NCT02582632Phase 3Nov 1, 2015AbbVie
NCT02486406Phase 3Oct 28, 2015AbbVie
Showing 20 of 76 trials
Page 1 / 4

Organizations

Research & Development (29)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbVieFor profit605142010
AbbottFor profit4412009
Assiut UniversityAcademic/Hospital4432017
Beni Suef UniversityAcademic/Hospital2212017
Sohag UniversityAcademic/Hospital2022018
South Valley UniversityAcademic/Hospital2022018
University of New South WalesAcademic/Hospital2222016
Ain Shams UniversityAcademic/Hospital1112016
American Research Corporation (ARC)For profit1112016
Cancer Research NetworkAcademic/Hospital1012016
Dalhousie UniversityAcademic/Hospital1012015
Emek Medical CenterAcademic/Hospital1112017
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112016
Government of CanadaGovernment1012015
Government of Nova ScotiaGovernment1112015
Hannover Clinical Trial Center GmbHFor profit1012016
Harvard UniversityAcademic/Hospital1112017
Humanity & Health Research CentreAcademic/Hospital1112015
Johns Hopkins UniversityAcademic/Hospital1012015
Kaiser PermanenteAcademic/Hospital1112015
29 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDADec 19, 2014
AbbVieFor profitNDA2Dec 19, 2014
AbbVieFor profitSYNJul 24, 2015