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dasabuvir

Trade name: Exviera

Small moleculeapprovedFast Track FDABreakthrough Therapy FDA

Approved

Dec 19, 2014

Dasabuvir is a non-nucleoside inhibitor of the hepatitis C virus (HCV) NS5B palm polymerase inhibitor. It is used in the treatment of adult patients with chronic hepatitis C virus infection in combination with ombitasvir, paritaprevir, and ritonavir as the combination product Viekira Pak. Viekira PAK combines three direct-acting antiviral agents with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle. Dasabuvir is extensively evaluated in large clinical trials and shown excellent sustained virological response among hepatitis C virus genotype1 patient population in combination with other oral direct acting antivirals, with good safety profile and tolerance. — NCATS

Clinical trial activity

59 trials · 24 clinical orgs · 1 marketing orgs

Phase 1
7
Phase 2
40
Phase 3
29
Phase 4
11

Earliest trial started Jun 1, 2008 (NCT00696904)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    AbbVie — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2012

    AbbVie — Earliest Phase 3 Sponsor(trial)

  2. Dec 19, 2014

    AbbVie — Earliest FDA Approval

  3. Dec 19, 2014

    AbbVie — NDA Organization

  4. Dec 19, 2014

    AbbVie — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • viekira pak (copackaged)

    with ritonavir, ombitasvir, paritaprevir

    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

COc1c(-c2ccc3cc(NS(C)(=O)=O)ccc3c2)cc(-n2ccc(=O)[nH]c2=O)cc1C(C)(C)C
Mol. weight
493.59 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • abt-333
  • abt-333
  • abt-333
  • abt-333
  • dasabuvir
  • dasabuvir
  • dasabuvir
  • dasabuvir
  • dasabuvir
  • dasabuvir
  • dasabuvir
  • dasabuvir
  • dasabuvir
  • dasabuvir sodium
  • dasabuvir sodium
  • dasabuvir sodium
  • dasabuvir sodium
  • dasabuvir sodium monohydrate
  • exviera
  • exviera
  • exviera
  • n-{6-[3-tert-butyl-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-2-methoxyphenyl]naphthalen-2-yl}methanesulfonamide
  • n-{6-[3-tert-butyl-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-2-methoxyphenyl]naphthalen-2-yl}methanesulfonamide
  • sodium 3-(3-tert-butyl-4-methoxy-5-{6­ [(methylsulfonyl)amino]naphthalene-2-yl}phenyl)-2,6-dioxo-3,6-dihydro-2h-pyrimidin-1-ide hydrate (1:1:1)
  • sodium 3-(3-tert-butyl-4-methoxy-5-{6­ [(methylsulfonyl)amino]naphthalene-2-yl}phenyl)-2,6-dioxo-3,6-dihydro-2h-pyrimidin-1-ide hydrate (1:1:1)

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02874066Phase 4Mar 13, 2017AbbVie, National Taiwan University
NCT03050905Phase 4Mar 1, 2017AbbVie, Emek Medical Center
NCT02946034Phase 4Feb 1, 2017AbbVie, Harvard University
NCT02950870Phase 4Dec 1, 2016University of Modena and Reggio Emilia
NCT02498015Phase 4Jun 1, 2016University of New South Wales
NCT02786537Phase 4Jun 1, 2016AbbVie, Cancer Research Network, Merck, University of Florida
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)
NCT02582632Phase 3Nov 1, 2015AbbVie
NCT02486406Phase 3Oct 28, 2015AbbVie
NCT02609659Phase 3Oct 1, 2015AbbVie
NCT02487199Phase 3Sep 1, 2015AbbVie
NCT02534870Phase 1Sep 1, 2015AbbVie
NCT02194998Phase 2Aug 1, 2015Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID)
NCT02517515Phase 3Jul 16, 2015AbbVie
NCT02504099Phase 3Jul 1, 2015AbbVie
NCT02734173Phase 4Jul 1, 2015AbbVie, University of Ottawa
NCT02517528Phase 3Jul 1, 2015AbbVie
NCT02460133Phase 4Jul 1, 2015Dalhousie University, Government of Canada, Government of Nova Scotia, PEI Provincial Correction Centre
Showing 20 of 59 trials
Page 1 / 3

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbVieFor profit494042008
AbbottFor profit5512008
University of New South WalesAcademic/Hospital2222016
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
MerckFor profit1012016
National Institute of Allergy and Infectious Diseases (NIAID)Government1112015
National Taiwan UniversityAcademic/Hospital1112017
PEI Provincial Correction CentreGovernment1012015
People's Liberation Army of ChinaGovernment1012015
24 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDADec 19, 2014
AbbVieFor profitNDA2Dec 19, 2014
AbbVieFor profitSYNDec 19, 2014