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pibrentasvir

Trade name: Mavyret

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Aug 3, 2017

Pibrentasvir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS5A inhibitor that targets the the viral RNA replication and viron assembly. NS5A is a phosphoprotein that plays an essential role in replication, assembly and maturation of infectious viral proteins. The basal phosphorylated form of NS5A, which is maintained by C-terminal serine cluster, is key in ensuring its interaction with the viral capsid protein, or the core protein. By blocking this interaction, pibrentasvir inhibits the assembly of proteins and production of mature HCV particles. In the United States and Europe, Pibrentasvir is approved for use with glecaprevir as the combination drug glecaprevir/pibrentasvir (trade name Mavyret in the US and Maviret in the EU) for the treatment of hepatitis C. This fixed-dose combination therapy was FDA-approved in August 2017 to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. — NCATS

Clinical trial activity

55 trials · 25 clinical orgs · 2 marketing orgs

Phase 1
5
Phase 2
33
Phase 3
25
Phase 4
15

Earliest trial started Nov 1, 2013 (NCT01995071)

Timeline

2010s

  1. Jan 1, 2013

    AbbVie — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2014

    AbbVie — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2015

    AbbVie — Earliest Phase 3 Sponsor(trial)

  4. Jan 9, 2017

    Orphan Drug Designation

  5. Aug 3, 2017

    Gilead Sciences — Earliest FDA Approval

  6. Aug 3, 2017

    AbbVie — NDA Secondary Org

  7. Aug 3, 2017

    Gilead Sciences — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • mavyret

    with glecaprevir

    Also known as glecaprevir and pibrentasvir

Approval history

  • approvedPriority reviewFast trackBreakthroughAug 3, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CO[C@H](C)[C@H](NC(=O)OC)C(=O)N1CCC[C@H]1C2=NC3=C(N2)C=C(F)C(=C3)[C@H]4CC[C@@H](N4C5=CC(F)=C(N6CCC(CC6)C7=CC=C(F)C=C7)C(F)=C5)C8=CC9=C(NC(=N9)[C@@H]%10CCCN%10C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)C=C8F
Mol. weight
1113.1802 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • a-1325912.0
  • a-1325912.0
  • abt-530
  • abt-530
  • abt-530
  • mavyret
  • pibrentasvir
  • pibrentasvir
  • pibrentasvir
  • pibrentasvir
  • pibrentasvir
  • pibrentasvir

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07040319Phase 1/Phase 2 (Phase 2)Nov 28, 2025AbbVie, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
NCT05637879Phase 2/Phase 3 (Phase 3)Jul 1, 2023Department of Veteran Affairs
NCT05446857Phase 2/Phase 3 (Phase 3)Jan 1, 2023Department of Veteran Affairs
NCT05582681Phase 4Nov 11, 2022AbbVie, Cornell University
NCT05108935Phase 4Dec 1, 2021Duke University
NCT04903626Phase 3Aug 24, 2021AbbVie
NCT04682509Early Phase 1 (Phase 1)Mar 1, 2021New York University
NCT04575896Phase 4Nov 20, 2020Johns Hopkins University
NCT04614142Phase 4Nov 1, 2020Harvard University
NCT04515797Phase 4Oct 31, 2020Harvard University
NCT04596475Phase 1/Phase 2 (Phase 2)Oct 31, 2020University of California, San Diego
NCT04508907Phase 4Sep 10, 2020Mayo Clinic
NCT04235049Phase 4May 1, 2020Government of Maryland, Merck, University of Maryland
NCT04042740Phase 2Oct 15, 2019AbbVie, Duke University, Harvard University, National Institute of Allergy and Infectious Diseases (NIAID), University of Colorado
NCT03981211N/AOct 1, 2019University of New South Wales
NCT03855917Phase 4Apr 30, 2019University of New South Wales
NCT03781726Phase 4Apr 10, 2019AbbVie, Cornell University, Harvard University, Johns Hopkins University, Northwestern University, University of Cincinnati, University of Michigan, University of Pennsylvania
NCT03492112Phase 4Nov 30, 2018University of New South Wales
NCT03623568Phase 4Oct 15, 2018Harvard University
NCT03625687Phase 4Oct 15, 2018Harvard University
Showing 20 of 55 trials
Page 1 / 3

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbVieFor profit362952013
Harvard UniversityAcademic/Hospital6522018
University of New South WalesAcademic/Hospital5532016
Johns Hopkins UniversityAcademic/Hospital3212018
Cornell UniversityAcademic/Hospital2112019
Department of Veteran AffairsGovernment2212023
Duke UniversityAcademic/Hospital2122019
National Institute of Allergy and Infectious Diseases (NIAID)Government2212019
New York UniversityAcademic/Hospital2222018
Government of MarylandGovernment1012020
Id CareAcademic/Hospital1112018
Mayo ClinicAcademic/Hospital1112020
MerckFor profit1012020
National Institute of Mental Health (NIMH)Government1012025
National Institutes of Health (NIH)Government1012025
Northwestern UniversityAcademic/Hospital1012019
University of California, San DiegoAcademic/Hospital1112020
University of CincinnatiAcademic/Hospital1012019
University of ColoradoAcademic/Hospital1012019
University of FloridaAcademic/Hospital1112017
25 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Aug 3, 2017
AbbVieFor profitSYNAug 3, 2017
Gilead SciencesFor profitNDAAug 3, 2017