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glecaprevir

Trade name: Mavyret

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Aug 3, 2017

Glecaprevir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS3/4A protease inhibitor that targets the the viral RNA replication. In combination with Pibrentasvir, glecaprevir is a useful therapy for patients who experienced therapeutic failure from other NS3/4A protease inhibitors. It demonstrates a high genetic barrier against resistance mutations of the virus. Glecaprevir is available as an oral combination therapy with Pibrentasvir under the brand name Mavyret. On 3 August 2017 the FDA approved the combination for hepatitis C treatment. Mavyret is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). Mavyret is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both. — NCATS

Clinical trial activity

54 trials · 25 clinical orgs · 1 marketing orgs

Phase 1
5
Phase 2
32
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

    AbbVie — Earliest FDA Approval

  6. Aug 3, 2017

    AbbVie — NDA Secondary Org

  7. Aug 3, 2017

    AbbVie — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • mavyret

    with pibrentasvir

    Also known as glecaprevir and pibrentasvir

Approval history

  • approvedPriority reviewFast trackBreakthroughAug 3, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C)[C@@H]1NC(=O)O[C@@H]2CCC[C@H]2OC\C=C\C(F)(F)C3=C(O[C@@H]4C[C@H](N(C4)C1=O)C(=O)N[C@@]5(C[C@H]5C(F)F)C(=O)NS(=O)(=O)C6(C)CC6)N=C7C=CC=CC7=N3
Mol. weight
838.865 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-{(1r,2r)-2­ (difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro­ 5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12­ methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10­ carboxamide hydrate
  • (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-{(1r,2r)-2­ (difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro­ 5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12­ methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10­ carboxamide hydrate
  • a-1282576.0
  • a-1282576.0
  • abt-493
  • abt-493
  • abt-493
  • glecaprevir
  • glecaprevir
  • glecaprevir
  • glecaprevir
  • glecaprevir
  • glecaprevir
  • glécaprévir
  • glécaprévir
  • glecaprevir / pibrentasvir
  • glecaprevirum
  • glecaprevirum

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
NCT04596475Phase 1/Phase 2 (Phase 2)Oct 31, 2020University of California, San Diego
NCT04515797Phase 4Oct 31, 2020Harvard University
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
NCT03625687Phase 4Oct 15, 2018Harvard University
NCT03623568Phase 4Oct 15, 2018Harvard University
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbVieFor profit352852013
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 profitNDAAug 3, 2017
AbbVieFor profitSYNAug 3, 2017