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abacavir

Trade name: ziagen

Small moleculeapprovedFast Track FDA

Approved

Dec 17, 1998

Abacavir is a nucleoside reverse transcriptase inhibitor used for treatment of HIV infection (either alone or in combination with other antiviral drugs). It was shown that abacavir exerts its antiviral activity through its active metabolite, carbovir triphosphate. Carbovir triphosphate is a guanine analogue and a potent and selective inhibitor of viral reverse transcriptases. Upon administration, abacavir is first converted to abacavir monophosphate by ADK, then the monophosphate is deaminated to carbovir monophosphate, which is then anabolized by cellular kinases to carbovir diphosphate and then finally to carbovir triphosphate. Abacavir causes hypersensitivity reaction in patients with HLA-B*57:01 allele. — NCATS

Clinical trial activity

203 trials · 171 clinical orgs · 16 marketing orgs

Phase 1
29
Phase 2
100
Phase 3
67
Phase 4
53

Earliest trial started Jul 1, 1994 (NCT00002141)

Timeline

1990s

  1. Jan 1, 1994

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  3. Dec 17, 1998

    Earliest FDA Approval

  4. Dec 17, 1998

    ViiV Healthcare — NDA Secondary Org

  5. Jan 1, 1999

    Glaxo Wellcome — Earliest Phase 3 Sponsor(trial)

2000s

  1. Apr 5, 2007

    Matrix Laboratories Limited — Marketing Organization

  2. Sep 12, 2008

    Aurobindo Pharma — NDA Secondary Org

  3. Dec 19, 2008

    Aurobindo Pharma — Marketing Organization

  4. Mar 30, 2009

    Matrix Laboratories Limited — NDA Secondary Org

2010s

  1. Feb 16, 2011

    Cipla — NDA Secondary Org

  2. Jan 31, 2012

    Mylan — Marketing Organization

  3. Dec 17, 2012

    Apotex — Marketing Organization

  4. Sep 13, 2013

    Hetero Labs Ltd — Marketing Organization

  5. Dec 5, 2013

    Lupin — Marketing Organization

  6. Oct 23, 2014

    Mylan — NDA Secondary Org

  7. Nov 13, 2015

    Hetero Labs Ltd — NDA Secondary Org

  8. Sep 29, 2016

    Teva — Marketing Organization

  9. Oct 28, 2016

    Strides Pharma Science — Marketing Organization

  10. Mar 28, 2017

    Cipla — Marketing Organization

  11. Mar 28, 2017

    Chartwell Pharmaceuticals — Marketing Organization

  12. Nov 15, 2018

    Zydus Discovery DMCC — Marketing Organization

2020s

  1. Jul 25, 2022

    Laurus Labs Ltd — Marketing Organization

  2. Dec 22, 2023

    PHARMOBEDIENT — NDA Secondary Org

  3. Dec 19, 2024

    Macleods Pharmaceuticals, Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewAcceleratedFast trackDec 17, 1998

Chemistry & pharmacology

Loading structure…

SMILES

Nc1nc(NC2CC2)c2ncn([C@H]3C=C[C@@H](CO)C3)c2n1
Mol. weight
286.34 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • 1592u89
  • 1592u89
  • 1592u89
  • 1592u89
  • 1592u89
  • 1592u89
  • (1s,4r)-4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)-2-cyclopentene-1-methanol
  • {(1s-cis)-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]cyclopent-2-en-1-yl}methanol
  • {(1s-cis)-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]cyclopent-2-en-1-yl}methanol
  • abacavir
  • abacavir
  • abacavir
  • abacavir
  • abacavir
  • abacavir
  • abacavir
  • abacavir
  • abacavir
  • abacavir
  • abacavir (as sulfate) / lamivudine / zidovudine
  • abacavir hydroxyacetate
  • abacavir hydroxyacetate
  • abacavir - lamivudine
  • abacavir / lamivudine
  • abacavir-lamivudine combination
  • abacavir, lamivudine drug combination
  • abacavir succinate
  • abacavir succinate
  • abacavir sulfate
  • abacavir sulfate
  • abacavir sulfate
  • abacavir sulfate
  • abacavir sulfate
  • abacavir sulfate
  • abacavir sulfate / dolutegravir sodium / lamivudine
  • abacavir sulfate-lamivudine combination
  • abc
  • abc
  • epzicom
  • epzicom
  • epzicom
  • kivexa
  • kivexa
  • lamivudine / zidovudine / abacavir sulfate
  • prurisol
  • prurisol
  • prurisol
  • ziagen
  • ziagen
  • ziagen
  • ziagen
  • ziagen
  • ziagen

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05393193Phase 4Jul 4, 2022Botswana Harvard Aids Institute, Botswana Ministry of Health, Harvard University, National Institutes of Health (NIH), Ragon Institute of MGH, MIT and Harvard
NCT05193994Phase 3Feb 24, 2022Macquarie University, Stichting TRICALS Foundation, University of London
NCT05030025Early Phase 1 (Phase 1)Aug 1, 2021Mylan, ViiV Healthcare
NCT04731103Phase 2Jun 30, 2021Medical Research Council, NHS Lothian, University of Edinburgh
NCT04493216Phase 2Nov 16, 2020ViiV Healthcare
NCT04155554Phase 3Dec 31, 2019Azienda Ospedaliera Universitaria Senese, Catholic University of Sacred Heart, Rome, Ospedale Amedeo di Savoia, University of Genoa, University of Milan
NCT03836833Phase 1/Phase 2 (Phase 2)Jun 4, 2019Baylor University, Drugs for Neglected Diseases Initiative, Epcentre Centre Mbarara Research Centre, Institute of Tropical Medicine, Belgium, Joint Clinical Research Centre, Kampala, Uganda, UNITAID
NCT03760458Phase 1/Phase 2 (Phase 2)Apr 30, 2019International Maternal Pediatric Adolescent AIDS Clinical Trials Network, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Stellenbosch University, St. Jude Children's Hospital, University of Colorado, ViiV Healthcare
NCT03685500Phase 4Oct 15, 2018Fundacion SEIMC-GESIDA, Johnson and Johnson
NCT03360682Phase 4Apr 12, 2018University of Barcelona
NCT03067285Phase 4Jul 1, 2017Fundacion SEIMC-GESIDA
NCT02659761Phase 4Nov 1, 2016Mater Misericordiae University Hospital, National University of Ireland, ViiV Healthcare
NCT02938520Phase 3Oct 27, 2016GlaxoSmithKline, Janssen Pharmaceutica NV, ViiV Healthcare
NCT02949388Phase 2Oct 1, 2016Innovation Pharmaceuticals
NCT02957864Phase 4Oct 1, 2016Erasmus University Rotterdam, Gilead Sciences
NCT02868580Phase 1/Phase 2 (Phase 2)Oct 1, 2016Calvary Health Care Bethlehem, Macquarie University, Neuroscience Trials Australia, The Albion Centre, University of Sydney
NCT02924389N/ASep 1, 2016Emory University, National Institutes of Health (NIH)
NCT02893488Phase 1Sep 1, 2016ViiV Healthcare
NCT02588820Phase 3Apr 1, 2016University of Barcelona
NCT02569346Phase 1Mar 1, 2016Radboud University
Showing 20 of 203 trials
Page 1 / 11

Organizations

Research & Development (171)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit381542001
National Institute of Allergy and Infectious Diseases (NIAID)Government383641997
Glaxo WellcomeFor profit302851999
ViiV HealthcareFor profit261652002
Gilead SciencesFor profit221831999
National Institutes of Health (NIH)Government12051999
University of BarcelonaAcademic/Hospital9522004
Badalona Hospital Germans Trias i PujolAcademic/Hospital5522004
Fundacio Lluita Contra la SIDAAcademic/Hospital5122004
Fundacion SEIMC-GESIDAAcademic/Hospital4412008
Janssen Pharmaceutica NVFor profit4022009
Johnson and JohnsonFor profit4232011
ShionogiFor profit4022010
University of New South WalesAcademic/Hospital4412003
University of WashingtonAcademic/Hospital4122002
AbbottFor profit3022007
Duke UniversityAcademic/Hospital3222002
French National Agency for Research on AIDS and Viral HepatitisGovernment3312009
Harvard UniversityAcademic/Hospital3132005
Innovation PharmaceuticalsFor profit3322014
171 organizations
Page 1 / 9

Marketing (28)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGDec 17, 2012
Aurobindo PharmaFor profitNDA2Sep 12, 2008
Aurobindo PharmaFor profitMKTGDec 19, 2008
Aurobindo PharmaFor profitSYNAug 14, 2023
Chartwell PharmaceuticalsFor profitMKTGMar 28, 2017
CiplaFor profitNDA2Feb 16, 2011
CiplaFor profitMKTGMar 28, 2017
Glaxo WellcomeFor profitNDA—
Hetero Labs LtdFor profitMKTGSep 13, 2013
Hetero Labs LtdFor profitSYNSep 25, 2014
Hetero Labs LtdFor profitNDA2Nov 13, 2015
Laurus Labs LtdFor profitMKTGJul 25, 2022
Laurus Labs LtdFor profitSYNAug 11, 2022
LupinFor profitMKTGDec 5, 2013
LupinFor profitSYNDec 5, 2013
Macleods Pharmaceuticals, LtdFor profitMKTGDec 19, 2024
Matrix Laboratories LimitedFor profitNDA2Mar 30, 2009
Matrix Laboratories LimitedFor profitMKTGApr 5, 2007
MylanFor profitMKTGJan 31, 2012
MylanFor profitSYNJul 15, 2009
MylanFor profitSYNJun 18, 2012
MylanFor profitNDA2Oct 23, 2014
PHARMOBEDIENTFor profitNDA2Dec 22, 2023
Strides Pharma ScienceFor profitMKTGOct 28, 2016
TevaFor profitMKTGSep 29, 2016
ViiV HealthcareFor profitNDA2Dec 17, 1998
Zydus Discovery DMCCFor profitMKTGNov 15, 2018
Zydus Discovery DMCCFor profitSYNNov 15, 2018