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atazanavir

Trade name: reyataz

Small moleculeapproved

Approved

Jun 20, 2003

Atazanavir is the first once-daily protease inhibitor for the treatment of human immunodeficiency virus type 1 infection and should be used only in combination therapy, as part of a highly active antiretroviral therapy (HAART) regimen. In addition to being the most potent protease inhibitor in vitro, atazanavir has a distinct cross-resistance profile that does not confer resistance to other protease inhibitors. However, resistance to other protease inhibitors often confers clinically relevant resistance to atazanavir. — NCATS

Clinical trial activity

187 trials · 141 clinical orgs · 13 marketing orgs

Phase 1
42
Phase 2
75
Phase 3
57
Phase 4
54

Earliest trial started Mar 1, 1999 (NCT00002240)

Timeline

1990s

  1. Jan 1, 1999

    Bristol-Myers Squibb — Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2001

    Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)

  3. Jun 20, 2003

    Bristol-Myers Squibb — Earliest FDA Approval

  4. Jun 20, 2003

    Bristol-Myers Squibb — NDA Organization

  5. Feb 4, 2008

    Emcure — Marketing Organization

2010s

  1. Sep 15, 2010

    Matrix Laboratories Limited — Marketing Organization

  2. Nov 18, 2011

    Mylan — NDA Secondary Org

  3. Mar 17, 2014

    Emcure — NDA Secondary Org

  4. Apr 22, 2014

    Teva — Marketing Organization

  5. Jan 29, 2015

    Bristol-Myers — NDA Secondary Org

  6. Jan 29, 2015

    Bristol-Myers Squibb — Marketing Organization

  7. Jan 9, 2017

    Pharmacare PLC, Palestine — Marketing Organization

  8. Jun 25, 2018

    Aurobindo Pharma — Marketing Organization

  9. Aug 9, 2018

    Cipla — Marketing Organization

  10. Sep 24, 2018

    Mylan — Marketing Organization

2020s

  1. Jun 1, 2020

    Amneal Pharmaceuticals — Marketing Organization

  2. Jun 4, 2020

    Zydus Discovery DMCC — Marketing Organization

  3. Apr 30, 2021

    Laurus Labs Ltd — Marketing Organization

  4. Feb 2, 2022

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewJun 20, 2003

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)N[C@H](C(=O)N[C@@H](Cc1ccccc1)[C@@H](O)CN(Cc1ccc(-c2ccccn2)cc1)NC(=O)[C@@H](NC(=O)OC)C(C)(C)C)C(C)(C)C
Mol. weight
704.87 g/mol
Lipinski Ro5
1 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

  • atazanavir
  • atazanavir
  • atazanavir
  • atazanavir
  • atazanavir
  • atazanavir
  • atazanavir
  • atazanavir
  • atazanavir
  • atazanavir sulfate
  • atazanavir sulfate
  • atazanavir sulfate
  • atazanavir sulfate
  • atazanavir sulfate
  • atazanavir sulfate / cobicistat
  • atazanavir sulphate
  • atazanavir sulphate
  • atazanavirum
  • atazanavirum
  • atv
  • atv
  • atz
  • atz
  • bms-232632
  • bms-232632
  • bms-232632
  • bms-232632
  • bms-232632
  • bms-232632
  • bms-232632-05
  • bms-232632-05
  • cgp-73547
  • cgp-73547
  • latazanavir
  • latazanavir
  • reyataz
  • reyataz
  • reyataz
  • reyataz
  • reyataz
  • zrivada
  • zrivada

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05587543Early Phase 1 (Phase 1)Dec 31, 2022Fudan University, Government of China
NCT05236738Phase 1May 13, 2022Bristol-Myers Squibb
NCT04468087Phase 2/Phase 3 (Phase 3)Dec 1, 2020Hospital do Coracao
NCT04518228Phase 4Oct 15, 2020Boston University, Gilead Sciences, Merck, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), ViiV Healthcare
NCT04452565Phase 2/Phase 3 (Phase 3)Oct 15, 2020NeuroActiva
NCT04459286Phase 2Oct 9, 2020African Centre of Excellence for Genomics of Infectious Diseases, government of nigeria, Infectious Disease Hospital Olodo, Obafemi Awolowo University, Olabisi Onabanjo University, University of Liverpool
NCT04480333Phase 1Sep 15, 2020NeuroActiva
NCT05680792N/ASep 10, 2020Obafemi Awolowo University, University of Liverpool
NCT04311957Phase 4Jun 1, 2020Analysis Group, Inc., Cornell University, Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Harvard University
NCT04263350Phase 1Feb 29, 2020Bristol-Myers Squibb
NCT04021290Phase 3Nov 11, 2019GlaxoSmithKline, PPD, ViiV Healthcare
NCT04022967Phase 3Sep 15, 2019CHU Treichville, Government of France, Mylan, University of Bordeaux, University of Paris
NCT04184869Phase 1Aug 5, 2019Acrotech Biopharma LLC, AXIS Clinicals Limited
NCT04531072Phase 4Sep 18, 2018National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), University of Lagos
NCT03631732Phase 3Aug 28, 2018Gilead Sciences
NCT02951052Phase 3Oct 28, 2016GlaxoSmithKline, Janssen Pharmaceutica NV, ViiV Healthcare
NCT02697851Phase 1Jul 1, 2016Bristol-Myers Squibb, St Stephens Aids Trust
NCT02652624Phase 3Feb 1, 2016Gilead Sciences
NCT02556268Phase 1Feb 1, 2016Bayer
NCT03708861Phase 3Jan 31, 2016University of Turin
Showing 20 of 187 trials
Page 1 / 10

Organizations

Research & Development (141)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit674551999
Gilead SciencesFor profit292332002
National Institute of Allergy and Infectious Diseases (NIAID)Government171042000
GlaxoSmithKlineFor profit9242004
MerckFor profit9152007
University of BarcelonaAcademic/Hospital8542005
ViiV HealthcareFor profit8632007
National Institutes of Health (NIH)Government6132000
AIDS Clinical Trials GroupAcademic/Hospital5442004
Boehringer IngelheimFor profit5432003
Harvard UniversityAcademic/Hospital5342005
Radboud UniversityAcademic/Hospital5532008
RocheFor profit5332004
Janssen Pharmaceutica NVFor profit4022009
The HIV Netherlands Australia Thailand Research CollaborationAcademic/Hospital4432007
University of New South WalesAcademic/Hospital4332004
University of ParisAcademic/Hospital4032008
Badalona Hospital Germans Trias i PujolAcademic/Hospital3322005
French National Agency for Research on AIDS and Viral HepatitisGovernment3322002
Northwestern UniversityAcademic/Hospital3132002
141 organizations
Page 1 / 8

Marketing (22)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGJun 1, 2020
Aurobindo PharmaFor profitMKTGJun 25, 2018
Aurobindo PharmaFor profitSYNJun 25, 2018
Bristol-MyersFor profitNDA2Jan 29, 2015
Bristol-Myers SquibbFor profitNDAJun 20, 2003
Bristol-Myers SquibbFor profitMKTGJan 29, 2015
CiplaFor profitMKTGAug 9, 2018
EmcureFor profitMKTGFeb 4, 2008
EmcureFor profitSYNAug 19, 2010
EmcureFor profitSYNMar 17, 2014
EmcureFor profitNDA2Mar 17, 2014
Hetero Labs LtdFor profitMKTGFeb 2, 2022
Laurus Labs LtdFor profitMKTGApr 30, 2021
Laurus Labs LtdFor profitMKTGApr 30, 2021
Matrix Laboratories LimitedFor profitMKTGSep 15, 2010
MylanFor profitSYNSep 24, 2018
MylanFor profitSYNSep 4, 2014
MylanFor profitMKTGSep 24, 2018
MylanFor profitNDA2Nov 18, 2011
Pharmacare PLC, PalestineFor profitMKTGJan 9, 2017
TevaFor profitMKTGApr 22, 2014
Zydus Discovery DMCCFor profitMKTGJun 4, 2020