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nevirapine

Trade name: viramune

Small moleculeapproved

Approved

Jun 21, 1996

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (nNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). HIV-2 RT and eukaryotic DNA polymerases (such as human DNA polymerases alpha, beta, or sigma) are not inhibited by nevirapine. Nevirapine is, in general, only prescribed after the immune system has declined and infections have become evident. It is always taken with at least one other HIV medication such as Retrovir or Videx. The virus can develop resistance to nevirapine if the drug is taken alone, although even if used properly, nevirapine is effective for only a limited time. Nevirapine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates. Nevirapine is used for use in combination with other antiretroviral drugs in the ongoing treatment of HIV-1 infection. — NCATS

Clinical trial activity

175 trials · 158 clinical orgs · 19 marketing orgs

Phase 1
36
Phase 2
77
Phase 3
48
Phase 4
44

Earliest trial started Mar 3, 1997 (NCT00001644)

Timeline

1990s

  1. Jun 21, 1996

    Boehringer Ingelheim — Earliest FDA Approval

  2. Jun 21, 1996

    Boehringer Ingelheim — NDA Secondary Org

  3. Jun 21, 1996

    Boehringer Ingelheim — NDA Organization

  4. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 1999

    Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 24, 2005

    Pharmacare PLC, Palestine — NDA Secondary Org

  2. Jun 20, 2005

    Ranbaxy — Marketing Organization

  3. Jun 30, 2006

    Aurobindo Pharma — NDA Secondary Org

  4. Nov 17, 2006

    Cipla — NDA Secondary Org

  5. Mar 2, 2007

    Strides Pharma Science — Marketing Organization

  6. Mar 2, 2007

    Strides Pharma Science — NDA Secondary Org

  7. Sep 28, 2007

    Emcure — Marketing Organization

  8. Oct 21, 2008

    Mylan — NDA Secondary Org

  9. Feb 27, 2009

    Pharmacare PLC, Palestine — Marketing Organization

  10. May 7, 2009

    Hetero Labs Ltd — Marketing Organization

  11. May 7, 2009

    Hetero Labs Ltd — NDA Secondary Org

  12. Jul 16, 2009

    Emcure — NDA Secondary Org

2010s

  1. Feb 8, 2012

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  2. Feb 8, 2012

    Macleods Pharmaceuticals, Ltd — NDA Secondary Org

  3. May 22, 2012

    Apotex — Marketing Organization

  4. May 22, 2012

    Mylan — Marketing Organization

  5. May 22, 2012

    Prinston Inc — Marketing Organization

  6. May 22, 2012

    Cipla — Marketing Organization

  7. May 22, 2012

    PHARMOBEDIENT — Marketing Organization

  8. Apr 3, 2014

    Sandoz — Marketing Organization

  9. Apr 3, 2014

    Novartis — Marketing Organization

  10. Jul 10, 2015

    Alvogen — Marketing Organization

  11. Nov 23, 2016

    Aurobindo Pharma — Marketing Organization

  12. Oct 6, 2017

    Neogen — Marketing Organization

  13. Aug 13, 2018

    Micro Labs Ltd India — Marketing Organization

  14. Aug 13, 2018

    Micro Labs Ltd India — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • lamivudine/zidovudine 150 mg/300 mg tablets co-packaged with nevirapine 200 mg tablets

    with lamivudine, zidovudine

    Also known as lamivudine/nevirapine/zidovudine tablets, lamivudine, zidovudine tabs 150mg/300mg co-packaged with nevirapine tabs 200mg

Approval history

  • approvedPriority reviewAcceleratedJun 21, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CC1=C2NC(=O)C3=CC=CN=C3N(C4CC4)C2=NC=C1
Mol. weight
266.2979 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 11-cyclopropyl-5,11-dihydro-4-methyl-6h-dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one
  • 11-cyclopropyl-5,11-dihydro-4-methyl-6h-dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one
  • birg-0587
  • birg-0587
  • gpo-vir
  • nev
  • nev
  • nevarapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine
  • nevirapine hemihydrate
  • nevirapine hemihydrate
  • nevirapine hemihydrate
  • nevirapine hemihydrate
  • nevirapine hemihydrate
  • nevirapine hemihydrate
  • nvp
  • nvp
  • stavudine - lamivudine - nevirapine
  • stavudine, lamivudine, nevirapine drug combination
  • triomune
  • triomune
  • triomune
  • viramune
  • viramune
  • viramune
  • viramune
  • viramune
  • viramune xr
  • viramune xr

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03916328Phase 4Aug 1, 2019Johns Hopkins University
NCT07014189Phase 4Apr 12, 2019Cantonal Hospital of St. Gallen
NCT03631732Phase 3Aug 28, 2018Gilead Sciences
NCT03642704Phase 4Feb 22, 2017CHU Donka, Government of France
NCT03223402N/ADec 23, 2016Cantonal Hospital of St. Gallen
NCT03664440N/ADec 1, 2016Mahidol University
NCT02712801Phase 4Apr 1, 2016Government of China, Guangdong Provincial Maternal and Child Health Hospital, Guangxi Medical University, Maternal and Child Health Hospital of Yunan Province, Sichuan University, Xinjiang Medical University
NCT03088410Phase 4Apr 1, 2016Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT02605954Phase 3Nov 18, 2015Gilead Sciences
NCT02431975Phase 4Aug 1, 2015Columbia University, National Institutes of Health (NIH), University of the Witwatersrand
NCT02469246Phase 3Jun 29, 2015Gilead Sciences
NCT02397096Phase 3Jun 9, 2015Merck
NCT02369406Phase 2/Phase 3 (Phase 3)Feb 1, 2015Harvard University, Ragon Institute of MGH, MIT and Harvard, University of California, San Diego
NCT02858401Phase 1Jan 29, 2015Gilead Sciences
NCT02140255Phase 1/Phase 2 (Phase 2)Jan 1, 2015National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Northwestern University, University of California, Los Angeles
NCT02285114Phase 2/Phase 3 (Phase 3)Jan 1, 2015Gilead Sciences
NCT02116660Phase 2Sep 3, 2014Merck
NCT02202005Phase 1Aug 1, 2014Ratiopharm, University of London
NCT02121795Phase 3May 8, 2014Gilead Sciences
NCT01632891Phase 1/Phase 2 (Phase 2)Jul 1, 2013AIDS Clinical Trials Group, Johns Hopkins University, Kenya Medical Research Institute, National Institute of Allergy and Infectious Diseases (NIAID)
Showing 20 of 175 trials
Page 1 / 9

Organizations

Research & Development (158)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government575051997
Boehringer IngelheimFor profit433251998
National Institutes of Health (NIH)Government28251999
Harvard UniversityAcademic/Hospital11342001
Gilead SciencesFor profit9742007
Johns Hopkins UniversityAcademic/Hospital9242001
AbbottFor profit6231999
Bristol-Myers SquibbFor profit6231999
Makerere UniversityAcademic/Hospital6432006
National Institute of Child Health and Human Development (NICHD)Government5322005
University of the WitwatersrandAcademic/Hospital5042005
University of WashingtonAcademic/Hospital5222002
Badalona Hospital Germans Trias i PujolAcademic/Hospital4422003
Chulalongkorn UniversityAcademic/Hospital4032005
Government of ChinaGovernment4112005
Government of FranceGovernment4422001
Mahidol UniversityAcademic/Hospital4242006
Tsinghua UniversityAcademic/Hospital4232005
Bamrasnaradura Infectious Diseases InstituteAcademic/Hospital3232004
B.I. South Africa (Pty.) Ltd.For profit3032002
158 organizations
Page 1 / 8

Marketing (46)

OrganizationOrg typeRelationshipDate
AlvogenFor profitMKTGJul 10, 2015
AlvogenFor profitSYNJul 10, 2015
ApotexFor profitMKTGMay 22, 2012
ApotexFor profitSYNApr 3, 2014
Aurobindo PharmaFor profitMKTGNov 23, 2016
Aurobindo PharmaFor profitNDA2Jun 30, 2006
Aurobindo PharmaFor profitSYNMay 22, 2012
Boehringer IngelheimFor profitNDA2Jun 21, 1996
Boehringer IngelheimFor profitNDAJun 21, 1996
CiplaFor profitNDA2Nov 17, 2006
CiplaFor profitSYNMay 22, 2012
CiplaFor profitSYNOct 16, 2012
CiplaFor profitMKTGMay 22, 2012
EmcureFor profitMKTGSep 28, 2007
EmcureFor profitNDA2Jul 16, 2009
Hetero Labs LtdFor profitMKTGMay 7, 2009
Hetero Labs LtdFor profitSYNMay 22, 2012
Hetero Labs LtdFor profitSYNNov 18, 2011
Hetero Labs LtdFor profitNDA2May 7, 2009
Macleods Pharmaceuticals, LtdFor profitMKTGFeb 8, 2012
Macleods Pharmaceuticals, LtdFor profitNDA2Feb 8, 2012
Matrix Laboratories LimitedFor profitSYNOct 21, 2008
Matrix Laboratories LimitedFor profitSYNSep 8, 2011
Micro Labs Ltd IndiaFor profitMKTGAug 13, 2018
Micro Labs Ltd IndiaFor profitSYNMay 22, 2012
Micro Labs Ltd IndiaFor profitNDA2Aug 13, 2018
MylanFor profitMKTGMay 22, 2012
MylanFor profitSYNAug 26, 2014
MylanFor profitSYNMay 22, 2012
MylanFor profitSYNOct 27, 2014
MylanFor profitNDA2Oct 21, 2008
NeogenFor profitMKTGOct 6, 2017
NovartisFor profitMKTGApr 3, 2014
PHARMOBEDIENTFor profitMKTGMay 22, 2012
Pharmacare PLC, PalestineFor profitMKTGFeb 27, 2009
Pharmacare PLC, PalestineFor profitNDA2Jan 24, 2005
Prinston IncFor profitMKTGMay 22, 2012
RanbaxyFor profitMKTGJun 20, 2005
SandozFor profitSYNApr 3, 2014
SandozFor profitMKTGApr 3, 2014
Strides Pharma ScienceFor profitMKTGMar 2, 2007
Strides Pharma ScienceFor profitSYNMar 20, 2008
Strides Pharma ScienceFor profitSYNDec 22, 2009
Strides Pharma ScienceFor profitSYNMay 22, 2012
Strides Pharma ScienceFor profitSYNMay 22, 2012
Strides Pharma ScienceFor profitNDA2Mar 2, 2007