CDEK
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efavirenz

Trade name: sustiva

Small moleculeapprovedFast Track FDA

Approved

Sep 17, 1998

Efavirenz (brand names Sustiva® and Stocrin®) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. For HIV infection that has not previously been treated, efavirenz and lamivudine in combination with zidovudine or tenofovir is the preferred NNRTI-based regimen. Efavirenz is also used in combination with other antiretroviral agents as part of an expanded postexposure prophylaxis regimen to prevent HIV transmission for those exposed to materials associated with a high risk for HIV transmission. — NCATS

Clinical trial activity

357 trials · 272 clinical orgs · 19 marketing orgs

Phase 1
70
Phase 2
155
Phase 3
94
Phase 4
83

Earliest trial started Oct 1, 1997 (NCT00000893)

Timeline

1990s

  1. Dec 1, 1996

    DuPont — IND Organization

  2. Dec 1, 1996

    DuPont — IND Organization

  3. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  5. Sep 17, 1998

    DuPont — Earliest FDA Approval

  6. Sep 17, 1998

    Bristol-Myers Squibb — NDA Secondary Org

  7. Sep 17, 1998

    Bristol-Myers Squibb — Marketing Organization

  8. Sep 17, 1998

    DuPont — NDA Organization

  9. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Mar 6, 2006

    Aurobindo Pharma — Marketing Organization

  2. Mar 6, 2006

    Aurobindo Pharma — NDA Secondary Org

  3. Jul 12, 2006

    Gilead Sciences — Marketing Organization

  4. Jul 12, 2006

    Gilead Sciences — NDA Secondary Org

  5. Dec 20, 2007

    Emcure — Marketing Organization

  6. Aug 12, 2009

    Matrix Laboratories Limited — NDA Secondary Org

  7. Nov 24, 2009

    Mylan — NDA Secondary Org

2010s

  1. Feb 12, 2010

    Strides Pharma Science — NDA Secondary Org

  2. Aug 29, 2011

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  3. Jan 19, 2012

    Micro Labs Ltd India — Marketing Organization

  4. Jun 25, 2012

    Par Pharmaceuticals — Marketing Organization

  5. Dec 30, 2013

    Cipla — Marketing Organization

  6. Dec 30, 2013

    Cipla — NDA Secondary Org

  7. Aug 14, 2014

    Neogen — NDA Secondary Org

  8. Sep 4, 2014

    Mylan — Marketing Organization

  9. Nov 23, 2015

    Teva — Marketing Organization

  10. May 19, 2017

    Pharmacare PLC, Palestine — Marketing Organization

  11. Jun 30, 2017

    Hetero Labs Ltd — Marketing Organization

  12. Jun 30, 2017

    Hetero Labs Ltd — NDA Secondary Org

  13. Feb 23, 2018

    Micro Labs Ltd India — NDA Secondary Org

  14. Mar 12, 2018

    Strides Pharma Science — Marketing Organization

  15. Mar 12, 2018

    PHARMOBEDIENT — Marketing Organization

2020s

  1. May 14, 2020

    Laurus Labs Ltd — Marketing Organization

  2. Sep 13, 2021

    Neogen — Marketing Organization

  3. Oct 3, 2023

    Chartwell Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewAcceleratedFast trackSep 17, 1998

Chemistry & pharmacology

Loading structure…

SMILES

FC(F)(F)[C@]1(OC(=O)NC2=CC=C(Cl)C=C12)C#CC3CC3
Mol. weight
315.675 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

Sources

Also known as

  • 6-chloro-4-(2-cyclopropyl-1-ethynyl)-4-trifluoromethyl-(4s)-1,4-dihydro-2h-benzo[d][1,3]oxazin-2-one
  • 6-chloro-4-(2-cyclopropyl-1-ethynyl)-4-trifluoromethyl-(4s)-1,4-dihydro-2h-benzo[d][1,3]oxazin-2-one
  • (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2h-3,1-benzoxazin-2-one
  • (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2h-3,1-benzoxazin-2-one
  • bristol-myers squibb brand of efavirenz
  • dmp 266
  • dmp-266
  • du pont brand of efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • efavirenz
  • (-)-efavirenz
  • éfavirenz
  • éfavirenz
  • efavirenza
  • efavirenz / emtricitabine / tenofovir disoproxil fumarate
  • efavirenz / emtricitabine / tenofovir disoproxil maleate
  • efavirenz / emtricitabine / tenofovir disoproxil, phosphate
  • efavirenz / emtricitabine / tenofovir disoproxil succinate
  • efavirenz, (r)-isomer
  • efavirenz, (s)-isomer
  • efavirenzum
  • efavirenzum
  • efavirenzy
  • l 743726
  • l 743,726
  • l-743726
  • l-743,726
  • merck sharp & dohme brand of efavirenz
  • mk0831
  • nano-efavirenz
  • nano-lopinavir
  • (s)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2h-3,1-benzoxazin-2-one
  • (s)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2h-3,1-benzoxazin-2-one
  • (s)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2h-3,1-benzoxazin-2-one
  • (s)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one
  • (s)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one
  • stocrin
  • stocrin
  • sustiva
  • sustiva
  • sustiva
  • sustiva
  • sustiva
  • sustiva
  • sustiva 600
  • united drug brand of efavirenz

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06914869Phase 1Feb 18, 2025X4 Pharmaceuticals
NCT06797674Phase 1Feb 10, 2025Merck
NCT06823596N/AJan 14, 2025Maple Leaf Research, Ontario HIV Treatment Network, Unity Health Toronto, University of Toronto
NCT06464939Phase 2Oct 8, 2024HysensBio Co., Ltd, The Forsyth Institute
NCT06580678Phase 2Sep 13, 2024HysensBio Co., Ltd, Seoul National University
NCT06264453Phase 2Mar 19, 2024HysensBio Co., Ltd
NCT06294561Phase 1Mar 4, 2024Government of China, Nanjing Medical University, Nanjing University
NCT05789173Early Phase 1 (Phase 1)Oct 6, 2023Indiana University, National Institute of General Medical Sciences (NIGMS)
NCT05995249Phase 1Aug 11, 2023Takeda
NCT06698016Phase 1Jul 25, 2023Merck
NCT05909644Phase 1Jul 5, 2023Altasciences Company Inc., Biogen, Celerion, Q2 solutions
NCT07193875Phase 4Feb 9, 2023Washington University in St. Louis
NCT05560360Phase 1Nov 4, 2022Hengrui Therapeutics, Inc.
NCT05330273Phase 1Apr 28, 2022Medicines for Malaria Venture, Novartis
NCT05141422Phase 1Dec 15, 2021Hengrui Therapeutics, Inc.
NCT05067439Phase 1Oct 21, 2021Pfizer
NCT04973020Phase 1Sep 1, 2021Hengrui Therapeutics, Inc.
NCT04804514Phase 1/Phase 2 (Phase 2)Feb 26, 2021HysensBio Co., Ltd
NCT04680091Phase 1Nov 12, 2020Hengrui Therapeutics, Inc.
NCT04513379Phase 3Nov 1, 2020Fudan University
Showing 20 of 357 trials
Page 1 / 18

Organizations

Research & Development (272)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government634751997
Gilead SciencesFor profit402351999
Bristol-Myers SquibbFor profit271651999
MerckFor profit251251999
French National Agency for Research on AIDS and Viral HepatitisGovernment212141999
GlaxoSmithKlineFor profit15542001
National Institutes of Health (NIH)Government15151997
University of BarcelonaAcademic/Hospital12832004
AIDS Clinical Trials GroupAcademic/Hospital101032005
ViiV HealthcareFor profit10732004
AbbottFor profit9432000
Harvard UniversityAcademic/Hospital8342002
Glaxo WellcomeFor profit7521999
Johns Hopkins UniversityAcademic/Hospital7242005
TibotecFor profit7732005
University of New South WalesAcademic/Hospital7722003
Indiana UniversityAcademic/Hospital6632007
Makerere UniversityAcademic/Hospital6132008
RocheFor profit6541999
St Stephens Aids TrustAcademic/Hospital6632008
272 organizations
Page 1 / 14

Marketing (42)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitSYNDec 15, 2017
Aurobindo PharmaFor profitMKTGMar 6, 2006
Aurobindo PharmaFor profitNDA2Mar 6, 2006
Bristol-Myers SquibbFor profitNDA2Sep 17, 1998
Bristol-Myers SquibbFor profitMKTGSep 17, 1998
Chartwell PharmaceuticalsFor profitMKTGOct 3, 2023
CiplaFor profitMKTGDec 30, 2013
CiplaFor profitSYNMay 24, 2006
CiplaFor profitNDA2Dec 30, 2013
DuPontFor profitINDDec 1, 1996
DuPontFor profitNDASep 17, 1998
EmcureFor profitMKTGDec 20, 2007
Gilead SciencesFor profitMKTGJul 12, 2006
Gilead SciencesFor profitNDA2Jul 12, 2006
Hetero Labs LtdFor profitMKTGJun 30, 2017
Hetero Labs LtdFor profitSYNApr 27, 2018
Hetero Labs LtdFor profitSYNOct 31, 2013
Hetero Labs LtdFor profitNDA2Jun 30, 2017
Laurus Labs LtdFor profitMKTGMay 14, 2020
Laurus Labs LtdFor profitMKTGMay 14, 2020
Macleods Pharmaceuticals, LtdFor profitMKTGAug 29, 2011
Matrix Laboratories LimitedFor profitNDA2Aug 12, 2009
Matrix Laboratories LimitedFor profitSYNApr 25, 2008
Micro Labs Ltd IndiaFor profitNDA2Feb 23, 2018
Micro Labs Ltd IndiaFor profitSYNJan 19, 2012
Micro Labs Ltd IndiaFor profitMKTGJan 19, 2012
MylanFor profitSYNFeb 17, 2016
MylanFor profitMKTGSep 4, 2014
MylanFor profitSYNFeb 17, 2016
MylanFor profitNDA2Nov 24, 2009
NeogenFor profitNDA2Aug 14, 2014
NeogenFor profitMKTGSep 13, 2021
PHARMOBEDIENTFor profitMKTGMar 12, 2018
Par PharmaceuticalsFor profitMKTGJun 25, 2012
Pharmacare PLC, PalestineFor profitMKTGMay 19, 2017
Strides Pharma ScienceFor profitNDA2Feb 12, 2010
Strides Pharma ScienceFor profitSYNJun 1, 2007
Strides Pharma ScienceFor profitSYNMar 26, 2007
Strides Pharma ScienceFor profitSYNMar 12, 2018
Strides Pharma ScienceFor profitMKTGMar 12, 2018
TevaFor profitSYNNov 23, 2015
TevaFor profitMKTGNov 23, 2015