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elvitegravir

Trade name: vitekta

Small moleculeapprovedFast Track FDA

Approved

Aug 27, 2012

Elvitegravir is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor used in combination with cobicistat, emtricitabine and tenofovir alafenamid (GENVOYA®) for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults. Because integrase is necessary for viral replication, inhibition prevents the integration of HIV-1 DNA into the host genome and thereby blocks the formation of the HIV-1 provirus and resulting propagation of the viral infection. — NCATS

Clinical trial activity

54 trials · 46 clinical orgs · 2 marketing orgs

Phase 1
11
Phase 2
24
Phase 3
24
Phase 4
11

Earliest trial started Jan 1, 2002 (NCT00537966)

Timeline

2000s

  1. Apr 1, 2005

    Japan Tobacco Inc. — IND Organization

  2. Apr 1, 2005

    Japan Tobacco Inc. — IND Organization

  3. Jan 1, 2006

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2008

    Gilead Sciences — Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 27, 2012

    Earliest FDA Approval

  2. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  3. Sep 24, 2014

    Gilead Sciences — First NDA Organization

  4. Sep 24, 2014

    Gilead Sciences — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedFast trackAug 27, 2012

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC2=C(C=C1CC3=CC=CC(Cl)=C3F)C(=O)C(=CN2[C@H](CO)C(C)C)C(O)=O
Mol. weight
447.884 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-(3-chloro-2-fluorobenzyl)-1-[(2s)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
  • 6-(3-chloro-2-fluorobenzyl)-1-[(2s)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitegravir
  • elvitégravir
  • elvitégravir
  • elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
  • elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate
  • evg
  • evg
  • gs9137
  • gs9137
  • gs 9137
  • gs 9137
  • gs-9137
  • gs-9137
  • gs-9137
  • gs-9137
  • gs-9137
  • gs-9137
  • gs-9137
  • jtk303
  • jtk303
  • jtk 303
  • jtk 303
  • jtk-303
  • jtk-303
  • jtk-303
  • jtk-303
  • vitekta

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06337032Phase 4Aug 27, 2024Gilead Sciences
NCT06274398Phase 1Jan 16, 2024Centers for Disease Control and Prevention (CDC), CONRAD, Eastern Virginia Medical School, Emory University
NCT06087913Phase 1Nov 8, 2023Centre for the AIDS Programme of Research in South Africa, CONRAD, Eastern Virginia Medical School, Kenya Medical Research Institute, United States Agency for International Development, University of Pittsburgh
NCT04442737Phase 4Jul 1, 2020Janssen Pharmaceutica NV
NCT04047420Phase 1Oct 31, 2019CONRAD, National Institute of Allergy and Infectious Diseases (NIAID), University of Pittsburgh
NCT03717129Phase 4Apr 15, 2019Gilead Sciences, Johns Hopkins University
NCT03877536N/AMar 17, 2019Gilead Sciences, Henry M. Jackson Foundation for the Advancement of Military Medicine
NCT03762772Phase 1Dec 10, 2018CONRAD, Eastern Virginia Medical School, United States Agency for International Development
NCT03251144Phase 1/Phase 2 (Phase 2)Sep 8, 2018Gilead Sciences, University of California, Los Angeles
NCT03472963Phase 1Apr 27, 2018Centers for Disease Control and Prevention (CDC), Emory University
NCT03405194N/AMar 31, 2018Analysis Group, Inc., Cornell University, Gilead Sciences, Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Harvard University
NCT03067285Phase 4Jul 1, 2017Fundacion SEIMC-GESIDA
NCT02985996Phase 1Feb 6, 2017Centers for Disease Control and Prevention (CDC), Emory University
NCT02998320Phase 3Jan 1, 2017Gilead Sciences, Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
NCT02859558Phase 2Jan 1, 2017AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID)
NCT02383108Phase 2/Phase 3 (Phase 3)Jun 1, 2016PENTA Foundation
NCT02707601Phase 3Apr 1, 2016Gilead Sciences
NCT02660905Phase 3Apr 1, 2016CIHR Canadian HIV Trials Network, Gilead Sciences, McGill University, University of Ottawa
NCT02556268Phase 1Feb 1, 2016Bayer
NCT02652624Phase 3Feb 1, 2016Gilead Sciences
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (46)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit352452006
CONRADFor profit4112018
Centers for Disease Control and Prevention (CDC)Government3012017
Eastern Virginia Medical SchoolAcademic/Hospital3212018
Emory UniversityAcademic/Hospital3212017
National Institute of Allergy and Infectious Diseases (NIAID)Government3232003
Janssen Pharmaceutica NVFor profit2122015
United States Agency for International DevelopmentGovernment2012018
University of BarcelonaAcademic/Hospital2212015
University of PittsburghAcademic/Hospital2012019
AIDS Clinical Trials GroupAcademic/Hospital1112017
Analysis Group, Inc.For profit1012018
Asociación Civil Impacta Salud y Educación, PeruAcademic/Hospital1012013
BayerFor profit1112016
Boston UniversityAcademic/Hospital1012003
Centre for the AIDS Programme of Research in South AfricaGovernment1012023
CIHR Canadian HIV Trials NetworkAcademic/Hospital1012016
Cornell UniversityAcademic/Hospital1012018
Fenway Community HealthAcademic/Hospital1112013
Fundacion SEIMC-GESIDAAcademic/Hospital1112017
46 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitSYNAug 27, 2012
Gilead SciencesFor profitNDASep 24, 2014
Japan Tobacco Inc.For profitINDApr 1, 2005