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dolutegravir

Trade name: tivicay

Small moleculeapprovedFast Track FDA

Approved

Aug 12, 2013

Dolutegravir is an integrase inhibitor that is meant to be used as part of combination therapy for the treatment of HIV. Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Dolutegravir coadministered with dofetilide can result in potentially life-threatening adverse events. — NCATS

Clinical trial activity

258 trials · 216 clinical orgs · 13 marketing orgs

Phase 1
81
Phase 2
114
Phase 3
74
Phase 4
59

Earliest trial started Jan 1, 2002 (NCT00537966)

Timeline

2000s

  1. Jan 1, 2007

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  2. Oct 24, 2007

    GlaxoSmithKline — IND Organization

  3. Oct 24, 2007

    GlaxoSmithKline — IND Organization

  4. Jan 1, 2008

    ViiV Healthcare — Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 12, 2013

    ViiV Healthcare — Earliest FDA Approval

  2. Aug 12, 2013

    ViiV Healthcare — NDA Organization

  3. Sep 19, 2016

    Aurobindo Pharma — Marketing Organization

  4. Aug 2, 2017

    Mylan — Marketing Organization

  5. Aug 2, 2017

    Mylan — NDA Secondary Org

  6. Mar 5, 2018

    Cipla — Marketing Organization

  7. Feb 1, 2019

    Laurus Labs Ltd — Marketing Organization

  8. Feb 1, 2019

    Laurus Labs Ltd — NDA Secondary Org

  9. Mar 25, 2019

    Neogen — NDA Secondary Org

  10. Sep 13, 2019

    Micro Labs Ltd India — Marketing Organization

2020s

  1. Oct 6, 2020

    Desano — NDA Secondary Org

  2. Mar 16, 2021

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  3. Mar 22, 2021

    Neogen — Marketing Organization

  4. Jun 25, 2021

    Lupin — NDA Secondary Org

  5. Mar 30, 2022

    Cipla — NDA Secondary Org

  6. Jan 13, 2023

    Lupin — Marketing Organization

  7. May 26, 2023

    Aurobindo Pharma — NDA Secondary Org

  8. Jul 12, 2023

    Emcure — NDA Secondary Org

  9. Sep 14, 2023

    Strides Pharma Science — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • dovato

    with lamivudine

    Also known as dolutegravir 50 mg / lamivudine 300 mg oral tablet [dovato], dolutegravir/lamivudine, dolutegravir/lamivudine 50 mg-300 mg oral tablet [dovato], dolutegravir/lamivudine as a single pill, dolutegravir / lamivudine oral tablet, dolutegravir plus lamivudine in a fdc

  • juluca

    with rilpivirine

  • triumeq

    with abacavir, lamivudine

Approval history

  • approvedPriority reviewFast trackAug 12, 2013

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1CCO[C@H]2Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N12
Mol. weight
419.38 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

  • 2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9- carboxamide, n-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a- hexahydro-7-hydroxy-4-methyl-6,8-dioxo-, (4r,12as)-
  • (4r,9as)-5-hydroxy-2-methyl-6,10-dioxo-3,4,6,9,9a,10-hexahydro-2h-1-oxa-4a,8a-diaza-anthracene-7-carboxylic acid- 2,4 difluorobenzylamide
  • abacavir sulfate / dolutegravir sodium / lamivudine
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir
  • dolutegravir sodium
  • dolutegravir sodium
  • dolutegravir sodium
  • dolutegravir sodium
  • dolutegravir sodium
  • dolutegravir sodium
  • dolutegravir sodium
  • dolutegravir sodium monohydrate
  • dolutegravir sodium monohydrate
  • gsk1349572
  • gsk1349572
  • gsk1349572
  • gsk 1349572
  • gsk-1349572
  • gsk1349572a
  • gsk1349572a
  • gsk1349572a
  • gsk 1349572a
  • s-349572
  • s-349572
  • s-349572
  • s-gsk1349572
  • tivicay
  • tivicay
  • tivicay
  • tivicay
  • tivicay
  • triumeq

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07124559Phase 1/Phase 2 (Phase 2)Dec 15, 2025National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
NCT07202546Phase 2Nov 28, 2025ViiV Healthcare
NCT06967753Phase 4Jul 31, 2025Hospital Fernandez, University of Buenos Aires, ViiV Healthcare
NCT06747507Phase 3Jun 30, 2025Government of Mozambique, Muhimbili University, SolidarMed, University of London, University of Nairobi
NCT06774872Phase 2Apr 30, 2025Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida, Government of France, Sorbonne University
NCT06787976Phase 4Apr 19, 2025Instituto Mexicano del Seguro Social
NCT06805656N/AApr 1, 2025Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Sao Paulo
NCT07031063Phase 4Apr 1, 2025Instituto Mexicano del Seguro Social
NCT06497465Phase 3Jan 31, 2025Johns Hopkins University, ViiV Healthcare
NCT06203132Phase 3Nov 30, 2024Assistance Publique - Hôpitaux de Paris, European and Developing Countries Clinical Trials Partnership (EDCTP), Government of France, Merck
NCT06560684Phase 2Oct 29, 2024National Institute of Allergy and Infectious Diseases (NIAID)
NCT06338826Phase 2Oct 1, 2024Assistance Publique - Hôpitaux de Paris, Government of France
NCT06580873Phase 4Sep 30, 2024Government of Canada, ViiV Healthcare
NCT06281834Phase 1Sep 30, 2024APIN Public Health Initiatives, Harvard University, University of Cape Town
NCT06444620Phase 3Jul 22, 2024University of Nairobi, ViiV Healthcare
NCT06485154Phase 4Jun 1, 2024Bill and Melinda Gates Foundation, University of the Witwatersrand, Wits Health Consortium (Pty) Ltd
NCT06250504Phase 3Feb 27, 2024Africa Health Research Institute
NCT05993767Phase 2Jan 31, 2024AMS-PHPT Research Collaboration, Baylor University, Clinton Health Access Initiative, Nigeria, PENTA Foundation, Radboud University, University of Zimbabwe
NCT06450275Phase 1Jan 3, 2024Humanis Saglık Anonim Sirketi
NCT05979311Phase 3Dec 29, 2023ViiV Healthcare
Showing 20 of 258 trials
Page 1 / 13

Organizations

Research & Development (216)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ViiV HealthcareFor profit1147252008
GlaxoSmithKlineFor profit671132007
ShionogiFor profit31032008
National Institute of Allergy and Infectious Diseases (NIAID)Government201442003
Gilead SciencesFor profit181342009
Radboud UniversityAcademic/Hospital11442015
Janssen Pharmaceutica NVFor profit10142015
National Institutes of Health (NIH)Government9142003
Johns Hopkins UniversityAcademic/Hospital8332016
Fundacion SEIMC-GESIDAAcademic/Hospital7722017
University of Cape TownAcademic/Hospital7342016
University of LiverpoolAcademic/Hospital7532015
University of LondonAcademic/Hospital7332015
Government of FranceGovernment6422016
St Stephens Aids TrustAcademic/Hospital6622014
PPDFor profit5012014
University of BarcelonaAcademic/Hospital5422015
University of North Carolina at Chapel HillAcademic/Hospital5432011
Infectious Disease Institute, Kampala, UgandaAcademic/Hospital4032015
MerckFor profit4022009
216 organizations
Page 1 / 11

Marketing (22)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGSep 19, 2016
Aurobindo PharmaFor profitNDA2May 26, 2023
CiplaFor profitMKTGMar 5, 2018
CiplaFor profitNDA2Mar 30, 2022
DesanoFor profitNDA2Oct 6, 2020
EmcureFor profitNDA2Jul 12, 2023
GlaxoSmithKlineFor profitINDOct 24, 2007
Laurus Labs LtdFor profitMKTGFeb 1, 2019
Laurus Labs LtdFor profitSYNApr 28, 2023
Laurus Labs LtdFor profitNDA2Feb 1, 2019
LupinFor profitNDA2Jun 25, 2021
LupinFor profitSYNJan 13, 2023
LupinFor profitMKTGJan 13, 2023
Macleods Pharmaceuticals, LtdFor profitMKTGMar 16, 2021
Micro Labs Ltd IndiaFor profitMKTGSep 13, 2019
MylanFor profitMKTGAug 2, 2017
MylanFor profitSYNJul 6, 2018
MylanFor profitNDA2Aug 2, 2017
NeogenFor profitNDA2Mar 25, 2019
NeogenFor profitMKTGMar 22, 2021
Strides Pharma ScienceFor profitNDA2Sep 14, 2023
ViiV HealthcareFor profitNDAAug 12, 2013