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lamivudine

Trade name: epivir

Small moleculeapproved

Approved

Nov 17, 1995

Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1) and hepatitis B (HBV). Intracellularly, lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is inhibition of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. The most common reported adverse reactions in adults are headache, nausea, malaise and fatigue. No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine. — NCATS

Clinical trial activity

571 trials · 410 clinical orgs · 41 marketing orgs

Phase 1
66
Phase 2
272
Phase 3
169
Phase 4
172

Earliest trial started Sep 1, 1995 (NCT00001457)

Timeline

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  2. Nov 17, 1995

    Earliest FDA Approval

  3. Nov 17, 1995

    ViiV Healthcare — NDA Secondary Org

  4. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  6. Dec 8, 1998

    GlaxoSmithKline — NDA Secondary Org

2000s

  1. Jan 24, 2005

    Pharmacare PLC, Palestine — NDA Secondary Org

  2. Mar 6, 2006

    Aurobindo Pharma — Marketing Organization

  3. Mar 6, 2006

    Aurobindo Pharma — NDA Secondary Org

  4. Mar 2, 2007

    Strides Pharma Science — Marketing Organization

  5. Mar 2, 2007

    Strides Pharma Science — NDA Secondary Org

  6. Aug 8, 2007

    Emcure — Marketing Organization

  7. Nov 2, 2007

    Matrix Laboratories Limited — Marketing Organization

  8. Nov 2, 2007

    Mylan — NDA Secondary Org

  9. Jan 29, 2008

    Invagen Pharms — Marketing Organization

  10. Oct 7, 2008

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  11. Mar 16, 2009

    Alkem Labs Ltd — Marketing Organization

  12. May 7, 2009

    Hetero Labs Ltd — NDA Secondary Org

2010s

  1. Aug 30, 2010

    Macleods Pharmaceuticals, Ltd — NDA Secondary Org

  2. Mar 22, 2011

    Teva — Marketing Organization

  3. May 25, 2011

    Chartwell Pharmaceuticals — Marketing Organization

  4. Dec 2, 2011

    Apotex — Marketing Organization

  5. May 15, 2012

    Lupin — Marketing Organization

  6. Nov 8, 2012

    Neogen — NDA Secondary Org

  7. May 17, 2013

    Ranbaxy — Marketing Organization

  8. May 17, 2013

    Ranbaxy — NDA Secondary Org

  9. Dec 30, 2013

    Cipla — Marketing Organization

  10. Aug 28, 2014

    Natco Pharma — Marketing Organization

  11. Sep 4, 2014

    Mylan — Marketing Organization

  12. Oct 31, 2014

    Lannett Company, Inc. — Marketing Organization

  13. Feb 6, 2015

    Merck — NDA Secondary Org

  14. May 13, 2015

    PHARMOBEDIENT — NDA Secondary Org

  15. Nov 21, 2016

    Arise Pharmaceuticals — Marketing Organization

  16. Nov 21, 2016

    Eci Pharmaceuticals Llc — Marketing Organization

  17. Nov 21, 2016

    Pharma Life Sciences LLC — Marketing Organization

  18. Nov 21, 2016

    Esteve Labs — Marketing Organization

  19. Nov 21, 2016

    Upsher-Smith Laboratories — Marketing Organization

  20. Nov 21, 2016

    Appco Pharma — Marketing Organization

  21. Nov 21, 2016

    Centaur Pharmaceuticals — Marketing Organization

  22. Nov 21, 2016

    Somerset Pharmaceuticals — Marketing Organization

  23. Mar 17, 2017

    Pharmacare PLC, Palestine — Marketing Organization

  24. Apr 10, 2018

    Shanghai Acebright Pharmaceuticals Co., Ltd. — Marketing Organization

  25. Apr 10, 2018

    ANDA Repository — Marketing Organization

  26. Apr 10, 2018

    Epic Pharma Llc — Marketing Organization

  27. Aug 13, 2018

    Micro Labs Ltd India — Marketing Organization

  28. Aug 13, 2018

    Micro Labs Ltd India — NDA Secondary Org

  29. Aug 29, 2018

    Neogen — Marketing Organization

  30. Aug 30, 2018

    Merck — Marketing Organization

  31. Nov 15, 2018

    Zydus Discovery DMCC — Marketing Organization

  32. Nov 16, 2018

    Celltrion — Marketing Organization

  33. Nov 16, 2018

    Chartwell Pharmaceuticals — NDA Secondary Org

  34. Feb 1, 2019

    Laurus Labs Ltd — Marketing Organization

  35. Feb 1, 2019

    Laurus Labs Ltd — NDA Secondary Org

  36. Mar 21, 2019

    Hetero Labs Ltd — Marketing Organization

2020s

  1. Oct 6, 2020

    Desano — NDA Secondary Org

  2. Jun 25, 2021

    Lupin — NDA Secondary Org

  3. Mar 30, 2022

    Cipla — NDA Secondary Org

  4. Jul 12, 2023

    Emcure — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • combivir

    with zidovudine

  • delstrigo

    with doravirine, tenofovir

    Also known as doravirine/lamivudine/tenofovir disoproxil fumarate 100 mg-300 mg-300 mg oral tablet [delstrigo]

  • dovato

    with dolutegravir

    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

  • dutrebis

    with raltegravir

  • epzicom

    with abacavir

  • lamivudine/tenofovir disoproxil fumarate fdc tabs

    with tenofovir

    Also known as cimduo, temixys

  • lamivudine; zidovudine

    with efavirenz, zidovudine

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

    with nevirapine, zidovudine

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

  • symfi lo

    with efavirenz, tenofovir

    Also known as efavirenz, lamivudine,and tenofovir disoproxil fumarate, symfi

  • triumeq

    with abacavir, dolutegravir

  • trizivir

    with abacavir, zidovudine

    Also known as abacavir sulfate; lamivudine; zidovudine

Approval history

  • approvedPriority reviewAcceleratedNov 17, 1995

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=O)N(C=C1)[C@@H]2CS[C@H](CO)O2
Mol. weight
229.256 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

Black box warningProdrug

Sources

Also known as

  • (-)-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
  • (-)-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
  • 2',3'-dideoxy-3'-thiacytidine
  • 2',3'-dideoxy-3'-thiacytidine
  • (-)-2'-deoxy-3'-thiacytidine
  • (-)-2'-deoxy-3'-thiacytidine
  • 3tc
  • 3tc
  • 3tc
  • 3'-thia-2',3'-dideoxycytidine
  • 3'-thia-2',3'-dideoxycytidine
  • abacavir (as sulfate) / lamivudine / zidovudine
  • abacavir / lamivudine
  • abacavir sulfate / dolutegravir sodium / lamivudine
  • beta-l-2',3'-dideoxy-3'-thiacytidine
  • beta-l-2',3'-dideoxy-3'-thiacytidine
  • beta-l-3'-thia-2',3'-dideoxycytidine
  • beta-l-3'-thia-2',3'-dideoxycytidine
  • combivir
  • combivir
  • epivir
  • epivir
  • epivir
  • epivir
  • epivir-hbv
  • epivir-hbv
  • gr-109714x
  • gr-109714x
  • lamiduvine
  • lamivudin
  • lamivudin
  • lamivudina
  • lamivudina
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine
  • lamivudine / raltegravir potassium
  • lamivudine / zidovudine
  • lamivudine / zidovudine / abacavir sulfate
  • lamivudinum
  • lamivudinum
  • triomune
  • triomune
  • virolam
  • zeffix
  • zeffix
  • zeffix

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07202546Phase 2Nov 28, 2025ViiV Healthcare
NCT07058974Phase 1Aug 25, 2025Icahn School of Medicine at Mount Sinai
NCT06967753Phase 4Jul 31, 2025Hospital Fernandez, University of Buenos Aires, ViiV Healthcare
NCT07075146Phase 3May 5, 2025Instituto Mexicano del Seguro Social
NCT06774872Phase 2Apr 30, 2025Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida, Government of France, Sorbonne University
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
NCT06519357Phase 2Oct 28, 2024FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA, IrsiCaixa
NCT06338826Phase 2Oct 1, 2024Assistance Publique - Hôpitaux de Paris, Government of France
NCT06494579Phase 1/Phase 2 (Phase 2)Sep 30, 2024Icahn School of Medicine at Mount Sinai
NCT06580873Phase 4Sep 30, 2024Government of Canada, ViiV Healthcare
NCT06503796Phase 4Aug 31, 2024People's Liberation Army of China
NCT06602622Phase 4Aug 14, 2024Instituto Mexicano del Seguro Social
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
NCT06811246Phase 1Feb 7, 2024Merck
NCT06056596Early Phase 1 (Phase 1)Jan 31, 2024University of Wisconsin
NCT05979311Phase 3Dec 29, 2023ViiV Healthcare
Showing 20 of 571 trials
Page 1 / 29

Organizations

Research & Development (410)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government1028551997
ViiV HealthcareFor profit613452002
GlaxoSmithKlineFor profit591742000
Gilead SciencesFor profit372741999
National Institutes of Health (NIH)Government34251999
Bristol-Myers SquibbFor profit302151996
Glaxo WellcomeFor profit282451999
MerckFor profit261351999
French National Agency for Research on AIDS and Viral HepatitisGovernment161632002
University of BarcelonaAcademic/Hospital161232000
AbbottFor profit15631997
University of the WitwatersrandAcademic/Hospital12752005
Boehringer IngelheimFor profit10741999
Fundacion SEIMC-GESIDAAcademic/Hospital101022008
Government of FranceGovernment10732011
Harvard UniversityAcademic/Hospital10542002
RocheFor profit10931999
University of LondonAcademic/Hospital9541999
University of WashingtonAcademic/Hospital9342002
Government of ChinaGovernment8232005
410 organizations
Page 1 / 21

Marketing (84)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGApr 10, 2018
Alkem Labs LtdFor profitMKTGMar 16, 2009
ApotexFor profitMKTGDec 2, 2011
ApotexFor profitSYNJan 2, 2014
Appco PharmaFor profitMKTGNov 21, 2016
Arise PharmaceuticalsFor profitMKTGNov 21, 2016
Arise PharmaceuticalsFor profitSYNNov 21, 2016
Aurobindo PharmaFor profitMKTGMar 6, 2006
Aurobindo PharmaFor profitSYNDec 31, 2014
Aurobindo PharmaFor profitSYNNov 21, 2016
Aurobindo PharmaFor profitNDA2Mar 6, 2006
Burroughs WellcomeFor profitIND—
CelltrionFor profitMKTGNov 16, 2018
Centaur PharmaceuticalsFor profitMKTGNov 21, 2016
Chartwell PharmaceuticalsFor profitMKTGMay 25, 2011
Chartwell PharmaceuticalsFor profitSYNOct 31, 2014
Chartwell PharmaceuticalsFor profitNDA2Nov 16, 2018
CiplaFor profitMKTGDec 30, 2013
CiplaFor profitSYNJun 22, 2006
CiplaFor profitSYNOct 16, 2012
CiplaFor profitNDA2Mar 30, 2022
DesanoFor profitNDA2Oct 6, 2020
Eci Pharmaceuticals LlcFor profitMKTGNov 21, 2016
EmcureFor profitMKTGAug 8, 2007
EmcureFor profitNDA2Jul 12, 2023
Epic Pharma LlcFor profitMKTGApr 10, 2018
Esteve LabsFor profitMKTGNov 21, 2016
Glaxo WellcomeFor profitNDA—
GlaxoSmithKlineFor profitNDA2Dec 8, 1998
Hetero Labs LtdFor profitMKTGMar 21, 2019
Hetero Labs LtdFor profitSYNMay 7, 2009
Hetero Labs LtdFor profitSYNMay 29, 2012
Hetero Labs LtdFor profitSYNJan 2, 2014
Hetero Labs LtdFor profitSYNNov 18, 2011
Hetero Labs LtdFor profitNDA2May 7, 2009
Invagen PharmsFor profitMKTGJan 29, 2008
Lannett Company, Inc.For profitMKTGOct 31, 2014
Laurus Labs LtdFor profitMKTGFeb 1, 2019
Laurus Labs LtdFor profitMKTGMay 14, 2020
Laurus Labs LtdFor profitNDA2Feb 1, 2019
LupinFor profitMKTGMay 15, 2012
LupinFor profitNDA2Jun 25, 2021
LupinFor profitSYNDec 5, 2013
Macleods Pharmaceuticals, LtdFor profitNDA2Aug 30, 2010
Macleods Pharmaceuticals, LtdFor profitMKTGOct 7, 2008
Macleods Pharmaceuticals, LtdFor profitSYNFeb 8, 2012
Matrix Laboratories LimitedFor profitMKTGNov 2, 2007
Matrix Laboratories LimitedFor profitSYNMar 30, 2009
MerckFor profitSYNFeb 6, 2015
MerckFor profitMKTGAug 30, 2018
MerckFor profitNDA2Feb 6, 2015
Micro Labs Ltd IndiaFor profitMKTGAug 13, 2018
Micro Labs Ltd IndiaFor profitSYNMay 30, 2012
Micro Labs Ltd IndiaFor profitNDA2Aug 13, 2018
MylanFor profitSYNJan 31, 2012
MylanFor profitMKTGSep 4, 2014
MylanFor profitSYNJul 15, 2009
MylanFor profitSYNAug 28, 2014
MylanFor profitSYNAug 28, 2014
MylanFor profitNDA2Nov 2, 2007
Natco PharmaFor profitMKTGAug 28, 2014
NeogenFor profitNDA2Nov 8, 2012
NeogenFor profitMKTGAug 29, 2018
PHARMOBEDIENTFor profitNDA2May 13, 2015
Pharma Life Sciences LLCFor profitMKTGNov 21, 2016
Pharmacare PLC, PalestineFor profitMKTGMar 17, 2017
Pharmacare PLC, PalestineFor profitSYNFeb 27, 2009
Pharmacare PLC, PalestineFor profitNDA2Jan 24, 2005
RanbaxyFor profitSYNMay 27, 2005
RanbaxyFor profitMKTGMay 17, 2013
RanbaxyFor profitNDA2May 17, 2013
Shanghai Acebright Pharmaceuticals Co., Ltd.For profitMKTGApr 10, 2018
Somerset PharmaceuticalsFor profitMKTGNov 21, 2016
Strides Pharma ScienceFor profitMKTGMar 2, 2007
Strides Pharma ScienceFor profitSYNMar 20, 2008
Strides Pharma ScienceFor profitSYNDec 22, 2009
Strides Pharma ScienceFor profitSYNMay 13, 2015
Strides Pharma ScienceFor profitNDA2Mar 2, 2007
TevaFor profitMKTGMar 22, 2011
TevaFor profitSYNSep 29, 2016
Upsher-Smith LaboratoriesFor profitMKTGNov 21, 2016
ViiV HealthcareFor profitNDA2Nov 17, 1995
Zydus Discovery DMCCFor profitMKTGNov 15, 2018
Zydus Discovery DMCCFor profitSYNNov 15, 2018