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lamotrigine

Trade name: lamictal

Small moleculeapproved

Approved

Dec 27, 1994

Lamotrigine (marketed as Lamictal) is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. The precise mechanism(s) by which lamotrigine exerts its anticonvulsant action are unknown. In animal models designed to detect anticonvulsant activity, lamotrigine was effective in preventing seizure spread in the maximum electroshock (MES) and pentylenetetrazol (scMet) tests, and prevented seizures in the visually and electrically evoked after-discharge (EEAD) tests for antiepileptic activity. Lamotrigine also displayed inhibitory properties in the kindling model in rats both during kindling development and in the fully kindled state. The relevance of these models to human epilepsy, however, is not known. One proposed mechanism of action of lamotrigine, the relevance of which remains to be established in humans, involves an effect on sodium channels. In vitro pharmacological studies suggest that lamotrigine inhibits voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and consequently modulating presynaptic transmitter release of excitatory amino acids (e.g., glutamate and aspartate). Effect of Lamotrigine on N-Methyl d-Aspartate-Receptor Mediated Activity Lamotrigine did not inhibit N-methyl d-aspartate (NMDA)-induced depolarizations in rat cortical slices or NMDA-induced cyclic GMP formation in immature rat cerebellum, nor did lamotrigine displace compounds that are either competitive or noncompetitive ligands at this glutamate receptor complex (CNQX, CGS, TCHP). The IC50 for lamotrigine effects on NMDA-induced currents (in the presence of 3 uM of glycine) in cultured hippocampal neurons exceeded 100 uM. The mechanisms by which lamotrigine exerts its therapeutic action in bipolar disorder have not been established. The mechanisms that underpin the passage of lamotrigine at the blood-brain barrier to its site of action in the brain is poorly understood. — NCATS

Clinical trial activity

180 trials · 173 clinical orgs · 52 marketing orgs

Phase 1
47
Phase 2
65
Phase 3
47
Phase 4
48

Earliest trial started Jan 1, 1993 (NCT00000192)

Timeline

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  2. Dec 27, 1994

    Earliest FDA Approval

  3. Dec 27, 1994

    GlaxoSmithKline — NDA Secondary Org

  4. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Teva — Earliest Phase 1 Sponsor(trial)

  2. Jun 21, 2006

    Roxane Laboratories — Marketing Organization

  3. Jun 21, 2006

    Teva — Marketing Organization

  4. Jun 21, 2006

    Boehringer Ingelheim — Marketing Organization

  5. Nov 9, 2007

    Caraco Pharmaceutical Laboratories — Marketing Organization

  6. Nov 9, 2007

    Sun Pharmaceuticals — Marketing Organization

  7. Jan 22, 2009

    Dr. Reddy's Laboratories — Marketing Organization

  8. Jan 22, 2009

    Mylan — Marketing Organization

  9. Jan 22, 2009

    Sandoz — Marketing Organization

  10. Jan 22, 2009

    Watson Pharmaceuticals — Marketing Organization

  11. Jan 22, 2009

    Novartis — Marketing Organization

  12. Jan 22, 2009

    PHARMOBEDIENT — Marketing Organization

  13. Jan 27, 2009

    Rising Pharmaceuticals — Marketing Organization

  14. Jan 27, 2009

    Apotex — Marketing Organization

  15. Jan 27, 2009

    Aurobindo Pharma — Marketing Organization

  16. Jan 27, 2009

    Jubilant Innovation Ltd. — Marketing Organization

  17. Jan 27, 2009

    Wockhardt — Marketing Organization

  18. Jan 27, 2009

    Zydus Discovery DMCC — Marketing Organization

  19. Jan 27, 2009

    Celltrion — Marketing Organization

  20. Jan 27, 2009

    Granules India — Marketing Organization

  21. Jan 27, 2009

    AiPing Pharm Inc — Marketing Organization

  22. Jan 27, 2009

    Natco Pharma — Marketing Organization

  23. Feb 4, 2009

    Zennova — Marketing Organization

  24. Feb 4, 2009

    Pharmasciences — Marketing Organization

  25. Feb 4, 2009

    Taro Pharmaceuticals — Marketing Organization

2010s

  1. Jan 29, 2010

    SmithKline Beecham — NDA Secondary Org

  2. Jun 1, 2010

    Lupin — Marketing Organization

  3. Nov 1, 2010

    Cipla — Marketing Organization

  4. Nov 1, 2010

    Chartwell Pharmaceuticals — Marketing Organization

  5. Jan 13, 2011

    Alembic — Marketing Organization

  6. Apr 19, 2011

    Hikma — Marketing Organization

  7. Oct 6, 2011

    Unichem — Marketing Organization

  8. May 4, 2012

    Glenmark Pharmaceuticals — Marketing Organization

  9. Dec 26, 2012

    Anchen Pharmaceuticals, Inc — Marketing Organization

  10. Dec 26, 2012

    PH HEALTH — Marketing Organization

  11. Jan 4, 2013

    Atlantide Pharmaceuticals — Marketing Organization

  12. Jan 18, 2013

    Par Pharmaceuticals — Marketing Organization

  13. Jun 14, 2013

    Alkem Labs Ltd — Marketing Organization

  14. Jun 17, 2013

    Handa Pharmaceuticals — Marketing Organization

  15. Jun 17, 2013

    Rubicon Research — Marketing Organization

  16. Jul 15, 2013

    Impax Laboratories — Marketing Organization

  17. Oct 17, 2013

    Actavis — Marketing Organization

  18. Dec 23, 2013

    Torrent Pharmaceuticals Limited — Marketing Organization

  19. Oct 27, 2015

    Bristol-Myers Squibb — Marketing Organization

  20. Jun 17, 2016

    Sciegen Pharmaceticals — Marketing Organization

  21. Nov 30, 2018

    Amneal Pharmaceuticals — Marketing Organization

2020s

  1. Jan 19, 2021

    Ajanta Pharma Ltd — Marketing Organization

  2. Dec 8, 2021

    Yiling Pharmaceutical Inc. — Marketing Organization

  3. Feb 3, 2022

    Amring Pharmaceticals — Marketing Organization

  4. Sep 26, 2024

    IPCA Laboratories Ltd. — Marketing Organization

  5. Sep 16, 2025

    OWP PHARMS — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 27, 1994

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NN=C(C(N)=N1)C2=CC=CC(Cl)=C2Cl
Mol. weight
256.091 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

  • 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine
  • 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine
  • 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine
  • 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine
  • amide
  • amide
  • bw 430c
  • bw-430c
  • bw-430c
  • bw-430c
  • crisomet
  • labileno
  • lamictal
  • lamictal
  • lamictal
  • lamictal
  • lamictal
  • lamictal
  • lamictal
  • lamictal
  • lamictal cd
  • lamictal cd
  • lamictal odt
  • lamictal odt
  • lamictal xr
  • lamictal xr
  • lamiktal
  • lamitrin
  • lamotrigin
  • lamotrigina
  • lamotrigina
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotrigine
  • lamotriginum
  • lamotriginum
  • lp-08

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07140913Phase 3Oct 8, 2025Bristol-Myers Squibb
NCT07102459Phase 2Jul 24, 2025Latigo Biotherapeutics
NCT06929273Phase 3Jul 18, 2025Bristol-Myers Squibb
NCT06774625Phase 2Dec 19, 2024Latigo Biotherapeutics
NCT06184581Phase 4Mar 1, 2024Mental Health Services in the Capital Region, Denmark
NCT05973786Phase 4Nov 1, 2023University of Munster, Utrecht University
NCT06049095Phase 1Oct 17, 2023Latigo Biotherapeutics
NCT05603104Phase 4Aug 1, 2023University of Munster, Utrecht University
NCT05881928Phase 4Jul 25, 2023Assiut University
NCT06199791Phase 1Apr 3, 2023BioPharma Services, Desitin Arzneimittel GmbH
NCT05639257N/ADec 5, 2022Government of Denmark, Lupin, University of Copenhagen, ZiteLab
NCT05748236Phase 4Nov 1, 2022Dhaka Medical College
NCT04770493Phase 2Dec 31, 2021Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT05017155Phase 3Aug 12, 2021University of London
NCT04939675N/AJul 1, 2021National Taiwan University
NCT05050188Phase 1Jun 24, 2021Jiangsu Carephar Pharmaceutical Co., Ltd.
NCT05420350Phase 2Dec 16, 2020Cures Within Reach, Dent Neurologic Institute, Dent Neuroscience Research Center
NCT04650204Phase 4Dec 15, 2020Mayo Clinic, National Cancer Institute (NCI)
NCT04602221Phase 1Dec 1, 2020Boehringer Ingelheim
NCT04938856Phase 1Sep 4, 2020G D Searle, University of Karachi
Showing 20 of 180 trials
Page 1 / 9

Organizations

Research & Development (173)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit523852000
National Institute of Mental Health (NIMH)Government9241995
Dr. Reddy's LaboratoriesFor profit8812002
The University of Texas, DallasAcademic/Hospital5312002
University of CincinnatiAcademic/Hospital5431997
AAIPharmaFor profit4012002
Bioserve Clinical ResearchFor profit4012010
Case Western Reserve UniversityAcademic/Hospital4322002
Department of Veteran AffairsGovernment4231993
Harvard UniversityAcademic/Hospital4331998
Mayo ClinicAcademic/Hospital4322004
SFBC AnapharmFor profit4012002
TevaFor profit4412002
Agios Pharmaceuticals, Inc.For profit3322019
Bristol-Myers SquibbFor profit3222005
Food and Drug AdministrationGovernment3212012
Hoosier Cancer Research NetworkAcademic/Hospital3032005
Latigo BiotherapeuticsFor profit3322023
Mclean HospitalAcademic/Hospital3222004
Seoul National UniversityAcademic/Hospital3122007
173 organizations
Page 1 / 9

Marketing (66)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGOct 17, 2013
ActavisFor profitSYNApr 8, 2011
AiPing Pharm IncFor profitMKTGJan 27, 2009
Ajanta Pharma LtdFor profitMKTGJan 19, 2021
AlembicFor profitMKTGJan 13, 2011
AlembicFor profitSYNJun 12, 2014
Alkem Labs LtdFor profitMKTGJun 14, 2013
Amneal PharmaceuticalsFor profitMKTGNov 30, 2018
Amring PharmaceticalsFor profitMKTGFeb 3, 2022
Anchen Pharmaceuticals, IncFor profitMKTGDec 26, 2012
ApotexFor profitMKTGJan 27, 2009
Atlantide PharmaceuticalsFor profitMKTGJan 4, 2013
Aurobindo PharmaFor profitMKTGJan 27, 2009
Boehringer IngelheimFor profitMKTGJun 21, 2006
Bristol-Myers SquibbFor profitMKTGOct 27, 2015
Burroughs WellcomeFor profitNDA—
Caraco Pharmaceutical LaboratoriesFor profitMKTGNov 9, 2007
CelltrionFor profitMKTGJan 27, 2009
Chartwell PharmaceuticalsFor profitMKTGNov 1, 2010
Chartwell PharmaceuticalsFor profitSYNJan 22, 2009
CiplaFor profitMKTGNov 1, 2010
Dr. Reddy's LaboratoriesFor profitMKTGJan 22, 2009
GlaxoSmithKlineFor profitNDA2Dec 27, 1994
Glenmark PharmaceuticalsFor profitMKTGMay 4, 2012
Glenmark PharmaceuticalsFor profitSYNFeb 19, 2009
Granules IndiaFor profitMKTGJan 27, 2009
Handa PharmaceuticalsFor profitMKTGJun 17, 2013
HikmaFor profitMKTGApr 19, 2011
IPCA Laboratories Ltd.For profitMKTGSep 26, 2024
Impax LaboratoriesFor profitMKTGJul 15, 2013
Jubilant Innovation Ltd.For profitMKTGJan 27, 2009
Jubilant Innovation Ltd.For profitSYNFeb 28, 2011
LupinFor profitMKTGJun 1, 2010
MylanFor profitMKTGJan 22, 2009
MylanFor profitSYNFeb 11, 2009
Natco PharmaFor profitMKTGJan 27, 2009
NovartisFor profitMKTGJan 22, 2009
OWP PHARMSFor profitMKTGSep 16, 2025
PH HEALTHFor profitMKTGDec 26, 2012
PHARMOBEDIENTFor profitMKTGJan 22, 2009
Par PharmaceuticalsFor profitMKTGJan 18, 2013
PharmasciencesFor profitMKTGFeb 4, 2009
Rising PharmaceuticalsFor profitMKTGJan 27, 2009
Rising PharmaceuticalsFor profitSYNJan 27, 2009
Roxane LaboratoriesFor profitMKTGJun 21, 2006
Rubicon ResearchFor profitMKTGJun 17, 2013
Rubicon ResearchFor profitSYNJan 27, 2009
SandozFor profitMKTGJan 22, 2009
Sciegen PharmaceticalsFor profitMKTGJun 17, 2016
SmithKline BeechamFor profitNDA2Jan 29, 2010
Sun PharmaceuticalsFor profitMKTGNov 9, 2007
Taro PharmaceuticalsFor profitMKTGFeb 4, 2009
Taro PharmaceuticalsFor profitSYNJan 27, 2009
TevaFor profitMKTGJun 21, 2006
Torrent Pharmaceuticals LimitedFor profitMKTGDec 23, 2013
Torrent Pharmaceuticals LimitedFor profitSYNJan 27, 2009
UnichemFor profitMKTGOct 6, 2011
Watson PharmaceuticalsFor profitMKTGJan 22, 2009
WockhardtFor profitMKTGJan 27, 2009
WockhardtFor profitSYNJan 4, 2013
WockhardtFor profitSYNJan 4, 2013
Yiling Pharmaceutical Inc.For profitMKTGDec 8, 2021
ZennovaFor profitMKTGFeb 4, 2009
Zydus Discovery DMCCFor profitMKTGJan 27, 2009
Zydus Discovery DMCCFor profitSYNJan 22, 2009
Zydus Discovery DMCCFor profitSYNApr 1, 2020