Lamotrigine

also known as Lamictal · LTG · 430C78 · BW430C · Lamictal (Registered Trademark) · Lamictal cd · Lamictal odt · Lamictal-XR · +6 more

Small molecule targets HCN1 via activation

Developed for: epilepsy · bipolar disorder · bipolar depression · schizophrenia · focal epilepsy · depressive disorder · major depressive disorder · manic bipolar affective disorder
+37 more
· alcohol dependence · bipolar I disorder · epilepsy with generalized tonic-clonic seizures · mood disorder · psychotic disorder · substance-related disorder · alcohol-related disorders · asthma · binge eating disorder · brain disorder · brain injury · chemotherapy-induced toxicity · childhood absence epilepsy · cognitive disorder · diabetic neuropathy · epilepsy syndrome · neurofibromatosis type 1 · neurotic disorder · obesity disorder · post-traumatic stress disorder · relapsing-remitting multiple sclerosis · secondary progressive multiple sclerosis · substance dependence · synaptopathy · trigeminal neuralgia · bipolar II disorder · borderline personality disorder · brain neoplasm · cocaine dependence · facial neuralgia · hyperkalemic periodic paralysis · Meniere disease · myotonic dystrophy type 1 · neurotic excoriation · nondystrophic myotonia · paramyotonia congenita of Von Eulenburg · potassium-aggravated myotonia
Investigated by: GlaxoSmithKline · National Institute of Mental Health (NIMH) · University of Cincinnati · Yale University · American Epilepsy Society · Assiut University
+84 more
· Boehringer Ingelheim · Epilepsy Foundation · MaineHealth · Ministry of Health, Italy · Mylan Pharmaceuticals Inc · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · National Institute on Drug Abuse (NIDA) · Teva Pharmaceuticals USA · Torrent Pharmaceuticals Limited · University Hospitals Cleveland Medical Center · University of Aarhus · University of Minnesota · Agios Pharmaceuticals, Inc. · Alliance for Clinical Trials in Oncology · Azienda Ospedaliera San Gerardo di Monza · Baylor College of Medicine · Beth Israel Medical Center · Bial - Portela C S.A. · Brown University · Cantonal Hospital of St. Gallen · Central Mental Clinic for Outpatients of Baku City · Centre of Chinese Medicine, Georgia · Chang Gung Memorial Hospital · Charite University, Berlin, Germany · Chinese University of Hong Kong · Dr. Reddy's Laboratories Limited · Dutch Epilepsy Clinics Foundation · Eli Lilly and Company · Emory University · Erasmus Medical Center · Federal University of Rio Grande do Sul · Glaxo Wellcome · Hannover Medical School · Hospital Sant Joan de Deu · Hospital de Clinicas de Porto Alegre · IRCCS National Neurological Institute "C. Mondino" Foundation · International Brain Research Foundation · Karuna Therapeutics, Inc. · Korean Epilepsy Society · Lindner Center of HOPE · Louisiana State University Health Sciences Center in New Orleans · Mario Negri Institute for Pharmacological Research · Massachusetts General Hospital · Mclean Hospital · Medical University of South Carolina · Merck Sharp & Dohme LLC · National Alliance for Research on Schizophrenia and Depression · National Cancer Institute (NCI) · National Center for Research Resources (NCRR) · National Taiwan University Hospital · Parke-Davis · Patient-Centered Outcomes Research Institute · Per Damkier · Radboud University Medical Center · Rambam Health Care Campus · Rea Rehabilitation Centre, Georgia · Rhode Island Hospital · Robert Wood Johnson Foundation · Seoul National University Hospital · St. Petersburg State Pavlov Medical University · Stanford University · Stanley Medical Research Institute · Stony Brook University · Taipei City Hospital · Technical University of Munich · The Dana Foundation · The University of Texas Health Science Center at San Antonio · UCB Biopharma S.P.R.L. · US Department of Veterans Affairs · Universitaire Ziekenhuizen KU Leuven · University College London Hospitals · University Health Network, Toronto · University Hospital, Rouen · University Magna Graecia · all 90 on the full record

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	LAMICTAL ODT	—	2015-05-18	fda.gov ↗
Label expansion	US (FDA)	LAMICTAL XR	—	2011-04-25	fda.gov ↗
Label expansions (6)	US (FDA)	LAMICTAL CD	—	1998-12-14 – 2006-09-22	fda.gov ↗
Label expansion	US (FDA)	LAMICTAL	—	1998-08-24	fda.gov ↗
Approved	US (FDA)	LAMICTAL	—	1994-12-27	fda.gov ↗

Trials 107 · started per year

today

US approved 1994

1992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 119 trials · 2 met primary · 1 missed
Phase 1	NCT06729970	Dec 2024 → Jan 2026	—	Karuna Therapeutics, Inc.	Completed	No outcome recorded
Phase 1	NCT04602221	Dec 2020 → Aug 2022	—	Boehringer Ingelheim	Completed	Missed primary
Phase 1	NCT04015687	Jul → Oct 2019	—	Agios Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT03695094	Sep 2018 → May 2019	epilepsy	UCB Biopharma S.P.R.L.	Completed	No outcome recorded
Phase 1	NCT02513654	Sep → Nov 2015	bipolar disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02708849	Jun 2015 → Mar 2020	mental disorder	Yale University	Terminated	No outcome recorded
Phase 1	NCT01888757	Sep 2010	—	Dr. Reddy's Laboratories Limited	Completed	No outcome recorded
Phase 1	NCT00907985	May 2009 → Jun 2010	bipolar disorder	GlaxoSmithKline	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT01607086	Jul 2008	mental disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00618241	Feb → Oct 2008	HIV infectious disease	Radboud University Medical Center	Completed	No outcome recorded
Phase 1	NCT00410371	Dec 2006 → Jan 2007	mental disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02283801	Nov 2006 → Jan 2007	epilepsy	Bial - Portela C S.A.	Completed	No outcome recorded
Phase 1	NCT00144872	Nov 2004 → Apr 2006	childhood absence epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00647751	Aug 2004	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00650208	Jul → Aug 2004	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00838279	Feb → Mar 2002	—	Teva Pharmaceuticals USA	Completed	Met primary
Phase 1	NCT00838136	Feb → Mar 2002	—	Teva Pharmaceuticals USA	Completed	Met primary
Phase 1	NCT00939614	—	—	Torrent Pharmaceuticals Limited	Completed	No outcome recorded
Phase 1	NCT00939458	—	—	Torrent Pharmaceuticals Limited	Completed	No outcome recorded

Phase 1/22 trials
Phase 1/2	NCT02696512	Mar 2016 → Mar 2017	brain injury	International Brain Research Foundation	Unknown	No outcome recorded
Phase 1/2	NCT00789113	Nov 2008 → Jan 2011	bipolar depression, epilepsy	University of Minnesota	Completed	No outcome recorded
Phase 213 trials · 1 missed
Phase 2	NCT04770493	Jan 2022 → Oct 2023	alcohol-related disorders	Brown University	Completed	No outcome recorded
Phase 2	NCT03504501	Mar 2019 → Feb 2023	cognitive disorder, synaptopathy	Technical University of Munich	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03220256	Aug 2016 → Aug 2018	—	Seoul National University Hospital	Unknown	No outcome recorded
Phase 2	NCT00917839	Jun 2009 → Dec 2010	relapsing-remitting multiple sclerosis	Cantonal Hospital of St. Gallen	Unknown	No outcome recorded
Phase 2	NCT00269594	Jan → Sep 2006	neurotic disorder, obsessive-compulsive disorder	University of Minnesota	Completed	No outcome recorded
Phase 2	NCT00257855	Nov 2005 → Jan 2009	secondary progressive multiple sclerosis	University College London Hospitals	Completed	Missed primary
Phase 2	NCT00176228	Feb 2004 → Jan 2008	bipolar disorder	University of Illinois at Chicago	Completed	No outcome recorded
Phase 2	NCT00206778	Jul 2003 → Jul 2007	manic bipolar affective disorder	Beth Israel Medical Center	Completed	No outcome recorded
Phase 2	NCT00044278	Sep 2000 → Jun 2006	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00043875	May 2000 → Nov 2003	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00015106	Nov 1997 → Jan 1999	substance-related disorder	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00001482	May 1995 → May 2001	anxiety disorder, mood disorder, psychotic disorder	National Institute of Mental Health (NIMH)	Completed	No outcome recorded
Phase 2	NCT00000192	Jan 1993 → Jan 1998	substance-related disorder	Yale University	Withdrawn	No outcome recorded

Phase 2/33 trials · 1 missed
Phase 2/3	NCT02556060	Sep 2015 → May 2017	substance dependence	Taipei City Hospital	Completed	No outcome recorded
Phase 2/3	NCT02256124	Oct 2014 → Apr 2020	neurofibromatosis type 1	Erasmus Medical Center	Terminated	Missed primary
Phase 2/3	NCT00913107	Sep 2007 → Feb 2008	trigeminal neuralgia	University of Malaya	Completed	No outcome recorded
Phase 326 trials · 2 met primary · 4 missed
Phase 3	NCT02374567	Jan 2015 → Jun 2017	anxiety disorder, dementia, depressive disorder, schizophrenia +1	Hannover Medical School	Terminated	No outcome recorded
Phase 3	NCT01602510	Aug 2012 → Dec 2015	bipolar I disorder	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT00571246	Jun 2012 → Jun 2016	alcohol dependence, post-traumatic stress disorder	Yale University	Withdrawn	No outcome recorded
Phase 3	NCT01431976	Sep 2011 → Feb 2014	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01431963	Sep 2011 → Mar 2013	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00723450	Jul 2008 → Aug 2013	bipolar disorder	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT00566020	May 2008 → Oct 2010	bipolar I disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00621842	Jan 2008 → Mar 2010	bipolar depression	University Hospitals Cleveland Medical Center	Completed	No outcome recorded
Phase 3	NCT00579982	Jan → Feb 2008	mood disorder	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT00516139	Aug 2007 → Jul 2010	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00395694	Aug 2006 → Mar 2009	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00355082	May 2006 → Nov 2008	focal epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00277641	Mar 2006 → Jan 2009	binge eating disorder, obesity disorder	Lindner Center of HOPE	Completed	No outcome recorded
Phase 3	NCT00264615	Oct 2005 → Jun 2006	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00104416	Dec 2004 → Jul 2008	epilepsy with generalized tonic-clonic seizures	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT00113165	Oct 2004 → Jul 2007	focal epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00086593	May 2004 → Jul 2005	schizophrenia	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00068445	Feb 2004 → May 2006	chemotherapy-induced toxicity	Alliance for Clinical Trials in Oncology	Completed	Missed primary
Phase 3	NCT00071747	Aug 2003 → Jan 2005	schizophrenia	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00266149	Jun 2003 → May 2005	epilepsy	University of Aarhus	Terminated	No outcome recorded
Phase 3	NCT00074776	May 2003 → Oct 2007	bipolar disorder	Stanford University	Completed	Missed primary
Phase 3	NCT00056277	Feb 2003 → Aug 2005	bipolar disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00224510	Aug 2002 → Sep 2006	bipolar depression	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00063362	Feb 2002 → Jul 2007	bipolar disorder	University Hospitals Cleveland Medical Center	Terminated	No outcome recorded Stop: Business
Phase 3	NCT00226135	Mar 2001 → Dec 2006	bipolar disorder	University of Aarhus	Completed	No outcome recorded
Phase 3	NCT00007670	Jan 1998 → Mar 2003	epilepsy	US Department of Veterans Affairs	Completed	No outcome recorded

Phase 429 trials · 3 met primary · 1 missed
Phase 4	NCT07795593	Oct 2026 → May 2031 expected	diabetic kidney disease, diabetic neuropathy	University of Michigan	Not yet recruiting	No outcome recorded
Phase 4	NCT05881928	Jul 2024 overdue	epilepsy	Assiut University	Not yet recruiting	No outcome recorded
Phase 4	NCT03689114	May 2021 → Jun 2024	focal epilepsy	Mario Negri Institute for Pharmacological Research	Completed	No outcome recorded
Phase 4	NCT03161509	Jul 2017 → Dec 2018	—	Rambam Health Care Campus	Terminated	No outcome recorded
Phase 4	NCT02303106	Nov 2014 → Apr 2015	—	Per Damkier	Completed	No outcome recorded
Phase 4	NCT02100644	Apr 2014 → May 2015	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT01713777	Apr 2013 → Sep 2015	epilepsy	University of Cincinnati	Completed	Met primary
Phase 4	NCT01733394	Dec 2012 → Sep 2016	epilepsy	University of Cincinnati	Completed	Met primary
Phase 4	NCT02429596	May 2012 → May 2015	epilepsy	IRCCS National Neurological Institute "C. Mondino" Foundation	Unknown	No outcome recorded
Phase 4	NCT01015586	Feb 2010 → May 2014	alcohol dependence, depressive disorder, manic bipolar affective disorder, psychotic disorder	Medical University of South Carolina	Completed	No outcome recorded
Phase 4	NCT00807989	Mar 2008 → May 2012	epilepsy	Yonsei University	Completed	No outcome recorded
Phase 4	NCT01000402	Feb 2008 → Oct 2012	attention deficit-hyperactivity disorder, bipolar disorder	Federal University of Rio Grande do Sul	Unknown	No outcome recorded
Phase 4	NCT00855738	May 2007 → Jun 2009	focal epilepsy	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00419003	Dec 2006 → Jul 2008	major depressive disorder	Baylor College of Medicine	Completed	Missed primary
Phase 4	NCT00896987	May 2006 → Dec 2008	epilepsy	Korean Epilepsy Society	Completed	No outcome recorded
Phase 4	NCT00360126	Oct 2005 → Feb 2007	bipolar disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00223509	Aug 2005 → Nov 2007	bipolar disorder	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT00947375	Jan 2005 → Jan 2006	schizophrenia	Central Mental Clinic for Outpatients of Baku City	Terminated	No outcome recorded
Phase 4	NCT00181844	Jan 2005 → Feb 2008	manic bipolar affective disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT00137709	Nov 2004 → Jul 2008	epilepsy	Chinese University of Hong Kong	Unknown	No outcome recorded
Phase 4	NCT00485771	Nov 2003 → Jan 2005	bipolar disorder	Eli Lilly and Company	Completed	No outcome recorded
Phase 4	NCT02989727	Nov 2003 → Aug 2005	bipolar depression, melancholia	University of Saskatchewan	Completed	Mixed
Phase 4	NCT00067938	Aug 2003 → Aug 2004	bipolar disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00153244	Aug 2002 → May 2003	asthma	Centre of Chinese Medicine, Georgia	Completed	No outcome recorded
Phase 4	NCT00223262	Aug 2002 → Sep 2005	brain disorder	University of Texas Southwestern Medical Center	Completed	No outcome recorded
Phase 4	NCT00043914	Jan 2002 → Jan 2003	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00188643	Jan 2002 → Jan 2007	bipolar disorder	University Health Network, Toronto	Completed	No outcome recorded
Phase 4	NCT00177567	Jul 2001 → Jan 2004	bipolar disorder	University of Pittsburgh	Completed	No outcome recorded
Phase 4	NCT00043901	Dec 2000 → Nov 2003	epilepsy with generalized tonic-clonic seizures	GlaxoSmithKline	Completed	Met primary

Phase not applicable14 trials · 1 met primary · 1 missed
—	NCT04939675	Jul 2021 → Jun 2023	epilepsy	National Taiwan University Hospital	Unknown	No outcome recorded
—	NCT04156035	Mar → Dec 2020	—	Charite University, Berlin, Germany	Completed	No outcome recorded
—	NCT04396938	May 2017 → Nov 2018	—	University of Oxford	Completed	No outcome recorded
—	NCT05236166	Apr 2017 → May 2021	epilepsy	University Magna Graecia	Completed	No outcome recorded
—	NCT02556320	May 2013 → Aug 2015	drug allergy, epilepsy	University Hospital, Rouen	Completed	No outcome recorded
—	NCT01880957	Nov 2011 → Jun 2017	bipolar depression, major depressive disorder	Stony Brook University	Completed	No outcome recorded
—	NCT01463111	May 2011 → Apr 2016	bipolar disorder	Emory University	Completed	No outcome recorded
—	NCT00531518	Oct 2007 → May 2013	bipolar disorder, depressive disorder, schizophrenia	MaineHealth	Completed	Met primary
—	NCT00720473	Apr 2006 → Jul 2011	bipolar depression	Mclean Hospital	Completed	No outcome recorded
—	NCT00284791	Jan 2006 → Feb 2007	—	MaineHealth	Terminated	No outcome recorded
—	NCT00901407	Dec 2003 → Jul 2006	major depressive disorder	Louisiana State University Health Sciences Center in New Orleans	Completed	Missed primary
—	NCT00208520	Jul 2003 → Jun 2007	epilepsy syndrome	Dutch Epilepsy Clinics Foundation	Unknown	No outcome recorded
—	NCT00012558	Sep 1998 → Sep 2005	bipolar disorder	National Institute of Mental Health (NIMH)	Completed	Mixed
—	NCT00241995	—	—	St. Petersburg State Pavlov Medical University	Completed	No outcome recorded

Phase not stated1 trial
—	NCT03419949	—	—	Assiut University	Available	No outcome recorded
Comparator or background therapy49 trials
Phase 1	NCT05145608 Comparator	Jan → Feb 2018	—	Alembic Pharmaceuticals Ltd.	Completed	No outcome recorded
Phase 1	NCT02707965 Comparator	Jun 2017 → Aug 2018	epilepsy	Food and Drug Administration (FDA)	Completed	No outcome recorded
Phase 1	NCT02821338 Comparator	Jun → Sep 2016	—	Food and Drug Administration (FDA)	Completed	No outcome recorded
Phase 1	NCT02081287 Comparator	May 2014 → Jul 2018	manic bipolar affective disorder	San Diego Veterans Healthcare System	Completed	No outcome recorded
Phase 1	NCT00627575 Comparator	Feb → Sep 2008	epilepsy	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT05420350 Comparator	Dec 2020 → Jul 2024	Meniere disease	Dent Neuroscience Research Center	Unknown	No outcome recorded
Phase 2	NCT02158585 Comparator	Jun 2014 → Mar 2017	Meniere disease	Dent Neuroscience Research Center	Completed	No outcome recorded
Phase 2	NCT01674010 Background	Aug 2012 → Jun 2014	bipolar I disorder	OPKO Health, Inc.	Terminated	No outcome recorded Stop: Business
Phase 2	NCT00475137 Comparator	Dec 2007 → Jun 2015	bipolar II disorder	University of British Columbia	Completed	No outcome recorded
Phase 2	NCT00513019 Comparator	Aug 2007 → Aug 2009	neurotic excoriation	University of Chicago	Completed	No outcome recorded
Phase 3	NCT06929273 Background	Jul 2025 → Jun 2028 expected	bipolar I disorder	Bristol-Myers Squibb	Recruiting	No outcome recorded
Phase 3	NCT05017155 Comparator	Aug 2021 → Aug 2023	nondystrophic myotonia	University College, London	Unknown	No outcome recorded
Phase 3	NCT04274179 Comparator	Aug 2020 → May 2028 expected	childhood absence epilepsy	Johns Hopkins University	Recruiting	No outcome recorded
Phase 3	NCT03831854 Comparator	Jan 2019 → Dec 2020	—	The Cleveland Clinic	Completed	No outcome recorded
Phase 3	NCT01939561 Comparator	Nov 2013 → Nov 2015	hyperkalemic periodic paralysis, myotonic dystrophy type 1, paramyotonia congenita of Von Eulenburg, potassium-aggravated myotonia	Grete Andersen, MD	Completed	No outcome recorded
Phase 3	NCT01891890 Comparator	Aug 2013 → Oct 2015	focal epilepsy	Emory University	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01042496 Comparator	Dec 2009 → Sep 2014	bipolar depression	Mayo Clinic	Completed	No outcome recorded
Phase 3	NCT00550407 Comparator	Nov 2007 → Oct 2009	bipolar disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00280059 Comparator	Aug 2006 → Dec 2009	focal epilepsy	Viatris Inc.	Completed	Missed primary
Phase 3	NCT00292461 Comparator	Mar 2006 → Aug 2009	epilepsy	Eisai Inc.	Completed	No outcome recorded
Phase 3	NCT00242606 Comparator	Mar 2005 → Jun 2008	epilepsy	Philipps University Marburg	Completed	No outcome recorded
Phase 3	NCT00088452 Comparator	Jul 2004 → Jan 2013	childhood absence epilepsy	Children's Hospital Medical Center, Cincinnati	Completed	No outcome recorded
Phase 3	NCT00652171 Comparator	Jan 2004 → Jan 2006	depressive disorder	Institute of Social Security of the Civil Servants of Minas Gerais	Completed	No outcome recorded
Phase 3	NCT00274677 Comparator	Nov 2003 → Aug 2005	bipolar disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00221975 Comparator	Jul 2002 → Jun 2007	bipolar disorder	University Hospitals Cleveland Medical Center	Completed	No outcome recorded
Phase 4	NCT06184581 Comparator	May 2024 → Dec 2027 expected	bipolar II disorder	University Hospital Bispebjerg and Frederiksberg	Recruiting	No outcome recorded
Phase 4	NCT05697614 Comparator	Mar → May 2023	epilepsy	Dr Cipto Mangunkusumo General Hospital	Unknown	No outcome recorded
Phase 4	NCT05748236 Comparator	Nov 2022 → Oct 2023	focal epilepsy	Dhaka Medical College	Unknown	No outcome recorded
Phase 4	NCT02670161 Comparator	May 2016 → Dec 2026 expected	Parkinson disease, brain neoplasm, cognitive impairment with or without cerebellar ataxia, epilepsy +6	Endeavor Health	Enrolling by invitation	No outcome recorded
Phase 4	NCT02404168 Comparator	Jul 2015 → Jan 2016	epilepsy	University of Maryland, Baltimore	Completed	No outcome recorded
Phase 4	NCT02389712 Comparator	Mar 2015 → May 2018	bipolar disorder	Mayo Clinic	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02205931 Comparator	Jan 2015 → Jun 2018	epilepsy	University College, London	Unknown	No outcome recorded
Phase 4	NCT01588457 Comparator	Jun 2011 → Dec 2016	bipolar I disorder, bipolar II disorder	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT01142310 Comparator	Jun 2010 → Jun 2015	cognitive disorder	University of Texas Southwestern Medical Center	Completed	No outcome recorded
Phase 4	NCT00926835 Comparator	May 2009 → May 2015	major depressive disorder	Ministry of Health & Welfare, Korea	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01864551 Comparator	Aug 2008 → Jul 2009	bipolar disorder	Tri-Service General Hospital (TSGH)	Completed	No outcome recorded
Phase 4	NCT00552526 Comparator	Nov 2007 → Jan 2011	epilepsy	Oslo University Hospital	Unknown	No outcome recorded
Phase 4	NCT00438451 Comparator	Jan 2007 → Jul 2010	focal epilepsy	Johannes Gutenberg University Mainz	Completed	No outcome recorded
Phase 4	NCT00280293 Comparator	Mar 2006 → Jan 2010	bipolar disorder, cocaine dependence	University of Texas Southwestern Medical Center	Completed	No outcome recorded
Phase 4	NCT04523935 Comparator	Dec 2005 → Aug 2020	cerebral palsy	Sathbhavana Brain Clinic	Completed	No outcome recorded
Phase 4	NCT00277212 Background	Dec 2005 → Jul 2009	bipolar disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 4	NCT00183469 Comparator	Dec 2004 → Feb 2009	bipolar disorder, depressive disorder	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT00634062 Comparator	Dec 2004 → Sep 2007	borderline personality disorder	Mclean Hospital	Completed	No outcome recorded
—	NCT05639257 Comparator	Dec 2022 → Apr 2024	nondystrophic myotonia	Grete Andersen, MD	Unknown	No outcome recorded
—	NCT03636958 Background	Feb 2021 → Jul 2025	epilepsy	Assistance Publique Hopitaux De Marseille	Withdrawn	No outcome recorded
—	NCT02300051 Background	Feb 2011 → Apr 2015	sexual disorder	University of Sao Paulo General Hospital	Completed	No outcome recorded
—	NCT00916149 Comparator	Jan 2007 → Oct 2012	epilepsy	Massachusetts General Hospital	Completed	No outcome recorded
—	NCT00243152 Comparator	Oct 2005 → Jul 2008	facial neuralgia	Pain and Analgesia Imaging and Neuroscience Group	Completed	No outcome recorded
—	NCT00203229 Comparator	Jun 2003 → May 2006	trigeminal neuralgia	Thomas Jefferson University	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 8

Date	Issuer	Release
2026-02-01	Alembic Pharmaceuticals Ltd.	Regulatory 26th February, 2026 Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg.
2024-10-01	Alembic Pharmaceuticals Ltd.	Regulatory 3rd October, 2024, Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg.
2020-04-02	Zydus Lifesciences Limited	Regulatory Zydus receives final approval from the USFDA for Lamotrigine Extended-Release Tablets zyduslife.com ↗ Zydus Cadila has received final approval from the USFDA to market Lamotrigine Extended - Release Tablets USP in the strengths of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg.
2018-02-15	Upsher-Smith Laboratories	Regulatory Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗ Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approvals by the Ministry of Health, Labour and Welfare for eight molecules in 19 presentations of generic drugs.
2015-01-26	Impax Laboratories, LLC	Regulatory Impax Receives FDA Approval for a Generic Version of Lamictal® Orally Disintegrating Tablets (ODT) amneal.com ↗ Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that the U.S. Food and Drug Administration ( FDA ) has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25mg, 50mg, 100mg and 200mg in blister packaging.
2011-07-01	GlaxoSmithKline	Regulatory GlaxoSmithKline receives new approval for Rotarix and significant new indication for Lamictal® (lamotrigine) in Japan gsk.com ↗ GSK also today gained approval for a significant new indication in Japan for Lamictal® (lamotrigine) Tablets 25mg and 100mg for the prevention of depressive episodes in adult patients with bipolar disorder.
2006-05-22	Eli Lilly and Company	Results First Head-to-Head Study Suggests Significantly Greater Symptom Improvement for Symbyax® Compared to Lamotrigine in Bipolar Depression lilly.com ↗ The results were presented today at a major medical meeting.
2005-05-24	Eli Lilly and Company	Results First Head-to-Head Study Shows Patients with Bipolar Depression Had Greater Symptom Improvement on Olanzapine and Fluoxetine HCl Capsules than Lamotrigine lilly.com ↗ Additionally, results show that patients treated with OFC responded more quickly to therapy than patients treated with lamotrigine.

All press releases naming this drug 12 releases

Date	Issuer	Release
2026-02-01	Alembic Pharmaceuticals Ltd.	26th February, 2026 Vadodara, India alembicpharmaceuticals.com ↗
2024-10-01	Alembic Pharmaceuticals Ltd.	3rd October, 2024, Vadodara, India alembicpharmaceuticals.com ↗
2020-04-02	Zydus Lifesciences Limited	Zydus receives final approval from the USFDA for Lamotrigine Extended-Release Tablets zyduslife.com ↗
2018-02-15	Upsher-Smith Laboratories	Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗
2015-01-26	Impax Laboratories, LLC	Impax Receives FDA Approval for a Generic Version of Lamictal® Orally Disintegrating Tablets (ODT) amneal.com ↗
2014-09-09	Ligand Pharmaceuticals	Ligand Licenses Captisol-enabled™ Lamotrigine to CURx Pharmaceuticals, Inc. ligand.com ↗
2013-01-08	Wockhardt	WOCKHARDT LAUNCHES GENERIC VERSION OF ANTI – CONVULSANT DRUG LAMICTAL XR wockhardt.com ↗
2011-07-01	GlaxoSmithKline	GlaxoSmithKline receives new approval for Rotarix and significant new indication for Lamictal® (lamotrigine) in Japan gsk.com ↗
2008-07-23	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Introduces First Generic Lamictal® Tablets in the United States tevapharm.com ↗
2006-05-22	Eli Lilly and Company	First Head-to-Head Study Suggests Significantly Greater Symptom Improvement for Symbyax® Compared to Lamotrigine in Bipolar Depression lilly.com ↗
2005-05-24	Eli Lilly and Company	First Head-to-Head Study Shows Patients with Bipolar Depression Had Greater Symptom Improvement on Olanzapine and Fluoxetine HCl Capsules than Lamotrigine lilly.com ↗
2005-02-17	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Settlement Of Lamictal® Litigation With Glaxosmithkline tevapharm.com ↗

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 162 sources stand behind the page.

Field	Value	Cited text
Known as	lamotrigine	“Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗ 152 “Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗ “Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ “In this study, we evaluated the efficacy and occurrence of side effects of lamotrigine (LTG) in comparison with carbamazepine (CBZ), in trigeminal neuralgia (TN) patients.” PMID 21621166 ↗ May 2011 “The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome” NCT00241995 ↗ “Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)” NCT02556320 ↗ “This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures.” NCT00113165 ↗ “mood stabilizers (topiramate 25 - 200 mg/day, divalproex sodium (500 - 1500 mg/day, oxcarbazepine (300 - 1200 mg/day, and lamotrigine 50 - 200 mg/day).” NCT02300051 ↗ “Lamotrigine monotherapy for newly diagnosed typical absence seizures in children: A multi-center, uncontrolled, open-label study.” PMID 26518979 ↗ Oct 2015 “Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide” NCT05236166 ↗ “The purpose of this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate” NCT00947375 ↗ Show 142 more sources
Known as	430C78	“The objective of this sensory analysis study is to determine whether volunteers observe a significant difference in organoleptic properties between lamotrigine (430C78) cherry...” NCT01607086 ↗
Known as	BW430C	“BW430C (lamotrigine)” NCT00566020 ↗
Known as	Lamictal	“The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single,...” NCT00650208 ↗ 19 “This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of...” NCT00044278 ↗ “The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional...” NCT00243152 ↗ “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935 ↗ “A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed...” NCT00280059 ↗ “A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal) compared to placebo as add-on therapy to lithium” NCT00224510 ↗ “switched from your regular lamotrigine (Lamictal®) to once daily morning dosing of an extended-release formulation of Lamictal-XR® (at the same total daily dose).” NCT00789113 ↗ “This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures.” NCT00113165 ↗ “The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be tested are approved by the FDA for the treatment of seizures.” NCT01733394 ↗ “This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.” NCT00074776 ↗ “Lamotrigine (Lamictal®) recently gained approval by the FDA for maintenance treatment of bipolar disorder in adults.” NCT00284791 ↗ Show 9 more sources
Known as	Lamictal (Registered Trademark)	“Lamotrigine (Lamictal® (Registered Trademark)” NCT00001482 ↗
Known as	Lamictal cd	ChEMBL registry synonym — accepted as the source's own label CHEMBL741 ↗
Known as	Lamictal odt	ChEMBL registry synonym — accepted as the source's own label CHEMBL741 ↗
Known as	Lamictal-XR	“switched from your regular lamotrigine (Lamictal®) to once daily morning dosing of an extended-release formulation of Lamictal-XR® (at the same total daily dose).” NCT00789113 ↗
Known as	Lamotrigina	ChEMBL registry synonym — accepted as the source's own label CHEMBL741 ↗
Known as	Lamotrigine (generic name for Lamictal)	“Lamotrigine (generic name for Lamictal®)” NCT00913107 ↗
Known as	Lamotrigine Generic "A"	“Drug: Lamotrigine Generic "A"” NCT01713777 ↗
Known as	Lamotrigine generic "B"	“Drug: Lamotrigine generic "B"” NCT01713777 ↗
Known as	LTG	“To evaluate the tolerability and efficacy of levetiracetam (LEV) in newly diagnosed elderly patients (aged 60 yrs or above) with focal epilepsy compared to lamotrigine (LTG) or...” NCT00438451 ↗ 9 “Lamotrigine (LTG) is administered according to the package insert: that is, 25 mg of LTG will be orally administered once every other day for the first 2 weeks and then once...” NCT02100644 ↗ “In animal studies, pathway-specific pharmacological interventions with lovastatin (LOV) and lamotrigine (LTG) have been shown to improve synaptic plasticity as well as...” PMID 37280688 ↗ Jun 2023 “PURPOSE: To evaluate the efficacy and safety of lamotrigine (LTG) monotherapy for treating Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures.” PMID 26518979 ↗ Oct 2015 “This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures.” NCT00144872 ↗ “The objective of this study was to compare lamotrigine (LTG) and lithium (Li) monotherapy for the treatment of BDII depression.” PMID 18358540 ↗ Mar 2008 “This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy.” NCT00516139 ↗ “Lamotrigine (LTG) is a second generation AED , and also has the function of resisting depression and stabilizing mood .” NCT05881928 ↗ “example anti epilepsy drug (AED) used for this study will be lamotrigine (LTG).” NCT01733394 ↗ “lamotrigine (LTG)” PMID 22595362 ↗ May 2012
Known as	NSC-759171	ChEMBL registry synonym — accepted as the source's own label CHEMBL741 ↗
Known as	Reference- Lamictal XRTM (Lamotrigine) ER tablet 50mg	“Reference- Lamictal® XRTM (Lamotrigine) ER tablet 50mg” NCT05145608 ↗
Action	Inhibit	“Lamotrigine, a phenyltriazine use-dependent sodium channel blocker that inhibits release of excitatory amino acids” NCT00001482 ↗
Modality	Small molecule	— CHEMBL741 ↗
Route	Oral	“Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks.” NCT00068445 ↗
Target	HCN1	“Lamotrigine, an HCN1-agonist, rescued this electrophysiological phenotype in an NF1 mouse model.” PMID 40121838 ↗ Mar 2025