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Drug

Lamotrigine

Approved · FDA
ClassSodium channel alpha subunit blockerEmerging researchLate-stage developmentSteady momentum
Also known as LaMICtal, Subvenite, Lamotrigina, 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine+1 more

LaMICtal, Subvenite, Lamotrigina, 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine, Lamotriginum.

RxNorm28439ChEMBLCHEMBL741ATCN03AX09UNIIU3H27498KS
4
Research papers
3
Active clinical trials
10
Protein targets
63
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: LAMOTRIGINE (ANDA206382)

Regulatory2026-07-27FDA

Label change: LAMOTRIGINE (NDA218879)

Regulatory2026-07-17FDA

Label change: LAMOTRIGINE (NDA218879)

Regulatory2026-07-17FDA

Label change: LAMOTRIGINE (ANDA219677)

Regulatory2026-07-13FDA

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Clinical trial2026-06-24Results expected Q2 2028 · ClinicalTrials.gov

Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)

Clinical trial2026-03-20Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

Clinical trial2026-01-23Completed · ClinicalTrials.gov

Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial

Clinical trial2025-07-08Results posted · ClinicalTrials.gov

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.

Research2018-03-14Bipolar disorders

Lamotrigine vs. lamotrigine plus divalproex in randomized, placebo-controlled maintenance treatment for bipolar depression.

Research2012-06-18Bowden CL · Acta psychiatrica Scandinavica

A fMRI evaluation of lamotrigine for the treatment of trigeminal neuropathic pain: pilot study.

Research2010-05-11Scrivani S · Pain medicine (Malden, Mass.)

Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3.

Research2008-06-01Rao RD · Cancer

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lamotrigine
Aliases & brands
LaMICtalSubveniteLamotrigina3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazineLamotriginum
RxNorm CUI
28439
ChEMBL ID
CHEMBL741
ATC codes
N03AX09
UNII
U3H27498KS
Primary mechanism
Sodium channel alpha subunit blocker
Regulatory jurisdictions
fda

Pharmacology & targets

10 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium channel protein type 1 subunit alpha
SCN1A · P35498
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 5 subunit alpha
SCN5A · Q14524
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 4 subunit alpha
SCN4A · P35499
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 7 subunit alpha
SCN7A · Q01118
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 2 subunit alpha
SCN2A · Q99250
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 9 subunit alpha
SCN9A · Q15858
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 3 subunit alpha
SCN3A · Q9NY46
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 11 subunit alpha
SCN11A · Q9UI33
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 8 subunit alpha
SCN8A · Q9UQD0
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 10 subunit alpha
SCN10A · Q9Y5Y9
BLOCKERSodium channel alpha subunit blocker

Regulatory timeline

63 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-05-08
Latest approval
2025-10-07
Authorities
FDA
Total events
63
fdaU.S. Food and Drug Administration· 63 events
2026-07-27Label change
Label change: LAMOTRIGINE (ANDA206382)
Evidence ↗
2026-07-17Label change
Label change: LAMOTRIGINE (NDA218879)
Evidence ↗
2026-07-17Label change
Label change: LAMOTRIGINE (NDA218879)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

132 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
132
registered trials across all phases
LATEST COMPLETION 2026
3
Active studies
3
Recruiting
79
Late-stage (III+)
108
Completed
21
Discontinued
PHASE DISTRIBUTIONn = 132
Phase 136Phase 217Phase 2 / 32Phase 332Phase 431Phase N / A14

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)

RecruitingPH IVUniversity Hospital Bispebjerg and Frederiksbergn=2002027

Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study

Not yet recruitingPH IVAssiut Universityn=502025

Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial

CompletedPH IVMario Negri Institute for Pharmacological Researchn=582024

The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy: A Randomized, Open Label Clinical Trial in Dhaka Medical College Hospital

Unknown statusPH IVDhaka Medical Collegen=702023

The Efficacy and Safety of First-Line Anti-Epileptic Drugs (AEDs) as Substitution Therapy in Children Who Are Resistant to Second-Line AEDs

Unknown statusPH IVDr Cipto Mangunkusumo General Hospitaln=1002023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

CompletedPH IKaruna Therapeutics, Inc., a Bristol Myers Squibb companyn=1332026

Proof-of-Concept Clinical Trial of Lamotrigine as a Candidate Pharmacotherapy for Adolescent Alcohol Use Disorder

CompletedPH IIBrown Universityn=442024

Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial

CompletedPH IVMario Negri Institute for Pharmacological Researchn=582024

Single-Dose, Randomized, Two-Way Crossover, Bioequivalence of Lamotrigine 100 mg Tablet (Desitin Arzneimittel GmbH, Germany) and Lamictal 100 mg Tablet (GlaxoSmithKline GmbH & Co. KG, Germany) in Healthy, Male Volunteers, Fasting

CompletedPH IDesitin Arzneimittel GmbHn=242023

A Randomized, Placebo Controlled, Double-blind, Double-dummy Three-way Cross Over Trial to Investigate the Effect of BI 409306, BI 425809 and Lamotrigine on Ketamine-induced Cognitive Deficits in Healthy Male Subjects

CompletedPH IBoehringer Ingelheimn=402022

The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use

CompletedPH IIIThe Cleveland Clinicn=462020

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20082018
Journals, researchers & institutions
Top journals
  • Acta psychiatrica Scandinavica1
  • Bipolar disorders1
  • Cancer1
  • Pain medicine (Malden, Mass.)1
Leading researchers
  • Alda M1
  • Bajwa Z1
  • Beaulieu S1
  • Becerra L1
  • Berk M1
  • Bond DJ1
  • Borsook D1
  • Bowden CL1
Leading institutions
free-text, unnormalised
  • Brain Imaging Center1
  • Dalhousie University1
  • Department of Psychiatry & Behavioral Sciences Stanford University1
  • George Washington University1
  • IMPACT Strategic Research Centre1
  • Institute of Neuroscience1

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Bupropion

Studied across the same disease area as Lamotrigine in the shared literature.

1 shared disease1 shared paper
Olanzapine

Studied across the same disease area as Lamotrigine in the shared literature.

1 shared disease1 shared paper
Quetiapine Fumarate

Studied across the same disease area as Lamotrigine in the shared literature.

1 shared disease1 shared paper
Valproic Acid

Studied across the same disease area as Lamotrigine in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.