Lamictal

(Lamotrigine)

ApprovedSmall molecule

Lamotrigine is used to treat seizures in people with epilepsy and to prevent mood episodes (depression and mania) in people with bipolar disorder.[2] Lamictal is currently approved and in use across 27 indications[4].[1]

Lamictal is one of 435 small molecule programs targeting Bilateral tonic-clonic seizure. It is currently in Approved.

Indications

148

Total Trials

Active Trials

434

Competitors

148

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Bilateral Tonic-Clonic SeizureActive, not recruiting

Borderline Personality DisorderActive, not recruiting

Memory ImpairmentActive, not recruiting

Drug DependenceApproved

Fish-Eye DiseaseApproved

Neurofibromatosis Type 1Approved

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

Trigeminal NeuralgiaApproved

Mental or Behavioural DisorderApproved

Facial Nerve DiseaseActive, not recruiting

Bilateral Tonic-Clonic SeizureApproved

Active, not recruiting

Borderline Personality DisorderApproved

Active, not recruiting

Memory ImpairmentApproved

Active, not recruiting

Drug DependenceApproved

Approved

Fish-Eye DiseaseApproved

Approved

Neurofibromatosis Type 1Approved

Approved

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

Approved

Trigeminal NeuralgiaApproved

Approved

Mental or Behavioural DisorderApproved

Approved

Facial Nerve DiseasePreclinical

Active, not recruiting

Showing 10 of 27 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Lamictal

GGlaxo Dba Glaxosmithkline

Approved

148 2

Maridebart Cafraglutide

Amgen

Phase 3

7 3

Retatrutide

Eli Lilly

Phase 3

6 4

Synthroid

IInstitut Jerome Lejeune

Phase 3

1 5

Vivia

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Phase 3

1 6

IBI362

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

4 7

HRS9531

FFujian Shengdi Pharmaceutical Co., Ltd.

Phase 3

1 8

Mibavademab

Regeneron

Phase 3

2 9

Elecoglipron

AstraZeneca

Phase 3

1 10

Aleniglipron

GGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Obesity, Morbid

NCT03497143

Q2 2027

Phase 3Recruiting

Mania

NCT07140913

Q4 2027

Post-ApprovalRecruiting

Bipolar Disorder

NCT06184581

Q2 2028

Recruiting

Pregnancy

NCT05450978

Phase 3Recruiting

Bipolar Disorder

NCT06929273

Clinical

Trials by Indication[1]

LAM19 trials

Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition

Completed·—·Phase 1·NCT01888250·36 enrolled

Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01618825·28 enrolled

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

Completed·—·Phase 1·NCT01513681·20 enrolled

Show 16 more trials

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition

Completed·—·Phase 1·NCT01131975·26 enrolled

Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

Completed· GSK logo

GSK·Phase 1·NCT00412191·180 enrolled

Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition

Completed·—·Phase 1·NCT01888731·62 enrolled

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fasting Condition

Completed·—·Phase 1·NCT01131949·26 enrolled

Pharmacokinetic Study on Raltegravir and Lamotrigine

Completed·RRadboud University Medical Center·Phase 1·NCT00618241·24 enrolled

Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650208·27 enrolled

Lamotrigine 25 mg Chewable Tablets, Fasting

Completed· Teva logo

Teva·Phase 1·NCT00838279·32 enrolled

Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00647751·28 enrolled

Lamotrigine 25 mg Chewable Tablets, Non-Fasting

Completed· Teva logo

Teva·Phase 1·NCT00838136·32 enrolled

Bioequivalence and Food Effect of 250mg of Lamotrigine XR

Completed· GSK logo

GSK·Phase 1·NCT00605371·209 enrolled

A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02821338·30 enrolled

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition

Completed·—·Phase 1·NCT01513720·20 enrolled

Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01618799·28 enrolled

Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT00410371·96 enrolled

Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition

Completed·—·Phase 1·NCT01888263·32 enrolled

Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition

Completed·—·Phase 1·NCT01888757·62 enrolled

Bipolar Disorder19 trials

An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder

Completed· GSK logo

GSK·Phase 4·NCT00360126·11 enrolled

A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium

Completed· GSK logo

GSK·Phase 3·NCT00224510·120 enrolled

Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder

Completed·TTri-Service General Hospital·Phase 4·NCT01864551·60 enrolled

Show 16 more trials

Bipolar Disorder Study for Men and Women

Completed· GSK logo

GSK·Phase 3·NCT00056277·150 enrolled

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Pregnant Women Taking Lamictal for Bipolar Disorder

Completed·NNorthwestern University··NCT01996293·30 enrolled

Decision-Making in Bipolar Disorder

Completed·EEmory University·N/A·NCT01463111·37 enrolled

Depression And Bipolar Disorder

Completed· GSK logo

GSK·Phase 3·NCT00274677·221 enrolled

PET and MRI Brain Imaging of Bipolar Disorder

Completed·SStony Brook University·N/A·NCT01880957·76 enrolled

Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00280293·112 enrolled

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Recruiting·UUniversity Hospital Bispebjerg and Frederiksberg·Phase 4·NCT06184581·200 enrolled

Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT00223509·28 enrolled

Combination Therapy for the Treatment of Bipolar Disorders

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 3·NCT00063362·49 enrolled

Sequential Multiple Assignment Treatment for Bipolar Disorder

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT01588457·112 enrolled

Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

Completed·SSan Diego Veterans Healthcare System·Phase 1·NCT02081287·8 enrolled

Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

Completed·NNational Institute of Mental Health (NIMH)·N/A·NCT00012558·5,000 enrolled

Lamotrigine Monotherapy in Pediatric Bipolar Disorder

Completed·UUniversity of Illinois at Chicago·Phase 2·NCT00176228·48 enrolled

Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder

Completed·MMassachusetts General Hospital·Phase 4·NCT00181844·51 enrolled

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)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06929273·450 enrolled

Epilepsy18 trials

Pediatric Epilepsy Trial in Subjects 1-24 Months

Completed· GSK logo

GSK·Phase 2·NCT00043875·177 enrolled

Hormone Profiles in Adults With Newly Diagnosed Epilepsy

Unknown status·—·Phase 4·NCT00137709·80 enrolled

Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy

Completed· GSK logo

GSK··NCT00264680·333 enrolled

Show 15 more trials

The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children

Unknown status·—·Phase 4·NCT05697614·100 enrolled

Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

Terminated·EEmory University·Phase 3·NCT01891890·72 enrolled

Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy

Completed·PPhilipps University Marburg·Phase 3·NCT00242606·409 enrolled

Precision Medicine in the Treatment of Epilepsy

Recruiting·GGitte Moos Knudsen··NCT05450822·550 enrolled

Modification of Epilepsy Screen Questionnaire and Treatment Feasibility Evaluation

Unknown status·NNational Taiwan University Hospital·N/A·NCT04939675·40 enrolled

Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

Completed· GSK logo

GSK·Phase 3·NCT00264615·45 enrolled

Characterization of Epilepsy Patients BEEP 2b

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02707965·21 enrolled

Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)

Completed·UUniversity of Cincinnati·Phase 4·NCT01733394·54 enrolled

Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

Completed· GSK logo

GSK·Phase 4·NCT00043914·72 enrolled

The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy

Unknown status·—·Phase 4·NCT05748236·70 enrolled

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

Not yet recruiting·—·Phase 4·NCT05881928·50 enrolled

Pediatric Epilepsy Study in Subjects 1-24 Months

Completed· GSK logo

GSK·Phase 2·NCT00044278·197 enrolled

Second-Line Treatment Choice for Epilepsy

Unknown status·DDutch Epilepsy Clinics Foundation·N/A·NCT00208520·60 enrolled

Lamotrigine Extended-Release In Elderly Patients With Epilepsy

Completed· GSK logo

GSK·Phase 3·NCT00516139·122 enrolled

A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil

Completed· UCB logo

UCB·Phase 1·NCT03695094·31 enrolled

Fasting Conditions6 trials

A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions

Completed·PPharmtechnology LLC·Phase 1·NCT03898011·28 enrolled

Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00835263·32 enrolled

Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00834561·32 enrolled

Show 3 more trials

Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT00939614

Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions

Completed·UUniversity of Karachi·Phase 1·NCT04938856·26 enrolled

Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions

Completed· Roche logo

Roche·Phase 1·NCT06199791·24 enrolled

Treatment5 trials

Enhancing the Effects of Alcohol Treatment With Lamotrigine

Completed·—·Phase 2·NCT04770493·44 enrolled

Cognitive Effects of Treatment of Interictal Discharges

Completed·MMassachusetts General Hospital·N/A·NCT00916149·31 enrolled

Lamotrigine as Treatment of Myotonia

Completed·GGrete Andersen, MD·Phase 3·NCT01939561·27 enrolled

Show 2 more trials

Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania

Completed·—·Phase 2·NCT00206778·36 enrolled

Treatment of Myotonia - Lamotrigine Versus Namuscla

Unknown status·GGrete Andersen, MD·N/A·NCT05639257·32 enrolled

51 more indications

Seizure5 trials

A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT00292461·64 enrolled

Does Gabapentin and Lamotriginel Have Significantly Fewer Side-effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly.

Completed·UUS Department of Veterans Affairs·Phase 3·NCT00007670·720 enrolled

Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

Completed· GSK logo

GSK·Phase 4·NCT00043901·141 enrolled

Show 2 more trials

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures

Completed· GSK logo

GSK·Phase 3·NCT00104416·153 enrolled

LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

Completed· GSK logo

GSK·Phase 1·NCT00144872·54 enrolled

Bipolar Depression4 trials

16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression

Terminated·MMayo Clinic·Phase 4·NCT02389712·2 enrolled

Lamotrigine Therapy in Geriatric Bipolar Depression

Completed·MMclean Hospital·N/A·NCT00720473·69 enrolled

Bipolar Depression Before and After Lamotrigine Treatment

Completed·MMayo Clinic·Phase 3·NCT01042496·72 enrolled

Show 1 more trial

Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine

Completed·UUniversity of Saskatchewan·Phase 4·NCT02989727·150 enrolled

Drug4 trials

Drug Use Investigation for LAMICTAL

Completed· GSK logo

GSK··NCT01376180·3,000 enrolled

Special Drug Use Investigation for LAMICTAL Bipolar

Completed· GSK logo

GSK··NCT01428518·1,036 enrolled

Special Drug Use Investigation for LAMICTAL® (Long Term)

Completed· GSK logo

GSK··NCT01863602·850 enrolled

Show 1 more trial

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Completed·—··NCT00612235·80 enrolled

Depression4 trials

Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00485771·403 enrolled

Acute Treatment of Bipolar II Depression

Completed·SStanford University·Phase 3·NCT00074776·102 enrolled

Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression

Completed·UUniversity of British Columbia·Phase 2·NCT00475137·15 enrolled

Show 1 more trial

Lamotrigine Augmentation in Resistant Depression

Completed·LLouisiana State University Health Sciences Center in New Orleans·N/A·NCT00901407·138 enrolled

Ketamine4 trials

Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

Completed·TThe Cleveland Clinic·Phase 3·NCT03831854·46 enrolled

Lamotrigine for Ketamine Dependence Trial

Completed·TTaipei City Hospital·Phase 2/3·NCT02556060·30 enrolled

The Sustained Effects of Ketamine

Terminated·YYale University·Phase 1·NCT02708849·3 enrolled

Show 1 more trial

Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine

Completed·—·N/A·NCT04156035·75 enrolled

Single Dose3 trials

A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects

Terminated· GSK logo

GSK·Phase 1·NCT00907985·12 enrolled

A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults

Completed·AAgios Pharmaceuticals, Inc.·Phase 1·NCT04015687·22 enrolled

The Effect of a Single Dose of Lamotrigine on Brain Function in Healthy Volunteers

Completed·UUniversity of Oxford·N/A·NCT04396938·36 enrolled

Bipolar I Disorder3 trials

Lamotrigine Phase III Study in Bipolar I Disorder

Completed· GSK logo

GSK·Phase 3·NCT01602510·265 enrolled

An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients

Completed· GSK logo

GSK·Phase 3·NCT00550407·215 enrolled

Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder

Terminated·OOPKO Health, Inc.·Phase 2·NCT01674010·309 enrolled

Tics3 trials

A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

Completed·KKaruna Therapeutics·Phase 1·NCT06729970·133 enrolled

Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects

Completed· GSK logo

GSK·Phase 1·NCT02513654·16 enrolled

BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT02404168·4 enrolled

Interaction3 trials

Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.

Completed·BBial - Portela C S.A.·Phase 1·NCT02283801·32 enrolled

Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

Completed·PPer Damkier·Phase 4·NCT02303106·12 enrolled

AED/Statin Interaction Study

Completed· GSK logo

GSK·Phase 1·NCT00627575·119 enrolled

Mood Disorder3 trials

An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder

Completed· GSK logo

GSK·Phase 3·NCT00579982·97 enrolled

New Drugs in the Treatment of Mood Disorders

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00001482·60 enrolled

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Completed·UUniversity of Pittsburgh·Phase 4·NCT00177567·60 enrolled

Alcohol Dependence2 trials

Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

Completed·MMedical University of South Carolina·Phase 4·NCT01015586·43 enrolled

The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder

Withdrawn·YYale University·Phase 3·NCT00571246

Schizophrenia2 trials

Clinical Study Of Schizophrenia in Both Men and Women

Completed· GSK logo

GSK·Phase 3·NCT00071747·176 enrolled

Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia

Completed· GSK logo

GSK·Phase 3·NCT00086593·209 enrolled

Cognitive Function2 trials

Synaptic Plasticity and Cognitive Function in RASopathies

Terminated·TTechnical University of Munich·Phase 2·NCT03504501·16 enrolled

Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Completed·KKorean Epilepsy Society·Phase 4·NCT00896987·121 enrolled

MPR2 trials

The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg

Completed· GSK logo

GSK·Phase 1·NCT02064465·138 enrolled

Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China

Completed· GSK logo

GSK·Phase 1·NCT01357902·24 enrolled

Skin rash1 trial

Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients

Unknown status·SSeoul National University Hospital·Phase 2·NCT03220256·30 enrolled

Asthma1 trial

Study of Efficacy of Lamotrigine in Therapy of Bronchial Asthma

Completed·CCentre of Chinese Medicine, Georgia·Phase 4·NCT00153244·76 enrolled

Observational Study1 trial

Lamictal Bipolar Observational Study

Completed· GSK logo

GSK··NCT00460226·238 enrolled

Maintenance Treatment1 trial

Maintenance Treatment of Bipolar Depression

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT00183469·86 enrolled

Trigeminal Neuralgia1 trial

Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia

Completed·TThomas Jefferson University·N/A·NCT00203229·20 enrolled

Childhood Absence Epilepsy1 trial

Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study

Completed·—·Phase 3·NCT00088452·453 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Cognition1 trial

Effect of Lamotrigine on Cognition in NF1

Terminated·EErasmus Medical Center·Phase 2/3·NCT02256124·41 enrolled

Ménière1 trial

Study of Lamotrigine to Treat Ménière's Disease

Completed·—·Phase 2·NCT02158585·15 enrolled

Opioid Dependence1 trial

Neurobiology of Opioid Dependence: 1 - 1

Withdrawn·YYale University·Phase 2·NCT00000192

Partial Epilepsy1 trial

Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00280059·660 enrolled

Pregnancy1 trial

Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Recruiting·UUniversity of Pittsburgh··NCT05450978·60 enrolled

Facial Pain1 trial

Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Completed·PPain and Analgesia Imaging and Neuroscience Group·N/A·NCT00243152·6 enrolled

Combination Therapy1 trial

Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 3·NCT00221975·98 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Completed·—·Phase 3·NCT00652171·34 enrolled

Memory1 trial

A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04602221·40 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Unknown status·—·Phase 2·NCT00917839·88 enrolled

Treatment Resistant Depression1 trial

Lamotrigine in Treatment Resistant Depression in Adolescents

Terminated·MMaineHealth·N/A·NCT00284791·50 enrolled

Chronic pain1 trial

Comparison of Oral Lamotrigine Versus Pregabalin for Control of Acute and Chronic Pain

Available·—··NCT03419949

Cognitive impairment1 trial

Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00223262·28 enrolled

Absorption1 trial

Determination of Absorption and Elimination of Lamotrigine-XR

Completed·UUniversity of Minnesota·Phase 1/2·NCT00789113·12 enrolled

Myotonia1 trial

MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias

Unknown status·UUniversity College, London·Phase 3·NCT05017155·60 enrolled

Major Depressive Disorder1 trial

Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

Completed·—·Phase 4·NCT00419003·26 enrolled

Adult1 trial

Bipolar Study in Adults at Least 18 Years of Age

Completed· GSK logo

GSK·Phase 4·NCT00067938·1,200 enrolled

Aseptic Meningitis1 trial

WEUSKOP6166: Lamotrigine and Aseptic Meningitis

Completed· GSK logo

GSK··NCT01657864·1 enrolled

Elderly Patients1 trial

Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs

Completed·JJohannes Gutenberg University Mainz·Phase 4·NCT00438451·361 enrolled

Secondary Progressive Multiple Sclerosis1 trial

A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis

Completed·UUniversity College London Hospitals·Phase 2·NCT00257855·120 enrolled

Memory Impairment1 trial

Reversing Corticosteroid Induced Memory Impairment

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT01142310·54 enrolled

Peripheral Neuropathy1 trial

Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00068445·131 enrolled

Eating Disorder1 trial

Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity

Completed·LLindner Center of HOPE·Phase 3·NCT00277641·70 enrolled

Borderline personality disorder1 trial

Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Completed·MMclean Hospital·Phase 4·NCT00634062·28 enrolled

Adult Subject1 trial

Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT00939458

Oral1 trial

Lamotrigine and Oral Contraceptives

Terminated·UUniversity of Aarhus·Phase 3·NCT00266149·10 enrolled

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT07140913·424 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 27, 1994

LAMICTAL

NDA NDA020241

Dec 27, 1994

LAMICTAL

NDA NDA020241

Mar 11, 1997

LAMICTAL

NDA NDA020241

Mar 16, 1998

LAMICTAL

NDA NDA020241

Mar 16, 1998

LAMICTAL

NDA NDA020241

Aug 24, 1998

LAMICTAL

NDA NDA020241

Dec 14, 1998

LAMICTAL

NDA NDA020241

Dec 14, 1998

LAMICTAL CD

NDA NDA020764

May 10, 1999

LAMICTAL

NDA NDA020241

Jun 8, 1999

LAMICTAL

NDA NDA020241

Jun 8, 1999

LAMICTAL CD

NDA NDA020764

Jun 12, 2000

LAMICTAL

NDA NDA020241

Sep 8, 2000

LAMICTAL

NDA NDA020241

Sep 8, 2000

LAMICTAL CD

NDA NDA020764

Sep 8, 2000

LAMICTAL CD

NDA NDA020764

Feb 23, 2001

LAMICTAL

NDA NDA020241

Feb 23, 2001

LAMICTAL CD

NDA NDA020764

May 25, 2001

LAMICTAL

NDA NDA020241

May 25, 2001

LAMICTAL CD

NDA NDA020764

Jan 17, 2003

LAMICTAL

NDA NDA020241

Jan 17, 2003

LAMICTAL CD

NDA NDA020764

Apr 4, 2003

LAMICTAL

NDA NDA020241

Jun 20, 2003

LAMICTAL

NDA NDA020241

Jun 20, 2003

LAMICTAL CD

NDA NDA020764

Jan 14, 2004

LAMICTAL

NDA NDA020241

Jan 14, 2004

LAMICTAL CD

NDA NDA020764

Mar 17, 2006

LAMICTAL

NDA NDA020241

Mar 17, 2006

LAMICTAL CD

NDA NDA020764

Sep 22, 2006

LAMICTAL CD

NDA NDA020764

Sep 22, 2006

LAMICTAL

NDA NDA020241

Sep 25, 2006

LAMICTAL CD

NDA NDA020764

Sep 25, 2006

LAMICTAL

NDA NDA020241

Sep 25, 2006

LAMICTAL CD

NDA NDA020764

Sep 25, 2006

LAMICTAL CD

NDA NDA020764

Sep 25, 2006

LAMICTAL CD

NDA NDA020764

Sep 25, 2006

LAMICTAL

NDA NDA020241

Sep 25, 2006

LAMICTAL

NDA NDA020241

Sep 25, 2006

LAMICTAL

NDA NDA020241

Apr 23, 2009

LAMICTAL

NDA NDA020241

Apr 23, 2009

LAMICTAL CD

NDA NDA020764

Apr 23, 2009

LAMICTAL CD

NDA NDA020764

Apr 23, 2009

LAMICTAL

NDA NDA020241

May 8, 2009

LAMICTAL ODT

NDA NDA022251

May 8, 2009

LAMICTAL CD

NDA NDA020764

May 8, 2009

LAMICTAL

NDA NDA020241

May 8, 2009

LAMICTAL ODT

NDA NDA022251

May 29, 2009

LAMICTAL XR

NDA NDA022115

Apr 14, 2010

LAMICTAL XR

NDA NDA022115

Apr 14, 2010

LAMICTAL XR

NDA NDA022115

Oct 24, 2010

LAMICTAL CD

NDA NDA020764

Oct 24, 2010

LAMICTAL XR

NDA NDA022115

Oct 24, 2010

LAMICTAL ODT

NDA NDA022251

Oct 24, 2010

LAMICTAL

NDA NDA020241

Oct 24, 2010

LAMICTAL XR

NDA NDA022115

Oct 24, 2010

LAMICTAL CD

NDA NDA020764

Oct 24, 2010

LAMICTAL ODT

NDA NDA022251

Oct 24, 2010

LAMICTAL

NDA NDA020241

Apr 25, 2011

LAMICTAL XR

NDA NDA022115

May 31, 2011

LAMICTAL CD

NDA NDA020764

May 31, 2011

LAMICTAL

NDA NDA020241

May 31, 2011

LAMICTAL ODT

NDA NDA022251

Jun 21, 2011

LAMICTAL XR

NDA NDA022115

Aug 4, 2011

LAMICTAL

NDA NDA020241

Aug 4, 2011

LAMICTAL XR

NDA NDA022115

Aug 4, 2011

LAMICTAL CD

NDA NDA020764

Aug 4, 2011

LAMICTAL ODT

NDA NDA022251

Nov 29, 2011

LAMICTAL

NDA NDA020241

Nov 29, 2011

LAMICTAL CD

NDA NDA020764

Nov 29, 2011

LAMICTAL XR

NDA NDA022115

Nov 29, 2011

LAMICTAL ODT

NDA NDA022251

Aug 1, 2012

LAMICTAL CD

NDA NDA020764

Aug 1, 2012

LAMICTAL XR

NDA NDA022115

Aug 1, 2012

LAMICTAL ODT

NDA NDA022251

Aug 1, 2012

LAMICTAL

NDA NDA020241

Dec 20, 2013

LAMICTAL CD

NDA NDA020764

Dec 20, 2013

LAMICTAL XR

NDA NDA022115

Dec 20, 2013

LAMICTAL

NDA NDA020241

Jun 10, 2014

LAMICTAL

NDA NDA020241

Jun 10, 2014

LAMICTAL ODT

NDA NDA022251

Jun 10, 2014

LAMICTAL XR

NDA NDA022115

Jun 10, 2014

LAMICTAL CD

NDA NDA020764

Dec 30, 2014

LAMICTAL XR

NDA NDA022115

Dec 30, 2014

LAMICTAL ODT

NDA NDA022251

Dec 30, 2014

LAMICTAL

NDA NDA020241

Dec 30, 2014

LAMICTAL CD

NDA NDA020764

Dec 30, 2014

LAMICTAL ODT

NDA NDA022251

Dec 30, 2014

LAMICTAL XR

NDA NDA022115

Dec 30, 2014

LAMICTAL

NDA NDA020241

Dec 30, 2014

LAMICTAL CD

NDA NDA020764

Mar 24, 2015

LAMICTAL

NDA NDA020241

Mar 24, 2015

LAMICTAL XR

NDA NDA022115

Mar 24, 2015

LAMICTAL ODT

NDA NDA022251

Mar 24, 2015

LAMICTAL ODT

NDA NDA022251

Mar 24, 2015

LAMICTAL XR

NDA NDA022115

Mar 24, 2015

LAMICTAL CD

NDA NDA020764

Mar 24, 2015

LAMICTAL

NDA NDA020241

Mar 24, 2015

LAMICTAL CD

NDA NDA020764

May 18, 2015

LAMICTAL

NDA NDA020241

May 18, 2015

LAMICTAL CD

NDA NDA020764

May 18, 2015

LAMICTAL ODT

NDA NDA022251

Jun 27, 2018

LAMICTAL CD

NDA NDA020764

Jun 27, 2018

LAMICTAL ODT

NDA NDA022251

Jun 27, 2018

LAMICTAL XR

NDA NDA022115

Jun 27, 2018

LAMICTAL

NDA NDA020241

Jul 23, 2018

LAMICTAL CD

NDA NDA020764

Jul 23, 2018

LAMICTAL

NDA NDA020241

Jul 23, 2018

LAMICTAL XR

NDA NDA022115

Jul 23, 2018

LAMICTAL ODT

NDA NDA022251

Aug 14, 2019

LAMICTAL ODT

NDA NDA022251

Aug 14, 2019

LAMICTAL XR

NDA NDA022115

Aug 14, 2019

LAMICTAL CD

NDA NDA020764

Aug 14, 2019

LAMICTAL

NDA NDA020241

Sep 25, 2019

LAMICTAL XR

NDA NDA022115

Sep 25, 2019

LAMICTAL CD

NDA NDA020764

Sep 25, 2019

LAMICTAL

NDA NDA020241

Sep 25, 2019

LAMICTAL ODT

NDA NDA022251

Aug 19, 2020

LAMICTAL CD

NDA NDA020764

Aug 19, 2020

LAMICTAL ODT

NDA NDA022251

Aug 19, 2020

LAMICTAL

NDA NDA020241

Aug 31, 2020

LAMICTAL CD

NDA NDA020764

Aug 31, 2020

LAMICTAL

NDA NDA020241

Aug 31, 2020

LAMICTAL XR

NDA NDA022115

Aug 31, 2020

LAMICTAL ODT

NDA NDA022251

Oct 9, 2020

LAMICTAL XR

NDA NDA022115

Oct 9, 2020

LAMICTAL CD

NDA NDA020764

Oct 9, 2020

LAMICTAL ODT

NDA NDA022251

Oct 9, 2020

LAMICTAL

NDA NDA020241

Mar 31, 2021

LAMICTAL ODT

NDA NDA022251

Mar 31, 2021

LAMICTAL XR

NDA NDA022115

Mar 31, 2021

LAMICTAL

NDA NDA020241

Mar 31, 2021

LAMICTAL CD

NDA NDA020764

Apr 25, 2025

LAMICTAL

NDA NDA020241

Apr 25, 2025

LAMICTAL XR

NDA NDA022115

Apr 25, 2025

LAMICTAL

NDA NDA020241

Apr 25, 2025

LAMICTAL ODT

NDA NDA022251

Apr 25, 2025

LAMICTAL XR

NDA NDA022115

Apr 25, 2025

LAMICTAL CD

NDA NDA020764

Apr 25, 2025

LAMICTAL ODT

NDA NDA022251

Apr 25, 2025

LAMICTAL CD

NDA NDA020764

Sep 16, 2025

SUBVENITE

NDA NDA218879

Oct 10, 2025

LAMICTAL

NDA NDA020241

Oct 10, 2025

LAMICTAL

NDA NDA020241

Oct 10, 2025

LAMICTAL XR

NDA NDA022115

Oct 10, 2025

LAMICTAL CD

NDA NDA020764

Oct 10, 2025

LAMICTAL ODT

NDA NDA022251

Oct 10, 2025

LAMICTAL CD

NDA NDA020764

Oct 10, 2025

LAMICTAL ODT

NDA NDA022251

Oct 10, 2025

LAMICTAL XR

NDA NDA022115

Sources

References

[1]
ClinicalTrials.gov — 148 trial records for Lamotrigine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lamictal drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lamotrigine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lamotrigine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020241). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lamictal. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Patent Landscape[6]

Patent Cliff

Jan 7, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8637512Jan 7, 2029

12629377May 28, 2040

12636289May 28, 2040

11596634May 29, 2040

11612566May 29, 2040

Lamictal

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q2 2028

Trials by Indication[1]

LAM19 trials

Bipolar Disorder19 trials

Epilepsy18 trials

Fasting Conditions6 trials

Treatment5 trials

Seizure5 trials

Bipolar Depression4 trials

Drug4 trials

Depression4 trials

Ketamine4 trials

Single Dose3 trials

Bipolar I Disorder3 trials

Tics3 trials

Interaction3 trials

Mood Disorder3 trials

Alcohol Dependence2 trials

Schizophrenia2 trials

Cognitive Function2 trials

MPR2 trials

Skin rash1 trial

Asthma1 trial

Observational Study1 trial

Maintenance Treatment1 trial

Trigeminal Neuralgia1 trial

Childhood Absence Epilepsy1 trial

Pediatrics1 trial

Cognition1 trial

Ménière1 trial

Opioid Dependence1 trial

Partial Epilepsy1 trial

Pregnancy1 trial

Facial Pain1 trial

Combination Therapy1 trial

Efficacy and Safety1 trial

Memory1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

Treatment Resistant Depression1 trial

Chronic pain1 trial

Cognitive impairment1 trial

Absorption1 trial

Myotonia1 trial

Major Depressive Disorder1 trial

Adult1 trial

Aseptic Meningitis1 trial

Elderly Patients1 trial

Secondary Progressive Multiple Sclerosis1 trial

Memory Impairment1 trial

Peripheral Neuropathy1 trial

Eating Disorder1 trial

Borderline personality disorder1 trial

Adult Subject1 trial

Oral1 trial

Cocaine Dependence1 trial

Obesity, Morbid1 trial

Mania1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News