NDAORALTABLETPriority Review
Approved
Dec 1994
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
LAMICTAL (lamotrigine) by GSK is organic cation transporter 2 inhibitors [moa]. Approved for anti-epileptic agent [epc]. First approved in 1994.
Drug data last refreshed 16h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMICTAL (lamotrigine) is an oral anti-epileptic agent approved in 1994 that works as an organic cation transporter 2 inhibitor to reduce seizure activity. It is indicated for epilepsy management and is available in multiple formulations including immediate-release tablets, extended-release (XR), and orally disintegrating (ODT) forms. The drug treats patients across broad seizure disorder populations with varying epilepsy types.
$0.112BPart D
LOE ApproachingAs a mature, LOE-approaching product with $112M in annual spending, the brand team is likely focused on defending market share and managing transition to generics rather than growth.
Mechanism of Action
Organic Cation Transporter 2 Inhibitors
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Started Oct 2025
424 enrolled
ManiaBipolar Disorder
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
Started Dec 2024
133 enrolled
Healthy Volunteers
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Started Dec 2020
40 enrolled
Healthy
Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine
Started Mar 2020
75 enrolled
Emotions
A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults
Started Jul 2019
22 enrolled
Healthy Participants
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.