Wednesday, July 8, 2026

Drug profile · INN

lamotrigine

lamotrigine (APX-LAMOTRIGINE) is a sodium channel alpha subunit blocker. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 2
Pipeline programs 7
News articles 0
Drug details — lamotrigine
US status
approved
Class
Route
ORAL
Patents
2
Programs
7
Data quality
0.89

Quick answer

lamotrigine (APX-LAMOTRIGINE) is a sodium channel alpha subunit blocker. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN lamotrigine
Brand APX-LAMOTRIGINE
Mechanism Sodium channel alpha subunit blocker
Target Sodium channel alpha subunit
Route ORAL
Formulation TABLET, ORALLY DISINTEGRATING

Mechanism of action

Sodium channel alpha subunit blocker

Primary target: Sodium channel alpha subunit

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. lamotrigine, 300 mg/day Phase 3 · GSK Glaxo Smith · Epilepsy, Partial
  2. Lamotrigine Phase 2 · BRIGHT MINDS BIOSCIENCES · Cocaine-Related Disorders
  3. LAMOT-04-24 Phase 1 · Anaxis Pharma · Bipolar disorder, Epilepsy
  4. Lamotrigine Phase 1 · Teva Pharma · Healthy
  5. Lamotrigine 25 mg Chewable Tablets Phase 1 · Teva Pharma · Healthy
  6. Lamotrigine Extended Release Phase 1 · BRIGHT MINDS BIOSCIENCES · Healthy
  7. Brand lamotrigine Approved · BRIGHT MINDS BIOSCIENCES · Epilepsy

Related & competitor drugs

  1. carbamazepine Sodium channel alpha subunit blocker
  2. disopyramide phosphate Sodium channel alpha subunit blocker
  3. eslicarbazepine acetate Nervous system (N03)
  4. fosphenytoin sodium Sodium channel alpha subunit blocker
  5. lacosamide Nervous system (N03)
  6. lidocaine Nervous system (N01)
  1. US 7390807

    Crystal forms of lamotrigine and processes for their preparations

    Expires Mon Jun 19 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 6861426

    Crystal forms of lamotrigine and processes for their preparations

    Expires Mon Feb 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is lamotrigine?

lamotrigine (APX-LAMOTRIGINE) is a sodium channel alpha subunit blocker. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for lamotrigine?

APX-LAMOTRIGINE is a marketed brand name for lamotrigine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of lamotrigine?

lamotrigine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.