Drug

Lamotrigine

As of the edition of 20 October 2026, Lamotrigine is a small molecule: marketed, first approved in 1994 (CH); acts on SCN10A, SCN11A and SCN1A and 7 more.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2008
Kind
Small molecule
Brand name
Lamictal
First approved
23 December 1994 (CH)
Approvals on record
35 in 7 regions
Holder of the most recent approval
Owp Pharmaceuticals; 3 holders in all
Registered trials
141, 12 stopped early
Disease areas
Nervous system; Mental health; Chemically induced; Immune system; Inherited and neonatal; Nutrition and metabolism

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

9 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

9 company-target rows are on route B because of Lamotrigine.

Targets

GeneProteinUniProt
SCN1ASodium channel protein type 1 subunit alphaP35498
SCN4ASodium channel protein type 4 subunit alphaP35499
SCN7ASodium channel protein type 7 subunit alphaQ01118
SCN5ASodium channel protein type 5 subunit alphaQ14524
SCN9ASodium channel protein type 9 subunit alphaQ15858
SCN2ASodium channel protein type 2 subunit alphaQ99250
SCN3ASodium channel protein type 3 subunit alphaQ9NY46
SCN11ASodium channel protein type 11 subunit alphaQ9UI33
SCN8ASodium channel protein type 8 subunit alphaQ9UQD0
SCN10ASodium channel protein type 10 subunit alphaQ9Y5Y9

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated292032
Phase 1393702
Phase 2161103
Phase 3302415
Phase 4272500
All trials141

Who has held its approvals

CompanyRoleYears
GSKApplicant and Lead sponsor of trials1994 to now
Owp PharmaceuticalsLater holder2025 to now