Product Description
Lamotrigine (Lamictal), a phenyltriazine derivative, is a well established anticonvulsant agent that has shown efficacy in the prevention of mood episodes in adult patients with bipolar I disorder. The mechanism of action of the drug in patients with bipolar disorder may be related to the inhibition of sodium and calcium channels in presynaptic neurons and subsequent stabilisation of the neuronal membrane. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/12962521/)
Mechanisms of Action: HCN Agonist, Calcium Channel Blocker, Sodium Channel Blocker
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: GSK
Company Location: Europe
Company CEO: Emma Walmsley
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Bulgaria, Canada, Denmark, France, India, Israel, Italy, Japan, Poland, Romania, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Bipolar Disorder|Epilepsy
Phase 1: Healthy Volunteers|Tobacco Use Disorder
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06199791 |
LTG-008/K | P1 |
Completed |
Tobacco Use Disorder |
2023-05-09 |
2024-01-11 |
Primary Endpoints|Treatments |
|
NCT07140913 |
CN012-0046 | P3 |
Recruiting |
Bipolar Disorder |
2027-06-28 |
44% |
2025-10-15 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2016-004954-13 |
2016-004954-13 | P3 |
Active, not recruiting |
Epilepsy |
2022-10-05 |
2022-03-13 |
Treatments |
|
NCT06729970 |
CN012-0035 | P1 |
Recruiting |
Healthy Volunteers |
2026-01-18 |
50% |
2025-08-29 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2015-004901-18 |
2015-004901-18 | P3 |
Active, not recruiting |
Epilepsy |
2015-02-06 |
2022-03-13 |
Treatments |