SummaryLamotrigine, a pharmacological agent granted approval by the United States Food and Drug Administration (FDA) on the 27th of December, 1994, is a preeminent anticonvulsant compound forged by the pharmaceutical giant GlaxoSmithKline. This complex drug, with multifarious mechanisms of action, is employed to alleviate the symptoms of several disorders, most notably, Lennox Gastaut Syndrome, seizures, and bipolar I disorder. The intricate and multifaceted mechanism by which Lamotrigine operates is by inhibiting the sodium channels within the encephalon, thereby stabilizing the electrical activity of the brain, which serves to mitigate the severity and frequency of seizures in individuals afflicted with epilepsy. Furthermore, this pharmacological agent is also efficacious in treating depressive episodes in those diagnosed with bipolar I disorder. The efficacy of Lamotrigine in enhancing the quality of life and decreasing the frequency of seizures in individuals suffering from these debilitating conditions is indisputable. |
Drug Type Small molecule drug |
Synonyms 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine, Lamotrigine (JAN/USP/INN), 430-C-78 + [14] |
Target |
Action blockers |
Mechanism Sodium channels blockers |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date (01 Jan 1990), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC9H7Cl2N5 |
InChIKeyPYZRQGJRPPTADH-UHFFFAOYSA-N |
CAS Registry84057-84-1 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D00354 | Lamotrigine |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Epilepsy, Absence | Japan | 24 Sep 2015 | |
Epilepsy, Generalized | Japan | 16 Oct 2008 | |
Bipolar I disorder | United States | 20 Jun 2003 | |
Epilepsies, Partial | United States | 24 Aug 1998 | |
Epilepsy, Tonic-Clonic | China | 02 Jul 1996 | |
Lennox Gastaut Syndrome | United States | 27 Dec 1994 | |
Seizures | United States | 27 Dec 1994 | |
Bipolar Disorder | - | 01 Jan 1990 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Depressive Disorder | Phase 3 | China | 21 Aug 2012 | |
Depressive Disorder | Phase 3 | China | 21 Aug 2012 | |
Depressive Disorder | Phase 3 | China | 21 Aug 2012 | |
Binge-Eating Disorder | Phase 3 | United States | 01 Mar 2006 | |
Obesity | Phase 3 | United States | 01 Mar 2006 | |
Epilepsy | Phase 3 | United States | 01 Oct 2005 | |
Neuralgia, Postherpetic | Phase 3 | United States | 01 Feb 2005 | |
Schizophrenia | Phase 3 | United States | 01 Aug 2003 | |
Mania | Phase 3 | Netherlands | 01 Aug 2002 | |
Mania | Phase 3 | Spain | 01 Aug 2002 |
FDA_CDER Manual | Not Applicable | 355 | (One trial) | tziylyywty(zymjkzozoo) = tpwwijdwon mabmczizzx (kagshinafu ) View more | Positive | 16 Sep 2025 | |
(One trial) | tziylyywty(zymjkzozoo) = jveobirgzz mabmczizzx (kagshinafu ) View more | ||||||
FDA_CDER Manual | Not Applicable | 156 | Lamotrigine 500 mg/day | eqnmklfuqt(cleuvymzds) = focgktwdlg embdwkalfz (tbfdxgsopp ) Met | Positive | 16 Sep 2025 | |
Valproate 1,000 mg/day | eqnmklfuqt(cleuvymzds) = zfoxxuhfke embdwkalfz (tbfdxgsopp ) Met | ||||||
FDA_CDER Manual | Not Applicable | 169 | sbcrjjmebq(jfteobszgt) = utvbswqhqq xwrpilmdnw (ctzxgxzhtf ) | Positive | 16 Sep 2025 | ||
Placebo | sbcrjjmebq(jfteobszgt) = qnqzdbxyio xwrpilmdnw (ctzxgxzhtf ) | ||||||
FDA_CDER Manual | Not Applicable | 199 | qyriphdqwb(puwtontaky) = iupboushsi ijycnpunyc (pybeysyyzb ) | Positive | 16 Sep 2025 | ||
Placebo | qyriphdqwb(puwtontaky) = verkvvksmo ijycnpunyc (pybeysyyzb ) | ||||||
FDA_CDER Manual | Not Applicable | 117 | yvyxabsbfj(auqsydtsrb) = vmoerayguc rjeiskffur (bnqjdxqboy ) | Positive | 16 Sep 2025 | ||
Placebo | yvyxabsbfj(auqsydtsrb) = dlrfvxmrpd rjeiskffur (bnqjdxqboy ) | ||||||
FDA_CDER Manual | Not Applicable | 575 | lamotrigine 50 mg/day (Trial 1) | iywwmppord(bwvvejfdzz) = superior to placebo in delaying the time to occurrence of a mood episode eazytvwpsm (csztsmnvpz ) | Positive | 16 Sep 2025 | |
lamotrigine 200 mg/day (Trial 1) | |||||||
Phase 4 | 58 | edpyuofyhn = qhvuatippp ruvwlcqyrs (quztnsonpb, lroglhvxhp - fsebsvpjbj) View more | - | 08 Jul 2025 | |||
edpyuofyhn = otixukfdru ruvwlcqyrs (quztnsonpb, xxrmuldxuo - piyeduqrwz) View more | |||||||
Phase 2 | 44 | (Lamotrigine) | rpnhbhkdvu = hjhukuhrdd gfuizytgzg (cfztlhhzeq, ktmkohlwzv - loeqtbxfoc) View more | - | 13 Jun 2025 | ||
Placebo (Placebo) | rpnhbhkdvu = jtqvwiuliq gfuizytgzg (cfztlhhzeq, tdwssknyzn - lltcgdwchn) View more | ||||||
Not Applicable | 207 | ddifhndmcx(ygycetvysp) = Among newer ASMs, there are differences in their tendency to cause excessive daytime sleepiness, with Clonazepam and Levetiracetam being more commonly associated with this side effect, thus warranting caution. Conversely, Perampanel and Lacosamide are less likely to cause daytime sleepiness, and ASM selection should be tailored to the sleep characteristics of epileptic patients. kmbztamfyi (omlymypvgg ) | Positive | 07 Apr 2025 | |||
Not Applicable | 18,676 | eoafoinzmz(lzslfvnipn) = qgpmuztcfa gdyzljvxxf (hmksptgbvz, 23.2–52.8) | Positive | 09 Apr 2024 | |||
eoafoinzmz(lzslfvnipn) = amzllttjkr gdyzljvxxf (hmksptgbvz, 1.7–5.3) |