Lamotrigine
Lamictal, Lamotrigine (lamotrigine) is a small molecule pharmaceutical. Lamotrigine was first approved as Lamictal on 1994-12-27. It is used to treat bipolar disorder, epilepsy, lennox gastaut syndrome, mood disorders, and partial epilepsies amongst others in the USA. It is known to target sodium channel protein type 2 subunit alpha.
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Commercial
Trade Name
FDA
EMA
Lamictal, Lamotrigine (discontinued: Lamictal, Lamotrigine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lamictal | New Drug Application | 2025-04-25 |
| lamotrigine | ANDA | 2025-10-04 |
| lamotrigine er | ANDA | 2025-01-22 |
| lamotrigine extended release | ANDA | 2022-01-14 |
| lamotrigine lamotrigine | ANDA | 2025-07-15 |
| subvenite | New Drug Application | 2025-09-30 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lamotrigine, Lamictal Xr, Glaxosmithkline Llc | |||
| 8637512 | 2028-06-14 | DP | |
HCPCS
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Clinical
Clinical Trials
227 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 11 | 4 | 15 | 22 | 24 | 74 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 7 | 5 | 17 | 19 | 14 | 60 |
| Depression | D003863 | — | F33.9 | 3 | 3 | 8 | 6 | 9 | 27 |
| Healthy volunteers/patients | — | — | — | 20 | — | — | 1 | 2 | 23 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 1 | 6 | 4 | 6 | 17 |
| Seizures | D012640 | — | G40.4 | 2 | 1 | 7 | 3 | 3 | 15 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | — | 4 | 5 | — | 9 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 4 | 1 | 2 | 7 |
| Mania | D000087122 | — | F30 | — | 1 | 2 | 3 | — | 6 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | 1 | 2 | 2 | 5 |
Show 36 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Absence epilepsy | D004832 | — | G40.A | 1 | — | 3 | — | — | 4 |
| Myotonia | D009222 | — | — | — | — | 2 | — | 1 | 3 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | 1 | — | — | 2 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | 1 | 1 | — | 1 | 2 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | 1 | 1 | — | 1 | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | — | 1 |
| Ketogenic diet | D055423 | — | — | — | — | 1 | — | — | 1 |
| Neurofibromatosis 1 | D009456 | — | Q85.01 | — | 1 | 1 | — | — | 1 |
Show 18 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | — | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Gliosarcoma | D018316 | — | — | 1 | 2 | — | — | — | 2 |
| Sclerosis | D012598 | — | — | — | 2 | — | — | — | 2 |
| Vertigo | D014717 | — | H81.39 | — | 2 | — | — | — | 2 |
| Meniere disease | D008575 | EFO_0006862 | H81.0 | — | 2 | — | — | — | 2 |
| Dizziness | D004244 | — | R42 | — | 2 | — | — | — | 2 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | — | — | — | 1 |
| Consciousness disorders | D003244 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 6 | — | — | — | — | 6 |
| Fasting | D005215 | EFO_0002756 | — | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 2 | 2 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | — | — | 2 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Financial stress | D000086522 | — | — | — | — | — | — | 1 | 1 |
| Chronic pain | D059350 | — | — | — | — | — | — | 1 | 1 |
| Compulsive sexual behavior disorder | D000096583 | — | — | — | — | — | — | 1 | 1 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
| Psychotic affective disorders | D000341 | — | F39 | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 1 | 1 |
Show 14 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lamotrigine |
| INN | lamotrigine |
| Description | Lamotrigine is a member of the class of 1,2,4-triazines in which the triazene skeleton is substituted by amino groups at positions 3 and 5, and by a 2,3-dichlorophenyl group at position 6. It has a role as an anticonvulsant, an antimanic drug, an antidepressant, a non-narcotic analgesic, a calcium channel blocker, an excitatory amino acid antagonist, an EC 3.4.21.26 (prolyl oligopeptidase) inhibitor, an environmental contaminant, a xenobiotic and a geroprotector. It is a member of 1,2,4-triazines, a primary arylamine and a dichlorobenzene. |
| Classification | Small molecule |
| Drug class | sodium channel blockers, signal transduction modulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nnc(-c2cccc(Cl)c2Cl)c(N)n1 |
Identifiers
| PDB | — |
| CAS-ID | 84057-84-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL741 |
| ChEBI ID | 6367 |
| PubChem CID | 3878 |
| DrugBank | DB00555 |
| UNII ID | U3H27498KS (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SCN2A
SCN2A
Organism
Homo sapiens
Gene name
SCN2A
Gene synonyms
HBA, NAC2, SCN2A1, SCN2A2
NCBI Gene ID
Protein name
sodium channel protein type 2 subunit alpha
Protein synonyms
HBSC II, Sodium channel protein brain II subunit alpha, Sodium channel protein type II subunit alpha, sodium channel protein, brain type 2 alpha subunit, sodium channel, voltage-gated, type II, alpha 1 polypeptide, sodium channel, voltage-gated, type II, alpha 2 polypeptide, sodium channel, voltage-gated, type II, alpha subunit, voltage-gated sodium channel subtype II, Voltage-gated sodium channel subunit alpha Nav1.2, voltage-gated sodium channel type II alpha subunit
Uniprot ID
Mouse ortholog
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—
Variants
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Financial
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Estimated US medical usage
Lamotrigine
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Trends
PubMed Central
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Additional graphs summarizing 19,510 documents
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Safety
Black-box Warning
Black-box warning for: Lamictal, Lamotrigine er, Lamotrigine extended release, Lamotrigine lamotrigine, Subvenite
Adverse Events
Top Adverse Reactions
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82,068 adverse events reported
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