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Lamotrigine Generic "A"
Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability.
Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability. Used for Epilepsy (adjunctive therapy for partial seizures), Bipolar I disorder (maintenance treatment to delay time to occurrence of mood episodes).
At a glance
| Generic name | Lamotrigine Generic "A" |
|---|---|
| Sponsor | University of Cincinnati |
| Drug class | Anticonvulsant / Mood stabilizer |
| Target | Voltage-gated sodium channels; glutamate release inhibition |
| Modality | Small molecule |
| Therapeutic area | Neurology / Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Lamotrigine stabilizes neuronal membranes by blocking sodium channels, which prevents the repetitive firing of action potentials. It also inhibits the release of glutamate, an excitatory neurotransmitter, thereby reducing excessive neuronal activity. These combined effects make it effective as an anticonvulsant and mood stabilizer.
Approved indications
- Epilepsy (adjunctive therapy for partial seizures)
- Bipolar I disorder (maintenance treatment to delay time to occurrence of mood episodes)
Common side effects
- Rash (including Stevens-Johnson syndrome risk)
- Dizziness
- Ataxia
- Somnolence
- Headache
- Diplopia
- Nausea
Key clinical trials
- Lamotrigine Bioequivalence (PHASE4)
- A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects (PHASE1)
- Characterization of Epilepsy Patients BEEP 2b (PHASE1)
- A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults (PHASE1)
- Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study) (PHASE4)
- Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Chronic-Dose 4-Period Replicate Design (PHASE4)
- A Trial of Generic Substitution of Antiepileptic Drugs (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lamotrigine Generic "A" CI brief — competitive landscape report
- Lamotrigine Generic "A" updates RSS · CI watch RSS
- University of Cincinnati portfolio CI