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Label indication LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) seizures. • generalized seizures of Lennox-Gastaut syndrome. FDA label
Also known as LAMICTAL XR, Lamictal
Lamotrigine · 8 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Lamotrigine Extended Release Tablets | EXPERIMENTAL | Lamotrigine Extended Release Tablets, 25 mg, 50 mg, 100 mg, 200 mg and 300 mgof Dr. Reddy's Laboratories Limited |
| LAMICTAL XR | ACTIVE_COMPARATOR | (containing Lamotrigine)Extended Release tablets 50 mg of GlaxoSmithKline Research Triangle Park, NC |
| Lamotrigine (chewable, dispersible) | EXPERIMENTAL | Lamotrigine Tablets (chewable, dispersible),25 mg of Dr. Reddy's Laboratories Limited |
| Lamictal | ACTIVE_COMPARATOR | Lamictal Tablets 25 mg of Glaxo SmithKline |
| Lamotrigine Tablets 200 mg | EXPERIMENTAL | Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited |
| Lamictal® 200 mg Tablets | ACTIVE_COMPARATOR | Lamictal® 200 mg Tablets of GlaxoSmithKline Inc |
| Name | Type | Description |
|---|---|---|
| Lamotrigine | DRUG | Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg |
| Lamictal® | DRUG | Lamictal® 200 mg Tablets |
Inclusion Criteria: Subjects were selected based on the following inclusion criteria: * Provide written informed consent. * Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. * Having a body mass index between 18.5 and 24.9 (both inclusive)...
Lamotrigine is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed, and the work falls within a general therapeutic area rather than a named disease category.
Lamotrigine targets the sodium channel proteins SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker at these targets. By blocking these sodium channels, the drug modulates the ion channel activity associated with this target class.
Lamotrigine is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor behind the clinical program for this asset.
Lamotrigine is in Phase 1 clinical development. It is an investigational drug and has not been approved. Eight trials have been completed and none are currently active, with a total of 284 participants enrolled across the program.
Completed Phase 1 trials include NCT01888757 and NCT01888731, both bioequivalence studies of 50 mg extended-release tablets in healthy male volunteers in India, plus NCT01888263 and NCT01888250, which tested 200 mg extended-release tablets under fed and fasting conditions.
The Lamotrigine trials were randomized and active controlled, though not double blind. They enrolled healthy adult male volunteers aged 18 years and older in India, and none of the studies used biomarker-based patient selection.