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lamotrigine

Generic: LAMOTRIGINE·Brand: LAMICTAL, LAMICTAL CD, LAMICTAL ODT, LAMICTAL XR, LAMOTRIGINE, Lamictal, SUBVENITE, Subvenite

lamotrigine: sourced relationships with 1 company · 2 clinical trials tracked · 2 FDA decisions.

lamotrigine evidence translation

What we can confirm

2 FDA records · 2 tracked trials

What it means

Source-backed records connect lamotrigine to TEVA; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could lamotrigine → TEVA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors

Related indications

Healthy Volunteers
Dated Pipeline Records (1)
CompanyDated record stage
Teva Pharmaceutical Industries Limited (TEVA)
Reported 2006-06-21 · Current development: unknownSource
Approved
Clinical Trial Registry Records (2)

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

NCT06929273Registry updated 2026-09-14·Phase 3·BMY
Recruiting

Primary endpoint: Number of participants with treatment emergent adverse events (TEAEs)

Interventionalopen450 targetStarted 2025-07Completion 2028-0650 sites · United StatesBristol-Myers Squibb

A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

NCT06729970Registry updated 2026-02-24·Phase 1
Completed

Primary endpoint: Maximum observed plasma concentration (Cmax)

Interventionalopen133 enrolledStarted 2024-12Completion 2026-011 site · United StatesKaruna Therapeutics
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE Lamotrigine orally disintegrating tablets are 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. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older : Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valpro(TEVA)FDA ↗
ANDA076388OralTablet
Approval1 INDICATIONS AND USAGE Lamotrigine orally disintegrating tablets are 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. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older : Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valpro(TEVA)FDA ↗
ANDA076420OralTablet, For Suspension

Frequently asked questions

Which companies have sourced relationships with lamotrigine?

lamotrigine has dated SEC/FDA relationship records for Teva Pharmaceutical Industries Limited.

How many clinical trials involve lamotrigine?

BioSniper tracks 2 clinical trials involving lamotrigine.

What is lamotrigine's latest FDA decision?

The most recent tracked FDA decision for lamotrigine is Approval for 1 INDICATIONS AND USAGE Lamotrigine orally disintegrating tablets are 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. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older : Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valpro, dated August 30, 2006.