SUBVENITE (lamotrigine)
Subvenite (lamotrigine) is an anti-epileptic drug and mood stabilizer. It is indicated as adjunctive therapy for patients aged 2 years and older with partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures, and seizures associated with Lennox-Gastaut syndrome. It is also indicated for conversion to monotherapy in patients aged 16 years and older with partial-onset seizures who are currently receiving a single specific anti-epileptic drug (carbamazepine, phenytoin, phenobarbital, primidone, or valproate). For Bipolar I disorder, Subvenite is used as maintenance treatment to delay the time to occurrence of mood episodes in patients treated for acute episodes with standard therapy. **Limitations of Use:** It is not recommended for the acute treatment of manic or mixed episodes, and its use as initial monotherapy for epilepsy has not been established.
How SUBVENITE Works
While the precise mechanism of action is unknown, Subvenite is proposed to inhibit voltage-sensitive sodium channels. This action stabilizes neuronal membranes and consequently modulates the presynaptic release of excitatory amino acids, such as glutamate and aspartate. By regulating these neurotransmitters, the medication helps suppress seizure spread and contributes to mood stabilization. In vitro studies indicate it does not significantly inhibit NMDA-receptor-mediated activity.
Details
- Status
- Prescription
- First Approved
- 2025-09-16
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
SUBVENITE Approval History
What SUBVENITE Treats
5 indicationsSUBVENITE is approved for 5 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Partial-Onset Seizures
- Generalized Tonic-Clonic Seizures
- Lennox-Gastaut Syndrome
- Bipolar Disorder
SUBVENITE Boxed Warning
SERIOUS SKIN RASHES See full prescribing information for complete boxed warning. Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine, the active ingredient in SUBVENITE. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: coadministration with valproate. exceeding recommended initial dose of SUBVENI...
WARNING: SERIOUS SKIN RASHES See full prescribing information for complete boxed warning. Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine, the active ingredient in SUBVENITE. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: coadministration with valproate. exceeding recommended initial dose of SUBVENITE. exceeding recommended dose escalation for SUBVENITE. presence of the HLA-B*1502 allele. ( 5.1 ) Benign rashes are also caused by lamotrigine, the active ingredient in SUBVENITE; however, it is not possible to predict which rashes will prove to be serious or life threatening. SUBVENITE should be discontinued at the first sign of rash, unless the rash is clearly not drug related. ( 5.1 ) WARNING: SERIOUS SKIN RASHES SUBVENITE can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by lamotrigine include (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, (3) exceeding the recommended dose escalation for lamotrigine, or (4) the presence of
SUBVENITE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SUBVENITE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
41 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06929273 | CN012-0038 U1111-1316-9287, 2024-520259-26 | Ph 3 | recruiting | A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) |
| NCT06184581 LiLa-Bipolar | 2023-509607-32-00 10.46540/2096-00007B | Ph 4 | recruiting | Lithium Versus Lamotrigine in Bipolar Disorder, Type II |
| NCT06729970 | CN012-0035 | Ph 1 | completed | A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants |
| NCT04770493 results posted | 2004002676 R21AA028394 | Ph 2 | completed | Enhancing the Effects of Alcohol Treatment With Lamotrigine |
| NCT05881928 | lamotrigine , sodium valproate | Ph 4 | not yet recruiting | Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study |
| NCT04602221 results posted | 1289-0057 | Ph 1 | completed | A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine |
| NCT03504501 SynCoRAS | SYN-1748-MAL-0030-I 2016-005022-10 | Ph 2 | terminated | Synaptic Plasticity and Cognitive Function in RASopathies |
| NCT02158585 results posted | Zhang-001 | Ph 2 | completed | Study of Lamotrigine to Treat Ménière's Disease |
| NCT00571246 | 0705002634 | Ph 3 | withdrawn | The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder |
| NCT00618241 GRANOLA | UMCN-AKF 07.06 | Ph 1 | completed | Pharmacokinetic Study on Raltegravir and Lamotrigine |
| NCT01588457 SMART results posted | HSC20110361H 1P30MH086045-01A2 | Ph 4 | completed | Sequential Multiple Assignment Treatment for Bipolar Disorder |
| NCT02708849 results posted | 1501015203 | Ph 1 | terminated | The Sustained Effects of Ketamine |
| NCT03695094 results posted | UP0070 2018-001941-16 | Ph 1 | completed | A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil |
| NCT02256124 NF1-EXCEL | MEC-2013-460 2013-003405-26, NL 44912.078.13 | Ph 2, Ph 3 | terminated | Effect of Lamotrigine on Cognition in NF1 |
| NCT01674010 results posted | ELND005-BPD201 2012-001935-30 | Ph 2 | terminated | Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder |
| NCT04015687 | AG881-C-006 | Ph 1 | completed | A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults |
| NCT02389712 FLAME results posted | 13-003545-1 UL1TR000135 | Ph 4 | terminated | 16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression |
| NCT03898011 | LMTR-270418 v.1.1 01/29/2019 | Ph 1 | completed | A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions |
| NCT01015586 results posted | HR#19550 K23AA017666 | Ph 4 | completed | Treatment of Alcohol Dependence and Comorbid Bipolar Disorder |
| NCT01142310 results posted | 122009-028 R01MH082845 | Ph 4 | completed | Reversing Corticosteroid Induced Memory Impairment |
| NCT02081287 | DBDAT-2013-MJM | Ph 1 | completed | Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder? |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02556060 | TCHIRB-102309 | Ph 2, Ph 3 | completed | Lamotrigine for Ketamine Dependence Trial |
| NCT01357902 | 115261 | Ph 1 | completed | Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China |
| NCT01891890 COPE results posted | IRB00066541 PCORI 527 | Ph 3 | terminated | Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) |
| NCT00627575 | LEP108937 | Ph 1 | completed | AED/Statin Interaction Study |
| NCT00907985 | 112676 | Ph 1 | terminated | A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects |
| NCT01733394 | EQUIGEN Single Dose Protocol 005-1005 | Ph 4 | completed | Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study) |
| NCT02513654 | 114536 | Ph 1 | completed | Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects |
| NCT01602510 results posted | 113783 | Ph 3 | completed | Lamotrigine Phase III Study in Bipolar I Disorder |
| NCT00579982 results posted | LBI108884 | Ph 3 | completed | An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder |
| NCT01939561 | 2013-MY 2013-003309-24 | Ph 3 | completed | Lamotrigine as Treatment of Myotonia |
| NCT01042496 1HMRS-BP results posted | 09-004163 R01MH079261-01A2 | Ph 3 | completed | Bipolar Depression Before and After Lamotrigine Treatment |
| NCT02303106 | AKF-386 | Ph 4 | completed | Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study |
| NCT01888731 | 717/09 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition |
| NCT01888757 | 718/09 | Ph 1 | completed | Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition |
| NCT01888263 | 672/09 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition |
| NCT01888250 | 671/09 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition |
| NCT01864551 OCTLPODEPWBD | TSGH 097-05-061 | Ph 4 | completed | Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder |
| NCT01618825 | Ipca/BA/1264034 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition |
| NCT01618799 | Ipca/BA/1264033 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUBVENITE FDA Label Details
Indications & Usage
FDA Label (PDF)SUBVENITE is indicated for the treatment of Epilepsy; Partial-Onset Seizures; Generalized Tonic-Clonic Seizures; Lennox-Gastaut Syndrome; Bipolar Disorder.
WARNING: SERIOUS SKIN RASHES See full prescribing information for complete boxed warning. Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine, the active ingredient in SUBVENITE. The ra...
SUBVENITE Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for SUBVENITE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.