Data updated: May 26, 2026
VIMPAT (lacosamide)
CNS
Approved 2008-10-28
VIMPAT is indicated for the treatment of Partial-Onset Seizures; Generalized Tonic-Clonic Seizures.
Source: FDA Label • UCB INC
How VIMPAT Works
While the precise mechanism in humans is not fully understood, lacosamide has been shown in studies to selectively enhance the slow inactivation of voltage-gated sodium channels. This biological activity results in the stabilization of hyperexcitable neuronal membranes. By stabilizing these membranes, the medication inhibits the repetitive neuronal firing associated with seizure activity.
8
Indications
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Phase 3 Trials
17
Years on Market
Details
- Status
- Prescription
- First Approved
- 2008-10-28
- Patent Cliff
- 2026
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- SOLUTION, TABLET
VIMPAT Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
199 FDA actions from 2008 to 2023 · 6 indication expansions
Sep 2021 SUPPL
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Jan 2017 SUPPL
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Nov 2016 SUPPL
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Jul 2016 SUPPL
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Jun 2016 SUPPL
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May 2016 SUPPL
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Jun 2014 SUPPL
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Apr 2014 SUPPL
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Oct 2013 SUPPL
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Oct 2013 SUPPL
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Dec 2012 SUPPL
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What VIMPAT Treats
2 indicationsVIMPAT is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
- Generalized Tonic-Clonic Seizures
Source: FDA Label
VIMPAT Competitive Set
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Direct competitors
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Indication competitors
10
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Drugs Similar to VIMPAT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
42 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05603702 STTEPP | SHHBRBAPSM35 1R01DK132709-01 | Ph 1 | recruiting | STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis |
| NCT06866691 SEIZE-TBI | IRB00123210 | Ph 4 | recruiting | Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide |
| NCT01345058 results posted | 2010-P-001630 | Ph 3 | completed | Add on Lacosamide Versus High Dose Monotherapy |
| NCT07412132 | Lacosamide on bipolar disorder | Ph 3 | recruiting | Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II. |
| NCT04627285 results posted | EP0151 2020-001478-30, 2022-502639-21-00 | Ph 3 | completed | A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment |
| NCT02582866 results posted | SP1042 2015-001549-96 | Ph 3 | completed | A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994 |
| NCT03436433 results posted | Pro00081334 | Ph 2 | terminated | Seizure Prophylaxis in Patients With Glioma or Brain Metastasis |
| NCT02710890 ASPIRE results posted | EP0060 2014-003294-42 | Ph 2, Ph 3 | completed | Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children. |
| NCT03777956 | LACOSAMIDE-2018 2018-003110-40 | Ph 2 | terminated | The Effect of Lacosamide in Peripheral Neuropathic Pain |
| NCT01964560 results posted | EP0034 2012-005012-26 | Ph 3 | completed | A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures |
| NCT00938912 results posted | SP848 2011-001559-35 | Ph 2 | completed | An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy |
| NCT01832038 results posted | EP0009 | Ph 3 | completed | Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures |
| NCT02477839 results posted | SP0967 2013-000717-20 | Ph 3 | completed | Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures |
| NCT03271528 results posted | H-36766 1R21AA026389-01 | Ph 1 | completed | Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers |
| NCT01243177 SP0993 results posted | SP0993 2010-019765-28 | Ph 3 | completed | Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older |
| NCT00832884 | 00570-FB | Ph 4 | completed | The Safety of Intravenous Lacosamide |
| NCT03186040 | G29007 | Ph 1, Ph 2 | completed | Open-label Clinical Trial of Lacosamide in ALS |
| NCT02124564 results posted | EP0057 | Ph 3 | completed | A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures |
| NCT01969851 results posted | SP0966 2012-001446-18 | Ph 2 | completed | A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures. |
| NCT00938431 results posted | SP0847 2011-001558-27 | Ph 2 | completed | A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures |
| NCT01921205 results posted | SP0969 2012-004996-38 | Ph 3 | completed | Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures |
| NCT01465997 results posted | SP0994 2010-021238-74 | Ph 3 | completed | Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older |
| NCT01484977 VERVE results posted | SP0980 2011-002461-37 | Ph 3 | completed | eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam |
| NCT00530855 results posted | SP0904 2007-005440-25 | Ph 3 | completed | Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures |
| NCT00955357 results posted | SP0954 2009-011181-28 | Ph 4 | completed | Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures |
| NCT01118949 results posted | SP0961 2014-004379-22 | Ph 2 | completed | Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy |
| NCT01118962 results posted | SP0962 2014-004375-23 | Ph 2 | completed | Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy |
| NCT00655486 results posted | SP0926 2014-004384-21 | Ph 3 | completed | Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures |
| NCT00655551 results posted | SP0925 2014-004378-40 | Ph 3 | completed | Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures |
| NCT01235403 SELF results posted | SP1007 2010-019268-35 | Ph 4 | completed | Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01911975 | SFN-Lacosamide 2013-001511-70 | Ph 3 | completed | Safety and Tolerability of Lacosamide in Patients With Gain-of-function Nav1.7 Mutations Related Small Fiber Neuropathy |
| NCT01175954 | NEREG-002 | Ph 4 | completed | Cognitive and Behavioral Effects of Lacosamide |
| NCT02726867 | MAES-003 | Ph 3 | withdrawn | Levetiracetam, Lacosamide and Ketamine as Adjunctive Treatment of Refractory Status Epilepticus |
| NCT01375374 VICTOR results posted | SP0978 2010-022534-84 | Ph 3 | terminated | Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide |
| NCT01190098 results posted | UCB-SLEEP | Ph 4 | completed | Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy |
| NCT01724918 LIVE | LIVE 001 | Ph 2 | terminated | Lacosamide IV and EEG/EKG (LIVE) Study |
| NCT02342977 | 1408905316 | Ph 2 | withdrawn | Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: |
| NCT02409433 | 100739 | Ph 4 | terminated | Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management |
| NCT01530386 | SP1031 | Ph 1 | completed | A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects |
| NCT01450111 | SP0952 | Ph 1 | completed | To Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects |
| NCT01375387 | SP1046 2010-023164-40 | Ph 1 | completed | Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males |
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Trial Timeline
Full development history with FDA approval milestones
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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.
VIMPAT FDA Label Details
Indications & Usage
FDA Label (PDF)VIMPAT is indicated for the treatment of Partial-Onset Seizures; Generalized Tonic-Clonic Seizures.
VIMPAT Patents & Exclusivity
Exclusivity: Apr 2026
Exclusivity
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Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.