TheraRadar
Data updated: Sep 20, 2026

LACOSAMIDE · GLENMARK PHARMS LTD

Generic · see MOTPOLY XR
CNS Approved 2008-10-28

LACOSAMIDE is FDA-approved to treat 2 conditions (same as MOTPOLY XR).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
36
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-10-28
Routes
ORAL, INTRAVENOUS
Dosage Forms
TABLET, SOLUTION

Companies

GLENMARK PHARMS LTD SCIEGEN PHARMS UNICHEM ALKEM LABS LTD GLAND REGCON HOLDINGS Sun Pharma HAINAN POLY PROD DEVELOPMENT Fresenius Kabi Apotex ACELLA Teva ZYDUS PHARMS MSN ASPIRO MSN LABS PVT LTD KANCHAN HLTHCARE AMNEAL PHARMS Aurobindo Pharma MACLEODS PHARMS HETERO LABS LTD III Dr. Reddy's NOVITIUM PHARMA ALEMBIC SOMERSET THERAPS LLC CHARTWELL RX STERANCO HLTHCARE HETERO LABS LTD V ACCORD HLTHCARE Hikma WESTMINSTER PHARMS AJENAT PHARMS
Active Ingredient: LACOSAMIDE

LACOSAMIDE Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
236 FDA actions from 2022 to 2026
Sep 2026 SUPPL
Mfg · Manufacturing (CMC)
Jul 2026 SUPPL
Mfg · Manufacturing (CMC)
Jun 2026 ORIGINAL
Update

What LACOSAMIDE Treats

2 indications

LACOSAMIDE is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as MOTPOLY XR (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

42 trials
Trial Sponsor ID Phase Status Title
NCT05603702 STTEPP SHHBRBAPSM35 1R01DK132709-01 Ph 1 active not 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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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

LACOSAMIDE FDA Label Details

Indications & Usage

LACOSAMIDE is FDA-approved to treat 2 conditions — same approved indications as MOTPOLY XR.

Looking for the branded version?

MOTPOLY XR

Full clinical data, patents, trials, and competitive landscape for lacosamide.

See MOTPOLY XR

Data Sources

FDA Approval: ANDA205006 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.