Delving into the Latest Updates on Lacosamide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Erlosamide, Harkoseride, Lacosamide (JAN/USAN/INN)

+ [16]

Target

Sodium channels

Action

blockers

Mechanism

Sodium channels blockers

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

EpilepsyEpilepsy, Tonic-ClonicEpilepsy, Idiopathic Generalized+ [2]

Inactive Indication

Brain Injuries, TraumaticDiabetic NeuropathiesDiabetic peripheral neuropathic pain+ [9]

Originator Organization

UCB SA

Active Organization

Aesica Pharmaceuticals GmbHUCB Biopharma SRL

Overseas Pharmaceuticals Ltd.

+ [11]

Inactive Organization

UCB Pharma GmbHUCB Biosciences, Inc.UCB BioSciences GmbH

License Organization

UCB SA

Drug Highest PhaseApproved

First Approval Date

European Union (29 Aug 2008),

Epilepsies, Partial

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC13H18N2O3

InChIKeyVPPJLAIAVCUEMN-GFCCVEGCSA-N

CAS Registry175481-36-4

Status epilepticus (SE) is an acute and critical form of neurological and systemic diseases involving multiple clinical disciplines, with an annual incidence of (20-73) per 100,000 people and a clinical case fatality rate of 20%. Although there are many causes of SE, the primary goal of treatment is to terminate the seizures quickly, and timely and standardized treatment can reduce mortality and improve prognosis. The prognosis is closely related to the duration of the episode, and the longer the episode, the worse the prognosis. If seizures of convulsive status epilepticus persist for more than 10 minutes and are not provided with optimal therapeutic intervention, serious adverse outcomes and even death are likely to occur. How to effectively terminate status epilepticus and actively find effective, reliable and safe treatment options is a key research problem at present. Due to critical illness, limited treatment options, and poor prognosis, new treatments are urgently needed to terminate persistent epileptic activity.
Lacosamide (LCM) is a third-generation new antiepileptic drug, which was approved in 2008 for the additive treatment of patients aged 16 years and older with focal seizures, with or without generalized seizures. In 2017, it was extended to patients over 4 years of age. Lacosamide is an anticonvulsant drug with a new dual mechanism of action: first, lacosamide antagonizes the glycine site of N-methyl-D-aspartate (NMDA) receptor; Second, lacosamide selectively acts on the slow inactivation of sodium channels and prolongs the inactivation time of sodium channels, which can more effectively reduce sodium influx and reduce the excitability of neurons, so as to achieve the purpose of treating epilepsy. Lacosamide exhibits linear pharmacokinetics, high oral bioavailability, protein binding of < 15%, rapid and almost complete absorption in a single oral dose, and maximum plasma concentrations within 1 to 4 hours. A number of randomized controlled clinical studies and real-world studies abroad have shown that lacosamide can significantly improve the effective rate and seizure-free rate of epilepsy control, and it is well tolerated and has fewer adverse reactions. The 2022 Chinese Expert Consensus on the Diagnosis and Treatment of Post-stroke Epilepsy recommended lacosamide injection as a first-line drug for non-convulsive status epilepticus after stroke, and the Chinese Expert Consensus on the Diagnosis and Treatment of Status Epilepticus in Children (2022) recommended that lacosamide be considered as an additive treatment for refractory convulsive status epilepticus in children > 60 minutes . There is a lack of clinical research data on the efficacy and safety of intravenous bolus lacosamide for status epilepticus, including convulsive status epilepticus and non-convulsive epilepticus.

Start Date06 Jun 2025

Sponsor / Collaborator

Second Affiliated Hospital of Guangzhou Medical University

[+4]

CTR20251369

/ CompletedNot Applicable

评估受试制剂拉考沙胺颗粒（规格：1 g: 0.1 g）与参比制剂拉考沙胺干糖浆（Vimpat® ）在健康成年参与者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study evaluating the test product, lacosamide granules (strength: 1 g: 0.1 g), and the reference product, lacosamide dry syrup (Vimpat®) in healthy adult participants under the fasting state

主要试验目的：研究空腹状态下单次口服受试制剂拉考沙胺颗粒（规格：1 g: 0.1 g）与参比制剂拉考沙胺干糖浆（Vimpat® ，规格：10%；UCB日本株式会社生产）在健康参与者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂拉考沙胺颗粒（规格：1 g: 0.1 g）和参比制剂拉考沙胺干糖浆（Vimpat® ）在健康参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation lacosamide granules (specifications: 1 g: 0.1 g) and the reference preparation lacosamide dry syrup (Vimpat®, specification: 10%; produced by UCB Japan Co., Ltd.) in healthy participants after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. The secondary purpose of the study is to study the safety of the test preparation lacosamide granules (specifications: 1 g: 0.1 g) and the reference preparation lacosamide dry syrup (Vimpat®) in healthy participants.

Start Date20 May 2025

Sponsor / Collaborator

Hainan Weikang Pharmaceutical Qianshan Co Ltd.

CTRI/2025/04/084766

/ Not yet recruitingNot Applicable

A Randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Test product (T): Lacosamide SR 200 mg Tablet of Eris Lifesciences Limited India with Reference product (R): MOTPOLY XR (Lacosamide Extended Release) Capsules 200 mg Marketed by Aucta Pharmaceuticals, Inc. Piscataway in healthy, adult, human subjects under fasting condition. - NIL

Start Date23 Apr 2025

Sponsor / Collaborator

Eris Lifesciences Ltd.

100 Clinical Results associated with Lacosamide

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100 Translational Medicine associated with Lacosamide

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100 Patents (Medical) associated with Lacosamide

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1,901

Literatures (Medical) associated with Lacosamide

01 Nov 2025·EPILEPSY & BEHAVIOR

Examining psychiatric and cognitive adverse effects of brivaracetam, clobazam, lacosamide, eslicarbazepine, and perampanel in a veteran population

Article

Author: Jimenez, Anthony D ; Gopaul, Margaret ; Orner, Michelle ; DeBonis, Danny ; Nuthalapati, Poojith ; Altalib, Hamada H ; Okafor, Chinenye M

INTRODUCTION:

Epilepsy is a chronic neurological disorder, affecting approximately 50 million people worldwide. There is limited data on the use of newer anti-seizure medicines (ASMs) and their cognitive and psychiatric adverse effects (AEs), despite increasing use. We aimed to describe the AE profile of newer ASMs in the real-world veteran population with Epilepsy comparing those who develop cognitive or psychiatric AEs to those who did not.

METHODS:

A retrospective analysis of veterans (n = 2636) diagnosed with epilepsy via ICD-10 codes was conducted in collaboration with the Veterans Affairs (VA) Office Quality and Patient Safety Analytics and Performance Integration program. Neurology notes of veterans diagnosed with epilepsy, between January 2011 and June 2022 across the VA system were sampled to evaluate cognitive and psychiatric AEs. For this index study, only patients who were prescribed any of the five newer anti-seizure medications (brivaracetam, clobazam, lacosamide, eslicarbazepine, and perampanel) were included. Selection of these ASMs were made a priori as these were the most recently approved ASMs for use in the VA.

RESULTS:

Among the 2636 Veterans that were included in the index study, median age (Q1-Q3) was 64 (50-73) years with 88.1 % male participants, a population known to have higher prevalence of psychiatric and cognitive disorders. Overall, 70.7 % White Veterans, and 6.5 % Hispanic. 86.8 % were prescribed lacosamide while only 4.1 %, 4.3 %, 4.4 %, and 4.8 % were prescribed perampanel, clobazam, brivaracetam, and eslicarbazepine respectively. Overall, 63 (2.4 %) and 39 (1.5 %) Veterans reported cognitive and psychiatric AEs, respectively. Veterans with epilepsy were more likely to experience cognitive AEs if they were independently older (p = 0.004) and on Perampanel (OR 2.58, p = 0.03). Similarly, psychiatric AEs were more likely among those on Perampanel (OR 4.49), whereas they were less frequent in those taking frequent lacosamide (OR 0.38). Cognitive or psychiatric AEs often lead to treatment discontinuation in this population.

CONCLUSION:

In a population of veterans with epilepsy, clinicians should exercise caution in monitoring for cognitive and psychiatric adverse effects prescribed with the newer ASMs. Further research could help elucidate the dosage and delay at which these side effects would occur after treatment initiation.

01 Oct 2025·TALANTA

Quantitative dried blood spot microsampling for therapeutic drug monitoring of -antiseizure medications by design of experiment and UHPLC-MS/MS

Article

Author: Cancellerini, Chiara ; Casadei, Francesco ; Bisulli, Francesca ; Derus, Nicolas ; Fiori, Jessica ; Esposito, Erika ; Merlotti, Alessandra ; Beatrice Belotti, Laura Maria ; Mostacci, Barbara ; Caravelli, Alice ; Soldà, Martina ; Vignatelli, Luca ; Licchetta, Laura

BACKGROUND:

Therapeutic drug monitoring (TDM) of Antiseizure Medications (ASMs) is an essential tool for persons with epilepsy (PwE). Compared to traditional venipuncture, microsampling requires lower blood volume through less painful and invasive fingerprick offering a sampling methodology potentially performed at-home. This study aimed to validate the extraction method of ASMs from Capitainer®-qDBS microsampling. Five ASMs were considered. According to EMA guidelines, through technical and clinical validation, ASMs' quantification from qDBS device was performed by UHPLC-MS/MS. Extraction parameters were optimized by Design of Experiment. Clinical validation was performed to compare ASMs concentrations in Capitainer®-qDBS with those in plasma in 30 PwE.

RESULTS:

The method used in the chosen extraction procedure was proven to be accurate and precise. Intra and inter-assay reproducibility analyses showed accuracy and precision ≤15 % across the calibration range. Recovery was >75 %, and matrix effect >75 %, for most of the ASMs analyzed. Stability was tested at 7, 15, and 30 days of storage, showing mutual robustness at 30 days at room temperature. No hematocrit effect was observed over a range of 20-70 %. Linear regression and Bland-Altman analysis indicated a good correlation for the ASMs considered.

SIGNIFICANCE:

A UHPLC-MS/MS assay was developed and validated according to EMA guidelines for quantifying ASMs from qDBS devices. This validation has the advantage of allowing the potential to utilize the new microsampling qDBS device, providing a patient-friendly approach to blood sampling eventually even at-home.

01 Oct 2025·JOURNAL OF APPLIED TOXICOLOGY

Impact of Lacosamide, Silver Nanoparticles, and Their PEG‐Conjugates on Life History Traits and Behavioral Responses in para^bss1 Mutant Drosophila

Article

Author: Bhavi, Santosh Mallikarjun ; Singh, Sapam Riches ; Thokchom, Bothe ; Yarajarla, Ramesh Babu ; Abbigeri, Megha B. ; Kulkarni, Sudheendra Rao

ABSTRACT:

The present study investigates the effects of lacosamide (LCM), silver nanoparticles (AgNPs), and their polyethylene glycol (PEG)‐based conjugates on parabss1 mutant Drosophila melanogaster, a model for epilepsy. Flies were cultured on standard wheat cream agar medium at 22± 1°C and exposed to three concentrations (2.5, 5, and 10 μg/mL) of each treatment. The size of the AgNPs was noted to be 8.21 ± 0.40 nm. Key life history traits and behavioral assays were assessed. Fecundity and fertility were highest in flies treated with the highest dose of LCM, the middle dose of AgNPs, and the lowest dose of the conjugate, relative to controls. Similarly, survival rates were enhanced in these treatment groups. Behavioral assays revealed that adult flies treated with higher concentrations of LCM, AgNPs, and the conjugate exhibited improved climbing performance, successfully reaching 16 cm within 1 min. Larval crawling assays showed co‐ordinated movements in lower dose LCM and AgNPs treated groups, while larvae exposed to the conjugate demonstrated impaired locomotion with circular movement patterns. Ovariole counts across treatments remained within the physiological range (18–43), indicating preserved reproductive potential. Overall, our findings suggest that LCM, AgNPs, and their PEG‐conjugates exhibit dose‐dependent effects on reproductive and behavioral parameters in parabss1 mutants, with the conjugate showing differential influence on larval motor coordination. These insights highlight the therapeutic potential and limitations of nanoparticle‐assisted drug delivery in neuro‐genetic models of epilepsy.

36

News (Medical) associated with Lacosamide

27 Jun 2025

·www.fiercepharma.com

UCB plots regulatory filings as Fintepla shows potential to treat a 3rd epilepsy disorder

After scoring approvals in two epilepsy disorders, UCB's Fintepla has excelled in a phase 3 trial in patients with a different epilepsy condition. UCB’s Fintepla has been approved to treat seizures associated with two epilepsy disorders and now has posted data that could pave the way for its use in another epilepsy condition.A phase 3 trial of Fintepla in patients with the ultra-rare CDKL5 deficiency disorder (CDD) has achieved its primary and most of its secondary endpoints, the Brussels-based company said in a June 27 press release.The study enrolled 87 participants between the ages of 1 and 35 who have been diagnosed with CDD and uncontrolled seizures. In comparing the performance of Fintepla to placebo, the primary endpoint was based on the median percent change in countable motor seizure frequency between baseline and the titration-plus-maintenance trial phase. UCB said it will present the results at an upcoming medical conference.In a statement, UCB's Fiona du Monceau, EVP of patient evidence, said the company looks forward to working with regulators to make the drug available "as soon as possible."Fintepla was well-tolerated in the trial, with its safety profile consistent with previous studies. UCB is conducting a 54-week extension phase of the trial to investigate the long-term tolerability of the oral treatment.The median age for CDD onset is 6 weeks, UCB said. The genetic condition causes neurodevelopmental delays resulting in intellectual, motor, cortical visual, and sleep impairments. It is estimated that CDD affects approximately 1 in 40,000 to 60,000 live births.Fintepla was first approved in 2020 to treat seizures associated with Dravet syndrome, a rare, severe form of epilepsy. Two years later, Fintepla gained expansion into a larger epilepsy indication, Lennox-Gastaut syndrome, which affects between 1 to 2 million people worldwide. Months before the Lennox-Gastaut nod, UCB paid $1.9 billion to acquire Fintepla and its developer, California-based biotech Zogenix. The deal was a strategic fit for UCB, which then had four epilepsy drugs on the market but was losing market exclusivity for the most successful one, Vimpat, a blockbuster that outsold the other three combined.Fintepla appears to be on a blockbuster track of its own, with sales reaching 340 million euros ($368 million) last year, which was a bump from sales of 226 million euros ($243 million) in 2023. After a 2023 settlement in a patent dispute, UCB expects to retain U.S. exclusivity on Fintepla until 2033.

Phase 3AcquisitionDrug ApprovalClinical Result

13 Apr 2025

·pharma.economictimes.indiatimes.com

Glenmark, Sun Pharma, Zydus recall products in US

New Delhi: Drug makers Glenmark , Sun Pharma and Zydus are recalling products in the US for manufacturing issues, the US Food and Drug Administration ( USFDA ) said in its latest Enforcement Report. As per the US health regulator, Mumbai-based Glenmark is recalling over 25 products in the US market due to Current Good Manufacturing Practice (CGMP) deviations. New Jersey-based Glenmark Pharmaceuticals Inc is recalling affected lots of medications like Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets in America, the USFDA said. It is also recalling products like Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets and Rufinamide Tablets. The company initiated the Class II recall on March 13 this year. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. A US-based subsidiary of Sun Pharma is recalling around 13,700 bottles of Gabapentin capsules, a medication used to treat and prevent seizures in people with epilepsy. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot due to 'Cross Contamination', the USFDA said. The company initiated the Class III recall on March 4, 2025. The US health regulator said Zydus Pharmaceuticals (USA) Inc is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets, USP 10 mg, a medication used to treat mental health conditions, like schizophrenia and bipolar disorder. The drug firm is recalling the affected lot due to CGMP deviations , the USFDA said. There was "presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit," it added. The company initiated the Class II recall on April 3, 2025.

16 Dec 2024

·pharma.economictimes.indiatimes.com

Glenmark launches oral solution for Epilepsy treatment

New Jersey: Glenmark Pharmaceuticals Inc., USA announced the launchof Lacosamide Oral Solution , 10 mg/mL, indicated to support the treatment of patients with epilepsy. The launched solution is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat oral solution, 10 mg/mL of UCB, Inc whose annual sales are estimated around $57 million for the 12-month period ending October 2024. Besides this launch currently the drug maker has 51 ANDA’s pending approval with the USFDA and the company is also exploring other partnership opportunities to expand its pipeline and portfolio. Commenting on the launch, Marc Kikuchi, President and Business Head, North America, said, “We are excited to announce the launch of Lacosamide oral solution, 10 mg/mL, strengthening our commitment to bring to market quality and affordable alternatives for patients .” By Online Bureau ,

Drug Approval

100 Deals associated with Lacosamide

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External Link

KEGG	Wiki	ATC	Drug Bank
D07299	Lacosamide	N03AX18	DB06218

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	European Union	Accord Healthcare SLU	18 Sep 2017
Epilepsy	Iceland	Accord Healthcare SLU	18 Sep 2017
Epilepsy	Liechtenstein	Accord Healthcare SLU	18 Sep 2017
Epilepsy	Norway	Accord Healthcare SLU	18 Sep 2017
Epilepsy, Tonic-Clonic	Japan	UCB Japan Co. Ltd.	04 Jul 2016
Epilepsy, Idiopathic Generalized	Australia	UCB Australia Pty Ltd.	20 Jul 2009
Seizures	Australia	UCB Australia Pty Ltd.	20 Jul 2009
Epilepsies, Partial	European Union	UCB Pharma SA	29 Aug 2008
Epilepsies, Partial	Iceland	UCB Pharma SA	29 Aug 2008
Epilepsies, Partial	Liechtenstein	UCB Pharma SA	29 Aug 2008
Epilepsies, Partial	Norway	UCB Pharma SA	29 Aug 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Epilepsy, Complex Partial	Phase 3	United States	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Australia	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Austria	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Canada	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Denmark	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	France	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Germany	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Ireland	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Italy	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Poland	UCB Biosciences, Inc.	01 Aug 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P9-9.015 (AAN2025)	Not Applicable	Excessive Daytime Sleepiness	207	Clonazepam	unbegwqddk(xvbonvijhf) = Among newer ASMs, there are differences in their tendency to cause excessive daytime sleepiness, with Clonazepam and Levetiracetam being more commonly associated with this side effect, thus warranting caution. Conversely, Perampanel and Lacosamide are less likely to cause daytime sleepiness, and ASM selection should be tailored to the sleep characteristics of epileptic patients. iglwazrmir (bcraslnjqu )	Positive	07 Apr 2025
P9-9.015 (AAN2025)	Not Applicable	Excessive Daytime Sleepiness	207	Levetiracetam		Positive	07 Apr 2025
NCT02408549 (EP0012, Pubmed \| Epilepsia) Manual	Phase 3	Seizures	239	Lacosamide	lrlqutjfpj(bzdadnsgzx) = kwogukwilw owsbdvqsma (vxoyrauxqs ) View more	Positive	26 Oct 2024
NCT02408549 (EP0012 \| VALUE, CTgov)	Phase 3	Epilepsy, Idiopathic Generalized \| Epilepsy, Tonic-Clonic	239	Lacosamide	akgcawjgzg = xdimhxnvtv rwrasrtxak (mxmpasweol, sopvngnxzm - bnilmznppg) View more	-	14 Dec 2023
NCT01969851 (SP0966, Pubmed \| Epilepsia)	Phase 2	Seizures \| Epileptic Syndromes	-	Lacosamide up to 12 mg/kg/day or 600 mg/day	stwfmoavbm(kfzfxyzdzd) = smhqpfqkcg kejorrcpke (dawzyxlgcc )	Positive	01 Nov 2023
CNS2023	Not Applicable	Epilepsy, Benign Neonatal	62	Lacosamide	wnwhrszpdp(lmnkzbnwxx) = Adverse events (AEs) were reported in 53%, none of which were attributed to lacosamide ecjfnjpujf (bbatedwqwc ) View more	-	01 Oct 2023
IEC2023	Not Applicable	Second line	67	Intravenous Lacosamide	qzqwhnopci(mzbcnphfdc) = 18 (26.9%) patient experienced bradycardia rvowkvzdtr (otqaxofrtu ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Seizures	-	Lacosamide	oeswcpskuc(tbudcwxhno) = No side effects pyobbtdwsh (yrxrcjtptk ) View more	-	04 Sep 2023
NCT00220337 (CTgov)	Phase 3	Diabetic Neuropathies	371	Lacosamide	qtpnxpbfcr = ybmpvudeua rcepfeppfn (febjargmyh, ecuqvttjgq - hxefqnjvar) View more	-	24 Jul 2023
NCT01964560 (EP0034, CTgov)	Phase 3	Epilepsies, Partial	540	Lacosamide	zdolorquhk = fkigupzkpd kcyndiojef (itphsghily, geuvpubdmi - fgbywsupwe) View more	-	25 Oct 2022
OS02.6.A (EANO2022)	Not Applicable	Brain Cancer	132	Lacosamide in monotherapy	ylbqgqauqg(riwipxkugm) = sinyijogwa crqwzbhpnq (xsocpqfmgi ) View more	Positive	05 Sep 2022