Xcopri (cenobamate) / SK Bio, Angelini Group, Endo, Ono Pharma, Eurofarma, Dong-A - LARVOL DELTA

Comparative Effectiveness of Brivaracetam, Cenobamate, Lacosamide, and Perampanel in Focal Epilepsy. (PubMed, JAMA Neurol) - "Cenobamate was associated with a higher likelihood of treatment retention at 12 months compared with brivaracetam (OR, 0.43; 95% CI, 0.26-0.69; P < .001) and perampanel (OR, 0.56; 95% CI, 0.32-0.99; P = .047), with no significant difference vs lacosamide (OR, 0.81; 95% CI, 0.41-1.59; P = .53). These study findings suggest superior effectiveness of cenobamate over brivaracetam, lacosamide, and perampanel in adults with drug-resistant focal epilepsy in a large real-world setting."

Clinical • HEOR • Journal • CNS Disorders • Epilepsy

Long-Term Impact of Cenobamate on Cognition, Adaptive Behavior, and Quality of Life in Patients with Tuberous Sclerosis Complex. (PubMed, Neurol Ther) - "Our study suggested that cenobamate add-on therapy was effective and generally well tolerated in this cohort. Neuropsychological assessments suggest beneficial effects on executive functions, emotional well-being, social functioning, and quality of life. Furthermore, an improvement in parental stress also emerged. These findings could support clinicians in the decision-making process, evaluating cenobamate as an early treatment option in drug-resistant epilepsy."

HEOR • Journal • CNS Disorders • Epilepsy • TSC1 • TSC2

Long-term outcomes of responsive neurostimulation in dominant-hemisphere Rasmussen encephalitis. (PubMed, Acta Neurol Belg) - "He failed 10 antiseizure medications, steroids, IVIG, and rituximab...Initiation of cenobamate correlated with further reduction in long episodes...Literature reports similarly show 50-75% seizure reduction with RNS, status epilepticus control, and stabilization of cognitive function, while other neuromodulation approaches-including chronic cortical stimulation, thalamic DBS, GPi and zona incerta stimulation, rTMS, tDCS, and VNS-also show promise. Overall, neuromodulation represents a feasible and evolving strategy for managing RE-related EPC, especially in dominant-hemisphere cases where conventional surgery carries high risk."

Journal • CNS Disorders • Epilepsy

Cenobamate beyond Epilepsy: exploring associations with vascular risk factors through serological markers. (PubMed, Epilepsy Behav) - "While this retrospective study has inherent limitations, our results indicate potential CNB-associated changes in metabolic biomarkers. Definitive evaluation of CNB's vascular effects will require prospective, controlled, multicenter studies that integrate serial biomarker monitoring with clinical endpoints and adjusting for concomitant ASM use, particularly enzyme-inducing agents."

Journal • Cardiovascular • CNS Disorders • Dyslipidemia • Epilepsy • Metabolic Disorders • Vascular Neurology

Cenobamate's effect on mood and seizure frequency. (PubMed, Epilepsy Behav) - "Our findings suggest that CNB is a safe and effective adjunctive ASM that improves seizure control in PWE and that does not significantly change PHQ-9 scores. While better seizure control may mask the drug's potential effects on mood-as reduced seizure burden itself could influence depressive symptoms-its impact on individual mood was variable. These results highlight the need for further research."

Clinical • Journal • CNS Disorders • Depression • Epilepsy • Psychiatry

Freedon study: Real-life outcomes of cenobamate in different lines of treatment. (PubMed, Epilepsia) - "Cenobamate was effective and well tolerated in patients who had tried 2-6 prior ASMs in a real-world setting. High effectiveness was confirmed at 1 year, with better outcomes in earlier users."

Journal • CNS Disorders • Epilepsy

Do Cenobamate Pharmacokinetics Change with Co-Administered Antiseizure Medications? An Exploratory Analysis of Responder Patients with Focal Drug-Resistant Epilepsy. (PubMed, Pharmaceutics) - "Higher CNB concentrations were observed in patients co-treated with lacosamide, while concomitant topiramate was associated with lower exposure. Carbamazepine and valproate showed non-significant trends consistent with their known enzyme-inducing and inhibiting properties...These findings highlight the importance of therapeutic drug monitoring and individualized titration strategies to optimize efficacy and safety in clinical practice. These results should be regarded as exploratory and hypothesis-generating due to the small and monocentric sample size and need to be confirmed in larger, multicenter cohorts."

Journal • PK/PD data • CNS Disorders • Epilepsy

Healthcare resource utilization in adults with focal onset seizures before and after initiating cenobamate: A US database analysis. (PubMed, Epilepsy Res) - "Epilepsy-related hospitalizations and Emergency Room visits (indicators of seizures) were reduced in adult FOS patients with epilepsy 6, 12 and 18 months after initiating cenobamate as monotherapy or stable polytherapy, leading to reduced HCRUs and epilepsy costs."

HEOR • Journal • CNS Disorders • Epilepsy

Does adjunctive Cenobamate lead to a reduction in the use of vagal nerve stimulation? A long-term observational study of patients on the epilepsy surgery pathway. (PubMed, Epilepsy Behav) - "Adjunctive CNB has the potential to influence decision making in people with epilepsy. VNS deferral and/or deactivation as a result of significant seizure reduction with CNB has a significant economic impact."

Journal • Observational data • CNS Disorders • Epilepsy

Real-world disproportionality analysis of sleep disturbances associated with antiseizure medications in epilepsy: a pharmacovigilance study. (PubMed, Front Pharmacol) - "Significant signals were detected for sodium channel blockers eslicarbazepine, stiripentol, and cenobamate, as well as for mechanistically diverse agents vigabatrin, pregabalin, brivaracetam, and cannabidiol. The distinct disproportionality reporting profiles identified for some agents, which differ from prior evidence, necessitate careful clinical interpretation. Overall, this study elucidates the complex sleep safety profiles of ASMs, offering evidence to support more informed drug selection and monitoring in practice."

Adverse events • Journal • Real-world evidence • CNS Disorders • Epilepsy • Insomnia • Sleep Disorder

Efficacy and Safety of Adjunctive Cenobamate in Chinese Participants with Focal Seizure. (PubMed, Adv Ther) - P3 | "Cenobamate demonstrated a very favorable efficacy and safety profile in Chinese participants with focal seizures. The combination of cenobamate with both SCB and non-SCB treatments was effective in reducing seizure frequency and improved responder rates compared to placebo."

Clinical • Journal • CNS Disorders • Epilepsy

Safety and Effectiveness of Cenobamate in Pediatric Patients With Treatment-Resistant Epilepsy. (PubMed, Pediatr Neurol) - "Our study showed that initiating cenobamate as adjunctive therapy was effective and safe for pediatric patients with treatment-resistant epilepsy, reducing seizure frequency and establishing improved seizure control."

Journal • Anesthesia • CNS Disorders • Epilepsy • Pediatrics

Safety and Effectiveness of Cenobamate in Pediatric Patients with Refractory Epilepsy (ASHP 2025) - No abstract available

Clinical • CNS Disorders • Epilepsy • Pediatrics

Wide range of cenobamate doses associated with initial seizure freedom in patients with uncontrolled focal seizures: Post-hoc analysis of a phase 3, multicenter, open-label study. (PubMed, Epilepsy Behav) - "Of 62/240 patients achieving 12-month seizure freedom at last visit, 35/62 started their seizure-free interval at cenobamate doses ≤200 mg/day (24-month: 25/33). Attaining seizure freedom at a lower dose may be predictive of remaining seizure-free for a longer period. Further prospective research is needed to better define cenobamate's efficacy at lower doses."

Journal • P3 data • Retrospective data • CNS Disorders • Epilepsy

Quality of life and synergistic combinations of antiseizure medication in patients treated with cenobamate in early therapy lines for focal-onset seizures. (PubMed, Epilepsy Behav) - "Our study provides evidence that CNB in early therapy lines for focal-onset seizures is associated with an increased HrQoL. Low-dose clobazam can wok synergistically with CNB. The combination with SV2A modulators showed a positive trend."

HEOR • Journal • CNS Disorders • Epilepsy

Expanding the toolkit: An update on the evolution of new therapies for Lennox-Gastaut Syndrome. (PubMed, Semin Pediatr Neurol) - "The purpose of this paper is to address three such aspects of treatment evolution for LGS: (1) To review data supporting the repurposing of existing drugs for use in LGS, specifically, perampanel and cenobamate. (2) To present recent (soticlestat), ongoing (carisbamate, bexicaserin, clemizole) and upcoming (opakalim) clinical drug trials for LGS...With the richness of recent trial development for LGS combined with the nascence of clinical trials for specific genetic epilepsies comes a new era in which treatment options for LGS will continue to expand. Increasing understanding of the underlying genetic and molecular underpinnings of LGS should enable development of unique therapies, with the continued aims of sustained, durable seizure control and additional positive impact on central nervous system outcomes and beyond."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy

On December 9, SK Biopharmaceuticals announced that its innovative epilepsy drug “Cenobamate“ and sleep disorder treatment “Solriamfetol“ have received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) of China. (The Asia Business Daily)

China approval • Epilepsy • Sleep Disorder

Cenobamate in adult patients with epilepsy and intellectual disability. (PubMed, Seizure) - "In adult PWE and intellectual disability, cenobamate is similarly efficacious and tolerated as in patients without ID."

Journal • CNS Disorders • Developmental Disorders • Epilepsy • Mental Retardation

Evaluating the impact of cenobamate in the management in patients with drug resistant focal epilepsy - A retrospective real world observational study of patients attending NHS Greater Glasgow and Clyde. (PubMed, Epilepsy Res) - "These results offer insights for clinicians regarding the real-world effectiveness, retention rates, and healthcare cost implications of CNB therapy in a cohort consisting largely of patients with severe drug resistant epilepsy. Further studies are ongoing to assess the efficacy of CNB when used earlier and also to provide a comprehensive assessment of health care resource use in this real world settings."

Journal • Observational data • Real-world evidence • Retrospective data • CNS Disorders • Epilepsy

Cenobamate for drug-resistant epilepsy: Initial experience from a single tertiary centre. (PubMed, Can J Neurol Sci) - No abstract available

Journal • CNS Disorders • Epilepsy

Psychiatric effects of cenobamate in adults with epilepsy: A retrospective study. (PubMed, Epilepsy Behav) - "Cenobamate did not induce new psychiatric side effects and was well tolerated in patients with pre-existing psychiatric conditions and normal intellectual functioning. However, in individuals with intellectual disabilities and baseline psychiatric comorbidities, CNB may exacerbate irritability through multifactorial mechanisms."

Journal • Retrospective data • CNS Disorders • Developmental Disorders • Epilepsy • Mental Retardation • Psychiatry

Individual Alpha Frequency as an EEG Biomarker of Drug-Related Cognitive Burden in Epilepsy. (PubMed, Eur J Neurol) - "EEG background activity, assessed via IAF, is sensitive to cognitive impairment related to ASMs in PwE, demonstrated in both cross-sectional and longitudinal contexts. IAF is thus a promising, simple, cost-effective biomarker to monitor cognitive burden in clinical epilepsy management."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy

Efficacy and safety of cenobamate in developmental and epileptic encephalopathies: A systematic review and meta-analysis. (PubMed, Seizure) - "Cenobamate demonstrates promising efficacy in highly refractory DEEs, with over half of patients achieving ≥50 % seizure reduction and ∼10 % attaining seizure freedom despite extensive prior treatment failures. The high retention rate and manageable safety profile support its use as a valuable therapeutic option in this difficult-to-treat population."

Journal • Retrospective data • Review • Ataxia • CNS Disorders • Epilepsy • Movement Disorders

EpiTrack: Direct and indirect role in the assessment of executive functions and memory - Systematic review. (PubMed, Appl Neuropsychol Adult) - "Perampanel and Cenobamate exhibited a neutral cognitive profile, with scores stable at "moderate impairment" (29.67-30.04). Lamotrigine and Levetiracetam demonstrated persistent severe impairment. Brivaracetam improved from severe to moderate impairment (not clinically significant). Only Topiramate showed a clinically significant decline (30.0 to 26.6)...In contrast, VNS with 3-4 AEDs maintained severe impairment. This review underscores the importance of accurate cognitive assessment in epilepsy management, with a monitoring frequency of no more than every six months for patients receiving AED therapy."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy

Safety and Effectiveness of Cenobamate in Pediatric Patients with Epilepsy (AES 2025) - "Overall, our study showed that initiation of cenobamate as adjunctive therapy was effective and safe for pediatric patients with refractory epilepsy, with the goals of reducing seizure frequency and establishing improved seizure control."

Clinical • Anesthesia • CNS Disorders • Epilepsy • Pediatrics