考察健康受试者在空腹及餐后条件下，单次口服由四川奥邦古得药业有限公司提供的苯巴那酯片（受试制剂T，规格：12.5mg）与相同条件下单次口服由Angelini Pharma S.p.A持证的苯巴那酯片（参比制剂R，商品名：ONTOZRY®，规格：12.5mg）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

开始日期2025-04-15

申办/合作机构

四川奥邦古得药业有限公司

NCT06716801

/ Not yet recruitingN/A

Observational Cohort Study on Adult Patients with Not-adequately Controlled FOcal-onset Seizures Treated with Cenobamate As Early AdjUnctive Therapy in a Real-world Setting - FOCUS

Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

开始日期2024-12-01

申办/合作机构

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA

[+1]

NCT06453213

/ Recruiting临床4期

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

开始日期2024-10-14

申办/合作机构

SK Life Science, Inc.

100 项与 Cenobamate 相关的临床结果

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100 项与 Cenobamate 相关的转化医学

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100 项与 Cenobamate 相关的专利（医药）

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236

项与 Cenobamate 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of cenobamate for epilepsy patients with drug-resistant focal onset seizures in the Netherlands

Article

作者: Rijkers, Kim ; Gubler, Felix ; Hiligsmann, Mickaël ; Laskier-Owens, Vicki ; Evers, Silvia ; Klarenbeek, Pim ; Li, Nannan ; Rouhl, Rob ; Majoie, Marian ; Lazeron, Richard

OBJECTIVE:

The objective of this study was to explore the financial consequences of adopting cenobamate as a treatment alternative in epilepsy patients with drug-resistant focal onset seizures (FOS) from a societal perspective in the Netherlands.

METHODS:

A previous budget impact model with a 5-year time horizon was adapted to the Dutch setting accounting for the eligible population, real-world market shares, treatment effectiveness and resource use in two scenarios: cenobamate with constant market share versus cenobamate with linearly increased market share up to 20%. Clinical inputs included treatment response, seizure reduction and adverse events. Costs consisted of drugs, medical and non-medical costs. One-way sensitivity analysis and scenario analysis were conducted to test the robustness of our results.

RESULTS:

14,723 patients were eligible for cenobamate in 2022. Although cenobamate adds a gross budget impact of €12,686,30, the displacement of other drugs yields a total impact on the drug budget of €3,722,596 over 5 years. Adopting cenobamate resulted in a medical cost savings of €13,499,498 due to less resource use, and non-medical cost savings of €22,144,054 due to reduced productivity losses. Overall, savings generated at medical and non-medical cost level offset the gross drug budget impact of cenobamate, resulting in a saving of €31,920,955 over 5 years. Results were robust in the sensitivity/scenario analyses.

CONCLUSION:

Treatment with cenobamate is associated with both medical and non-medical cost savings, which offset the increase in drug budget and result in a significant potential budget saving. The higher the market share of cenobamate, the larger the budget savings. We acknowledge several limitations; Complex scenarios such as drug interactions, stopping/switching drugs, and multiple drug use were not taken into account. The long-term efficacy and safety of cenobamate and its comparators remains uncertain. Future real-world data are needed to confirm our findings.

2025-07-01·SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

Cenobamate in developmental and epileptic encephalopathies and generalized epilepsies: A case report on epilepsy with myoclonic-atonic seizures and systematic review of current evidence

Review

作者: Vlakou, Zafeirenia ; Matsingos, Alexandros ; Tsivgoulis, Georgios ; Bonakis, Anastasios ; Kotsali-Peteinelli, Vasiliki ; Tsalouchidou, Panagiota-Eleni ; Konstantinidi, Maria ; Keramida, Anna ; Chondrogianni, Maria

BACKGROUND:

Cenobamate (CNB) has demonstrated remarkable efficacy in the treatment of drug-resistant focal epilepsy (FE). However, its role in other epilepsy types - such as drug-resistant generalized epilepsies (GEs), combined generalized and focal epilepsies (CGFEs), and developmental and epileptic encephalopathies (DEEs) - remains poorly explored. This article assesses the current evidence of CNB efficacy in these often complex and challenging patient populations.

METHODS:

A case report is presented detailing a 22-year-old male with drug-resistant epilepsy with myoclonic-atonic seizures (EMAtS) who achieved seizure freedom on CNB. A systematic literature review was conducted to evaluate CNB's efficacy in GEs, CGFEs, and DEEs, summarizing seizure outcomes, adverse events (AEs), and dose-response relationships.

RESULTS:

The case report highlights a patient achieving 18 months of sustained seizure freedom and improved quality of life with tapering of concomitant antiseizure medications (ASMs). The systematic review included 32 patients from six studies. Overall, 59.4 % achieved a ≥ 50 % seizure reduction, and 9.4 % attained seizure freedom. Subgroup analysis showed ≥50 % reduction in 50 % of patients with Lennox-Gastaut syndrome (LGS) and 80 % with Dravet syndrome (DS), with seizure freedom rates of 20 % in DS and 50 % in epilepsy with eyelid myoclonia (EEM). AEs, primarily sedation and fatigue, were reported in 74 % of patients, while 31.25 % reduced or tapered off ASMs.

DISCUSSION:

CNB demonstrates potential efficacy in managing seizures across drug-resistant epilepsy syndromes, extending its established use beyond FE. Further prospective trials are needed to validate these findings and optimize dosing strategies.

2025-06-01·Neurology-Clinical Practice

Cenobamate Monotherapy for Focal Epilepsy

Article

作者: Erol, Ferhat ; Zengin, Erkam ; Gil Guevara, Andrea ; Lado, Fred Alexander

Background and Objectives:

Cenobamate is a novel antiseizure medication (ASM) approved by the Food and Drug Administration for use as adjunctive therapy in focal epilepsy. However, there are limited data on its use as a standalone monotherapy. The aim of our study was to investigate the use of cenobamate monotherapy and evaluate its clinical efficacy and safety in treating focal epilepsy.

Methods:

This single-center retrospective study was conducted on patients who were transitioned to cenobamate monotherapy for more than 6 months at a daily dosage of at least 150 mg. The cohort comprised patients transitioned from monotherapy and those previously on polytherapy with ASMs. Efficacy was based on the seizure freedom and seizure frequency reduction rates between pretreatment and post-treatment with cenobamate while safety was estimated by the reported adverse events.

Results:

A total of 527 patients were found to use cenobamate as part of their treatment regimen; 45 patients (9%) were transitioned to cenobamate monotherapy and met our predefined criteria. The median follow-up was 14.6 months. Before treatment with cenobamate, 56% were taking one ASM, 33% two ASMs, and 9% three ASMs. The median dose for cenobamate was 250 mg. The mean seizure frequency on cenobamate was reduced from 4.3 to 0.7 per month; the responder rate (50% reduction in seizure frequency) was achieved at 77%, and 55% of the patients remained seizure-free during the 12-month observation period.

Discussion:

Cenobamate monotherapy was found to significantly reduce seizure frequency and achieve high seizure freedom rates and was well tolerated in patients with focal epilepsy, highlighting its promise as an emerging alternative for patients with refractory focal epilepsy.

项与 Cenobamate 相关的新闻（医药）

2025-04-04

·PRNewswire

SK Life Science, Inc. to Showcase Important XCOPRI® (cenobamate tablets) CV Data on Responsive Neurostimulation Epileptiform Events at the 77th American Academy of Neurology (AAN) Annual Meeting

PARAMUS, N.J., April 4, 2025 /PRNewswire/ -- SK Life Science, Inc., a global leader in developing treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., will present meaningful encore data on XCOPRI® (cenobamate tablets) CV, an anti-seizure medication, at the 77th American Academy of Neurology (AAN) Annual Meeting, taking place April 5-9, 2025, in San Diego, California. This presentation reinforces the growing body of clinical and real-world evidence supporting cenobamate's role in reducing seizure activity and optimizing epilepsy management. "Our goal at SK Life Science is to redefine seizure management by advancing research and education that translates into meaningful improvements for people living with epilepsy," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science, Inc. "Seizure freedom remains an elusive, yet critical, objective for many patients, and this research offers valuable insights into how RNS data can be used as an objective measure to assess the efficacy of XCOPRI, and possibly other add-on anti-seizure medications." At AAN 2025, SK Life Science will highlight the impact of cenobamate on RNS epileptiform events. A retrospective, multicenter, observational, 24-week study among 37 patients with uncontrolled seizures showed a meaningful reduction in epileptiform events and clinically reported seizures during adjunctive cenobamate treatment. Results from this analysis support, through electrocorticographic data and observation of clinical seizures, the effectiveness of cenobamate in the treatment of focal seizures. Additional clinical and real-world data exploring cenobamate's efficacy, safety, and therapeutic potential in diverse patient populations will also be presented. Select SK Life Science posters presented at 2025 AAN include: Title: The Effect of Cenobamate on Responsive Neurostimulation Epileptiform Events (Aboumatar et al) Session: P5: Epilepsy/Clinical Neurophysiology (EEG): Neuromodulation Devices and Seizure Tracking Date/Time: Monday, April 7, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 2991 Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Cenobamate in Asian Patients With Focal Seizures, With Optional Open-Label Extension (Misra et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials Date/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 1406 Title: Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (Pradhan et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials Date/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 1404 Title: Efficacy of Adjunctive Cenobamate by Focal Seizure Subtypes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (Ferrari et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials Date/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PT Abstract Number: 1408 Title: Clarification of the Mechanism of Action of Cenobamate (Sankar et al) Session: P9: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Mechanisms and Pharmacology Date/Time: Tuesday, April 8, from 11:45 a.m. – 12:45 p.m. PT Abstract Number: 1381 Title: 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 (Rosenfeld et al) Session: P12: Epilepsy/Clinical Neurophysiology (EEG): Retrospective Studies, Reviews, and Meta-analyses in Epilepsy Date/Time: Wednesday, April 9, from 11:45 a.m. – 12:45 p.m. PT Abstract Number: 158 A complete list of SK Life Science abstracts presented at AAN 2025 can be found here. In addition to these scientific presentations, SK Life Science, Inc. will host a booth (#223) in the Exhibit Hall, open from 11:30 a.m. PT on Sunday, April 6, 2025, until 4 p.m. PT on Wednesday, April 9, 2025. Attendees are encouraged to visit the booth to learn more about SK Life Science's commitment to epilepsy research and patient care. About SK Life Science, Inc. and SK Biopharmaceuticals Co., Ltd. SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with eight compounds currently in development. Utilizing target-based drug discovery, high-throughput organic screening/high content screening, computer-aided drug design, and combinatorial chemistry, the companies drive R&D efforts in biology/discovery, medicinal chemistry, pharmacology, and clinical development. For more information, visit . SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea's second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals and digital business. Based in Seoul, SK invests in building sustainable businesses around the world with a shared commitment to reducing global greenhouse gas emissions. SK companies combined have $151 billion in global annual revenue and employ more than 100,000 people worldwide. SK Group is one of TIME's 100 Most Influential Companies of 2023. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information about SK Inc., visit . For more information about SK Biopharmaceuticals, visit . About XCOPRI® (cenobamate tablets) CV Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium current and enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel. The precise mechanism by which cenobamate exerts its therapeutic effect is unknown. Cenobamate is marketed under the brand name XCOPRI® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals' partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland. Cenobamate is also being developed for commercialization by SK Biopharmaceuticals' partners in many other countries to meet the needs of patients living with epilepsy, including Dong-A ST Co., Ltd., Eurofarma Laboratórios S.A., Hikma MENA FZE, Ignis Therapeutics, Inc. and ONO Pharmaceutical Co., Ltd. IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV DO NOT TAKE XCOPRI IF YOU: Are allergic to cenobamate or any of the other ingredients in XCOPRI. Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart. XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING: Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider. QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood. Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you. Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider. DISCONTINUATION: Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). DRUG INTERACTIONS: XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. PREGNANCY AND LACTATION: XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888233-2334 or go to . Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI. COMMON SIDE EFFECTS: The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired. These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at . DRUG ABUSE: XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law. INDICATION: XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age. Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Please see full Prescribing Information. About Epilepsy Epilepsy is the fourth most common neurological disorder. There are approximately 3.4 million people living with epilepsy in the United States, with 150,000 new cases each year in the country.1,2 Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one's safety, relationships, work, driving, and much more.3,4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).3,4 Despite the availability of many antiepileptic therapies, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.5 XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. References Cleveland Clinic. Epilepsy. . Accessed April 2025. Epilepsy Foundation. Facts & Statistics About Epilepsy. . Accessed April 2025. Epilepsy Foundation. Staying Safe. . Accessed April 2025. Epilepsy Foundation. Complications and Risks. . Accessed April 2025. Chen Z, Brodie MJ, Liew D, Kwan P. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs: a 30-year longitudinal cohort study. . Published online December 26, 2017. SOURCE SK Life Science, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期

2025-03-28

·医脉通

《新生儿肠外营养管理专家共识（2025）》发布！近期更新重点指南一览~

经常错过自己最关注的指南上新内容？想要及时接收到指南上新提醒？临床指南APP——微信绑定功能即可满足~TIPS：首次完成绑定还可得3天临床指南VIP！>具体方法本周热门指南推荐直接点击即可阅读新生儿肠外营养管理专家共识（2025）肠外营养（parenteral nutrition, PN）已广泛应用于新生儿医学领域，本文对PN 的适应证、应用途径、能量、液体量、营养液组成、停止时机及监测等7 个方面提出24 条推荐意见，旨在为相关从业人员提供PN 管理的建议，以改善新生儿近远期预后。直接点击即可阅读预防性人乳头瘤病毒疫苗中国临床应用指南（2025版）该指南分为人乳头瘤病毒及其流行病学，预防性HPV疫苗，一般人群HPV疫苗接种，高风险、特殊人群HPV疫苗接种，HPV疫苗的安全性，以及注意事项等6个部分，为HPV疫苗的临床应用提供了权威指导。直接点击即可阅读儿童暴发性心肌炎诊治专家建议（2025）本文主要内容包括儿童暴发型心肌炎的诊断标准、鉴别诊断、治疗措施等，以期对儿童暴发性心肌炎的诊治提供依据，提高儿童暴发性心肌炎的救治水平。直接点击即可阅读成人创伤性颅脑损伤院前与急诊诊治中国专家共识创伤性颅脑损伤(TBI)是高死亡率和高致残率的严重损伤，本共识包括TBI 院前和急诊诊治2 个部分，形成24 条推荐意见，以便指导TBI 院前和急诊相关的临床工作。直接点击即可阅读2025 AHA科学声明：血培养阴性心内膜炎与血培养阳性的心内膜炎相比，血培养阴性心内膜炎的预后更差。新的诊断工具已经改变了这种综合征的现状，并可能改善患者的预后。本文提供了血培养阴性心内膜炎的最新情况以协助一线临床医生诊断和管理血培养阴性心内膜炎。直接点击即可阅读消化心身疾病中西医结合诊疗共识意见（2024）消化心身疾病是指心理、社会、环境因素参与消化系统疾病发生、发展、转归全过程的一种心身疾病。本文参照2017 年中国中西医结合学会消化系统疾病专业委员会发布的《消化心身疾病中西医结合整体诊治专家指导意见》 ,组织有关专家进行充分讨论、补充、完善,达成共识,形成《消化心身疾病中西医结合诊疗共识意见》,以期满足临床、教学和科研的需求。直接点击即可阅读2024 JGES指南：非静脉曲张性上消化道出血的管理（第2版）出血性胃十二指肠溃疡是非静脉曲张性上消化道出血的主要原因，内镜下止血是目前非静脉曲张上消化道出血的一线治疗方法。本文主要介绍了非静脉曲张上消化道出血的评估和初始治疗，以及非静脉曲张上消化道出血的内镜止血方法的选择和内镜止血后的处理。直接点击即可阅读阿尔茨海默病疾病修饰治疗专家共识本共识对阿尔茨海默病修饰治疗的适用人群、禁忌及高风险人群、用药前的评估流程、用药方法和周期、药物有效性评估和不良反应监测等临床应用实践及相关研发进展进行了系统梳理并给出17条推荐意见，旨在为阿尔茨海默病疾病修饰治疗的临床应用提供指导。直接点击即可阅读成人患者营养不良诊断与应用指南（2025版）本文涵盖了成人患者营养不良的定义、流行病学、营养风险筛查和多层次营养评估以及诊断的全过程，并针对不同患者群体（如肥胖、危重症患者）提出个性化诊断策略，提出营养不良诊断的规范流程，最终形成27个问题、38条推荐意见，以期提升中国营养不良诊断的实践能力。直接点击即可阅读2025 中国专家共识：钠通道阻滞剂治疗局灶性癫痫（英文版）本文主要针钠通道阻滞剂（SCBs）在局灶性癫痫治疗中的使用提供共识建议。涉及局灶性癫痫患者奥卡西平、拉莫三嗪、拉考沙胺、艾司利卡西平（eslicarbazepine）、托吡酯、唑尼沙胺和苯巴那酯(cenobamate)的治疗建议，并SCB的治疗调整等9项声明达成共识。临床指南app-医问答临床指南app7.3及之后版本新增医问答板块，汇聚临床专业问答知识，扫描下方二维码进入临床指南app，按如下步骤操作，即可参与学习~点点击“阅读原文”，即可查看相关指南内容

AHA会议疫苗

2025-02-07

·医药观澜

2025年有望在中国获批上市的9款神经系统疾病新药

▎药明康德内容团队报道中枢神经系统（CNS）和精神系统疾病往往疾病机制复杂、新药研发难度大，患者存在未被满足的临床需求。本文将盘点9款有望在2025年获NMPA批准上市的CNS领域新药*，它们覆盖的适应症包括精神分裂症、阿尔茨海默病、嗜睡、失眠症等等。（*本文统计范围为于2023年1月~2025年1月期间向CDE递交上市申请的新药；新药仅统计注册分类为1类、3.1类、5.1类的新药；仅盘点有望首次获批的新药，不含新适应症）图片来源：123RF 百时美施贵宝、再鼎医药：呫诺美林曲司氯铵作用机制：M1/M4型毒蕈碱乙酰胆碱受体激动剂和毒蕈碱受体拮抗剂的组合适应症：精神分裂症 2025年1月，百时美施贵宝和再鼎医药共同申报的5.1类新药呫诺美林曲司氯铵胶囊上市申请获得CDE受理。这是一款用于治疗精神分裂症的新药KarXT，为一种口服M1/M4型毒蕈碱乙酰胆碱受体激动剂和毒蕈碱受体拮抗剂的组合。与目前主要针对多巴胺或血清素受体的抗精神病药物不同，呫诺美林优先刺激中枢神经系统中与这些疾病有关的毒蕈碱受体。2024年9月，美国FDA已经批准该产品用于治疗成人精神分裂症。再鼎医药拥有在大中华区开发、生产和商业化KarXT的权益。再鼎医药在今年的摩根大通医疗健康年会（JPM）中曾表示，KarXT有望于2025~2026年获NMPA批准上市。扬子江药业：法赞雷生作用机制：双重食欲素受体拮抗剂适应症：失眠症 2025年1月，扬子江药业全资子公司海岸药业申报的1类新药法赞雷生片上市申请获得CDE受理。公开资料显示，这是一款双重食欲素受体拮抗剂（YZJ-1139片），它能够同时抑制食欲素受体1型和2型，加快睡眠速度，延长深睡时间。扬子江药业已经完成一项YZJ-1139片治疗失眠症的3期临床试验，针对的适应症为以入睡困难/睡眠维持障碍为特征的失眠症。梯瓦：瑞玛奈珠单抗作用机制：CGRP单克隆抗体适应症：偏头痛预防性治疗 2025年1月，梯瓦（Teva）公司申报的3.1类新药瑞玛奈珠单抗注射液（fremanezumab）上市申请获得CDE受理。这是一种人源化单克隆抗体，它可选择性结合CGRP配体，并阻断两种CGRP亚型（α-和β-CGRP）与受体结合。该产品此前已在美国和欧盟获批用于成年患者偏头痛的预防性治疗。该产品有两种给药方案，可每月一次皮下注射（225mg），或每3个月一次皮下注射（675mg）。此外，其不仅可由医疗专业人员给药，亦可在家由患者或护理人员给药。翼思生物：西诺氨酯作用机制：抑制电压门控钠通道和正变构调节GABAA受体适应症：癫痫 2024年12月，SK Life Science和翼思生物共同申报的西诺氨酯片（cenobamate）上市申请获得CDE受理。西诺氨酯是翼思生物2021年从SK生物医药授权引进的CNS创新药物，它可通过抑制电压门控钠通道和正变构调节GABAA受体来减少癫痫发作甚至实现零发作。西诺氨酯片自2019~2021年在美国、欧盟和英国先后获批上市以来，已被广泛用于治疗成人癫痫患者的部分性发作。翼思生物：索安非托作用机制：双效多巴胺和去甲肾上腺素再摄取抑制剂适应症：过度嗜睡 2024年12月，翼思生物等公司共同申报的索安非托片（solriamfetol）上市申请获得CDE受理。索安非托是一种双效多巴胺和去甲肾上腺素再摄取抑制剂，该产品用于治疗与发作性睡病或阻塞性睡眠呼吸暂停综合征（OSA）相关的白天过度嗜睡。发作性睡病是一种失能性神经疾病，患者无法正常调节睡眠与苏醒的循环，导致出现嗜睡症状。索安非托可通过双重机制起到促进患者保持清醒的作用，包括引起多巴胺和去甲肾上腺素水平上升。该产品不会刺激多巴胺释放，从而减轻患者上瘾的风险。通化金马：八氢氨吖啶作用机制：乙酰胆碱酯酶抑制剂适应症：阿尔茨海默病 2024年8月，通化金马药业申报的1类新药琥珀八氢氨吖啶片的上市申请获得受理。这是通化金马开发的一款小分子乙酰胆碱酯酶抑制剂，可以同时抑制乙酰胆碱酯酶和丁酰胆碱酯酶，主要开发用于治疗轻中度阿尔茨海默病。先声药业：达利雷生作用机制：双重食欲素受体拮抗剂适应症：失眠症 2024年7月，先声药业联合申报的盐酸达利雷生片新药上市申请获得CDE受理。盐酸达利雷生片是Idorsia公司开发的抗失眠药，为一款双食欲素受体拮抗剂。先声药业拥有该产品在大中华地区开发和商业化的独家权利。与传统镇静催眠药物通过镇静大脑来促进睡眠的疗法不同，达利雷生通过阻断食欲素神经肽（食欲素A和食欲素B）与其受体的结合，降低过度活跃的中枢觉醒，帮助患者入睡和保持睡眠。由于其仅阻断食欲素受体的启动，因此可减少唤醒驱动，诱导睡眠发生，而不改变睡眠阶段的比例，且没有次日残留效应。卫材（Eisai）：莱博雷生作用机制：双重食欲素受体拮抗剂适应症：失眠症 2024年1月，卫材申报的莱博雷生片（lemborexant）上市申请获CDE受理。莱博雷生片是一款双重食欲素受体拮抗剂，此前已经在中国香港地区获批上市，用于治疗成人失眠，特别是入睡困难和/或睡眠维持困难。莱博雷生是一款小分子药物，其通过竞争性结合两种食欲素受体亚型OX1R和OX2R，抑制食欲素神经传递，调节睡眠-觉醒节律。作为一种竞争性拮抗剂，莱博雷生对OX2R具有更强的抑制作用，可抑制REM和非REM睡眠驱动，从而可以为患者提供更快的睡眠开始、更好的睡眠维持。阿斯利康（AstraZeneca）：瑞利珠单抗作用机制：长效补体C5蛋白抑制剂适应症：视神经脊髓炎谱系疾病等瑞利珠单抗（ravulizumab）是阿斯利康开发的一款长效补体C5蛋白抑制剂。它可提供即时、完全和持续的补体抑制。独特的设计使该产品具有比第一代C5补体抑制剂更长的半衰期，成人患者在初始剂量给药后，后续只需要每8周静脉注射一次。该产品已经获FDA批准治疗阵发性睡眠性血红蛋白尿症、非典型溶血性尿毒症综合征、重症肌无力、视神经脊髓炎谱系疾病等。视神经脊髓炎谱系疾病（NMOSD）是免疫介导的中枢神经系统炎性脱髓鞘疾病，以视神经炎和脊髓炎为主要临床征象，病因主要与水通道蛋白4（AQP4）抗体相关。在中国，该产品的首个上市申请已经于2023年12月获得CDE受理，第二项上市申请也已经于2024年10月获CDE受理。希望这些新药早日来到患者身边，尽快造福患者！参考资料： [1]中国国家药监局药品审评中心（CDE）官网. [2]各公司官网及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

上市批准临床3期

100 项与 Cenobamate 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11150	Cenobamate	N03A	DB06119

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
癫痫	加拿大	Endo Ventures Unlimited Co.	2023-06-12
癫痫发作	欧盟	Angelini Pharma, Inc.	2021-03-26
癫痫发作	冰岛	Angelini Pharma, Inc.	2021-03-26
癫痫发作	列支敦士登	Angelini Pharma, Inc.	2021-03-26
癫痫发作	挪威	Angelini Pharma, Inc.	2021-03-26
癫痫部分性发作	美国	SK Life Science, Inc.	2019-11-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
全身性癫痫	临床3期	日本	Ono Pharmaceutical Co., Ltd.	2022-07-12
癫痫的复杂部分性发作	临床3期	美国	SK Life Science, Inc.	2021-03-08
癫痫的复杂部分性发作	临床3期	中国	SK Life Science, Inc.	2021-03-08
癫痫的复杂部分性发作	临床3期	日本	SK Life Science, Inc.	2021-03-08
HIV血清阳性	临床3期	美国	SK Life Science, Inc.	2021-03-08
HIV血清阳性	临床3期	中国	SK Life Science, Inc.	2021-03-08
HIV血清阳性	临床3期	日本	SK Life Science, Inc.	2021-03-08
继发性全身性癫痫发作	临床3期	美国	SK Life Science, Inc.	2021-03-08
继发性全身性癫痫发作	临床3期	中国	SK Life Science, Inc.	2021-03-08
继发性全身性癫痫发作	临床3期	日本	SK Life Science, Inc.	2021-03-08

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


P8-9.008 (AAN2025)	N/A	癫痫	59	Cenobamate	淵簾構鏇積繭獵襯憲鹽(壓壓壓觸觸鹽製壓網艱) = 12% 製鏇鏇願製遞膚構淵憲 (構鏇選獵艱鑰繭製鏇餘 ) 更多	积极	2025-04-07
NCT04557085 (P8-9.010, AAN2025)	临床3期	癫痫发作	519	Placebo	觸糧壓鏇餘遞鏇蓋糧選(膚遞獵製憲鬱襯廠糧鑰) = The most common TEAEs (≥20%) were dizziness in the cenobamate dose groups 蓋鑰鏇選積廠範願壓積 (觸鑰夢選網鏇顧範壓積 ) 更多	积极	2025-04-07
				Cenobamate 100 mg
NCT04557085 (P8-9.011, AAN2025)	临床3期	癫痫发作	519	Placebo	積襯積觸夢選鬱鑰淵襯(築廠範製壓範繭繭蓋簾) = 簾衊廠廠夢夢窪醖廠膚選膚鏇鹹憲憲鏇觸簾廠 (夢糧淵餘繭獵選夢構築 )	积极	2025-04-07
				Cenobamate 100 mg	積襯積觸夢選鬱鑰淵襯(築廠範製壓範繭繭蓋簾) = 願願鬱衊鬱餘範遞願憲選膚鏇鹹憲憲鏇觸簾廠 (夢糧淵餘繭獵選夢構築 )
NCT04557085 (YKP3089C035, AAN2025)	临床3期	癫痫发作	519	Placebo	構築鏇網憲鹹遞觸艱餘(積鏇艱顧願範獵襯鹹鹽) = The most common treatment-emergent adverse events (≥20%) with cenobamate were dizziness 衊醖蓋廠夢襯艱鬱淵願 (製壓鬱繭網積衊鹽鏇壓 ) 更多	积极	2025-04-07
				Cenobamate 100 mg
P5-9.011 (AAN2025)	N/A	追加	-	Cenobamate	憲築範積齋築壓獵簾艱(鹽積遞膚積觸簾壓窪艱) = Dizziness and lethargy were the most commonly reported adverse events during cenobamate treatment; these resolved with slower titration and/or reductions in concomitant ASMs 構鹽壓製廠夢糧襯淵鹽 (範積襯膚鹽願積遞簾艱 ) 更多	积极	2025-04-07
NCT04690751 (CTgov)	临床1期	癫痫部分性发作	28	Cenobamate 200Mg Tab Fasted (Treatment A)	簾襯鏇襯簾網鹽簾廠淵(遞顧製鹹壓齋鏇淵繭憲) = 鬱願襯構鏇淵鬱網願選鏇淵淵蓋膚餘簾蓋繭醖 (鹽觸遞鏇鹹鬱廠選築淵, 衊選繭齋壓願鬱顧壓廠 ~ 膚鹹觸糧獵衊積鹹鹹糧) 更多	-	2024-08-12
				Cenobomate Oral Suspension Fasted (Treatment B)	簾襯鏇襯簾網鹽簾廠淵(遞顧製鹹壓齋鏇淵繭憲) = 衊廠鹹醖製構鬱憲鏇獵鏇淵淵蓋膚餘簾蓋繭醖 (鹽觸遞鏇鹹鬱廠選築淵, 網觸艱獵顧遞襯積壓憲 ~ 築壓鏇簾壓顧夢襯糧簾) 更多
NCT03678753 (Pubmed \| Cochrane Database Syst Rev)	临床3期	耐药性癫痫追加	659	Cenobamate add-on therapy	顧網願窪衊繭顧窪鏇襯(鬱醖鏇蓋鹹衊鏇餘艱網) = 襯簾獵淵遞蓋鏇齋鑰鬱襯顧願網製鑰構鹽餘壓 (衊積膚夢餘壓鏇製鑰獵, 1.02 ~ 1.27) 更多	积极	2024-08-01
				Placebo	顧網願窪衊繭顧窪鏇襯(鬱醖鏇蓋鹹衊鏇餘艱網) = 製餘膚壓簾糧獵觸窪憲襯顧願網製鑰構鹽餘壓 (衊積膚夢餘壓鏇製鑰獵, 1.02 ~ 1.27) 更多
EAN2024	N/A	癫痫	16	Cenobamate	獵夢艱鏇選憲齋醖積積(廠鹹餘壓鑰製糧窪糧製) = 遞製糧淵艱網衊餘廠鑰繭顧願構繭淵壓餘醖積 (艱艱廠鹹顧衊獵夢壓淵 ) 更多	积极	2024-06-28
EAN2024	N/A	癫痫发作	-	Cenobamate	鏇膚構觸淵願鹹顧艱餘(製衊範衊願膚鏇鬱遞願) = 餘構繭糧蓋觸顧淵窪獵壓網構範製鹹簾選憲憲 (廠夢繭鏇鹽壓窪窪餘鹹 ) 更多	-	2024-06-28
AAN2024	N/A	-	-	Cenobamate monotherapy	製齋鑰鬱蓋築醖繭鹹膚(齋選憲願憲鏇鹹範網鬱) = 構製糧衊夢選願壓獵構淵構淵鏇鬱糧鬱獵醖構 (餘憲糧築獵鏇糧願築蓋 ) 更多	-	2024-04-09