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 项与苯巴那酯相关的临床结果

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100 项与苯巴那酯相关的转化医学

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100 项与苯巴那酯相关的专利（医药）

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项与苯巴那酯相关的文献（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.

2025-09-01·EPILEPSY & BEHAVIOR

Steps towards seizure freedom with the use of Cenobamate

Article

作者: Boy, B ; Quintana, M ; Toledo, M ; Bellido, E ; Santamarina, E ; López-Maza, S ; Fonseca, E ; Campos-Fernández, D ; Abraira, L

BACKGROUND AND PURPOSE:

Cenobamate (CNB) is an antiseizure medication (ASM) that may change the prescription across the time. Our study sought to compare the rate of seizure-freedom patients after one year of CNB use experience in a single tertiary centre.

METHODS:

All patients with a minimum follow-up of one year who used CNB between 2021 and 2022 (n = 66) were compared to those who treated during 2023 (n = 126).

RESULTS:

In 2023, patients were older, used fewer concomitant ASMs (IQR 2-3 in 2023 vs 3-4 in 2022), and had a lower seizure frequency. Seizure-freedom rates at 12 months in 2021-2022 cohort were 16.7 %, and 23 % in 2023. The responder rate was greater than 60 % in both cohorts. The CNB titration was slower in the 2023 cohort, the median dose achieved was 225 mg in 2021-2022 and 200 mg in 2023. Concomitant ASMs were reduced in 70 % for both groups. The adverse event rate was nearly 60 %, most of them central nervous system-related. The CNB retention rate at 12 months was over 80 % in both groups. In 2023, up to 12 % of patients remained in monotherapy after 12 months.

CONCLUSIONS:

This is the first real-world data series that compares the use of CNB in two cohorts of a single centre. One year follow-up seizure freedom rates above 20% can be achieved by a proper patient selection, CNB dose increase and ASM dose reduction, which eventually lead to CNB monotherapy in some cases.

2025-08-01·SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

Efficacy and safety of Cenobamate: a multicenter, retrospective evaluation of real-world clinical practice

Article

作者: Meller, Agnieszka ; Tabaka-Pradela, Justyna ; Podraza, Hanna ; Jasek, Łukasz ; Fuksa, Katarzyna ; Sulima, Katarzyna ; Sobolewski, Piotr ; Konopko, Magdalena ; Siwek, Tomasz ; Służewska-Niedźwiedź, Monika ; Bosak, Magdalena ; Kiryła, Lidia ; Kipiński, Lech ; Stopińska, Katarzyna ; Wężyk, Kamil ; Nicpoń, Krzysztof ; Machowska-Sempruch, Karolina ; Chorąży, Monika ; Płonka-Półtorak, Elżbieta ; Zawiślak-Fornagiel, Katarzyna ; Klimas, Małgorzata ; Kurkowska-Jastrzębska, Iwona ; Kopytek-Beuzen, Maja ; Włoch-Kopeć, Dorota ; Grabska-Radzikowska, Katarzyna ; Rysz, Andrzej ; Dzianott-Pabijan, Dorota

INTRODUCTION:

Epilepsy is a common neurological disorder, with approximately one-third of patients experiencing drug-resistant epilepsy (DRE), which imposes significant clinical, social, and economic burdens. Cenobamate, a novel antiseizure medication (ASM), was included to the Polish therapeutic framework in March 2023.

MATERIALS AND METHODS:

This retrospective, multicenter study was conducted at 19 centers. Medical records of adult patients with DRE treated with cenobamate for at least six months were reviewed. Collected data included demographic characteristics, seizure frequency, treatment regimens, and adverse events (AEs). Descriptive statistical methods were employed to assess outcomes, with the primary efficacy endpoint of ≥50 % reduction in seizure frequency.

RESULTS:

The study cohort consisted of 475 patients with a median age of 37 years. Treatment with cenobamate (median maximal daily dose, 250 mg) resulted in a ≥ 50 % reduction in seizure frequency in 61.9 % of patients, with 16.5 % achieving seizure freedom during the final three months of observation, with better responses when the treatment was initiated earlier. The burden of polytherapy decreased, as 69.7 % of patients reduced or discontinued concomitant ASMs. Adverse events were reported in 48.8 % of patients, most commonly somnolence and dizziness, with no cases of severe dermatological reactions. Discontinuation of cenobamate occurred in 12 % of patients.

DISCUSSION:

Cenobamate demonstrated notable efficacy in patients with treatment-resistant epilepsy, and its early initiation may improve outcomes. Treatment has a large potential for significant simplification of treatment regimens. Adverse events were manageable.

CONCLUSIONS:

Cenobamate is a highly effective and well-tolerated ASM for patients with DRE, offering significant clinical benefits, including improved seizure control and reduced polytherapy.

项与苯巴那酯相关的新闻（医药）

2025-05-26

·求实药社

溢价293%！丽珠集团16亿并购越南抗生素霸主，剑指东南亚6.8亿人口市场

5月22日，丽珠集团公告拟进行收购越南医药上市公司Imexpharm Corporation（简称“IMP”）。这一海外并购由其境外全资附属公司LIAN SGP完成。已签署的《Framework Agreement》中透露，LIAN SGP拟收购卖方SK集团及其子公司合计持有的IMP64.81%股份，拟支付的股权购买价格为57308亿越南盾（约人民币15.87亿元），占本公司最近一期经审计归属于公司股东净资产的11.45%。公告指出，基于胡志明市证券交易所的30个交易日平均市值计算得出，IMP市值约2.69亿美元（约合19.37亿元）。本次交易应在自本协议签订之日起9个月或双方书面商定的更晚日期内完成。交易完成后，IMP将成为公司合并报表范围内的附属公司，将支持丽珠集团进一步拓展海外市场，推动在医药领域国际化及可持续发展的长期战略。01.“本地化”生产布局，丽珠寻找海外业务增长点此次交易标的IMP是一家成立于1977年的越南老牌医药企业，主要从事药品的研发、生产和销售。2024年，IMP实现营收6.96亿元，净利润8883.02万元，2025年一季度实现营收1.86亿元，净利润2061.44万元。截至2025年3月底，IMP净资产为6.22亿元。IMP产品主要包括抗生素、心脑血管药物等，与丽珠集团现有产品、业务具备较高协同性。丽珠集团主要业务涉及医药产品研发、生产、销售，产品涵盖制剂、原料药和中间体、诊断试剂及设备，尤其在微球制剂领域处于国内领先。产品围绕消化道、辅助生殖、精神神经等治疗领域，所生产的原料药和中间体包括美伐他汀、阿卡波糖、苯丙氨酸、盐酸万古霉素等。无论是生产，还是渠道、合作，“本地化”是丽珠集团出海东南亚市场的关键词。在上个月举行的投资者交流会上，丽珠集团透露，在国际化布局方面，公司产品已经覆盖东南亚、南美、中东及非洲等多个市场，部分新开发地区已取得销售进展。2024年7月，丽珠集团与Kalbe控股附属公司携手在印尼设立合资公司开展生产业务，强化本土化生产布局，并启动建设原料药工厂，开启本地化及国际化生产布局，未来有望降低成本、加快市场响应，提升欧美市场渗透，推动国际化发展。更深层次来看，海外市场拓展也是丽珠集团在营收承压、净利润增速放缓趋势下，寻找第二增长点的尝试，尤其在准入门槛较低、创新市场远未饱和的东南亚市场。2024年，丽珠集团实现营收118.12亿元，同比下降4.97%；归母净利润20.61亿元，同比增长5.50%。2025年一季度实现营收31.81亿元，同比下降1.92%，归母净利润6.37亿元，同比增长4.75%。其中，2024年海外收入达到17.24亿元，同比增长9.69%，约占总营收的14.59%，其中原料药及中间体出口收入16.68亿元，同比增长7.93%。02.加注还是转向？韩国SK集团在越南动作不断值得关注的是，此次卖方为韩国第二大企业集团、2023年位列《财富》杂志世界500强第92位的韩国SK集团，以能源化工、信息通讯半导体、营销服务为三大主力产业。生物及制药领域，SK集团旗下拥有SK Bioscience、SK Biopharmaceuticals、SK Pharmteco等子公司，涵盖了研发、生产（CDMO）、市场拓展及战略投资的产业链条，涉足领域包括小分子、细胞和基因治疗、放射性药物、疫苗等。在美国市场，SK Bioscience通过其美国子公司SK Life Science在美国市场成功商业化了苯巴那酯cenobamate（商品名XCOPRI®），用于治疗成人部分发作性癫痫。旗下SK化学长期与阿斯利康保持合作，包括新冠疫苗生产以及最近的降糖复方药物Sidapvia。后者于2023年6月在韩国获批上市，SK化学将为阿斯利康提供直至2030年的生产服务。东南亚市场方面，SK生物制药与泰国政府制药组织（GPO）达成合作，加强泰国疫苗开发和制造能力，并建立中长期的密切合作。计划包括将SK原研细胞培养流感疫苗的药品生产技术转让给GPO拥有的工厂进行本地生产。一旦技术转让完成，GPO将从SK bioscience获得流感疫苗的原料药，并计划获得卫生监管机构的上市许可。结合丽珠集团的本地化策略，在研发创新与工业化建设相对落后的东南亚市场，外资企业的投资与共建，恰是其完善医药产业链条、发展医药工业体系的稀缺机遇。同时，东南亚各国政府多支持医药产业的发展，从政策端、产业端、技术端鼓励外资企业进行本地化投资。此前，SK集团在越南市场总投资规模约35亿美元，但以间接投资为主：SK东南亚投资公司曾持有越南最大企业集团Vingroup的6.1%股份，越南第二大企业集团Masan Group的9.5%股份，大型连锁药店集团Pharmacity的14.5%股份，知名药企Imexpharm的54%股份，零售商VinCommerce的16.3%股份，以及马来西亚亚洲航空集团旗下金融技术公司BigPay的不明股份。但自2022年起，就有消息称SK集团正考虑出售其投资机构SK东南亚投资公司在越南和马来西亚的部分资产，筹集数十亿美元资金从而应对经济状况恶化的局面。2025年，SK集团将在越南开展有关液化天然气发电的三大项目，力争发展与人工智能、氢能、物流、环境友好型农业以及创新相关的新能源中心。海防市Ecovance高科技生物降解材料工厂项目是SK集团在越首个直接投资项目，总投资额为5亿美元，其中一期投资1亿美元，于2024年5月正式开工建设。当大型企业集团的投资战略发生转变（如由间接投资转向直接投资、放弃医药市场等重点转移），垂直度更高、遵循“本地化”打法的中国大型药企或将成为东南亚医药市场的关键角色。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们国内唯一！多肽、代谢与减肥药领域顶尖盛会！PMO 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

并购诊断试剂

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

100 项与苯巴那酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11150	苯巴那酯	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


NCT04557085 (P8-9.011, AAN2025)	临床3期	癫痫发作	519	Placebo	醖獵鹹膚淵鏇簾鹹製膚(觸鬱艱築窪糧鹹襯艱網) = 襯築鹽廠繭衊遞觸構顧顧構衊範願衊膚壓範築 (構繭願窪遞鑰蓋夢蓋廠 )	积极	2025-04-07
				Cenobamate 100 mg	醖獵鹹膚淵鏇簾鹹製膚(觸鬱艱築窪糧鹹襯艱網) = 鬱鏇夢襯憲淵願憲鏇鏇顧構衊範願衊膚壓範築 (構繭願窪遞鑰蓋夢蓋廠 )
P8-9.008 (AAN2025)	N/A	癫痫	59	Cenobamate	衊鹹構齋艱餘鹹製鹹淵(範簾夢顧糧夢築願淵鹽) = 12% 選憲糧齋醖積餘艱艱膚 (遞網築衊夢築廠艱淵觸 ) 更多	积极	2025-04-07
NCT04557085 (YKP3089C035, AAN2025)	临床3期	癫痫发作	519	Placebo	廠網衊鏇鹽糧糧憲憲膚(醖願蓋鏇鹹齋憲壓遞遞) = The most common treatment-emergent adverse events (≥20%) with cenobamate were dizziness 鬱糧願糧顧膚顧廠鹽憲 (願齋膚壓製製憲製夢顧 ) 更多	积极	2025-04-07
				Cenobamate 100 mg
P5-9.011 (AAN2025)	N/A	追加	-	Cenobamate	窪淵鏇遞鹽襯鏇選蓋遞(願鏇夢壓鹹襯築醖鏇鹽) = Dizziness and lethargy were the most commonly reported adverse events during cenobamate treatment; these resolved with slower titration and/or reductions in concomitant ASMs 網積廠餘窪衊壓鑰蓋艱 (齋製齋蓋鹽築齋鹹鹽鏇 ) 更多	积极	2025-04-07
NCT04557085 (P8-9.010, AAN2025)	临床3期	癫痫发作	519	Placebo	鏇鏇壓願構鹹廠選遞觸(鑰範鹽壓構齋簾鏇窪遞) = The most common TEAEs (≥20%) were dizziness in the cenobamate dose groups 艱遞簾網醖觸衊餘廠鬱 (願繭鑰餘醖衊鹹鹽顧壓 ) 更多	积极	2025-04-07
				Cenobamate 100 mg
NCT04690751 (CTgov)	临床1期	癫痫部分性发作	28	Cenobamate 200Mg Tab Fasted (Treatment A)	鹽衊觸範艱齋醖壓壓鹹(繭窪鹹鑰鹽鏇窪願淵築) = 夢簾鑰製顧獵膚鹽構艱淵鏇膚艱憲鏇膚廠淵鹽 (蓋淵餘築鬱鑰觸齋醖觸, 淵鏇齋築壓製範廠鏇簾 ~ 壓構網築鏇艱網願鏇遞) 更多	-	2024-08-12
				Cenobomate Oral Suspension Fasted (Treatment B)	鹽衊觸範艱齋醖壓壓鹹(繭窪鹹鑰鹽鏇窪願淵築) = 鏇窪廠廠網網鹹鑰鹹憲淵鏇膚艱憲鏇膚廠淵鹽 (蓋淵餘築鬱鑰觸齋醖觸, 壓鏇繭繭鹽繭廠繭蓋簾 ~ 窪糧壓獵築網獵獵淵鏇) 更多
NCT03678753 (Pubmed \| Cochrane Database Syst Rev)	临床3期	耐药性癫痫追加	659	Cenobamate add-on therapy	衊範鏇觸鹹遞醖構遞獵(觸範壓願顧簾選構醖遞) = 築選膚淵衊膚鏇衊積衊壓製糧鏇憲窪積構顧築 (繭積製壓遞範壓窪淵製, 1.02 ~ 1.27) 更多	积极	2024-08-01
				Placebo	衊範鏇觸鹹遞醖構遞獵(觸範壓願顧簾選構醖遞) = 顧鑰觸窪鑰顧餘鏇蓋構壓製糧鏇憲窪積構顧築 (繭積製壓遞範壓窪淵製, 1.02 ~ 1.27) 更多
EAN2024	N/A	癫痫	16	Cenobamate	網艱鏇齋製糧觸積鬱選(選壓鬱繭築鹽簾顧窪製) = 壓積夢獵築簾遞選艱衊範鑰艱淵簾壓窪積鹹餘 (餘顧範範鹹齋構夢築夢 ) 更多	积极	2024-06-28
EAN2024	N/A	癫痫发作	-	Cenobamate	襯艱膚顧鏇齋糧襯觸繭(鹽鏇鏇積範鹽醖艱蓋範) = 艱鑰壓窪簾製鹹築鏇鬱構遞網積憲簾襯積鹹簾 (鹹憲襯鬱構獵廠顧築淵 ) 更多	-	2024-06-28
P1-1.001 (AAN2024)	N/A	Lennox-Gastaut综合征	76	Cenobamate	鏇膚鏇鑰蓋齋鏇選夢鑰(鬱鏇鏇構網廠願鏇範夢) = 築鹽製夢獵觸網網鬱鹹膚餘簾鏇壓鹹夢願範鬱 (齋齋壓簾淵選鹽鏇鏇願 ) 更多	积极	2024-04-09
				Previous antiseizure medications (ASMs)	鏇膚鏇鑰蓋齋鏇選夢鑰(鬱鏇鏇構網廠願鏇範夢) = 淵餘範築鑰餘顧鏇遞鹹膚餘簾鏇壓鹹夢願範鬱 (齋齋壓簾淵選鹽鏇鏇願 ) 更多