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。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral administration of phenbarate tablets (test preparation T, strength: 12.5 mg) provided by Sichuan Aobang Good Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of phenbarate tablets (reference preparation R, trade name: ONTOZRY®, strength: 12.5 mg) certified by Angelini Pharma S.p.A. under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date15 Apr 2025

Sponsor / Collaborator

Sichuan Aobang Gude Pharmaceutical Co., Ltd.

NCT06716801

/ Not yet recruitingNot Applicable

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).

Start Date01 Dec 2024

Sponsor / Collaborator

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

[+1]

NCT06453213

/ RecruitingPhase 4

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.

Start Date14 Oct 2024

Sponsor / Collaborator

SK Life Science, Inc.

100 Clinical Results associated with Cenobamate

100 Translational Medicine associated with Cenobamate

100 Patents (Medical) associated with Cenobamate

233

Literatures (Medical) associated with Cenobamate

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

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

Article

Author: Rijkers, Kim ; Gubler, Felix ; Hiligsmann, Mickaël ; Evers, Silvia ; Laskier-Owens, Vicki ; 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.

01 Jun 2025·Neurology-Clinical Practice

Cenobamate Monotherapy for Focal Epilepsy

Article

Author: 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.

04 May 2025·Expert Review of Neurotherapeutics

Cenobamate add-on therapy for drug-resistant focal seizures: a systematic review and meta-analysis

Review

Author: Tozzo, Théo Jacovani ; Lima, Aminah Abrão Fauaz Ritter ; Tanimoto, Larissa Emi ; Menegaz de Almeida, Artur ; de Oliveira Carriço, Hamilton Roberto Moreira ; de Paiva, Felipe Alves ; Ribeiro, Danilo Monteiro

INTRODUCTION:

Cenobamate (CNB) is an anti-seizure medication (ASM) utilized for drug-resistant focal-onset seizures, which are difficult to manage with usual agents. Previous studies demonstrated that it can be effective in patients with refractory epilepsy.

METHODS:

The MEDLINE, Cochrane, and Scopus databases were systematically searched up to 24 October 2024. A Random-effects model was employed to compute the Mean Difference (MD) and the Risk Ratio (RR) with 95% Confidence Intervals (CI). Statistical Analyses were performed utilizing RStudio 4.4.2.

RESULTS:

Four studies were included, comprising 906 patients; 527 (59%) received CNB as add-on therapy. The results indicated that the 50% responder rate (RR 1.77; 95% CI: 1.28 to 2.44, p = 0.000551, I² = 70.3%) and seizure freedom (RR of 3.09; 95% CI: 1.91 to 5.00, p = 0.000004, I² = 8.7%) were significantly higher in this group.

CONCLUSIONS:

In this meta-analysis of four studies, CNB as an add-on therapy significantly reduced seizure frequency in patients with uncontrolled focal seizures, making it a promising option for improved seizure control and quality of life.

News (Medical) associated with Cenobamate

04 Apr 2025

·www.prnewswire.com

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

Drug ApprovalPhase 3

17 Dec 2024

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SK Biopharmaceuticals Inks Research Collaboration Agreement with ProEn Therapeutics Further Accelerating Expansion of Oncology Research and Pipeline for Global Competitiveness in Radiopharmaceuticals

SK Biopharmaceuticals, ProEn Therapeutics aim to advance up to 2 preclinical radiopharmaceutical candidates by 2027, via ArtBody™, a bivalent binder platform designed to selectively target tumor cells SK Biopharmaceuticals eyes innovative small protein-based radiopharmaceuticals on safety and efficacy amid growing global demand through the joint research initiative building on the momentum for its radiopharmaceutical therapy business SEOUL, South Korea, Dec. 16, 2024 /PRNewswire/ -- SK Biopharmaceuticals, a biotech company focusing on the research, development and commercialization of treatments for disorders of the central nervous system and oncology worldwide, announced a research collaboration agreement with ProEn Therapeutics, a biotech company dedicated to advancing oncology treatments, to further extend its oncology research capability and expand its pipeline of radiopharmaceutical therapies (RPT). Under this agreement, both sides seek to advance up to two preclinical candidates for the development of novel radiopharmaceutical drugs by 2027 – the year when SK Biopharmaceuticals aims to become a global leading RPT player, via strengthened internal and external resources. This joint research builds on a series of SK Biopharmaceuticals' global strategic partnerships, including the in-licensing of a radiopharmaceutical compound, and a supply agreement to secure actinium-225, an alpha-particle emitting radioisotope, since the company unveiled its "RPT Roadmap" to gain a competitive edge in the rapidly growing field of nuclear medicine. SK Biopharmaceuticals will leverage ProEn Therapeutics' ArtBody™ platform, a dual-target binding technology that incorporates small proteins[1] to identify and target specific tumor antigens – enhancing tumor selectivity – for the development of potential cancer treatments, while minimizing damage to healthy tissues. ArtBody™, which has intrinsic advantages of high stability and structural robustness, can be mass-produced using bacteria, making it ideal for industrial applications. Il-Han Lee, Chief Executive Officer of ProEn Therapeutics, said, "We are pleased to enter this joint research, and positive that the ArtBody™ platform will generate synergy with and complement SK Biopharmaceuticals' radiopharmaceutical therapy business. ProEn Therapeutics will push to produce the best possible outcome that can meet not only the two companies' expectations, but also patients' needs." Donghoon Lee, Chief Executive Officer of SK Biopharmaceuticals, said, "This collaboration with ProEn Therapeutics is significant as the platform technology will help overcome the limitations of existing therapies. We will aim to develop more effective, safer treatments, while leading global RPT research and development efforts." About SK Biopharmaceuticals SK Biopharmaceuticals focuses on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin its expansion into oncology through research and development efforts. SK Biopharmaceuticals is the first and only Korean company to independently develop and commercialize an antiseizure medication, cenobamate (brand name: XCOPRI®), in the U.S. Cenobamate, which was commercially launched in the U.S. in 2020 by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, has successfully entered five major regions: North America, Europe, Asia, Central and South America, and the Middle East and North Africa. The company has a pipeline of eight compounds in development in both CNS disorders and oncology. For more information, visit SK Biopharmaceuticals' website at , and SK Life Science's website at . About ProEn Therapeutics ProEn Therapeutics is a biotechnology company dedicated to advancing oncology treatments through cutting-edge protein engineering. The company's innovative drug development platform, ArtBody™, focuses on bi-specific antibody-drug conjugates tailored for solid cancers. ProEn Therapeutics is also exploring next-generation therapies such as immune cell engagers and chimeric antigen receptor platforms, while extending its research in radiopharmaceuticals. The company is advancing its proprietary pipeline, while actively collaborating with partners specializing in various therapeutic modalities. For more information, visit ProEn Therapeutics' website at . SOURCE SK Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/in

08 Dec 2024

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SK Life Science, Inc. Presents XCOPRI® (cenobamate tablets) CV Data at the AES 2024 Annual Meeting Showing a Deeper Understanding of Cenobamate's Dual Mechanism of Action

PARAMUS, N.J., Dec. 8, 2024 /PRNewswire/ -- SK Life Science, Inc., a global leader in treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., presented data at the American Epilepsy Society (AES) Annual Meeting, showcasing its antiseizure medication XCOPRI® (cenobamate tablets) CV. Key data offered a better understanding of cenobamate's unique dual mechanism of action (MOA) that enhances GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel and reduces neuronal excitability by preferentially inhibiting the persistent sodium current. Continue Reading "We are a company dedicated to advancing treatment options for epilepsy, supporting the epilepsy community and providing meaningful solutions for patients and their families," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science. "It is critically important for patients with epilepsy to achieve seizure control as early as possible. The data we presented at AES offer new insights into our drug's unique dual MOA and highlight the potential for flexible and individualized dosing with cenobamate which, along with adjustment of concomitant ASMs to improve tolerability, may help more patients achieve optimal seizure reduction. Additionally, our data provided objective evidence of our treatment's effect on patterns of electrical activity in the brain and seizure reduction." We are dedicated to advancing treatment options and providing meaningful solutions for the epilepsy community. Post this Clarification of the MOA of cenobamate Deeper understanding of cenobamate's bi-modal mechanism of action further elucidates its dual role on voltage-gated sodium channels and GABAA receptors. Specifically, in preclinical studies, researchers observed cenobamate's selectivity for blockade of persistent sodium currents (INaP), while sparing the transient sodium current (INaT). The effect of cenobamate's selective INaP block on the resting membrane potential is augmented by its positive allosteric modulation of GABAA receptor-mediated tonic currents. Cenobamate's selectivity for the INaP over the INaT likely represents action on the NaV1.6 channel over the NaV1.1 channel, a feature not seen with traditional ASMs, like phenytoin or carbamazepine. Potential for flexible and individualized dosing New data examining the initial doses of cenobamate that were associated with seizure freedom in the phase 3 open-label efficacy subset showed the initial seizure freedom interval occurred at a wide range of cenobamate doses, with some patients requiring higher doses. These data highlight the potential for flexible and individualized dosing with cenobamate which, along with adjustment of concomitant antiseizure medication to improve tolerability, may help more patients achieve optimal seizure reduction. The effect of cenobamate on responsive neurostimulation epileptiform events A retrospective, multicenter, observational, 24-week study among 37 patients with uncontrolled seizures, showed a significant reduction in epileptiform events along with a significant reduction in clinically reported seizures during adjunctive cenobamate treatment. Results from this analysis demonstrate, through electrocorticographic data and observation of clinical seizures, the effectiveness of cenobamate in the treatment of focal seizures. The complete list of SK Life Science abstracts presented at AES can be found here. 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. SK Life Science and SK Biopharmaceuticals are committed to addressing critical unmet medical needs for patients with conditions such as epilepsy, sleep disorders, neuropathic pain, Alzheimer's disease, and schizophrenia. 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. 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. XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals 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 1-888-233-2334 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 References Epilepsy Foundation. Who Can Get Epilepsy? . Accessed December 2024. Epilepsy Foundation. Facts & Statistics About Epilepsy. . Accessed December 2024. Epilepsy Foundation. Staying Safe. . Accessed December 2024. Epilepsy Foundation. Complications and Risks. . Accessed December 2024. 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

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Cenobamate

External Link

KEGG	Wiki	ATC	Drug Bank
D11150	Cenobamate	N03A	DB06119

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	Canada	Endo Ventures Unlimited Co.	12 Jun 2023
Seizures	European Union	Angelini Pharma, Inc.	26 Mar 2021
Seizures	Iceland	Angelini Pharma, Inc.	26 Mar 2021
Seizures	Liechtenstein	Angelini Pharma, Inc.	26 Mar 2021
Seizures	Norway	Angelini Pharma, Inc.	26 Mar 2021
Epilepsies, Partial	United States	SK Life Science, Inc.	21 Nov 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Epilepsy, Generalized	Phase 3	Japan	Ono Pharmaceutical Co., Ltd.	12 Jul 2022
Epilepsy, Complex Partial	Phase 3	United States	SK Life Science, Inc.	08 Mar 2021
Epilepsy, Complex Partial	Phase 3	China	SK Life Science, Inc.	08 Mar 2021
Epilepsy, Complex Partial	Phase 3	Japan	SK Life Science, Inc.	08 Mar 2021
HIV Seropositivity	Phase 3	United States	SK Life Science, Inc.	08 Mar 2021
HIV Seropositivity	Phase 3	China	SK Life Science, Inc.	08 Mar 2021
HIV Seropositivity	Phase 3	Japan	SK Life Science, Inc.	08 Mar 2021
Secondarily generalized seizures	Phase 3	United States	SK Life Science, Inc.	08 Mar 2021
Secondarily generalized seizures	Phase 3	China	SK Life Science, Inc.	08 Mar 2021
Secondarily generalized seizures	Phase 3	Japan	SK Life Science, Inc.	08 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04557085 (YKP3089C035, AAN2025)	Phase 3	Seizures	519	Placebo	djcyaeftbp(lsczpcgyck) = The most common treatment-emergent adverse events (≥20%) with cenobamate were dizziness sysdwxvbuo (kbtenbbnke ) View more	Positive	07 Apr 2025
				Cenobamate 100 mg
NCT04557085 (P8-9.011, AAN2025)	Phase 3	Seizures	519	Placebo	uozubtgtjs(bqzwqmhwrg) = jowmkkwtpi kfmanxrtxb (bublyezedd )	Positive	07 Apr 2025
				Cenobamate 100 mg	uozubtgtjs(bqzwqmhwrg) = bzxosvntjo kfmanxrtxb (bublyezedd )
P5-9.011 (AAN2025)	Not Applicable	Add-on	-	Cenobamate	qocbvgholb(twpviibact) = Dizziness and lethargy were the most commonly reported adverse events during cenobamate treatment; these resolved with slower titration and/or reductions in concomitant ASMs vsqiskngqb (hcoapeudbx ) View more	Positive	07 Apr 2025
P8-9.008 (AAN2025)	Not Applicable	Epilepsy	59	Cenobamate	vleyoojmcs(qtczhsdmzh) = 12% bsyaypaiaq (arjvwcqxgh ) View more	Positive	07 Apr 2025
NCT04557085 (P8-9.010, AAN2025)	Phase 3	Seizures	519	Placebo	yxtdstcpyh(mouiqxqbjb) = The most common TEAEs (≥20%) were dizziness in the cenobamate dose groups bvevzejyfn (xrqodfxeyx ) View more	Positive	07 Apr 2025
				Cenobamate 100 mg
NCT04690751 (CTgov)	Phase 1	Epilepsies, Partial	28	Cenobamate 200Mg Tab Fasted (Treatment A)	bitldhcibv(hdtohecmwc) = kzqcctzpij evmaqucsdm (omexhqiufd, ienchehbmp - paqluecxap) View more	-	12 Aug 2024
				Cenobomate Oral Suspension Fasted (Treatment B)	bitldhcibv(hdtohecmwc) = sidlnueoaj evmaqucsdm (omexhqiufd, spdzbvhywg - rcdsjbsssn) View more
NCT03678753 (Pubmed \| Cochrane Database Syst Rev)	Phase 3	Drug Resistant Epilepsy Add-on	659	Cenobamate add-on therapy	swtzpamdvs(fgcjoxfhxx) = snjtyoglvc upxlgeltng (vzfpwfuwkj, 1.02 - 1.27) View more	Positive	01 Aug 2024
				Placebo	swtzpamdvs(fgcjoxfhxx) = bueaprooau upxlgeltng (vzfpwfuwkj, 1.02 - 1.27) View more
EAN2024	Not Applicable	Seizures	-	Cenobamate	eeqqltizzl(dnbxhewkar) = ewdmwbmjwn vdvktjwqlh (evnqjbsxxn ) View more	-	28 Jun 2024
EAN2024	Not Applicable	Epilepsy	16	Cenobamate	xxiieqvoto(ebtudzhhoy) = bryetfplbh vdmyemycsn (bhwjrpvzgz ) View more	Positive	28 Jun 2024
P8-1.004 (AAN2024)	Not Applicable	Pain, Postoperative	7,835	Cenobamate	incfgjeshk(mjziqfggse) = vvsjsbjayy gmlqcwxvys (gyghxratqs ) View more	Positive	09 Apr 2024

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