[Translation] A single-center, open-label, randomized, two-period, two-sequence, two-crossover, single-dose bioequivalence study was conducted to evaluate the test formulation, cinnoxapro tablets (12.5 mg), and the reference formulation, ONTOZRY® (12.5 mg), in healthy adult participants in a fasting state.

主要目的：研究空腹状态下单次口服受试制剂西诺氨酯片（规格：12.5 mg，浙江京新药业股份有限公司生产）与参比制剂西诺氨酯片（ONTOZRY®，规格：12.5 mg，Angelini Pharma S.p.A持证）在健康参与者体内的药代动力学特征，计算主要药动学参数，比较制剂间药动学参数AUC和Cmax的差异，评价受试制剂与参比制剂是否具有生物等效性。次要目的：研究受试制剂西诺氨酯片（规格： 12.5 mg）与参比制剂（ONTOZRY®）（规格：12.5 mg）在健康参与者中的安全性。

[Translation]

Primary Objective: To investigate the pharmacokinetic characteristics of the test formulation, cinnozoxystrobin tablets (12.5 mg, manufactured by Zhejiang Jingxin Pharmaceutical Co., Ltd.), and the reference formulation, cinnozoxystrobin tablets (ONTOZRY®, 12.5 mg, licensed by Angelini Pharma S.p.A.), in healthy participants under fasting conditions. Major pharmacokinetic parameters were calculated, and the differences in AUC and Cmax between the formulations were compared to evaluate bioequivalence. Secondary Objective: To investigate the safety of the test formulation, cinnozoxystrobin tablets (12.5 mg), and the reference formulation (ONTOZRY®) (12.5 mg) in healthy participants.

Start Date08 Jul 2026

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

CTR20262069

/ CompletedNot Applicable

西诺氨酯片在空腹条件下的人体生物等效性试验

[Translation] Human bioequivalence study of cinorum tablets under fasting conditions

考察健康试验参与者在空腹条件下，单次口服1片由宜昌东阳光长江药业股份有限公司提供的西诺氨酯片（受试制剂T，规格：12.5mg）或单次口服1片由Angelini Pharma S.p.A持证的西诺氨酯片（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]

This study investigated the pharmacokinetic characteristics of a single oral dose of either a 12.5 mg orally administered cinnoxamate tablet (test formulation T) from Yichang Dongyangguang Changjiang Pharmaceutical Co., Ltd., or a single oral dose of a 12.5 mg orally administered cinnoxamate tablet (reference formulation R) from Angelini Pharma S.p.A., under fasting conditions, to evaluate the bioequivalence and safety of the two formulations and to provide a basis for the registration application of the test formulation.

Start Date14 Jun 2026

Sponsor / Collaborator

YiChang HEC ChangJiang Pharmaceutical Co., Ltd.

CTR20261958

/ CompletedNot Applicable

森巴考特片在中国健康受试者中空腹状态下的人体生物等效性试验

[Translation] Bioequivalence study of Sambac tablets in healthy Chinese subjects under fasting conditions

本试验旨在研究单次空腹口服合肥立方制药股份有限公司研制、生产的森巴考特片（12.5 mg）的药代动力学特征；以Angelini Pharma S.p.A持证的森巴考特片（ONTOZRY®，12.5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-72，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of a single oral fasting dose of sambacourt tablets (12.5 mg) developed and manufactured by Hefei Lifang Pharmaceutical Co., Ltd.; using sambacourt tablets (ONTOZRY®, 12.5 mg) certified by Angelini Pharma S.p.A. as the reference formulation, the pharmacokinetic parameters Cmax and AUC0-72 of the two formulations were compared to evaluate their bioequivalence in humans.

Start Date05 Jun 2026

Sponsor / Collaborator

Hefei Lifeon Pharmaceutical Co., Ltd.

100 Clinical Results associated with Cenobamate

100 Translational Medicine associated with Cenobamate

100 Patents (Medical) associated with Cenobamate

327

Literatures (Medical) associated with Cenobamate

01 Oct 2026·EPILEPSY & BEHAVIOR

Anti-seizure medication in Germany over 25 years: trends in prices and prescription patterns from national data from 2000 to 2024

Article

Author: Strzelczyk, Adam ; Willems, Laurent M

PURPOSE:

To analyse trends in the prices and prescription volumes of anti-seizure medications (ASMs) in Germany from 2000 to 2024.

METHOD:

Data on prescription frequencies and costs per defined daily dose (DDD) were derived from annual prescription records (Arzneiverordnungs-Report). Gabapentoids such as gabapentin and pregabalin were excluded to avoid bias related to their common use for non-epilepsy indications. An interrupted time-series analysis (ITSA) using the Prais-Winsten approach was used to identify possible change points and consecutive effects on level and slope of ASM cost development.

RESULTS:

Over the 25-year period, levetiracetam rose from 0% to approximately 35% prescription share, becoming the most frequently prescribed ASM in Germany, followed by lamotrigine (∼20%) and valproate (∼16%). Carbamazepine declined from over 45% to below 10%. Newer ASMs including lacosamide, eslicarbazepine, perampanel, brivaracetam, and cenobamate have gained prescription shares since their respective market entries, whilst older enzyme-inducing ASMs have steadily declined. Each new ASM entered the market at high cost per DDD, which decreased substantially following statutory healthcare reforms, reimbursement negotiations or generic availability, which was confirmed by ITSA. Despite continued introduction of newer ASMs, the median cost per DDD has decreased markedly. In 2024, total ASM spending declined to approximately 300 million euros, over 100 million euros less than in 2021.

CONCLUSION:

The observed prescription shifts align well with the recommendations of German clinical practice guidelines, which advocate preferential use of lamotrigine and levetiracetam and lacosamide as first-line agents in focal epilepsies, whilst discouraging the use of enzyme-inducing ASMs due to their unfavourable pharmacokinetic interaction profiles and long-term tolerability concerns. The sustained stability of total ASM expenditure indicates that the German pharmaceutical regulatory framework seems to have contributed effectively to contain ASM expenditures whilst maintaining access to therapeutic innovations.

01 Aug 2026·EPILEPSY & BEHAVIOR

Self-reported quality of life outcomes after Cenobamate initiation

Article

Author: Garcés-Pellejero, María ; Bellido-Castillo, Enric ; Campos-Fernández, Daniel ; López-Maza, Samuel ; Casado-Cuadrado, Luis ; Fonseca, Elena ; Quintana, Manuel ; Abraira, Laura ; Toledo, Manuel ; Santamarina, Estevo

OBJECTIVE:

Cenobamate (CNB) has demonstrated to be highly effective for the treatment of focal epilepsy. However, further real-world data beyond seizure control are needed. We aimed to assess the self-reported quality of life (QoL) in patients who initiated CNB considering efficacy, safety, cognitive and psychiatric outcomes.

METHODS:

We prospectively recruited patients starting CNB in a tertiary center during 2 years. All patients had baseline and 6-month follow-up clinical visits, completing self-administered online questionnaires that included Hospital Anxiety and Depression Scale (HADS), Quality of life in Epilepsy Inventory-31 (QOLIE-31) and Short-Form-36 Health Survey (SF-36), as well as a Telephone-Montreal Cognitive Assessment (T-MoCA).

RESULTS:

106 subjects (91.5% focal epilepsy) were included, with a mean age 43 years and 6-months retention rate of 84.1%. Median monthly seizure frequency decreased from 3 (IQR 1-11) to 0.66 (IQR 0-4) at 6 months (p<0.001). Seizure freedom was achieved in 26.5%. Adverse events occurred in 51.9%, mainly somnolence and dizziness. Baseline anxiety and depressive symptoms were present in 55.4% and 41.4% of patients respectively, remaining unchanged in the follow-up. Cognitive function slightly improved (median T-MoCA 16 to 17, p=0.009), particularly in responders and seizure-free patients. QoL scores were below normative values at baseline. After adjusted multiple regression analysis, seizure frequency reduction was significantly associated with the SF-36 Mental Component (β=4.030; 95%CI: 1.277-6.783; p=0.005), particularly in the emotional role domain (β=4.976; 95%CI: 1.442-8.509; p=0.007).

CONCLUSIONS:

Greater seizure reduction in patients treated with CNB was associated with significant improvements in self-perceived QoL after 6 months.

01 Aug 2026·Epilepsia Open

Impact of cenobamate on cortical responses to transcranial magnetic stimulation in people with drug‐resistant focal epilepsy

Article

Author: Sander, Josemir W. ; Thijs, Roland D. ; Helling, Robert M. ; Gefferie, Silvano R. ; Jiménez‐Jiménez, Diego ; Balestrini, Simona ; van den Maagdenberg, Arn M. J. M. ; Visser, Gerhard H.

Abstract:

Objective:

Cenobamate (CNB) is an effective antiseizure medication, though its mechanisms of efficacy remain incompletely understood. We assessed changes in cortical responses to transcranial magnetic stimulation (TMS) following CNB treatment.

Methods:

We recruited people with drug‐resistant focal epilepsy scheduled to start add‐on CNB in a tertiary epilepsy center. We performed TMS coupled with electromyography (EMG) and electroencephalography (EEG) at baseline, at 100 mg/day and at the maximum tolerated or minimum effective dose. Participants were categorized as responders (≥50% seizure reduction) or nonresponders. We used linear mixed models and cluster‐based permutation tests to assess CNB effects on resting motor thresholds (rMTs), intracortical inhibition and the amplitude, mean field power and event‐related spectral perturbation of TMS‐evoked EEG potentials (TEPs). For TMS measures that were significantly affected by CNB dose ( p < 0.05), we assessed differences between responders and non‐responders and correlations with seizure frequency.

Results:

Twenty‐eight participants completed the study (16 females; median age, 50 years). rMT ( p < 0.01) increased and cortical silent period (CSP) lengthened ( p = 0.03) with increasing CNB dose. These changes did not differ between responders and nonresponders, nor did they correlate with reduced seizure frequency. Short‐ and long‐interval intracortical inhibition, as well as all TEP parameters, remained unchanged.

Conclusion:

While CSP lengthening may merely reflect higher stimulation intensities, rMT increases align with CNB's suggested modulation of sodium channels.

Significance:

rMT changes that are independent of clinical response suggest that sodium channel effects do not fully account for the therapeutic efficacy of CNB.

Plain Language Summary:

We used magnetic brain stimulation in people with epilepsy to find out how the antiseizure medication cenobamate affects brain activity. As its dose increased, cenobamate raised the stimulation strength required to activate a muscle, known as the resting motor threshold (rMT). These changes did not predict a reduction in seizures. This suggests that cenobamate's effectiveness involves more than its effects on mechanisms linked to the rMT.

News (Medical) associated with Cenobamate

31 Aug 2026

·www.fiercebiotech.com

SK Biopharma pens $795M deal to usher Biohaven’s epilepsy therapy towards hoped-for 2029 launch

SK Biopharmaceuticals has strengthened its epilepsy offering by paying $350 million upfront to help speed Biohaven’s Kv7 ion channel activator on its way to market. Biohaven is currently evaluating the daily oral therapy, called opakalim or BHV-7000, in a phase 2/3 study of patients with focal epilepsy. A topline readout is expected later this year. Rather than wait for the results, SK has agreed to hand over the upfront cash—along with another $50 million next year—for the worldwide license to both opakalim and Biohaven’s Kv7 platform. Beyond those near-term paydays, Biohaven will also be in line for up to $150 million in development and regulatory milestone payments, as well as a slice of the royalties should opakalim make it to market. Another element of the deal will see SK take on responsibility for certain milestone responsibilities that Biohaven owes the drug's original developer Knopp Biosciences in relation to the Kv7 platform. These obligations reach $245 million and mean that the total amount SK could eventually pay out in relation to this morning’s deal could reach $795 million. SK became an epilepsy player in its own right when it scored FDA approval for Xcopri in 2019 as a treatment for treat partial-onset seizures. The South Korean biopharma is hoping to launch opakalim in the U.S. as soon as 2029 via its U.S. subsidiary SK Life Science. SK’s CEO Donghoon Lee said the company’s experience with taking Xcopri from clinical development through to global rollout “has given us a deep understanding of what it takes to bring a differentiated CNS medicine to patients.” “We see opakalim as a highly complementary addition to our epilepsy portfolio, with a mechanism and tolerability profile that could extend our ability to serve patients who may benefit from additional treatment options,” Lee added. “We look forward to a close, collaborative partnership with the Biohaven team through NDA submission and beyond.” Biohaven CEO Vlad Coric, M.D., said that SK's “established epilepsy development and commercialization expertise gives opakalim, if approved, its fastest and strongest path to patients worldwide.” “Rather than stand up a commercial organization of our own for opakalim, we structured a partnership with a leading strategic partner in epilepsy to drive long-term revenue potential of this novel mechanism,” Coric explained. “This partnership also brings $400 million in near-term, non-dilutive capital to Biohaven while preserving substantial long-term upside for our shareholders.” Opakalim will be in a tough race with Xenon Pharmaceuticals’ own oral Kv7 ion channel activator azetukalner, which has already aced a phase 3 seizure trial earlier this year and is undergoing a late-stage study for generalized epilepsy. For its part, Biohaven has been touting opakalim’s ability to selectively activate the Kv7.2/7.3 heteromeric channels, while lacking GABA receptor activity, as “distinguishing it from other investigational Kv7 activators.” In this morning’s release, Coric explained that opakalim is designed to “deliver meaningful efficacy without the burdensome central nervous system side effects, including sedation and dizziness, associated with so many antiseizure medicines.” The Connecticut-based biopharma used its R&D Day in May to unveil an analysis from an open-label extension study of patients with ongoing focal epilepsy that showed that 54% of participants who received 75 mg of opakalim once daily achieved a 50% or greater reduction in seizure frequency over six months of treatment. The company also claimed at the time that the candidate had demonstrated “markedly lower incidence of nervous system adverse events” than other approved or investigational antiseizure medicines. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalLicense out/in

26 Aug 2026

·www.prnewswire.com

SK Biopharmaceuticals to In-License Epilepsy Drug Candidate 'Opakalim'

Paves the Way to Launch its Second Innovative Drug Directly in the U.S. Announces agreement to in-license near-commercial candidate at a press conference Targets U.S. commercial launch as early as 2029… Upfront and milestone payments related to the Kv7 platform of up to $795M, plus tiered royalties to Biohaven on U.S. net sales of opakalim and additional royalties on ex-U.S. net sales of opakalim and on certain other products Strong potential of success and clear differentiation points validated… Stepping up to another level SEOUL, South Korea, Aug. 26, 2026 /PRNewswire/ -- SK Biopharmaceuticals Co., Ltd. ( CEO: Donghoon Lee) held a press conference on August 26th and announced that it has entered into an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven Ltd. and/or its wholly owned subsidiaries ("Biohaven"). This in-licensing is part of SK Biopharmaceuticals' ongoing strategy to leverage its commercial infrastructure through the addition of a new product (second product). Upon regulatory approval, as planned, the company will step up beyond its status as a 'one commercial product company' and become the only drug development company in South Korea that directly markets multiple innovative medicines in the global market. Opakalim is a selective Kv7 potassium channel activator that has garnered attention as a novel anti-seizure therapy for epilepsy. In clinical studies conducted to date, the candidate has demonstrated a favorable safety and tolerability profile. The candidate is currently in Phase 2/3 studies for treatment of partial-onset seizures (POS) in adults. Provided clinical milestones remain on track, initial top-line results from the RISE 3 trial are expected by the end of this year. Following a second data readout in 2028, SK Biopharmaceuticals aims to launch the product in the U.S. market as early as 2029. The agreement provides for upfront and milestone payments related to the Kv7 platform totaling up to $795 million.[1] This amount consists of $400 million in upfront cash consideration, with $350 million payable at closing and an additional $50 million payable one year after closing, and up to $395 million in development and regulatory milestone payments. Under the agreement, a portion of milestones and royalty payments is payable to Knopp Biosciences, the original developer. Closing of the transaction is subject to receipt of required antitrust clearances and other customary closing conditions. Upon closing, SK Biopharmaceuticals will obtain exclusive global development and commercialization rights to opakalim. The company will also obtain access to the Kv7 discovery platform and related Kv7 targeting compounds generated through the platform, opening up additional opportunities to expand its pipeline in the future through this strategic arrangement. SK Biopharmaceuticals commented, "As with any clinical-stage product candidate, risks associated with clinical trials, regulatory approval, and commercialization remain." However, the company added, "Our company has accumulated end-to-end capabilities spanning discovery, clinical trials, regulatory approvals, and commercialization in the epilepsy field over the past 30 years. Following an extensive evaluation by our epilepsy experts, we believe the candidate has strong potential for success and offers meaningful differentiation, particularly with respect to its favorable tolerability profile." Cenobamate (U.S. brand name: XCOPRI®), SK Biopharmaceuticals' innovative anti-seizure medication, has settled on a growth trajectory by becoming the No. 1 branded new drug in the U.S. epilepsy market this year. Upon regulatory approval of opakalim, SK Biopharmaceuticals plans to prioritize the launch of opakalim through its U.S. subsidiary, SK Life Science, where it has built a dedicated epilepsy commercial organization with a purpose-built neurology field force of over 150 professionals and established coverage of epilepsy-center and neurologists. In particular, this strategic approach is expected to enhance SK Biopharmaceuticals' ability to address the diverse unmet needs of patients with epilepsy by combining the distinct strengths of cenobamate and opakalim. With two differentiated assets, the company aims to broaden treatment options and deliver meaningful benefits to more patients. This in-licensing transaction also represents an important step toward building a differentiated epilepsy portfolio focused on improving patient outcomes. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "Opakalim is one of the most exciting assets we have advanced; a selective Kv7.2/7.3 activator designed to deliver meaningful efficacy with low incidence of the burdensome central nervous system side effects, including sedation and dizziness, associated with so many antiseizure medicines." Dr. Coric added, "SK Biopharmaceuticals is an ideal partner having launched XCOPRI and is the only company to bring a new antiseizure medicine for partial-onset (focal) seizures to patients in the U.S. since 2020." "As this news has been long awaited, the agreement to in-license opakalim carries immense strategic significance to our company," said Donghoon Lee, CEO of SK Biopharmaceuticals. "This propels SK Biopharmaceuticals to another level – transitioning into a multi-product company that directly commercializes therapies in the U.S. market." He also stated, "Beyond introducing early-stage candidates from Asian biotech companies and U.S. research institutions, we have now agreed to in-license a late-stage candidate with near-term trial readouts from a publicly listed U.S. biopharmaceutical company. This clearly signals that our company has stepped into the major leagues across all dimensions." "Going forward, we will continue to lead the way in restoring market trust in K-Bio and establishing a new benchmark for sustainable growth through tangible achievements," he concluded. Meanwhile, SK Biopharmaceuticals is continuously strengthening its mid-to-long-term growth and profitability foundations through lifecycle management initiatives for cenobamate, such as indication expansion and formulation diversification. Early this year, the company submitted a New Drug Application (NDA) for an oral suspension formulation and is pursuing supplemental New Drug Applications (sNDAs) within the year to expand the label to include primary generalized tonic-clonic (PGTC) seizures and pediatric patients. Global market expansion is also being conducted in parallel. In China, commercialization commenced in March through SK Biopharmaceuticals' local partner, Ignis Therapeutics. In Latin America, cenobamate was also successfully launched this year in Peru, Chile, and Brazil through SK Biopharmaceuticals' partner, Eurofarma. Procedures for regulatory approval in Japan and launch preparations in South Korea are also progressing smoothly. Advisors Nomura Securities International, Inc. is serving as exclusive financial advisor and Paul Hastings LLP is serving as legal counsel to SK Biopharmaceuticals. J.P. Morgan Securities LLC is serving as exclusive financial advisor and Sullivan & Cromwell LLP is serving as legal advisor to Biohaven. About Opakalim and the Kv7 Ion Channel Platform Opakalim is a next-generation, selective Kv7.2/7.3 potassium channel activator targeting a clinically validated mechanism of action for the treatment of epilepsy. Opakalim is differentiated from both first- and second-generation Kv7 activators by its selectivity for the Kv7.2/7.3 heteromeric channels that are the predominant regulators of neuronal excitability, with substantially less activity at GABA receptors. This selectivity profile is hypothesized to contribute to opakalim's favorable tolerability, including the low rates of somnolence, dizziness, and fatigue observed in clinical studies to date. Opakalim has been studied in more than 1,200 participants across multiple clinical trials. There are currently two Phase 2/3 randomized, double-blind, placebo-controlled studies (NCT06132893 and NCT06309966) evaluating opakalim versus placebo as adjunctive therapy for refractory focal onset epilepsy, along with an open-label extension study (NCT06443463) assessing long-term efficacy and safety. About Biohaven Biohaven Ltd. is a public U.S. biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments across immunology, neuroscience, and oncology. Biohaven is advancing an innovative portfolio of therapeutics built on proven drug development experience and multiple proprietary drug development platforms, including Kv7 ion channel modulation for epilepsy. For more information, visit . About SK Biopharmaceuticals Co., Ltd. And SK Life Science, Inc 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 . SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean biopharmaceutical 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 . 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. 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. Liver problems: XCOPRI may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start XCOPRI and while you take XCOPRI if needed. Tell your healthcare provider right away if you have any symptoms of liver problems, such as: yellowing of the skin and eyes (jaundice), nausea, vomiting, unusual darkening of the urine, or feeling tired or weak. 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. XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. Media Contact: SK Biopharmaceuticals Public Relations Team [email protected] SOURCE SK Biopharmaceuticals. Co., Ltd. 21% more press release views with Request a Demo

License out/inDrug Approval

26 Aug 2026

·www.prnewswire.com

Biohaven and SK Biopharmaceuticals Enter into Strategic Global Licensing Agreement for Novel Kv7 Ion Channel Platform and Opakalim, Lead Candidate for Epilepsy

SK Biopharmaceuticals to provide upfront and milestone payments related to the Kv7 platform up to $795 million, along with tiered royalties to Biohaven ranging from the mid-teens to low twenties on U.S. net sales of opakalim. Opakalim, the lead candidate from Biohaven's Kv7 platform, is a next-generation, selective Kv7.2/7.3 potassium channel activator currently in Phase 2/3 development for focal epilepsy, with topline results from the RISE3 trial expected in 2H 2026. It is designed to offer an easy-to-use, once-daily oral treatment without the need for titration and a low incidence of burdensome CNS side effects. The agreement pairs Biohaven's innovative, wholly owned Kv7 platform with the proven epilepsy commercial platform of SK Biopharmaceuticals, the team that launched XCOPRI®. The deal gives opakalim an established path to patients worldwide through SK Biopharmaceuticals' commercial capabilities without Biohaven building its own capital-intensive infrastructure. The transaction delivers non-dilutive capital, while retaining meaningful long-term upside in opakalim through milestones and royalties, materially strengthening Biohaven's balance sheet and extending its runway to advance a differentiated pipeline. NEW HAVEN, Conn. and SEOUL, South Korea, Aug. 26, 2026 /PRNewswire/ -- Biohaven Ltd. and/or its wholly owned subsidiaries ("Biohaven") (NYSE: BHVN) and SK Biopharmaceuticals Co., Ltd. ("SK Biopharmaceuticals") today announced a strategic global licensing and collaboration agreement under which SK Biopharmaceuticals will obtain an exclusive worldwide license to Biohaven's Kv7 ion channel platform, led by opakalim (BHV-7000), a next-generation, selective Kv7.2/7.3 potassium channel activator in Phase 2/3 development for focal epilepsy, with RISE3 trial topline results expected in 2H 2026. Following the close of the transaction, the companies will collaborate to advance opakalim through development and U.S. Food and Drug Administration (FDA) approval, combining Biohaven's innovative Kv7 platform with SK Biopharmaceuticals' global development and regulatory capabilities and its proven commercial track record of bringing antiseizure medicines to patients worldwide. Continue Reading SK biopharmaceuticals Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "This is a landmark partnership that has the potential to deliver a novel treatment for millions of patients with epilepsy who still need better seizure control without exacerbating CNS adverse effects. Opakalim is one of the most exciting assets we have advanced; a selective Kv7.2/7.3 activator designed to deliver meaningful efficacy without the burdensome central nervous system side effects, including sedation and dizziness, associated with so many antiseizure medicines. SK Biopharmaceuticals is an ideal partner having launched XCOPRI and is the only company to bring a new antiseizure medicine for partial-onset (focal) seizures to patients in the U.S. since 2016. Pairing our scientific innovation with SK Biopharmaceuticals' established epilepsy development and commercialization expertise gives opakalim, if approved, its fastest and strongest path to patients worldwide. This partnership also brings $400 million in near-term, non-dilutive capital to Biohaven while preserving substantial long-term upside for our shareholders." Under the terms of the agreement, SK Biopharmaceuticals to make upfront and milestone payments up to $795 million related to the Kv7 platform plus tiered royalties to Biohaven ranging from the mid-teens to low twenties on U.S. net sales of opakalim. Biohaven will receive $400 million in cash consideration, consisting of $350 million payable at closing and an additional $50 million payable in 2027, and Biohaven is eligible to receive an additional $150 million in development and regulatory milestone payments plus royalties on global net sales of opakalim. In addition, SK Biopharmaceuticals will assume responsibility for Kv7 program costs going forward under the terms of the agreement, including certain specified Knopp Biosciences and Kv7 future milestone obligations totaling $245 million and mid-single digit royalty obligations to Knopp Biosciences. Donghoon Lee, President and Chief Executive Officer of SK Biopharmaceuticals, commented, "Our experience building XCOPRI into a therapy for epilepsy patients worldwide, from clinical development through global commercialization, has given us a deep understanding of what it takes to bring a differentiated CNS medicine to patients. We see opakalim as a highly complementary addition to our epilepsy portfolio, with a mechanism and tolerability profile that could extend our ability to serve patients who may benefit from additional treatment options. We look forward to a close, collaborative partnership with the Biohaven team through NDA submission and beyond." With a history of more than 30 years, SK Biopharmaceuticals is the first global biopharmaceutical company in more than a decade, as well as the first Korean company, to independently discover, develop, and commercialize a novel antiseizure medicine. Through its U.S. subsidiary SK Life Science, Inc., the company markets XCOPRI® (cenobamate) for partial-onset (focal) seizures in adults in the U.S., where it has built a dedicated epilepsy commercial organization with a purpose-built neurology field force of over 150 professionals and established epilepsy-center and neurologist coverage. That mature infrastructure, paired with SK Biopharmaceuticals' global development, regulatory, and commercialization capabilities, has led to the steady, double-digit growth of XCOPRI and expanded its reach to patients worldwide. Dr. Coric added, "Beyond opakalim, this transaction validates Biohaven's strategy of building differentiated, novel platforms that create value for patients and investors while pursuing monetization pathways beyond typical public-market equity raises. With such a robust pipeline, Biohaven has the potential to create value in numerous ways, including an outright sale, license agreements and partnerships with companies looking to expand their clinical-stage pipelines. Rather than stand up a commercial organization of our own for opakalim, we structured a partnership with a leading strategic partner in epilepsy to drive long-term revenue potential of this novel mechanism. This structure allows Biohaven to receive an upfront payment for our development efforts while sharing in future upside of opakalim through milestones and royalties. A strengthened balance sheet, coupled with a meaningfully lower go-forward burn and a world-class partner, lets us sharpen our focus and invest in the next wave of Biohaven innovation, from our MoDE and TRAP extracellular protein degraders in immunology to our programs in neuroscience, metabolic conditions, and rare diseases. We are building a diversified, self-sustaining engine for long-term value creation." Summary of Financial Terms Near-Term Cash Consideration to Biohaven: $400 million — $350 million payable at closing and $50 million payable in 2027 Development and Regulatory Milestones to Biohaven: $150 million U.S. Royalties: Tiered royalties on U.S. net sales of opakalim ranging from the mid-teens to low twenties Ex-U.S. Royalties: Mid-single digit royalty on net sales of opakalim outside the U.S. Assumption of Knopp and Future Kv7 Obligations: SK Biopharmaceuticals will assume certain specified Biohaven obligations, including upto $185 million payable to Knopp Biosciences upon U.S and EU approval, plus a mid-single digit worldwide royalty — separate from, and in addition to, SK Biopharmaceuticals' milestone and royalty obligations to Biohaven. SK Biopharmaceuticals will also assume up to $60 million in additional obligations for milestones related to future Kv7 pipeline programs. All figures are expressed in U.S. dollars. Closing of the licensing and collaboration agreement is contingent on completion of review under applicable regulatory and antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions. Advisors J.P. Morgan Securities LLC is serving as exclusive financial advisor and Sullivan & Cromwell LLP is serving as legal advisor to Biohaven. Nomura Securities International, Inc. is serving as exclusive financial advisor and Paul Hastings LLP is serving as legal counsel to SK Biopharmaceuticals. About Opakalim and Biohaven's Kv7 Ion Channel Platform The lead asset in Biohaven's Kv7 platform is opakalim (BHV-7000), a next-generation, selective Kv7.2/7.3 potassium channel activator targeting a clinically validated mechanism of action for the treatment of epilepsy. Opakalim is differentiated from both first- and second-generation Kv7 activators by its selectivity for the Kv7.2/7.3 heteromeric channels that are the predominant regulators of neuronal excitability, with substantially less activity at GABA receptors. This selectivity profile is hypothesized to contribute to opakalim's favorable tolerability, including the low rates of somnolence, dizziness, and fatigue observed in clinical studies to date. Opakalim has been studied in more than 1,200 participants across multiple clinical trials. Biohaven is currently conducting two Phase 2/3 randomized, double-blind, placebo-controlled studies (NCT06132893 and NCT06309966) evaluating opakalim versus placebo as adjunctive therapy for refractory focal onset epilepsy, along with an open-label extension study (NCT06443463) assessing long-term efficacy and safety. About Biohaven Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments across immunology, neuroscience, and oncology. Biohaven is advancing an innovative portfolio of therapeutics built on proven drug development experience and multiple proprietary platforms, including Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. For more information, visit . About SK Biopharmaceuticals SK Biopharmaceuticals Co., Ltd., together with its U.S. subsidiary SK Life Science, Inc., is a global biopharmaceutical company focused on the discovery, development, and commercialization of treatments for central nervous system disorders. The company independently developed and commercializes XCOPRI (cenobamate) for the treatment of partial-onset seizures in adults, and continues to build a global pipeline spanning CNS disorders and oncology. For more information, visit . Forward-Looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "will," "believe," "may," "expect," "on track," "potential," and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the expected timing, conduct, and outcomes of Biohaven's ongoing and planned clinical trials of opakalim; the potential therapeutic benefits, efficacy, safety, and tolerability of opakalim; the anticipated closing of the transaction and satisfaction of closing conditions; the ability to achieve milestones and earn royalties; and the timing of planned regulatory interactions and filings, are not guarantees of future performance and involve substantial risks and uncertainties. Actual results, developments, and events may differ materially from those in the forward-looking statements as a result of various factors, including: the expected timing, commencement, and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; the cost of Biohaven's development and commercialization initiatives; and the effectiveness and safety of Biohaven's product candidates. Additional important factors are described in Biohaven's filings with the Securities and Exchange Commission, including under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update them, whether as a result of new information, future events, or otherwise, except as required by law. XCOPRI is a registered trademark of SK Biopharmaceuticals Co., Ltd. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Contacts Biohaven Investor Contact: Jennifer Porcelli, Vice President, Investor Relations [email protected] | +1 (201) 248-0741 Biohaven Media Contact: Mike Beyer, Sam Brown Healthcare Communications [email protected] | +1 (312) 961-2502 SK Biopharmaceuticals Media Contact: Soohui Lim, Head of Public Relations [email protected] SOURCE Biohaven Ltd. 21% more press release views with Request a Demo

License out/inDrug ApprovalClinical Study

100 Deals associated with Cenobamate

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KEGG	Wiki	ATC	Drug Bank
D11150	Cenobamate	N03A	DB06119

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Epilepsy	Canada	ENDO VENTURES LTD	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	China	SK Life Science, Inc.	08 Mar 2021
Epilepsy, Complex Partial	Phase 3	Japan	SK Life Science, Inc.	08 Mar 2021
Epilepsy, Complex Partial	Phase 3	South Korea	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
HIV Seropositivity	Phase 3	South Korea	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
Secondarily generalized seizures	Phase 3	South Korea	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 (Pubmed \| Adv Ther)	Phase 3	Seizures	227	Cenobamate 100 mg	exnprivvkf(wqiffxdsmm) = Common TEAEs reported included dizziness and somnolence kxkjlqovps (mjhpnhqbqt )	Positive	01 Feb 2026
NCT04557085 (Pubmed \| Adv Ther)	Phase 3	Seizures	227	Cenobamate 200 mg		Positive	01 Feb 2026
NCT04557085 (Pubmed \| Seizure)	Phase 3	Epilepsies, Partial	519	Cenobamate 200 mg/day	wecnqbgfzz(anexvruxzb) = The most common cenobamate-related treatment-emergent adverse events (≥20 %) were dizziness and somnolence. oxvhlvsngc (jymdqmvvzi )	Positive	01 Dec 2025
NCT04557085 (Pubmed \| Seizure)	Phase 3	Epilepsies, Partial	519	Cenobamate 400 mg/day		Positive	01 Dec 2025
NCT03678753 (NEWS) Manual	Phase 3	Seizures	169	Cenobamate	wjyxtinpta(gvcoxzzqwf) = eivcltkvwc dxmispwnpe (pnklkyboun ) Met View more	Positive	16 Sep 2025
NCT03678753 (NEWS) Manual	Phase 3	Seizures	169	Placebo	wjyxtinpta(gvcoxzzqwf) = gvkcwyjuhq dxmispwnpe (pnklkyboun ) Met View more	Positive	16 Sep 2025
NCT02535091 (Company_Website) Manual	Phase 3	Epilepsies, Partial	129	Cenobamate	zdhowtnief(fbuavoamic) = nyygyyyfvj qdeseagkzm (jvjihogizg ) View more	Positive	01 Sep 2025
CiFES (EAN2025)	Not Applicable	Epilepsy	41	Cenobamate	fcyekisprt(raxyxrzevp) = 5 patients suffered side effects being dizziness the most reported (n = 2, 4.8%). niuduaybdd (wosaqzqdur )	Positive	21 Jun 2025
EAN2025	Not Applicable	Drug Resistant Epilepsy	96	Cenobamate	gjjuzvnvsk(wngrmvzcnb) = wubiiiycwl tcdtztzjbc (wxjlmcmwqk ) View more	Positive	21 Jun 2025
NCT02535091 (C021, EAN2025)	Phase 3	Seizures	127	Cenobamate	iezjmqzijn(vsfjrwbffw) = sooeopazox emqiqeklkl (xrvqviygnr ) View more	Positive	21 Jun 2025
NCT02535091 (C021, EAN2025)	Phase 3	Seizures	127	Cenobamate (Uncontrolled focal-onset seizures)	aqzecylver(dtneozwddp) = vthhmesyai gmqgxeginq (scwpgljavc ) View more	Positive	21 Jun 2025
EAN2025	Not Applicable	Seizures	1,132	Cenobamate and 1 additional ASM	olpsuzerqs(uzvgbfreiz) = ewanjwpvlq vznowjgpvn (yeuysbikmj ) View more	Positive	21 Jun 2025
P8-9.008 (AAN2025)	Not Applicable	Epilepsy	59	Cenobamate	ufnlwupovi(edetljkbgx) = 12% epqjfihqid (szocvmkftm ) View more	Positive	07 Apr 2025

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