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

/ 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 Date19 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

263

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 ; Laskier-Owens, Vicki ; Evers, Silvia ; Li, Nannan ; Klarenbeek, Pim ; 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.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of cenobamate, a novel adjunctive therapy for the treatment of drug resistant focal onset seizures, from the Belgian healthcare payer perspective

Article

Author: Weckhuysen, Sarah ; Van den Bergh, Lynn ; Legros, Benjamin ; Callebaut, Britt ; Verdonck, Caroline ; Tanghe, Ann ; Vonck, Kristl ; Bodart, Olivier

OBJECTIVE:

Cenobamate has recently been introduced as new anti-seizure medication (ASM) for patients with focal onset seizures (FOS) who are insufficiently controlled despite the use of three previous ASMs. To date, few evaluations have addressed the budgetary impact for the healthcare payer of add-on ASMs in patients with drug-resistant epilepsy (DRE). This study aims to assess the budgetary implications for the Belgian health insurer, the National Institute for Health and Disability Insurance (NIHDI), if cenobamate were reimbursed for the adjuvant treatment of FOS in adults with DRE.

METHODS:

A prevalence-based budget impact model (BIM) was developed from the perspective of the Belgian NIHDI, considering all direct healthcare costs over a 3-year time horizon. A standardized expert elicitation process with experienced epileptologists was conducted to collect data on Belgian clinical practice. Source data uncertainty impact was investigated through a one-way sensitivity analysis (OWSA).

RESULTS:

Over a 3-year period, considering the cumulative drug costs of cenobamate, replacement of other third-generation ASMs, and savings generated at medical cost level, the introduction of cenobamate as adjunctive treatment for the target population was estimated to reduce the NIHDI budget by -€8,105,616. The robustness of these savings was confirmed through an OWSA.

CONCLUSION:

The savings at medical cost level fully offset the impact of cenobamate on the drug budget, leading to an overall healthcare budget saving of -€8,105,616 for NIHDI. This favourable outcome is largely due to cenobamate's high efficacy reflected in its high response rate and significant effect on reducing seizure frequency.

01 Dec 2025·EPILEPSY RESEARCH

Electrographic seizures on responsive neurostimulation: An early and objective measure of response to cenobamate

Article

Author: Privitera, Michael ; Gavvala, Jay R ; Rosenfeld, William E ; Kuzniecky, Ruben ; Jaisani, Zeenat ; Pellinen, Jacob ; Aboumatar, Sami ; Ring, Madeline

OBJECTIVES:

Responsive neurostimulation (RNS) electrocorticographic (ECoG) data may have a role in objectively assessing the efficacy of add-on antiseizure medications (ASMs). This retrospective, multicenter, observational, 24-week study is the first to report the effects of cenobamate on RNS-detected events (RDE).

METHODS:

Patients included adults (≥18 years) with a history of recurrent focal seizures and implanted RNS who initiated adjunctive cenobamate ≥ 3 months after RNS implant between 4/1/20-12/15/23 and who received ≥ 2 weeks of cenobamate (≥50 mg/day). RDE ("long episodes," "long episodes with saturation," and "saturation") obtained from the NeuroPace Patient Data Management System were reviewed to select only electrographic seizures (ESs) based on electrographic ictal patterns. RDEs and ESs were counted during the 8-week baseline period, every 2 weeks for 12 weeks after starting cenobamate, and at study end. The main outcome was percent change from baseline to the end of the 16-week treatment period (12 + weeks) for overall ESs, ESs ≥ 50 seconds, and ESs < 50 seconds. Patient-reported clinical seizure frequency was recorded when available.

RESULTS:

Thirty-seven patients (mean age 36.7 years) were included. Median cenobamate dose was 150 mg/day (range, 50-250 mg/day). There was a significant median percent reduction from baseline to the end of cenobamate treatment in ESs (94.4 %; p < 0.0001), ESs ≥ 50 s (100.0 %; p < 0.0001), and ESs < 50 s (100.0 %; p < 0.0001). Among patients with available seizure data (n = 24), median percent reduction in clinical seizures per 28 days from baseline to end of treatment was 72.2 % (p < 0.0001). Adverse events were reported in 27 % (10/37) of patients; dizziness, fatigue, and sleepiness were most reported.

SIGNIFICANCE:

Patients with uncontrolled seizures after RNS had a significant reduction in ESs and clinically reported seizures during adjunctive cenobamate treatment. Results from this analysis support the potential use of RNS ECoG data as an objective measure to supplement clinical data when determining cenobamate efficacy and may provide a strategy for monitoring responses to ASMs more generally in this population.

DATA AVAILABILITY:

The data for the analyses described in this paper are available by request from the corresponding author or from SK Life Science, Inc., the company sponsoring the clinical development of cenobamate for the treatment of focal epilepsy.

News (Medical) associated with Cenobamate

19 Sep 2025

·www.fiercepharma.com

Fierce Pharma Asia—BMS’ China asset sale; 2 biotech debuts; 2 potential deals

Bristol Myers Squibb's exit from a Chinese joint venture, two new biotechs with Chinese assets and reported deal talks by Roche and Johnson & Johnson with Shanghai Henlius Biotech made our news this week. Bristol Myers Squibb is exiting the first U.S.-China pharmaceutical joint venture. Kalexo Bio and Ollin Biosciences have launched with big venture capital backers and Chinese assets. Roche and Johnson & Johnson are reportedly eyeing an antibody-drug conjugate deal with Henlius. And more. 1. BMS sells controlling stake in historic US-China pharmaceutical joint ventureBristol Myers Squibb is exiting its 60% stake in Sino-American Shanghai Squibb Pharmaceuticals, which was established in 1982 as the first U.S.-China pharmaceutical joint venture. An internal email circulating online suggests Hillhouse Capital is on the other end of the deal, which also includes five old or over-the-counter products that the unit makes exclusively for the mainland China market.2. VC Aditum launches cardiovascular biotech, offers Mabwell up to $1B for siRNA assetCalifornia venture capital firm Aditum Bio has hatched another biotech by partnering up with China’s Mabwell Bioscience. Called Kalexo Bio, the startup carries a dual-target siRNA candidate after Aditum licensed the asset from Mabwell for $12 million in upfront and near-term payments. Kalexo will develop the drug for dyslipidemia and high-risk atherosclerotic cardiovascular disease.3. Eye disease biotech launches with $100M and sights set on Roche showdownOllin Biosciences has launched with two assets from Chinese biotechs: a VEGFxAng2 bispecific from Innovent Biologics and a TSHRxIGF-1R bispecific from VelaVigo. The eye-disease-focused startup is co-founded and headed by Jason Ehrlish, M.D., who supported the development of Roche’s Vabysmo, and counts Arch Venture Partners, Mubadala Capital and Monograph Capital among its backers.4. Fosun’s Henlius in talks with J&J, Roche on PD-L1 ADC (Bloomberg)Shanghai Henlius Biotech is in talks with Johnson & Johnson and Roche about a licensing deal around HLX43, a PD-L1 antibody-drug conjugate that’s in midstage testing in China, Bloomberg reports, citing people familiar with the matter. A deal could be worth several hundred million dollars upfront, the people said. Pfizer, already in phase 3, is currently the furthest in development with a PD-L1 ADC.5. GE HealthCare considering stake sale in China division: reportGE Healthcare is exploring options for its China unit, including the sale of a stake, people familiar with the matter told Bloomberg. A transaction may value the China assets at several billion dollars, the people said. GE’s China business has encountered some challenges thanks to U.S.-China tariffs.6. SK's blockbuster hopeful Xcopri reduces seizures in phase 3 trial, teeing up FDA expansion bidSK Biopharmaceutical reported a positive phase 3 readout for Xcopri in primary generalized tonic-clonic seizures. The 169-patient trial showed the drug reduced seizure frequency by 71.9% from baseline, versus 39.6% for placebo, over 28-day intervals. SK plans to file for an FDA label expansion on top of Xcopri’s existing focal seizures indication.Other News of Note:7. Dr. Reddy's India biologics plant issued FDA Form 4838. QL Biopharm links once-monthly GLP-1 to incumbent-rivaling weight loss in phase 29. Celltrion, Becton Dickinson team up to boost prefilled syringe manufacturing (release)

Phase 3ADCClinical ResultLicense out/inAcquisition

17 Sep 2025

·www.fiercepharma.com

SK's blockbuster hopeful Xcopri reduces seizures in phase 3 trial, teeing up FDA expansion bid

SK Biopharmaceutical hopes to cross the $1 billion sales marker for Xcopri by 2029. SK Biopharmaceutical’s Xcopri (cenobamate) met the bar in a phase 3 trial that could support the company’s ambitions of building a blockbuster with an expansion into another seizures subtype.The South Korean pharma won FDA approval for Xcopri in 2019 as a treatment for partial-onset seizures, also known as focal seizures, in adults. Since then, with rapid global growth, SK has outlined blockbuster ambitions for the drug by 2029. Now, with a positive phase 3 trial, another indication for primary generalized tonic-clonic (PGTC) seizures could be on the table. In its phase 3 study, SK evaluated Xcopri in 169 adult and adolescent patients with PGTC seizures, finding a “statistically significant reduction” in the seizures, the company said in a filing on the Korea Exchange. Specifically, seizure frequency from baseline levels was reduced by 71.9% in the Xcopri-treated group and 39.6% in the placebo arm over 28-day intervals.PGTC seizures are the most common type of generalized seizures—which are less prevalent than focal seizures—and considered the most severe due to the high risk of seizure-related injury and sudden unexpected death in epilepsy, SK pointed out. With limited treatment options, the company hopes Xcopri can address an unmet need and contribute to quality-of-life improvements for epilepsy patients, it said.While the current treatment landscape for the seizure type is sparse and generally made up of antiseizure medications such as GSK’s off-patent Lamictal, SK isn’t the only one looking to edge in on the market. Xenon Pharmaceuticals is approaching an early 2026 phase 3 readout of its lead candidate, azetukalner, in focal seizures as an additional phase 3 trial in PGTC seizures continues.According to a note by Jefferies analysts, SK’s win in PGTC seizures “serves as a reminder” that Xenon’s azetukalner could show “broad-spectrum activity” as well, supporting peak sales expectations of $400 million from that indication alone and $1 billion on the focal seizures side. However, SK still has some breathing room from the competition as the analysts note that SK’s study took seven years to produce top-line data after its 2018 start, suggesting that Xenon’s phase 3 could take “several years” as well.SK will file for a label expansion with the FDA and present additional analysis from the study at the American Epilepsy Society Annual Meeting in December. Last quarter, Xcopri helped the company reach record sales with U.S. revenues of $111 million.

Phase 3Drug ApprovalClinical Result

08 Sep 2025

·www.fiercebiotech.com

Rapport\'s seizure drug hits in phase 2, sending stock soaring

If approved, RAP-219 could compete with SK Life Science’s Xcopri and Catalyst Pharmaceuticals’ Fycompa.\n A phase 2a trial of Rapport Therapeutics’ focal onset seizure drug candidate has hit its primary endpoint, sending shares in the biotech up more than 157% in premarket trading.The study enrolled 30 people with drug-resistant seizures who were taking a median of three antiseizure medicines such as lamotrigine, levetiracetam and cenobamate. Participants received daily oral doses of RAP-219, Rapport’s TARPγ8-specific AMPA receptor negative allosteric modulator, for eight weeks. The receptor is expressed in parts of the brain associated with seizures but not areas linked to side effects.After eight weeks, 23 of the 27 patients in the primary endpoint analysis had experienced at least a 30% decline in long episodes from baseline. The episodes are an electrographic biomarker for clinical seizure reduction. Rapport reported a 71% median reduction in episode frequency from baseline. Shares in the company jumped 140% to $34.50 at one point in premarket trading.The biotech also reported reductions in clinical seizures, a key secondary endpoint. In an analysis of 25 patients, Rapport found 72% of participants experienced a 50% or greater reduction in clinical seizures from baseline. Almost one-quarter of patients achieved seizure freedom. Rapport tracked a 77.8% median reduction in clinical seizure frequency from baseline. Three patients discontinued treatment because of treatment-emergent adverse events (TEAEs). Almost 80% of TEAEs were grade 1 cases, indicating that they were mild cases. The remaining TEAEs were grade 2. Dizziness, headache and fatigue were the most common TEAEs.Based on the data, Rapport plans to start two phase 3 trials of RAP-219 in the third quarter of 2026. The next steps are to hold an end-of-phase 2 meeting with the FDA, share data from the ongoing eight-week follow-up period and start an open-label long-term safety trial. Those events are all scheduled for this year. Rapport expects to share follow-up data and preliminary long-term results next year.The biotech has predicted that a multibillion-dollar commercial opportunity is open to RAP-219. The forecast reflects an analysis that suggests 30% to 40% of the 3 million epilepsy patients in the U.S. have drug-resistant focal onset seizures.If approved, RAP-219 could compete with SK Life Science’s Xcopri and Catalyst Pharmaceuticals’ Fycompa and potentially against other assets that are currently in development. The pipeline of potential rivals in focal onset seizures includes Biohaven’s BHV-7000, Praxis Precision Medicines’ vormatrigine and Xenon Pharmaceuticals’ azetukalner.

$Rapport\'s seizure drug hits in phase 2, sending stock soaring$

Phase 2Clinical Result

100 Deals associated with Cenobamate

External Link

KEGG	Wiki	ATC	Drug Bank
D11150	Cenobamate	N03A	DB06119

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03678753 (NEWS) Manual	Phase 3	Seizures	169	Cenobamate	ypewfrkshh(rjomacxgqj) = syzjdufymc pauqpclsvd (sbqamciscm ) Met View more	Positive	16 Sep 2025
				Placebo	ypewfrkshh(rjomacxgqj) = xjmljwueko pauqpclsvd (sbqamciscm ) Met View more
NCT02535091 (Company_Website) Manual	Phase 3	Epilepsies, Partial	129	Cenobamate	aacatcgrau(tlleptfhes) = enpwlrmosn wdabawypoz (dewkuzcjry ) View more	Positive	01 Sep 2025
NCT04557085 (P8-9.010, AAN2025)	Phase 3	Seizures	519	Placebo	dbonerolhc(rgdkplepmn) = The most common TEAEs (≥20%) were dizziness in the cenobamate dose groups dtrqwjrugk (wuzymgvugs ) View more	Positive	07 Apr 2025
				Cenobamate 100 mg
P5-9.011 (AAN2025)	Not Applicable	Seizures Add-on	-	Cenobamate	psqycjknyf(cbactshudk) = Dizziness and lethargy were the most commonly reported adverse events during cenobamate treatment; these resolved with slower titration and/or reductions in concomitant ASMs clexuculjs (wdeitypueu ) View more	Positive	07 Apr 2025
NCT04557085 (YKP3089C035, AAN2025)	Phase 3	Seizures	519	Placebo	eobmrmiqmi(twnoncmabx) = The most common treatment-emergent adverse events (≥20%) with cenobamate were dizziness imzaugucfp (lhnrkiindm ) View more	Positive	07 Apr 2025
				Cenobamate 100 mg
NCT04557085 (P8-9.011, AAN2025)	Phase 3	Seizures	519	Placebo	xelbhvpbhn(sqhpzjnlnw) = zdrliybrmv wthqvyqqnz (fcrlzqcvzr )	Positive	07 Apr 2025
				Cenobamate 100 mg	xelbhvpbhn(sqhpzjnlnw) = ggtmmcjsii wthqvyqqnz (fcrlzqcvzr )
P8-9.008 (AAN2025)	Not Applicable	Epilepsy	59	Cenobamate	emfkxomnyf(rulncvthko) = 12% dryyibhaco (yamkmnzfzm ) View more	Positive	07 Apr 2025
NCT04690751 (CTgov)	Phase 1	Epilepsies, Partial	28	Cenobamate 200Mg Tab Fasted (Treatment A)	lgovwadhmy(inivpgtwva) = ldzguakxhs tooauuxmcz (iokpntkpyc, qrjayhldin - dvoeadfcla) View more	-	12 Aug 2024
				Cenobomate Oral Suspension Fasted (Treatment B)	lgovwadhmy(inivpgtwva) = osboxdnjix tooauuxmcz (iokpntkpyc, huicydtvaz - acvqgzmnlu) View more
NCT03678753 (Pubmed \| Cochrane Database Syst Rev)	Phase 3	Drug Resistant Epilepsy Add-on	659	Cenobamate add-on therapy	ayduxhobrf(wtbnnpocgd) = idsgiyfrtt mqznygrpwj (vqapnntwje, 1.02 - 1.27) View more	Positive	01 Aug 2024
				Placebo	ayduxhobrf(wtbnnpocgd) = sjndjztaky mqznygrpwj (vqapnntwje, 1.02 - 1.27) View more
EAN2024	Not Applicable	Seizures	-	Cenobamate	tansjvxbtt(qmrcofobrj) = umvnzgtioa wsjznredzg (olypzlnwmk ) View more	-	28 Jun 2024

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