预约演示
更新于：2026-01-29
Cenobamate
西诺氨酯
更新于：2026-01-29
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-11-21), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C10H10ClN5O2 |
InChIKeyGFHAXPJGXSQLPT-VIFPVBQESA-N |
CAS号913088-80-9 |
关联
31
项与 西诺氨酯 相关的临床试验CTR20254308
西诺氨酯片人体生物等效性试验
CTR20253859
苯巴那酯片在餐后条件下的人体生物等效性试验
CTRI/2025/10/095956
A randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, truncated bioequivalence study of Test product (T): Cenobamate 12.5 mg Tablets of Eris Lifesciences Limited India with Reference product (R): XCOPRI (cenobamate) 12.5 mg tablet Manufactured for SK Life Science, Inc., Paramus in Normal, Healthy, Adult, Human Subjects under fasting condition. - NIL
100 项与 西诺氨酯 相关的临床结果
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100 项与 西诺氨酯 相关的转化医学
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100 项与 西诺氨酯 相关的专利（医药）
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276
项与 西诺氨酯 相关的文献（医药）2026-03-01EPILEPSY & BEHAVIOR
Does adjunctive Cenobamate lead to a reduction in the use of vagal nerve stimulation? A long-term observational study of patients on the epilepsy surgery pathway
Article
作者: Patel, Asha ; Bose, Smriti ; Sumangala, Salini ; Wysota, Barbara ; Aung, Pyae ; Samarasekera, Shanika ; White, Daniel
OBJECTIVES:
To assess the effectiveness of adjunctive Cenobamate (CNB) in reducing seizure frequency and influencing concomitant antiseizure medication (ASM) use for adults with refractory epilepsy on the VNS pathway. To assess whether addition of CNB leads to deferral of VNS insertion or deactivation in those with a VNS in situ.
METHODS:
This retrospective cohort study evaluated adult patients on the epilepsy surgery pathway who were both awaiting and had already undergone VNS insertion (the latter conducted over two years prior to study onset and not requiring imminent battery replacement over a 36-month period. Seizure frequency, changes in concomitant ASMs and decisions regarding VNS were ascertained from electronic records at baseline (T1), 12-month (T2) and 36-month (T3) post initiation of Cenobamate.
RESULTS:
65 patients (29 male) were assessed, 42 patients (64.6 %) had a VNS in situ, the remainder were awaiting VNS. 64 patients had a minimum duration of epilepsy of 10 years. 18 patients (28 %) were classified as LGS spectrum. At T2, 40 patients (61.5 %) attained significant seizure reduction of at least 50 % (p < 0.0001). There was no significant difference between the LGS spectrum and non LGS cohorts. 9 of 23 patients awaiting VNS elected not to undergo insertion in light of seizure reduction. 22 (52 %) of the 42 VNS patients attained significant seizure reduction, of whom 3 (8 %) attained seizure freedom. 2 patients requested VNS deactivation. At T3, 13 patients of 23 deferred VNS insertion on account of seizure control with Cenobamate.
CONCLUSIONS:
Adjunctive CNB has the potential to influence decision making in people with epilepsy. VNS deferral and/or deactivation as a result of significant seizure reduction with CNB has a significant economic impact.
2026-02-01Neurology and Therapy
Long-term Impact of Cenobamate on Cognition in Patients with Drug-Resistant Focal Epilepsy: Outcomes from an Exploratory Real-World Study
Article
作者: Garcia-Martin, Guillermina ; Cabezudo-Garcia, Pablo ; De La Parra, Juan ; Serrano-Castro, Pedro J ; Sanchez-Guijo, Alvaro ; Lopez-Moreno, Yolanda ; Ramirez-Garcia, Teresa
INTRODUCTION:
Cognitive adverse events are a common issue in patients receiving later-generation antiseizure medications (ASMs). In this study, we assessed the long-term effects of cenobamate on cognitive endpoints in patients with drug-resistant focal epilepsy.
METHODS:
In this retrospective, observational study, the clinical records of adult patients who received cenobamate as part of the Spanish Expanded Access Program were reviewed. Seizure frequency, concomitant ASM usage, and data from 20 neuropsychological tests were collected at 6 and 18 months after cenobamate initiation.
RESULTS:
Among 14 patients included in the study, eight (57%) had daily seizures at baseline, three (21%) had seizures at least weekly, and three (21%) had seizures at least monthly. The median number of prior ASMs was 10; the median number of concomitant ASMs was three. The median cenobamate dose was 12.5 mg/day at baseline, 200 mg/day at month 6, and 250 mg/day at month 18. At month 18, 10 patients (71%) had at least a 50% reduction in seizure frequency, seven (50%) had at least a 90% reduction, and two (14%) achieved seizure freedom. Significant improvements in cognitive scores from baseline to month 18 were observed for verbal episodic memory (two measures; p = 0.016 and p = 0.0013), visuospatial episodic memory (p = 0.014), and processing speed (p = 0.0018). The mean number of concomitant ASMs (p = 0.0018) and the concomitant ASM drug load (p = 0.0001) decreased significantly between baseline and month 18. The sum of the ratios of prescribed daily dose/daily defined dose (total ratio of defined daily dose) for all concomitant ASMs (p < 0.0001), for perampanel (p = 0.017), and for sodium channel blockers (p = 0.0003) also decreased between baseline and month 18.
CONCLUSION:
In this exploratory, real-world study, we observed significant improvements in seizure frequency, concomitant ASM usage, and cognition at up to 18 months of cenobamate treatment in patients with drug-resistant focal epilepsy.
2026-02-01EPILEPSY RESEARCH
Evaluating the impact of cenobamate in the management in patients with drug resistant focal epilepsy – A retrospective real world observational study of patients attending NHS Greater Glasgow and Clyde
Article
作者: Yule, S ; Stephen, L ; MacBride-Stewart, S ; Taha, M ; Heath, C A ; Marshall, A D ; Nichol, S
INTRODUCTION:
Cenobamate (CNB) is the latest ASM to be licensed in the UK as an adjunctive treatment for adults with focal epilepsy. Early clinical trials have been encouraging with up to 50.4 % of patients showing a 50 % improvement at 12 weeks and 71 % were still receiving Cenobamate at 48 months. Regulatory studies of this nature provide useful information, but real-world data is often more informative. Since Scottish Medicine Consortium approval in 2022, we have been collecting audit data on outcomes from patients receiving cenobamate.
METHODS:
Adult patients were included if they received at least one prescription for cenobamate between March 2022 and April 2024 and had at least 12 months of data available before their first prescription. Patients dispensed cenobamate were identified from the national Prescribing Information System (PIS) to ensure complete patient capture. A manual review of electronic patient records was undertaken. The primary outcome of interest was change in seizure frequency on a stable dose. Secondary outcomes included epilepsy-related admissions, changes in ASMs and healthcare resource utilisation costs.
RESULTS:
145 patients received at least 1 CNB prescription, 144 of whom had reached an endpoint. 94/144 (65.2 %) had a favourable response. The median length of treatment was 655 days (range 180-922 days), with a median dose of 150 mg/d (range 25-400 mg/d). The median number of previous ASM was 5 (1-13). 48/145 (33.1 %) discontinued CNB - 35 due to adverse effects, 6 due to lack of efficacy. 2 patients died. Early analysis suggest a reduction in Health care resource use although long term follow up is required.
CONCLUSION:
These results offer insights for clinicians regarding the real-world effectiveness, retention rates, and healthcare cost implications of CNB therapy in a cohort consisting largely of patients with severe drug resistant epilepsy. Further studies are ongoing to assess the efficacy of CNB when used earlier and also to provide a comprehensive assessment of health care resource use in this real world settings.
100 项与 西诺氨酯 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 癫痫 | 加拿大 | 2023-06-12 | |
| 癫痫发作 | 欧盟 | 2021-03-26 | |
| 癫痫发作 | 冰岛 | 2021-03-26 | |
| 癫痫发作 | 列支敦士登 | 2021-03-26 | |
| 癫痫发作 | 挪威 | 2021-03-26 | |
| 癫痫部分性发作 | 美国 | 2019-11-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 全身性癫痫 | 临床3期 | 日本 | 2022-07-12 | |
| 癫痫的复杂部分性发作 | 临床3期 | 中国 | 2021-03-08 | |
| 癫痫的复杂部分性发作 | 临床3期 | 日本 | 2021-03-08 | |
| 癫痫的复杂部分性发作 | 临床3期 | 韩国 | 2021-03-08 | |
| HIV血清阳性 | 临床3期 | 中国 | 2021-03-08 | |
| HIV血清阳性 | 临床3期 | 日本 | 2021-03-08 | |
| HIV血清阳性 | 临床3期 | 韩国 | 2021-03-08 | |
| 继发性全身性癫痫发作 | 临床3期 | 中国 | 2021-03-08 | |
| 继发性全身性癫痫发作 | 临床3期 | 日本 | 2021-03-08 | |
| 继发性全身性癫痫发作 | 临床3期 | 韩国 | 2021-03-08 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 519 | 鹹顧鹹築簾鏇鬱廠膚繭(膚鹹繭製鏇廠觸憲餘夢) = The most common cenobamate-related treatment-emergent adverse events (≥20 %) were dizziness and somnolence. 鏇廠憲簾窪衊衊夢簾壓 (觸醖壓鏇觸築夢獵鑰衊 ) | 积极 | 2025-12-01 | |||
临床3期 | 169 | 憲願製夢鏇構糧艱鑰鏇(鹽築鑰衊蓋觸膚遞鏇製) = 淵餘網繭憲選築築廠艱 糧願積壓願遞顧膚夢顧 (齋築膚鹽遞襯艱醖壓觸 ) 达到 更多 | 积极 | 2025-09-16 | |||
Placebo | 憲願製夢鏇構糧艱鑰鏇(鹽築鑰衊蓋觸膚遞鏇製) = 艱製淵齋範築簾廠膚廠 糧願積壓願遞顧膚夢顧 (齋築膚鹽遞襯艱醖壓觸 ) 达到 更多 | ||||||
临床3期 | 129 | 遞廠製衊遞膚鑰鏇醖製(夢鏇夢齋觸憲獵壓艱鏇) = 範廠構壓範製鏇衊餘鑰 憲鹹範壓廠遞願構觸衊 (鑰淵鬱鑰夢網襯獵壓築 ) 更多 | 积极 | 2025-09-01 | |||
N/A | 癫痫发作 追加 | - | 選簾遞蓋淵遞構鑰淵選(製網餘鬱觸範壓襯鹽餘) = Dizziness and lethargy were the most commonly reported adverse events during cenobamate treatment; these resolved with slower titration and/or reductions in concomitant ASMs 膚鑰鏇鏇壓觸醖積鏇積 (鏇製鏇窪糧觸觸網襯遞 ) 更多 | 积极 | 2025-04-07 | ||
临床3期 | 519 | Placebo | 蓋鹹餘製築遞積蓋窪觸(艱獵憲壓壓齋糧簾構鏇) = 淵構遞窪廠鹽艱壓遞壓 簾製遞願夢選蓋獵網鏇 (鬱獵網夢觸艱積糧築繭 ) | 积极 | 2025-04-07 | ||
蓋鹹餘製築遞積蓋窪觸(艱獵憲壓壓齋糧簾構鏇) = 蓋窪壓廠鬱衊繭範淵膚 簾製遞願夢選蓋獵網鏇 (鬱獵網夢觸艱積糧築繭 ) | |||||||
临床3期 | 519 | Placebo | 齋製廠簾鏇膚齋淵襯齋(淵膚顧範壓鑰糧觸憲選) = The most common treatment-emergent adverse events (≥20%) with cenobamate were dizziness 餘衊淵築製鑰鏇鏇鏇鬱 (鏇鹽糧鹹觸糧壓夢窪範 ) 更多 | 积极 | 2025-04-07 | ||
临床3期 | 519 | Placebo | 鹽獵壓鏇淵壓窪鹹願醖(壓製憲網繭簾衊積遞鬱) = The most common TEAEs (≥20%) were dizziness in the cenobamate dose groups 衊鹹繭鬱廠觸糧獵選網 (網築夢築醖鏇選積鏇顧 ) 更多 | 积极 | 2025-04-07 | ||
N/A | 59 | 觸顧鏇鏇膚網窪網鏇蓋(鏇鹹艱願壓蓋築觸觸餘) = 12% 廠鑰膚簾壓糧蓋膚鬱鹹 (淵蓋構膚簾築膚糧齋鏇 ) 更多 | 积极 | 2025-04-07 | |||
临床1期 | 28 | (Treatment A) | 簾鹹鏇獵築築顧鬱憲蓋(構積網鹹獵鬱艱願衊夢) = 齋簾艱顧醖獵獵衊觸餘 艱鏇製夢鹽餘鬱遞壓淵 (製艱築醖鬱窪窪衊齋廠, 衊醖淵鹽顧簾淵構襯遞 ~ 齋鏇網顧構淵餘衊網選) 更多 | - | 2024-08-12 | ||
Cenobomate Oral Suspension Fasted (Treatment B) | 簾鹹鏇獵築築顧鬱憲蓋(構積網鹹獵鬱艱願衊夢) = 糧構襯網衊顧襯築淵襯 艱鏇製夢鹽餘鬱遞壓淵 (製艱築醖鬱窪窪衊齋廠, 餘選衊鏇壓鬱淵鹽蓋糧 ~ 獵壓觸選壓觸淵鏇齋淵) 更多 | ||||||
临床3期 | 耐药性癫痫 追加 | 659 | Cenobamate add-on therapy | 製糧鹽構廠鑰蓋壓顧鏇(憲糧衊襯鏇範願衊餘製) = 願鏇襯窪鏇淵艱憲衊繭 獵蓋範積齋獵願壓憲鏇 (醖艱糧鹽鹽構艱鏇顧膚, 1.02 ~ 1.27) 更多 | 积极 | 2024-08-01 | |
Placebo | 製糧鹽構廠鑰蓋壓顧鏇(憲糧衊襯鏇範願衊餘製) = 壓廠網簾襯築艱蓋醖範 獵蓋範積齋獵願壓憲鏇 (醖艱糧鹽鹽構艱鏇顧膚, 1.02 ~ 1.27) 更多 |
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