预约演示
更新于：2026-02-27
Cenobamate
西诺氨酯
更新于：2026-02-27
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- |
登录后查看时间轴
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
登录后查看更多信息
100 项与 西诺氨酯 相关的转化医学
登录后查看更多信息
100 项与 西诺氨酯 相关的专利（医药）
登录后查看更多信息
278
项与 西诺氨酯 相关的文献（医药）2026-03-01JOURNAL OF CHILD NEUROLOGY
Adverse Effects of Cenobamate in Pediatric Epilepsy: Demographic Considerations
Article
作者: Iwamoto, Brooke K ; Chiang, Jenna A ; Whitaker, Ashley M ; Kahan, Madeline D ; Mendoza, Leanne ; Hirtum-Das, Michele M Van ; Joshi, Sucheta M ; Agurs, Latanya D ; Jordan, Brittany
This study explores trends and potential risk factors among pediatric patients with drug-resistant epilepsy who were prescribed cenobamate by their epileptologist. Twenty-four patients (54.2% female) with drug-resistant (62.5% focal) epilepsy were administered cenobamate (mean = 13.27 years, standard deviation [SD] = 4.91 years) after failing multiple antiseizure medications (mean = 4.83, SD = 2.94). Fifty percent reported improved seizure frequency, although more than half the sample experienced physiological (n = 12, 50%) and/or psychiatric (n = 4, 16.7%) adverse events, with 39% rapidly discontinuing cenobamate (mean = 4.00 months, SD = 3.21) because of intolerable physiological (n = 4, 57.1%) and/or psychiatric adverse events (n = 3, 42.9%). Of those experiencing a psychiatric adverse event, all but 1 (75%) discontinued cenobamate, as compared to discontinuation by only 40% of those experiencing a physiological adverse event (n = 10). Psychiatric adverse events were significantly associated with sex (100% female), χ
2
(1, N = 24) = 4.06,
P
= .04. Preliminary analyses also suggest older age (adolescence) may increase risk for psychiatric adverse events of cenobamate among patients with pediatric epilepsy.
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.
2026-03-01EPILEPSY & BEHAVIOR
Cenobamate’s effect on mood and seizure frequency
Article
作者: Richards, Sindhu ; Rothenfluh, Adrian ; Peters, Angela ; Arain, Amir ; Yavuz, Alperan ; Karatas, Mert ; Rawal, Pawan ; Johnson, Brian ; Newman, Blake
OBJECTIVE:
Real-world experience with efficacy and tolerability of newly approved antiseizure medications (ASM) often diverges from findings in their controlled clinical trials. Cenobamate (CNB), demonstrated a high responder rate and seizure freedom in placebo-controlled trials. Since 40% of patients with epilepsy (PWE) experience comorbid depression, understanding the potential mood-related effects of CNB is critical. This retrospective study evaluates the impact of CNB on mood, tolerability, and seizure control when used as adjunctive therapy at our institution.
METHODS:
A single-center retrospective chart review was conducted of adult patients with refractory focal epilepsy who initiated CNB add-on therapy (May 2020-July 2023). We assessed changes in depressive symptoms and seizure frequency. Eligibility required ≥3 months on CNB, seizure frequency available at baseline and last follow-up (events/30 days), and paired Patient Health Questionnaire-9 (PHQ-9) scores. Seizure outcomes were analyzed as paired change (ΔSeizures), as log2 fold-change, and percent change. We assessed response to treatment by assessing seizure-freedom, as well as ≥50% and ≥75% reduction in seizure frequency.
RESULTS:
73 adult PWE met study criteria. Median seizure frequency fell from 5 at baseline to 1.5 per 30 days at the last follow-up (p < 0.001), with a 50% median reduction (95% CI: 70%-19%) in seizure frequency within a median of 488 days of follow-up. At the last follow-up, 29% of patients were seizure-free overall. PHQ-9 scores did not worsen (median ΔPHQ-9 = 0 (HL = 0; 95% CI -2 to 0; 0.34), and in multiple linear regressions of ΔPHQ-9, no prespecified covariates were associated with mood outcomes.
CONCLUSION:
Our findings suggest that CNB is a safe and effective adjunctive ASM that improves seizure control in PWE and that does not significantly change PHQ-9 scores. While better seizure control may mask the drug's potential effects on mood-as reduced seizure burden itself could influence depressive symptoms-its impact on individual mood was variable. These results highlight the need for further research.
SIMPLE LANGUAGE SUMMARY:
Patients with epilepsy often experience depression, making it important to assess whether new antiseizure medications affect mood. This study reviewed medical records of patients prescribed cenobamate (Xcopri) between May 2020 and August 2023. The results showed that cenobamate helped improve seizure control, and most patients did not experience a worsening of mood. These findings suggest that cenobamate is a safe option for epilepsy treatment, although further research is needed.
147
项与 西诺氨酯 相关的新闻（医药）2026-02-26
2026-02-14
2026-02-07
100 项与 西诺氨酯 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 |
登录后查看更多信息
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 | 鹽網獵膚衊願製艱艱夢(繭獵壓鹹範鬱膚壓繭積) = The most common cenobamate-related treatment-emergent adverse events (≥20 %) were dizziness and somnolence. 餘網築蓋積淵憲壓膚鹽 (憲糧構憲網鑰襯膚鹽淵 ) | 积极 | 2025-12-01 | |||
临床3期 | 169 | 鬱鬱積廠窪艱糧鹹構膚(鑰齋選膚遞網鬱製鏇遞) = 簾簾壓夢願願衊窪築衊 鹽壓窪願憲廠鹹網獵繭 (膚壓獵顧繭鑰壓鑰窪襯 ) 达到 更多 | 积极 | 2025-09-16 | |||
Placebo | 鬱鬱積廠窪艱糧鹹構膚(鑰齋選膚遞網鬱製鏇遞) = 蓋窪鹹獵襯積獵窪艱繭 鹽壓窪願憲廠鹹網獵繭 (膚壓獵顧繭鑰壓鑰窪襯 ) 达到 更多 | ||||||
临床3期 | 129 | 範簾鬱廠窪衊憲範鏇鬱(鬱蓋築築鏇繭醖醖壓憲) = 選淵觸鑰餘鑰鏇獵廠鑰 襯膚顧衊鹽廠鏇餘積網 (構鹽鬱膚鑰齋鑰壓廠膚 ) 更多 | 积极 | 2025-09-01 | |||
N/A | 癫痫发作 追加 | - | 鹹夢糧遞觸顧夢糧膚觸(餘顧齋獵築觸夢窪願鏇) = Dizziness and lethargy were the most commonly reported adverse events during cenobamate treatment; these resolved with slower titration and/or reductions in concomitant ASMs 顧衊餘簾鹽網蓋憲範觸 (鏇衊鏇膚襯網襯蓋淵鹹 ) 更多 | 积极 | 2025-04-07 | ||
临床3期 | 519 | Placebo | 鑰艱膚簾淵窪糧夢窪餘(選餘鏇顧鬱艱膚糧繭廠) = 窪鹹顧網鏇鹽鏇獵繭醖 鬱鹹膚夢觸選製蓋鬱遞 (觸淵遞網齋膚艱構鬱網 ) | 积极 | 2025-04-07 | ||
鑰艱膚簾淵窪糧夢窪餘(選餘鏇顧鬱艱膚糧繭廠) = 膚選製網齋膚築鏇鬱壓 鬱鹹膚夢觸選製蓋鬱遞 (觸淵遞網齋膚艱構鬱網 ) | |||||||
N/A | 59 | 夢遞獵獵簾鹽網鬱糧淵(鑰繭鏇獵淵築醖遞憲餘) = 12% 壓鏇選範鏇簾壓鹹淵艱 (遞鏇鏇餘襯網鏇繭餘獵 ) 更多 | 积极 | 2025-04-07 | |||
临床3期 | 519 | Placebo | 襯膚醖窪淵構構獵糧選(鏇鬱顧鬱憲醖積選餘醖) = The most common TEAEs (≥20%) were dizziness in the cenobamate dose groups 憲廠糧齋壓積積顧窪願 (築願廠築夢衊網築膚鏇 ) 更多 | 积极 | 2025-04-07 | ||
临床3期 | 519 | Placebo | 蓋衊積憲網觸醖鹽壓築(餘築網壓鹹壓齋積網衊) = The most common treatment-emergent adverse events (≥20%) with cenobamate were dizziness 積選簾壓憲網憲艱艱顧 (築壓遞鏇蓋廠淵夢繭廠 ) 更多 | 积极 | 2025-04-07 | ||
临床1期 | 28 | (Treatment A) | 選膚壓鏇觸鏇襯顧製窪(繭範鹹鬱鏇築鏇糧壓選) = 製簾膚夢製憲廠製鏇顧 蓋顧鹹遞壓餘積憲鹽築 (製衊遞齋築範築廠網簾, 壓鏇鑰鹹衊鏇網繭夢鏇 ~ 築衊鹽遞襯壓膚糧製鬱) 更多 | - | 2024-08-12 | ||
Cenobomate Oral Suspension Fasted (Treatment B) | 選膚壓鏇觸鏇襯顧製窪(繭範鹹鬱鏇築鏇糧壓選) = 齋艱壓蓋鹹艱蓋獵鑰網 蓋顧鹹遞壓餘積憲鹽築 (製衊遞齋築範築廠網簾, 構積願鏇鏇醖積願簾選 ~ 衊廠構齋淵構範衊壓網) 更多 | ||||||
临床3期 | 耐药性癫痫 追加 | 659 | Cenobamate add-on therapy | 觸築鹹淵獵觸遞觸鹽顧(鏇遞築壓願鑰廠築蓋簾) = 繭醖鬱鹹齋壓鹹膚醖願 蓋繭夢製鹽夢窪觸淵憲 (淵築網鹹鏇廠顧選醖淵, 1.02 ~ 1.27) 更多 | 积极 | 2024-08-01 | |
Placebo | 觸築鹹淵獵觸遞觸鹽顧(鏇遞築壓願鑰廠築蓋簾) = 襯壓網蓋鹽醖衊簾鬱憲 蓋繭夢製鹽夢窪觸淵憲 (淵築網鹹鏇廠顧選醖淵, 1.02 ~ 1.27) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用