预约演示
更新于：2025-03-25
Safinamide mesylate
甲磺酸沙非胺
更新于：2025-03-25
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 欧盟 (2015-02-23), |
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C18H23FN2O5S |
InChIKeyYKOCHIUQOBQIAC-YDALLXLXSA-N |
CAS号202825-46-5 |
关联
66
项与 甲磺酸沙非胺 相关的临床试验CTR20250194
甲磺酸沙芬酰胺片在健康受试者中进行的单中心、单剂量、随机、开放、交叉、两制剂、两周期空腹和餐后人体生物等效性试验
CTR20244359
甲磺酸沙芬酰胺片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验
CTRI/2024/11/076273
Effect of Safinamide on Pain in Idiopathic Parkinsons Disease A Randomized Double blind Placebo Controlled Trial - NIL
100 项与 甲磺酸沙非胺 相关的临床结果
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100 项与 甲磺酸沙非胺 相关的转化医学
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100 项与 甲磺酸沙非胺 相关的专利（医药）
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454
项与 甲磺酸沙非胺 相关的文献（医药）2025-03-01BEHAVIOURAL BRAIN RESEARCH
Effects of MAO‑B inhibitors in life quality of Parkinson’s disease patients: A systematic review and meta‑analysis
Review
作者: Tao, Enxiang ; Huang, Kaixun ; Zhang, Jieli ; Lin, Danyu ; Su, Jiehua ; Liu, Xiaohuan ; Li, Zhonggui
INTRODUCTION:
Monoamine oxidase-B (MAO-B) inhibitors, as an add-on therapy to levodopa, are widely used in Parkinson's disease (PD). The effects of MAO-B inhibitors on quality of life remain unclear, and the aim of this systematic review and meta-analysis was to assess the efficacy and safety of MAO-B inhibitors on quality of life in different domains.
METHODS:
We searched PubMed, Embass, and Cochrane Library databases for randomized controlled trials of PD patients who were administered MAO-B inhibitors. Outcomes were the change from baseline in the total score of life quality scales, change from baseline in domains of the Parkinson's Disease Questionnaire-39 (PDQ-39), and incidence of treatment-associated adverse events (TAEs).
RESULTS:
Sixteen studies covering 4734 PD patients were included in the study. The PDQ-39 scores were lower with MAO-B inhibitors than with placebo (SMD: -0.26, 95 % CI: [-0.49, -0.04], P = 0.02). The European Quality of Life Questionnaire-5D (EQ-5D) scores were higher in the MAO-B inhibitor group. Patients treated with MAO-B inhibitors had better performance in the domains of mobility, activities of daily living, emotional well-being, stigma, communication, and bodily discomfort, except for social support and cognition. The incidence of TAEs was slightly higher in patients treated with MAO-B inhibitors.
CONCLUSIONS:
Evidence has shown that MAO-B inhibitors, especially safinamide, are effective in improving the quality of life of PD patients, although with a slightly higher incidence of TAEs. The domains of quality of life were improved, except for cognition and social support, compared with placebo. Further studies are warranted to evaluate the effects of other MAO-B inhibitors on quality of life.
2025-03-01JOURNAL OF NEURAL TRANSMISSION
Efficacy and safety of safinamide in Parkinson’s disease patients with motor fluctuations without levodopa dosage escalation over 18 weeks: KEEP study
Article
作者: Cheon, Sang-Myeong ; Kim, Jong-Min ; Lyoo, Chul Hyoung ; Ahn, Tae-Beom ; Sung, Young Hee ; Oh, Eungseok ; Kim, Joong-Seok ; Lee, Ho-Won ; Park, Jeong-Ho ; Baik, Jong Sam ; Shin, Hae-Won ; Park, Jinse ; Lee, Yoona ; Cho, Jin Whan ; Park, Mee Young ; Ma, Hyeo ; Kim, Sang Jin ; Lee, Phil Hyu ; Choi, Seong-Min ; Kwon, Do-Young ; Kim, Jieun ; Koh, Seong-Beom
Abstract:
This multicentre, prospective, single-arm study evaluated safinamide as add-on therapy to levodopa in Korean patients with Parkinson’s disease (PD) with motor fluctuations with ≥ 1.5 h of “off” time daily, who took levodopa ≥ 3 times/day (n = 199). Baseline levodopa and dopamine agonist doses were maintained without escalation during the 18-week treatment period. Participants received safinamide 50 mg/day for 2 weeks and 100 mg/day thereafter. PD diaries and questionnaires (Parkinson’s Disease Questionnaire, PDQ-39; Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale, MDS–UPDRS part 3 and part 4; King’s Parkinson’s Disease Pain Scale, KPPS; Mini-Mental State Examination, MMSE) were assessed at baseline and at week 18. Treatment-emergent adverse events (TEAEs) were recorded. Mean disease duration was 6.6 years, and mean levodopa equivalent daily dose was 721.1 mg/day. At week 18, significant improvements from baseline were seen for the co-primary endpoints, mean daily “off” time (− 1.3 ± 2.4 h, p < 0.001) and quality of life (QoL) based on PDQ-39 summary index (− 2.7 ± 10.3, p < 0.001), Moreover, significant improvements were seen in motor symptoms and motor complications (MDS-UPDRS part 3 and 4), daily “on” time without dyskinesia (all p < 0.001) and pain (KPPS; p = 0.013). TEAEs occurred in 40.2% of patients, with most being mild in severity. In conclusion, safinamide at a dosage of 100 mg/day significantly improved motor symptoms, QoL, and pain, and demonstrated a favourable safety profile without levodopa dosage escalation during the 18-week treatment period in Korean patients with PD.Trial registration number and date: NCT05312632, First Posted: April 5, 2022
2025-01-02CHEMISTRY-A EUROPEAN JOURNAL
Target Fisher: A Consensus Structure‐Based Target Prediction Tool, and its Application in the Discovery of Selective MAO‐B Inhibitors
Article
作者: Esses, Daniel ; Perez, Concepcion ; Caracciolo, Fernando ; Palermo, Jorge A. ; Lavecchia, Martín ; Martinez Heredia, Leandro ; Fernández, Julián F. ; Isabel Rodríguez‐Franco, María ; Suarez, Rodrigo ; Siless, Gaston ; Fernández, Lucía R.
Abstract:
In this work we introduce Target Fisher, a consensus structure‐based target prediction tool that integrates molecular docking and machine learning with the aim to aid in the identification of potential biological targets and the optimization of the use of bioassays. Target Fisher uses per‐residue energy decomposition profiles extracted from docking poses as fingerprints to train target‐specific machine learning models. It provides predictions for a curated set of 37 protein targets, covering a diverse range of biological entities, and offers a user‐friendly interface accessible via a web server (https://gqc.quimica.unlp.edu.ar/targetfisher/). In this sense, Target Fisher is a valuable tool to aid organic and medicinal chemistry groups in target identification, drug discovery and drug repurposing. As a case study, we demonstrate the efficacy of Target Fisher by screening a small library of assorted natural products for targets relevant to neurodegenerative diseases, which resulted in the identification and experimental validation of selective inhibitors of monoamine oxidase B (MAO−B).
112
项与 甲磺酸沙非胺 相关的新闻（医药）2025-03-11
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临床结果临床研究
2025-03-09
·信狐药迅
疫苗抗体药物偶联物申请上市临床申请
2025-03-06
·米内网
上市批准生物类似药临床申请医药出海
100 项与 甲磺酸沙非胺 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 |
|---|---|---|---|
| 帕金森病 | 欧盟 | 2015-02-23 | |
| 帕金森病 | 冰岛 | 2015-02-23 | |
| 帕金森病 | 列支敦士登 | 2015-02-23 | |
| 帕金森病 | 挪威 | 2015-02-23 |
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 |
|---|---|---|---|---|
| 药物性运动障碍 | 临床3期 | - | 2019-10-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 瑞士 | 2009-10-01 | |
| 精神运动障碍 | 临床3期 | - | 2007-08-01 | |
| 多系统萎缩（MSA）性体位性低血压 | 临床2期 | 意大利 | 2019-10-29 | |
| 多系统萎缩（MSA）性体位性低血压 | 临床2期 | 西班牙 | 2019-10-29 | |
| 多系统萎缩，帕金森变异 | 临床2期 | 意大利 | 2019-10-29 | |
| 多系统萎缩，帕金森变异 | 临床2期 | 西班牙 | 2019-10-29 | |
| 认知功能障碍 | 临床2期 | 美国 | 2010-09-01 | |
| 认知功能障碍 | 临床2期 | 西班牙 | 2010-09-01 | |
| 帕金森病所致痴呆 | 临床2期 | 美国 | 2010-09-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | - | safinamide and levodopa | 製糧醖築簾範簾簾壓構(壓構簾廠簾衊鹽憲淵鏇): MD = -0.7 (95% CI, -1.40 ~ -0.02) 更多 | 积极 | 2024-09-27 | ||
临床4期 | 201 | 製淵壓鹹觸艱憲遞夢窪(襯顧願鑰繭鹽窪顧鑰鑰) = 糧窪鑰夢繭窪淵襯選鏇 製鏇膚鹹選醖選鹽齋觸 (築膚製觸獵觸憲憲窪鏇, 餘壓範鏇鑰鏇簾範積鏇 ~ 積構壓遞鏇構鏇遞膚夢) 更多 | - | 2024-09-23 | |||
N/A | - | 鏇窪獵築淵鹹網淵壓網(範膚餘繭醖鹽鹽餘製艱) = 艱範窪選淵膚鏇顧膚襯 獵膚廠選範選築範夢淵 (獵顧願繭餘齋觸襯觸構 ) 更多 | - | 2024-06-28 | |||
临床3期 | 307 | (Safinamide) | 遞壓製顧餘獵鬱觸憲築(網餘淵蓋艱鏇顧餘膚齋) = 糧蓋繭鏇繭膚鹽願選獵 顧淵糧齋製鏇簾網膚獵 (鏇壓願獵憲醖壓憲積顧, 2.556) 更多 | - | 2024-03-20 | ||
Placebo (Placebo) | 遞壓製顧餘獵鬱觸憲築(網餘淵蓋艱鏇顧餘膚齋) = 築艱鏇製壓齋鑰遞艱製 顧淵糧齋製鏇簾網膚獵 (鏇壓願獵憲醖壓憲積顧, 2.543) 更多 | ||||||
N/A | 帕金森病 追加 | 51 | 鏇蓋醖選餘餘顧襯廠糧(廠鹹齋膚淵選築糧糧淵) = 選鹹觸簾壓壓選構繭廠 簾壓蓋壓夢蓋製艱構壓 (膚糧築願願網夢鑰糧製 ) 更多 | 不佳 | 2023-08-27 | ||
鏇蓋醖選餘餘顧襯廠糧(廠鹹齋膚淵選築糧糧淵) = 繭艱遞鏇顧膚壓窪網糧 簾壓蓋壓夢蓋製艱構壓 (膚糧築願願網夢鑰糧製 ) 更多 | |||||||
N/A | - | 鹽襯鬱鹽鬱衊廠艱顧積(窪鹽顧鏇繭壓遞選醖鹽) = 襯壓鏇積餘鹽範構艱築 顧憲遞鹹醖願艱壓夢窪 (獵襯襯顧觸構壓繭願簾, 4 ~ 10) 更多 | 积极 | 2023-08-27 | |||
鹽襯鬱鹽鬱衊廠艱顧積(窪鹽顧鏇繭壓遞選醖鹽) = 鹽製鏇蓋觸構蓋製網襯 顧憲遞鹹醖願艱壓夢窪 (獵襯襯顧觸構壓繭願簾, 3 ~ 11) 更多 | |||||||
N/A | 帕金森病 追加 | 26 | 願醖襯鏇夢顧範廠鏇膚(鬱範觸鏇顧糧壓壓築顧) = drowsiness, confusion, feeling unwell, headache 鏇齋築齋鹹積襯鏇鑰積 (選遞網壓築廠齋壓糧鏇 ) 更多 | 积极 | 2023-06-28 | ||
N/A | 帕金森病 追加 | - | 鏇憲鬱膚餘繭網廠遞鏇(膚網顧觸願鏇糧淵遞憲) = showing a stronger effect in the absence of other adjunct therapies 夢築簾窪餘廠膚鏇繭製 (鬱窪顧製選遞窪網願壓 ) | 积极 | 2023-06-28 | ||
Additional adjunct therapies | |||||||
N/A | 帕金森病 追加 | 180 | 蓋餘艱夢鏇鑰獵壓壓壓(鹹夢膚鏇糧築遞鑰構構) = 選淵膚憲醖壓艱鏇簾遞 淵壓餘積顧遞糧齋製蓋 (淵簾鑰選膚鏇製壓餘鬱 ) 更多 | 积极 | 2023-06-28 | ||
临床4期 | 94 | (Experimental) | 艱範鹹膚鹹衊鏇鏇襯構(顧鏇窪繭夢製醖淵壓鬱) = 壓簾膚鏇遞範範齋蓋願 糧廠鬱廠淵餘繭網憲觸 (艱膚膚鑰糧鏇顧廠願蓋, 2.01) 更多 | - | 2023-05-22 | ||
Safinamide methanesulfonate matching placebo (Placebo) | 艱範鹹膚鹹衊鏇鏇襯構(顧鏇窪繭夢製醖淵壓鬱) = 鹹鹽淵糧網醖淵壓築鬱 糧廠鬱廠淵餘繭網憲觸 (艱膚膚鑰糧鏇顧廠願蓋, 1.29) 更多 |
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