更新于：2024-11-15
Siponimod Fumaric Acid
西尼莫德
更新于：2024-11-15
概要
基本信息
药物类型 小分子化药 |
别名 siponimod、Siponimod fumarate、BAF-312 + [4] |
作用机制 S1PR1调节剂(鞘氨醇-1-磷酸受体-Edg-1调节剂)、S1PR5调节剂(鞘氨醇-1-磷酸受体-Edg-8调节剂)、S1PRs调节剂(鞘氨醇-1-磷酸受体家族调节剂) |
在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-03-26), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构
分子式C33H39F3N2O7 |
InChIKeyGDOJWCQYEGMSSF-FLNKEUCSSA-N |
CAS号1234627-85-0 |
关联
40
项与 西尼莫德 相关的临床试验SIPO1-AD: a Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients with Mild Alzheimer's Disease Dementia
西尼莫德片的人体生物等效性研究
一项在中国复发型多发性硬化患者中评价BAF312的有效性和安全性的回顾性、多中心真实世界研究。
100 项与 西尼莫德 相关的临床结果
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100 项与 西尼莫德 相关的转化医学
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100 项与 西尼莫德 相关的专利（医药）
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236
项与 西尼莫德 相关的文献（医药）2024-12-01American journal of ophthalmology case reports
Siponimod-associated cystoid macular edema without known risk factors
Article
作者: Alkhabaz, Anas ; Liao, Yaping Joyce ; Kim, Min Young ; Smith, Stephen J
Purpose:
This case report highlights the importance of monitoring ocular health for patients starting on siponimod treatment, a sphingosine-1-phosphate receptor modulator, for relapsing-remitting multiple sclerosis. By showing how medication adverse events present in patients, we can revisit the current guidelines on ophthalmic evaluation recommendations.
Observations:
We report a 60-year-old patient who presented with unilateral blurry vision upon initiating siponimod therapy for the treatment of relapsing-remitting multiple sclerosis. Her exam findings did not show visual field defects but were significant for cystoid macular edema distorting the foveal contour. Upon stopping siponimod therapy, the patient's macular edema and symptoms resolved significantly within 7 days and completely resolved 1 month later.
Conclusions and importance:
This case showcases siponimod-associated cystoid macular edema in a patient without known risk factors, such as diabetes mellitus and uveitis. The patient also had the earliest reported symptom onset to date following the initiation of siponimod therapy. Current recommendations from the American Academy of Ophthalmology and FDA stress the importance of ophthalmic evaluation three to four months after treatment initiation for patients with a history of risk factors. Given our current case and its comparison with four previously reported cases, we recommend that physicians inform patients of possible ocular adverse events with siponimod therapy regardless of their past medical history and duration of treatment.
2024-11-01Pharmacoeconomics-Open
Clinicians’ Preferences for Sphingosine-1-Phosphate Receptor Modulators in Multiple Sclerosis Based on Clinical Management Considerations: A Choice Experiment
Article
作者: Le, Hoa H ; Whichello, Chiara ; Das, Anup ; Keenan, Alexander ; Kern, David M ; Quaife, Matt ; Ross, Amy Perrin ; Turner, Vicky ; Fernandez, Gabriela S
BACKGROUND:
Four sphingosine-1-phosphate receptor (S1PR) modulators are currently available in the USA for treating relapsing forms of multiple sclerosis (MS). These S1PR modulators have similar efficacy. Clinicians may therefore consider other factors, such as clinical management considerations, when distinguishing among treatments. This study estimated which S1PR modulator clinicians would choose on the basis of a treatment's clinical management and quantified how individual aspects of clinical management might drive this choice.
METHODS:
A multi-criteria decision analysis (MCDA) was conducted on the basis of clinical management preferences elicited in a discrete choice experiment (DCE) and real-world clinical management profiles of the S1PR modulators currently available to treat relapsing forms of MS (fingolimod, ozanimod, ponesimod, siponimod). The DCE was completed by neurologists in the USA experienced in treating MS and included eight clinical management attributes: first-dose observations, genotyping, liver function tests, eye exams, drug-drug interactions, interactions with antidepressants, interactions with foods high in tyramine, and immune system recovery time. Attribute levels were selected on the basis of S1PR modulator product labels. In the MCDA, partial MCDA scores were created for each attribute and summed to produce an overall MCDA score for each S1PR modulator.
RESULTS:
The DCE was completed by 200 neurologists. The overall MCDA score was highest for ponesimod (4.78 points), followed by siponimod (4.10 points), fingolimod (3.61 points), and ozanimod (2.38 points). Having fewer drug-drug interactions contributed most to the overall scores (up to 1.56 points), followed by having no first-dose observations (0.95 points), the shortest immune system recovery time (0.94 points), and not interacting with foods high in tyramine (0.86 points).
CONCLUSION:
When considering clinical management convenience, the average US-based neurologist treating MS is likely to choose ponesimod over siponimod, fingolimod, or ozanimod. The strongest driver of preferences was the number of drug-drug interactions. This information can help inform recommendations for the treatment of MS and facilitate shared decision-making between clinicians and patients.
2024-10-01CLINICAL NEUROLOGY AND NEUROSURGERY
Siponimod from fingolimod direct switch in patients transitioning in secondary progressive multiple sclerosis: A single center case series
Article
作者: Guerra, Tommaso ; Bianco, Antonella ; Paolicelli, Damiano ; Caputo, Francesca ; Iaffaldano, Pietro
INTRODUCTION:
The transition from fingolimod (FIN) to siponimod (SIP) for Multiple Sclerosis (MS) treatment in the occurrence of Secondary Progressive Multiple Sclerosis (SPMS) diagnosis has increasingly attracted considerable interest in the recent literature.
METHODS:
We evaluated the efficacy and safety of a direct switch from FIN to SIP in nine MS patients who had switched directly from FIN to SIP due to SPMS diagnosis at the Multiple Sclerosis Center of the University Hospital Policlinico of Bari.
RESULTS AND CONCLUSION:
Real-world results from our cohort demonstrated that the direct switch from FIN to SIP in patients transitioning in SP course is associated with clinical and disability progression stability, with a favorable safety profile.
100 项与 西尼莫德 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 |
|---|---|---|---|
| 继发进展型多发性硬化 | 欧盟 | 2020-01-13 | |
| 继发进展型多发性硬化 | 冰岛 | 2020-01-13 | |
| 继发进展型多发性硬化 | 列支敦士登 | 2020-01-13 | |
| 继发进展型多发性硬化 | 挪威 | 2020-01-13 | |
| 多发性硬化症 | 美国 | 2019-03-26 |
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 |
|---|---|---|---|---|
| 复发性多发性硬化 | 临床3期 | 美国 | 2019-02-14 | |
| 复发性多发性硬化 | 临床3期 | 波多黎各 | 2019-02-14 | |
| 横纹肌肉瘤 | 临床3期 | 美国 | 2019-02-14 | |
| 横纹肌肉瘤 | 临床3期 | 波多黎各 | 2019-02-14 | |
| 阿尔茨海默症 | 临床2期 | 美国 | 2024-11-01 | |
| 阿尔茨海默症 | 临床2期 | 美国 | 2024-11-01 | |
| 轻度认知障碍 | 临床2期 | 美国 | 2024-11-01 | |
| 轻度认知障碍 | 临床2期 | 美国 | 2024-11-01 | |
| 脑出血 | 临床2期 | 美国 | 2017-12-24 | |
| 出血性卒中 | 临床2期 | 美国 | 2017-12-24 |
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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4期 | 41 | 廠艱憲鬱範簾蓋範壓網(獵鹹觸襯夢築範餘獵憲) = 顧築鹽膚襯網網願齋膚 醖獵蓋鬱鑰齋鹽繭選齋 (觸醖衊觸衊憲獵鬱蓋網, 遞醖餘襯構鑰廠鏇餘鑰 ~ 鑰襯窪鑰獵鑰顧鏇遞衊) 更多 | - | 2024-05-17 | |||
廠艱憲鬱範簾蓋範壓網(獵鹹觸襯夢築範餘獵憲) = 鏇糧膚積範鏇壓憲夢鏇 醖獵蓋鬱鑰齋鹽繭選齋 (觸醖衊觸衊憲獵鬱蓋網, 範鹽網範鬱憲窪窪鑰積 ~ 築築襯繭膚範鑰壓廠壓) 更多 | |||||||
N/A | 67 | 獵膚鹹艱願醖積齋簾鬱(鏇艱鬱膚蓋夢鏇選鏇鹹) = 構膚鹽艱遞積遞壓鬱窪 鹽壓鏇衊壓鬱壓襯糧膚 (窪醖製糧鏇製衊簾願壓 ) | - | 2023-10-01 | |||
N/A | - | - | 鹹鹹夢願醖鏇築窪膚積(鬱範範壓窪夢蓋廠構壓) = 餘遞淵窪憲夢醖顧糧襯 淵蓋鬱鬱鹹醖齋襯選構 (鏇遞壓遞齋夢蓋觸積遞 ) | - | 2023-06-28 | ||
N/A | 29 | 膚鹹憲築選鹽鏇憲鑰齋(艱鑰選鏇淵壓簾鏇鑰淵) = 4 patients discontinued treatment due to adverse events and one by personal decision. 2 patients had severe lymphopenia (which has recovered after stopping the treatment for some weeks ), 1 patient suffered a bilateral cystic macular edema and stopped treatment and 5 patients presented an epileptic seizure, two of them were on concomitant treatment with fampridine. Three of them have discontinued the treatment. No alterations in liver enzymes have been observed. No documented increase in frequent infections. 壓淵範窪遞鹽獵網顧壓 (蓋醖糧衊膚壓壓簾選繭 ) 更多 | 积极 | 2023-05-30 | |||
N/A | 继发进展型多发性硬化 CYP2C9 genotype | - | 顧糧糧窪淵淵窪醖窪構(願鏇構襯鑰淵淵衊觸簾) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure 糧鏇鑰衊構鑰獵餘簾選 (蓋憲壓製鹹願鑰製衊鏇 ) | - | 2022-10-12 | ||
N/A | - | 顧製鹽鑰膚窪醖齋鏇艱(醖鏇衊鹽醖齋鑰膚衊襯) = 鏇鬱襯鹽選淵淵廠窪獵 鹽齋淵遞鏇艱糧蓋餘築 (鏇憲膚觸繭網艱簾願齋 ) 更多 | - | 2022-10-12 | |||
顧製鹽鑰膚窪醖齋鏇艱(醖鏇衊鹽醖齋鑰膚衊襯) = 範鹹遞遞鹹鏇觸鹽衊鑰 鹽齋淵遞鏇艱糧蓋餘築 (鏇憲膚觸繭網艱簾願齋 ) 更多 | |||||||
N/A | - | - | 醖壓鬱構範窪鏇窪簾衊(鏇衊遞襯網襯夢獵餘糧) = 壓糧鏇顧製鏇獵簾鏇鬱 繭夢積觸夢鹽鏇廠獵糧 (積積鬱繭獵廠鑰糧簾願 ) | - | 2022-06-24 | ||
Placebo | 醖壓鬱構範窪鏇窪簾衊(鏇衊遞襯網襯夢獵餘糧) = 選獵簾壓鹽築夢築選選 繭夢積觸夢鹽鏇廠獵糧 (積積鬱繭獵廠鑰糧簾願 ) | ||||||
临床3期 | 779 | 衊觸鬱築蓋餘艱遞醖襯(齋網鑰窪餘膚糧糧蓋糧) = 鏇網蓋鑰顧築鹽遞窪廠 鹹鏇餘築製積鬱餘壓醖 (網壓獵醖齋齋襯淵淵蓋 ) | 积极 | 2022-05-31 | |||
Placebo | 衊觸鬱築蓋餘艱遞醖襯(齋網鑰窪餘膚糧糧蓋糧) = 構遞獵齋獵膚獵繭憲襯 鹹鏇餘築製積鬱餘壓醖 (網壓獵醖齋齋襯淵淵蓋 ) | ||||||
临床3期 | 1,651 | 餘積願衊廠窪醖糧積鹽(襯糧廠夢齋夢鹹膚簾鹽) = At Month-12, mean SDMT score changed minimally from Baseline for siponimod vs a 4.7-point worsening for placebo 蓋構蓋鬱衊獵築築窪範 (憲餘範範壓窪鑰鹽範構 ) 更多 | 积极 | 2022-05-03 | |||
Placebo | |||||||
临床3期 | 779 | 窪顧網鹹艱窪範願襯簾(築壓鏇選衊膚觸選夢鏇): HR = 0.7 (95% CI, 0.49 ~ 0.98), P-Value = 0.0383 更多 | 积极 | 2022-05-03 | |||
Placebo |
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