西尼莫德(Siponimod Fumaric Acid) - 药物靶点：S1PR1 x S1PR5 x S1PRs_在研适应症：继发进展型多发性硬化，多发性硬化症，阿尔茨海默症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

siponimod、Siponimod fumarate、BAF-312

+ [6]

靶点

S1PR1 x S1PR5 x S1PRs

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)

治疗领域

免疫系统疾病神经系统疾病其他疾病

在研适应症

继发进展型多发性硬化多发性硬化症阿尔茨海默症+ [1]

非在研适应症

脑出血皮肌炎出血性卒中+ [5]

原研机构

Novartis Pharma AG

在研机构

Novartis Pharmaceuticals Corp.Novartis Europharm Ltd.

Novartis AG

+ [4]

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),

多发性硬化症

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

NCT06639282 / Not yet recruiting临床2期IIT

SIPO1-AD: a Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients with Mild Alzheimer&#39;s Disease Dementia

Collaboration with multiple sclerosis (MS) specialty colleagues led us to formulate the central hypothesis that Siponimod could lower the rate of brain atrophy in Alzheimer's disease (AD) subjects. To test our central hypothesis, we will carry out an 18-month Phase II, double-blind, randomized, twoarmed, placebo controlled, proof-of-concept clinical study in early AD subjects (i.e. mild AD) who will be receiving an escalating dose of Siponimod or placebo in the ratio 2:1 for 12 months, followed by a 6-month washout period. The primary outcome measures are safety and tolerability of Siponimod in mild AD subjects. The secondary outcome measures are the rates of brain atrophy derived from volumetric MRI (vMRI) as a proxy for neurodegeneration conducted at baseline, 6, 12, and 18 months. The tertiary outcome measures are the changes in cognition and the levels of AD-associated (e.g., Aβ and tau) and inflammatory biomarkers in CSF after Siponimod exposure. In an exploratory effort, we will also measure plasma inflammatory markers during the entire duration of the study to investigate whether one or more of these markers can be used as dynamic surrogate markers of treatment response. Using our unique experience with the repurposing of immunomodulatory drugs for AD (and NCT #04032626), in the present project we are using elements of clinical trial design that we believe were successful and made some adjustments to fit the pharmacologic and toxic properties of Siponimod.

开始日期2024-11-01

申办/合作机构

St. Joseph's Medical Center, Inc.

[+5]

CTR20232992 / CompletedN/A

西尼莫德片的人体生物等效性研究

研究空腹/餐后状态下单次口服受试制剂西尼莫德片与参比制剂西尼莫德片（万立能®）在健康成年受试者体内的药代动力学，评价空腹/餐后状态下口服两种制剂的生物等效性和安全性。

开始日期2023-09-23

申办/合作机构

齐鲁制药有限公司

CTR20230278 / Completed临床4期

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。

1.在中国真实世界人群中，基于年复发率描述BAF312在复发型多发性硬化(RMS)患者中的有效性。 2.描述开始BAF312治疗后12个月时保持无复发的患者比例。 3.在中国真实世界人群中描述BAF312在RMS患者中的安全性特征。 4.描述开始BAF312治疗后12个月时无MRI活动性的患者比例。

开始日期2023-04-23

申办/合作机构

Novartis Farmacéutica SA

[+3]

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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242

项与西尼莫德相关的文献（医药）

2024-12-01·Multiple Sclerosis and Related Disorders

Untackling the economics of multiple sclerosis: A systematic review of economic evaluations of disease-modifying therapies indicated for multiple sclerosis

Review

作者: Petrou, Dr Panagiotis

OBJECTIVES:

Multiple sclerosis (MS) comprises a chronic, neurodegenerative, and inflammatory illness of the central nervous system that affects 2.8 million people worldwide. MS is only treatable, and to this direction, the disease armamentarium has been significantly enriched with new agents, albeit with burgeoning costs and engulfed by uncertainty. The scope of this review is to assess the efficiency of MS agents.

METHODS:

We performed a systematic literature review, spanning from 2000 to 2023 on adult patients with any form of MS, receiving any MS indicated modality and whose outcome was ICUR and ICER. The methodological quality of the studies was assessed with the Quality of Health Economics Studies tool.

RESULTS:

We identified 57 studies that met the inclusion criteria. Studies were hailing from 20 countries and a multitude of methodological approaches were documented across several types of MS. A substantial level of divergence regarding results was noted. Country setting, study perspective (societal vs payer) the selection of the benchmark treatment, data extrapolation beyond the reported timeframe of the trial and time horizon of the model exerted a substantial impact on the results. Dimethyl fumarate was consistently interrelated with a positive cost-effectiveness ratio. The same applies for fampridine, while Cladribine was proved to be a dominating agent. Ocrelizumab also evinced efficiency. The same applies for the early data of Siponimod and ofatumumab, however the breadth of their studies lags compares to other agents, and these results have to be further corroborated. On the contrary Interferons demonstrated a non-efficient profile and their use as a comparative benchmark arm brought about several complications regarding the incremental financial aspect of economic evaluations, since they are commonly used as such. The results of fingolimod and natalizumab studies are embroiled in uncertainty. Moreover, the efficiency factor was positively correlated by earlier access of patients to these products, rather than delayed one. Result discrepancies among the same country were also imputed to the adopted utility and disutility values and the methodological approach for data extrapolation. Results were sensitive to an array of factors. Among them, the effectiveness of the products, coupled with the cost of the agents emerged as the most important drivers. Uncertainty was further compounded by several other parameters such as discounting, efficacy waning, horizon of the study, disability base rate and utility of the patients. We also outlined that the efficiency of product is pertinent to the disease type. Results such as dominance must be interpreted with caution since in certain cases a dominating agent was proved to be as such by capitalizing on marginal incremental health gains, compared to the standard comparative treatment.

CONCLUSIONS:

An increasing body of evidence consisting of economic evaluations for MS was retrieved. These studies exhibited high quality, however, the consistency regarding results was impaired.

2024-12-01·American 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.

2024-12-01·CURRENT TOPICS IN MEDICINAL CHEMISTRY

The Current Landscape in the Development of Small-molecule Modulators Targeting Sphingosine-1-phosphate Receptors to Treat Neurodegenerative Diseases

Review

作者: Sahu, Sujit Kumar ; Kar, Sidhartha Sankar ; Gharai, Soumya Ranjan ; Swain, Sharada Prasanna ; Ravichandiran, Velayutham

::

Sphingosine 1-phosphate (S1P) is extensively researched as a lysophospholipid and is crucial in various physiological and pathological processes. It achieves this via signalling through five different subtypes of G protein-coupled receptors (GPCRs), namely S1PR1 to S1PR5. S1PR modulators possess the ability to traverse the blood-brain barrier, potentially leading to direct actions within the Central Nervous System (CNS). S1PR modulators specifically bind to receptors located on the surface of naive and central memory lymphocytes, causing these cells to be trapped or confined within the lymph node. The investigation of the S1P pathway has resulted in the approval of three S1PR modulators, namely fingolimod, siponimod, and ozanimod, as medications for the treatment of patients suffering from Multiple Sclerosis (MS). Additionally, new S1PR modulators, such as ponesimod and etrasimod, are currently being developed and tested in clinical trials. Research on the creation of S1P modulators in neurodegenerative illnesses is ongoing as scientists continue to explore novel possibilities for selective S1P modulators. This study provides a concise overview of sphingolipid metabolism, the mechanism by which S1P receptors are affected, and the structural characteristics of several small molecule S1P modulators, with a particular focus on their structure-activity connections.

47

项与西尼莫德相关的新闻（医药）

2024-11-26

·摩熵医药

3亿美元明星药，齐鲁制药抢国内首仿！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 11月26日，据CDE官网公示，齐鲁制药（海南）提交的苯磺酸美洛加巴林片上市申请已获受理。据摩熵医药数据库的统计，2023年苯磺酸美洛加巴林片在全球的销售额已接近3亿美元。截图来源：CDE 苯磺酸美洛加巴林片是第一三共的原研产品，是一种新一代钙离子通道调节剂，适应症为糖尿病性周围神经病理性疼痛（DPNP）。2019年1月，该药品在日本首次获得批准上市，其应用范围覆盖周围神经病理性疼痛（PNP）的治疗。作为一款临床上迫切需求的进口药物，苯磺酸美洛加巴林片自上市以来，全球销售额持续迅猛增长。据摩熵医药数据库的统计，2023年苯磺酸美洛加巴林片在全球的销售额已接近3亿美元，同比增长达12.26%。截图来源：摩熵医药全球药物研发数据库目前除原研企业外，国内尚无其他药企获得苯磺酸美洛加巴林片的生产许可。在仿制药领域，仅南京正大天晴制药与齐鲁制药（海南）两家企业提交了4类新注册仿制申请。其中，南京正大天晴制药率先完成了该药的生物等效性试验，从2023年9月至11月，现已步入上市申报阶段，展现了极高的效率。而齐鲁制药（海南）紧随其后，于7月启动了同类试验，这意味着首家仿制药的诞生很可能花落这两家药企之一。截图来源：摩熵医药中国药品批文数据库今年以来，齐鲁制药还提交了布瑞哌唑口崩片、注射用拉氧头孢钠、注射用米卡芬净钠、西尼莫德片等26款（含子公司）品种的仿制申请，其中苯磺酸美洛加巴林片、丙酸氟替卡松鼻喷雾剂、布瑞哌唑口崩片、布瑞哌唑片、丁酸氯维地平注射用乳剂、甲磺酸贝舒地尔片、立他司特滴眼液、芦曲泊帕片、西尼莫德片、盐酸帕洛诺司琼软胶囊、注射用阿立哌唑、注射用奥氮平12个产品暂无国产仿制药获批，公司有望争夺国内首仿。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，申请药融云企业版免费试用！

上市批准医药出海申请上市

2024-09-24

·米内网

【聚焦】齐鲁入局17亿注射剂

精彩内容近日，CDE官网显示，齐鲁制药的注射用硫酸多黏菌素B以仿制3类报产获受理，该产品2023年在中国公立医疗机构终端的销售额超过17亿元。今年以来，齐鲁制药有25个品种以新注册分类提交上市/临床申请，其中12个暂无首仿（含剂型首仿）获批。硫酸多黏菌素B是一组从多黏芽孢杆菌中分离出的抗菌性多肽，通过改变细菌细胞膜通透性导致细菌死亡，主要用于绿脓杆菌及其他假单胞菌引起的创面、尿路以及眼、耳、气管等部位感染，也可用于败血症、腹膜炎等。米内网数据显示，注射用硫酸多黏菌素B已被纳入国家医保乙类目录，目前仅上药第一生化拥有生产批文。该产品近年来在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端迅速放量，2021年突破10亿元，2022-2023年均超过17亿元。近年来中国公立医疗机构终端注射用硫酸多黏菌素B销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局仿制药申报方面，有10家企业的注射用硫酸多黏菌素B以新注册分类报产在审，包括倍特药业、汇宇制药、利泰尔药业、亿帆生物、华北制药、齐鲁制药、健康元药业、Xellia制药、四川上善六经医药、湖南埃威格林医药。米内网数据显示，今年以来，齐鲁制药已有25个品种以新注册分类提交上市/临床申请，涵盖10个治疗大类，集中在神经系统药物（6个）、全身用抗感染药物（5个）、心脑血管系统药物（4个）等治疗领域。 2024年至今齐鲁制药以新分类申报的品种来源：米内网中国申报进度（MED）数据库 25个品种中，瑞卢戈利片、奥氮平萨米多芬片、来特莫韦注射液、阿巴帕肽注射液、芦曲泊帕片、布瑞哌唑片、布瑞哌唑口崩片、丙酸氟替卡松鼻喷雾剂、醋酸地非法林注射液、注射用奥氮平、立他司特滴眼液、西尼莫德片12个品种暂无仿制药（以药品名称计）获批；注射用硫酸多黏菌素B、来特莫韦片、美阿沙坦钾片、丁酸氯维地平脂肪乳注射液等品种目前拥有生产批文的国内企业仅有1家。资料来源：米内网数据库、CDE官网等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至9月24日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

专利侵权

2024-06-04

·米内网

科伦开挂了！21款1类新药、66个新品发力，137个品种过评，4款新药上市可期

精彩内容近日，科伦药业的骨化三醇软胶囊获批上市、塔戈利单抗一线适应症申报NDA、芦康沙妥珠单抗最新研究结果公布……今年以来，科伦药业已有6个品种获批上市，累计137个品种过评（45个首家），26个品种备战第十批集采。目前公司有35款新药（21款1类新药）处于申报临床及以上研发阶段；66个新分类报产品种在审，18个暂无首仿获批。拿下6大重磅品种，137个品种过评 5月27日，NMPA官网显示，科伦药业以仿制4类报产的骨化三醇软胶囊获批生产并视同过评，为国产第6家。骨化三醇软胶囊是一种活性维生素D3类似物，为国家医保乙类品种。米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端骨化三醇软胶囊销售额超过7亿元。今年以来，科伦药业已有6个品种获批生产并视同过评，包括骨化三醇软胶囊、复方氨基酸注射液（18AA-Ⅶ）、吡拉西坦注射液、奥拉帕利片、艾曲泊帕乙醇胺片、ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液。 2024年至今科伦药业获批品种来源：米内网中国申报进度（MED）数据库 6个品种中，多个品种为国内首批上市，彰显了公司的研发实力。其中，艾曲泊帕乙醇胺片、ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液为国内首仿，奥拉帕利片为国产第2家，复方氨基酸注射液（18AA-Ⅶ）为国产第4家，骨化三醇软胶囊为国产第6家。截至目前，科伦药业已有137个品种通过/视同通过一致性评价。其中，45个品种为国内首家过评，阿奇霉素分散片、氨基酸葡萄糖注射液、钆特醇注射液、琥珀酸曲格列汀片、泊沙康唑口服混悬液、氢溴酸替格列汀片、氢溴酸西酞普兰胶囊等16个品种为独家过评。科伦药业通过/视同通过一致性评价品种第十批集采即将启动，科伦药业已有26个过评品种满足集采门槛，符合申报资格企业数达5家及以上。26个品种涉及15个注射剂、9个口服常释剂型，多个品种为2023年以来新获批品种，若被纳入第十批集采，有望借助集采中标快速打开市场。 21款1类新药在研，4款新药上市可期近年来科伦药业持续推进“创新驱动”战略，加大力度支持药品研发创新，2022年研发费用17.95亿元，同比增长3.37%；2023年研发费用19.44亿元，同比增长8.27%。科伦药业研发费用情况（单位：亿元）今年以来，科伦药业有一款1类新药塔戈利单抗注射液（一线治疗鼻咽癌）申报上市，此前该新药的三线治疗鼻咽癌适应症已申报上市；2款1类新药注射用SKB501、注射用SKB518相继申报临床。国际化方面，SKB264/MK2870项目（TROP2-ADC，芦康沙妥珠单抗）大放异彩：合作伙伴MSD启动该药非小细胞肺癌及子宫内膜癌等三项全球三期临床试验，公司收到里程碑款7500万美金；一线治疗PD-L1阴性TNBC获国家药监局突破性疗法认定；分别在2024 AACR和2024 ASCO年会上公布研究成果。此外，KL590586（RET抑制剂）获美国FDA授予快速通道资格认定。目前科伦药业主要有35款新药处于申报临床及以上阶段，涉及21款1类新药、12款2类改良型新药、2款生物类似药，聚焦肿瘤、精神神经、心血管、肝病等疾病领域，涵盖小分子、单抗、双抗、ADC等药物形式。科伦药业主要在研新药 35款新药中，3款1类新药A167/塔戈利单抗注射液（PD-L1单抗）、注射用A166（HER2-ADC）、注射用SKB264（TROP2-ADC）及生物类似药西妥昔单抗注射液（A140注射液）已申报NDA，上市可期。值得一提的是，A167是公司首个申报上市的1类新药，也是全球首个针对鼻咽癌适应症申报NDA的PD-L1单抗，有望于今年获批上市，实现1类新药“零”的突破。A140注射液是国内首款申报上市的西妥昔单抗生物类似药，有望拿下首仿。 66个新品抢攻230亿市场，18个首仿冲刺在仿制药方面，目前科伦药业还有66个新注册分类品种上市申请在审，形成了梯度丰富的研发管线。66个品种获批生产后将视同通过一致性评价，主要集中在血液和造血系统药物（14个）、消化系统及代谢药（12个）、全身用抗感染药物（8个）、抗肿瘤和免疫调节剂（8个）。 66个品种2023年在中国公立医疗机构终端的销售额合计接近230亿元。其中，结构脂肪乳注射液(C6-24)、罗沙司他胶囊、碘普罗胺注射液、地屈孕酮片、麦考酚钠肠溶片、盐酸乌拉地尔注射液等6个品种的销售额均超过10亿元。科伦药业新注册分类在审且暂无首仿获批的品种 18个品种暂无首仿（含剂型首仿）获批上市，包括恩扎卢胺片、罗替高汀贴片、阿帕他胺片、黄体酮阴道缓释凝胶、芦曲泊帕片、丁酸氯维地平脂肪乳注射液、奈妥匹坦帕洛诺司琼胶囊、西尼莫德片等，科伦药业将与多家企业竞争国内首仿。此外，棕榈酸帕利哌酮注射液、阿戈美拉汀片、布比卡因脂质体注射液、达可替尼片等13个品种获批国产企业数均只有1家，他克莫司缓释胶囊、阿瑞匹坦注射液、麦考酚钠肠溶片等9个品种获批国产企业数均只有2家，公司有望实现国内首批上市。资料来源：米内网数据库、公司公告注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

一致性评价上市批准带量采购

100 项与西尼莫德相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	西尼莫德	L04AA42	DB12371

研发状态

批准上市

10 条最早获批的记录,

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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	Novartis Europharm Ltd.	2020-01-13
继发进展型多发性硬化	冰岛	Novartis Europharm Ltd.	2020-01-13
继发进展型多发性硬化	列支敦士登	Novartis Europharm Ltd.	2020-01-13
继发进展型多发性硬化	挪威	Novartis Europharm Ltd.	2020-01-13
多发性硬化症	美国	Novartis Pharmaceuticals Corp.	2019-03-26

未上市

10 条进展最快的记录,

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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	Novartis Pharmaceuticals Corp.	2019-02-14
复发性多发性硬化	临床3期	波多黎各	Novartis Pharmaceuticals Corp.	2019-02-14
横纹肌肉瘤	临床3期	美国	Novartis Pharmaceuticals Corp.	2019-02-14
横纹肌肉瘤	临床3期	波多黎各	Novartis Pharmaceuticals Corp.	2019-02-14
阿尔茨海默症	临床2期	美国	Laboratory Corp. of America Holdings	2024-11-01
阿尔茨海默症	临床2期	美国	Novartis AG	2024-11-01
轻度认知障碍	临床2期	美国	Novartis AG	2024-11-01
轻度认知障碍	临床2期	美国	Laboratory Corp. of America Holdings	2024-11-01
脑出血	临床2期	美国	Novartis Pharmaceuticals Corp.	2017-12-24
出血性卒中	临床2期	美国	Novartis Pharmaceuticals Corp.	2017-12-24

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04792567 (AMA-VACC, CTgov)	临床4期	继发进展型多发性硬化	41	BAF312+BNT162+mRNA-1273 (Siponimod - Continuous)	衊範窪獵衊選簾膚築繭(憲壓簾繭範範鏇願鹽築) = 糧糧製積鹽網簾願廠範觸廠簾繭衊簾網廠衊鏇 (製齋鏇餘廠餘醖簾襯齋, 襯鏇獵鹽壓膚範鏇顧鹹 ~ 憲膚獵糧製膚範遞齋遞) 更多	-	2024-05-17
				BAF312+BNT162+mRNA-1273 (Siponimod- Interrupted)	衊範窪獵衊選簾膚築繭(憲壓簾繭範範鏇願鹽築) = 鹽壓憲糧蓋糧願繭襯網觸廠簾繭衊簾網廠衊鏇 (製齋鏇餘廠餘醖簾襯齋, 鏇鬱顧淵窪糧醖製淵獵 ~ 鑰鏇窪製觸淵遞壓構廠) 更多
ECTRIMS2023	N/A	多发性硬化症	67	Siponimod	餘構鬱夢選膚繭遞選鬱(願鹽製鬱願範鹹顧願繭) = 艱獵範觸窪壓鬱簾願齋簾遞廠獵構醖鬱觸廠觸 (廠鏇艱鹹襯選淵簾顧廠 )	-	2023-10-01
EAN2023	N/A	继发进展型多发性硬化	-	Siponimod	願願蓋壓醖製餘顧醖蓋(夢選壓鑰鹹鬱鬱襯膚遞) = 積積範齋衊餘壓願夢範淵窪糧製鹽願鑰鑰膚網 (醖選蓋憲製鹽築製簾衊 )	-	2023-06-28
ACTRIMS2023	N/A	继发进展型多发性硬化二线	29	Siponimod	餘選繭鬱艱積範網窪壓(繭鏇選簾醖鹹鏇製壓蓋) = 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. 鏇膚夢鏇廠選鹽顧鏇構 (遞糧齋鏇襯獵製壓壓廠 ) 更多	积极	2023-05-30
ECTRIMS2022	N/A	继发进展型多发性硬化 CYP2C9 genotype	-	Siponimod 2mg	醖廠醖願襯簾鹽鹹襯繭(鹽衊淵淵觸繭夢簾夢蓋) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure 膚廠網繭衊襯糧齋齋觸 (蓋鹽製醖鑰憲遞艱糧壓 )	-	2022-10-12
				Siponimod 1mg
ECTRIMS2022	N/A	新型冠状病毒感染	-	Fingolimod	選衊艱衊齋蓋餘襯觸顧(遞艱窪築築遞鑰製鹽製) = 鏇製願範網壓遞鹽願鬱蓋壓糧襯獵構齋憲醖顧 (餘築餘簾窪艱鹽願醖範 ) 更多	-	2022-10-12
				Siponimod	選衊艱衊齋蓋餘襯觸顧(遞艱窪築築遞鑰製鹽製) = 築憲繭廠艱糧範壓鹹廠蓋壓糧襯獵構齋憲醖顧 (餘築餘簾窪艱鹽願醖範 ) 更多
EAN2022	N/A	继发进展型多发性硬化	-	Siponimod	鏇窪艱廠襯廠觸範鹽餘(構繭網膚願衊簾簾齋艱) = 範觸憲網遞範醖選鏇窪憲鏇鹽鹽網範夢範夢襯 (繭範積壓艱廠製襯遞獵 )	-	2022-06-24
				Placebo	鏇窪艱廠襯廠觸範鹽餘(構繭網膚願衊簾簾齋艱) = 醖願鬱遞顧製衊網夢餘憲鏇鹽鹽網範夢範夢襯 (繭範積壓艱廠製襯遞獵 )
NCT01665144 (EXPAND, Pubmed)	临床3期	继发进展型多发性硬化	779	Siponimod	窪淵構膚構遞夢襯醖鏇(願艱糧築艱願鹹簾遞窪) = 遞鬱繭構淵製繭鹽繭襯膚遞製獵製積壓憲夢築 (構顧廠網廠網繭遞鹽鬱 )	积极	2022-05-31
				Placebo	窪淵構膚構遞夢襯醖鏇(願艱糧築艱願鹹簾遞窪) = 製壓鏇築餘壓蓋夢構選膚遞製獵製積壓憲夢築 (構顧廠網廠網繭遞鹽鬱 )
EXPAND (AAN2022)	临床3期	继发进展型多发性硬化	1,651	Siponimod 2mg daily	築構築艱鏇窪簾襯範衊(憲製範蓋構窪簾糧願鬱) = At Month-12, mean SDMT score changed minimally from Baseline for siponimod vs a 4.7-point worsening for placebo 築鬱窪餘餘築壓積願築 (壓廠齋構鹽壓淵鑰鹹鬱 ) 更多	积极	2022-05-03
				Placebo
EXPAND (AAN2022)	临床3期	继发进展型多发性硬化	779	Siponimod 2 mg daily	窪鏇鏇膚鏇蓋範遞願觸(繭鏇窪遞膚製網構鑰餘): HR = 0.7 (95% CI, 0.49 ~ 0.98), P-Value = 0.0383 更多	积极	2022-05-03
				Placebo