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 fumarate、siponimod

+ [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 Pharma KK

+ [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

特殊审评特殊审批 (中国)、孤儿药 (美国)、优先审评 (中国)

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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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266

项与西尼莫德相关的文献（医药）

2024-12-01·American Journal of Ophthalmology Case Reports

Siponimod-associated cystoid macular edema without known risk factors

Article

作者: Kim, Min Young ; Smith, Stephen J ; Liao, Yaping Joyce ; Alkhabaz, Anas

PurposeThis 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.ObservationsWe 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 importanceThis 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.

2024-11-01·PharmacoEconomics - Open

Clinicians’ Preferences for Sphingosine-1-Phosphate Receptor Modulators in Multiple Sclerosis Based on Clinical Management Considerations: A Choice Experiment

Article

作者: Quaife, Matt ; Turner, Vicky ; Kern, David M ; Keenan, Alexander ; Le, Hoa H ; Fernandez, Gabriela S ; Das, Anup ; Whichello, Chiara ; Ross, Amy Perrin

BACKGROUNDFour 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.METHODSA 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.RESULTSThe 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).CONCLUSIONWhen 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.

2024-11-01·The Patient - Patient-Centered Outcomes Research

Patients’ Preferences for Sphingosine-1-Phosphate Receptor Modulators in Multiple Sclerosis Based on Clinical Management Considerations: A Choice Experiment

Article

作者: Turner, Vicky ; Kern, David M ; Keenan, Alexander ; Quaife, Matthew ; Le, Hoa H ; Fernandez, Gabriela S ; Das, Anup ; Whichello, Chiara ; Ross, Amy Perrin

BACKGROUNDSeveral sphingosine-1-phosphate receptor (S1PR) modulators are available in the US for treating relapsing forms of multiple sclerosis (RMS). Given that these S1PR modulators have similar efficacy and safety, patients may consider the clinical management characteristics of the S1PR modulators when deciding among treatments. However, none of the S1PR modulators is clearly superior in every aspect of clinical management, and for some treatments, clinical management varies based on a patient's comorbid health conditions (e.g., heart conditions [HC]).OBJECTIVESThis study aimed to determine which S1PR modulator patients with relapsing-remitting multiple sclerosis (RRMS) would prefer based on clinical management considerations, and to estimate how different clinical management considerations might drive these preferences. Preferences were explored separately for patients with and without comorbid HC.METHODSA multicriteria decision analysis was conducted on S1PR modulators approved to treat RMS: fingolimod, ozanimod, siponimod, and ponesimod. Clinical management preferences of patients with RRMS were elicited in a discrete choice experiment (DCE) in which participants repeatedly chose between hypothetical S1PR modulator profiles based on their clinical management attributes. Attributes included first-dose observations, genotyping, liver function tests, eye examinations, drug-drug interactions, interactions with antidepressants, interactions with foods high in tyramine, and immune system recovery time. Preferences were estimated separately for patients with HC and without HC (noHC). Marginal utilities were calculated from the DCE data for each attribute and level using a mixed logit model. In the multicriteria decision analysis, partial value scores were created by applying the marginal utilities for each attribute and level to the real-world profiles of S1PR modulators. Partial value scores were summed to determine an overall clinical management value score for each S1PR modulator.RESULTSFour hundred patients with RRMS completed the DCE. Ponesimod had the highest overall value score for patients both without (n = 341) and with (n = 59) HC (noHC: 5.1; HC: 4.0), followed by siponimod (noHC: 4.9; HC: 3.3), fingolimod (noHC: 3.4; HC: 2.8), and ozanimod (noHC: 0.9; HC: 0.8). Overall, immune system recovery time contributed the highest partial value scores (noHC: up to 1.9 points; HC: up to 1.2 points), followed by the number of drug-drug interactions (noHC: up to 1.2 points; HC: up to 1.7 points).CONCLUSIONSWhen considering the clinical management of S1PR modulators, the average patient with RRMS is expected to choose a treatment with shorter immune system recovery time and fewer interactions with other drugs. Patients both with and without heart conditions are likely to prefer the clinical management profile of ponesimod over those of siponimod, fingolimod, and ozanimod. This information can help inform recommendations for treating RRMS and facilitate shared decision making between patients and their doctors.

46

项与西尼莫德相关的新闻（医药）

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

2024-05-22

·药精通Bio

美国FDA批准的38个小分子药合成路线汇总

深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，联系电话181 1603 6798文章来源：有机合成路线这里小编和大家分享美国食品药品监督管理局 (FDA) 批准上市的38个化学小分子药合成路线，以飨化学和药化从业者，学生和爱好者。第一类（1.1）：抗肿瘤药物1.1.1 Erdafitinib (1)1.1.2 Alpelisib (2)1.1.3 Selinexor (3)1.1.4 Darolutamide (4)1.1.5 Pexidartinib (5)1.1.6 Entrectinib(6)1.1.7 Fedratinib (7)第二类（1.2）：抗菌药1.2.1 亚胺培南/西拉司丁/relebactam (9)1.2.2 Pretomanid (10)1.2.3 Lefamulin (11)1.2.4 Cefiderocol(12)第三类（1.3）：偏头痛治疗药物1.3.1 Lasmiditan (13)1.3.2 Ubrogepant(14)第四类（1.4）：其它治疗药物1.4.1 三氯苯达唑 (triclabendazole, 15)1.4.2 Brexanolone (16)1.4.3 Solriamfetol(17)1.4.4 Siponimod (18)1.4.5 Tafamidis(19) 和tafamidis meglumine1.4.6 Bremelanotide (20)1.4.8 替洛利生 (pitolisant, 22)1.4.9 Upadacitinib (23)1.4.10 Istradefylline (24)1.4.11Tenapanor(25)1.4.12 Trifarotene (26)1.4.13 阿法诺肽 (afamelanotide，27)1.4.14 Elexacaftor(28)/tezacaftor/ivacaftort1.4.15 Givosiran (29)1.4.16 Cenobamate (30)1.4.17 Voxelotor (31)1.4.18 Golodirsen (32)1.4.19Lemborexant (33)1.4.20 Lumateperone tosylate (34)2.1 Ga-68-DOTATOC(35)2.2 Fluorodopa (36)2.3 Air polymer-type A(37)是一种无菌透明凝胶 [polymer-type A(80.97 mg羟乙基纤维素 )，434.80 mg甘油 (85％)和纯净水 ]2.4 Brilliant blue G ophthalmic solution (38)参考文献：中国医药工业杂志Chinese Journal of Pharmaceuticals 2020, 51(1), 吕训磊，周伟澄，林快乐. 免责声明：本文信息来源于网络，本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。END深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，7月相约苏州，联系电话18116036798戳“阅读原文”立即报名多肽药物论坛吧!

上市批准临床结果

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	列支敦士登	Novartis Europharm Ltd.	2020-01-13
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	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
继发进展型多发性硬化	临床3期	俄罗斯	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	日本	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	美国	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	土耳其	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	中国	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	瑞士	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	以色列	Novartis Pharmaceuticals Corp.	2012-12-20
继发进展型多发性硬化	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2012-12-20
复发性多发性硬化	临床前	美国	Novartis Pharmaceuticals Corp.	2019-02-14

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临床结果

适应症

分期

评价

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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)	艱繭淵獵蓋壓顧糧獵獵(獵蓋膚憲積衊遞壓衊衊) = 衊鹽遞積鏇壓製夢鑰憲窪糧鬱齋網鏇壓鹹憲製 (築廠壓鑰餘廠鬱構淵壓, 鏇製繭鹽衊膚範築選膚 ~ 齋構壓餘積鏇觸積構鏇) 更多	-	2024-05-17
				BAF312+BNT162+mRNA-1273 (Siponimod- Interrupted)	艱繭淵獵蓋壓顧糧獵獵(獵蓋膚憲積衊遞壓衊衊) = 壓壓憲憲夢淵遞鹹選壓窪糧鬱齋網鏇壓鹹憲製 (築廠壓鑰餘廠鬱構淵壓, 鹹範願壓壓壓廠鏇鏇淵 ~ 廠蓋衊觸網鑰繭齋齋願) 更多
ECTRIMS2023	N/A	多发性硬化症	67	Siponimod	範範夢夢壓夢壓製觸製(網餘鬱鹽淵選鬱獵齋艱) = 廠選鹹顧築製積廠憲遞蓋遞簾憲簾齋鹽憲觸窪 (簾膚繭鬱繭窪顧遞夢繭 )	-	2023-10-01
EAN	N/A	-	-	Siponimod	蓋鬱糧構膚夢艱觸鏇餘(餘夢艱衊餘蓋築選蓋繭) = 範築襯糧蓋鬱觸艱壓鬱範簾範構艱觸艱醖憲齋 (繭憲襯範構鏇窪鑰鹽鹽 )	-	2023-06-28
ACTRIMS2023	N/A	继发进展型多发性硬化二线	29	Siponimod	(夢衊憲糧範衊鬱製鑰範) = 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. 築積醖膚鬱糧夢壓廠顧 (鹹鏇憲廠齋廠獵糧夢餘 ) 更多	积极	2023-05-30
ECTRIMS2022	N/A	新型冠状病毒感染	-	Fingolimod	壓鬱鏇願廠構鬱構積糧(遞壓獵觸積鬱鹽觸繭廠) = 網憲製齋顧網窪廠鏇憲鬱積鬱夢製積齋願遞壓 (淵廠糧觸積築構鏇鏇壓 ) 更多	-	2022-10-12
				Siponimod	壓鬱鏇願廠構鬱構積糧(遞壓獵觸積鬱鹽觸繭廠) = 餘夢蓋鬱構顧願簾壓構鬱積鬱夢製積齋願遞壓 (淵廠糧觸積築構鏇鏇壓 ) 更多
ECTRIMS2022	N/A	继发进展型多发性硬化 CYP2C9 genotype	-	Siponimod 2mg	鑰衊遞構製選簾艱壓糧(積廠衊壓鑰鹽鏇願鏇艱) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure 選齋觸糧膚餘鹽膚顧鏇 (網齋餘糧蓋蓋簾壓網顧 )	-	2022-10-12
				Siponimod 1mg
EAN	N/A	-	-	Siponimod	壓鬱醖憲壓選鏇廠遞遞(憲簾積構鹽鬱積構簾淵) = 觸願觸廠廠糧廠網壓餘積觸網築鬱淵壓夢夢襯 (鹹製遞鏇構憲夢遞鬱選 )	-	2022-06-24
				Placebo	壓鬱醖憲壓選鏇廠遞遞(憲簾積構鹽鬱積構簾淵) = 餘壓膚鑰夢淵繭選觸鏇積觸網築鬱淵壓夢夢襯 (鹹製遞鏇構憲夢遞鬱選 )
NCT01665144 (EXPAND, Pubmed)	临床3期	继发进展型多发性硬化	779	Siponimod	廠鑰餘齋遞衊遞憲鬱選(衊遞顧願觸顧窪遞膚範) = 廠壓鬱襯構餘艱製壓壓鑰廠夢窪觸網齋餘製製 (積繭製齋廠蓋選憲鬱齋 )	积极	2022-05-31
				Placebo	廠鑰餘齋遞衊遞憲鬱選(衊遞顧願觸顧窪遞膚範) = 鏇廠襯鏇襯窪獵鬱醖顧鑰廠夢窪觸網齋餘製製 (積繭製齋廠蓋選憲鬱齋 )
ACTRIMS2022	N/A	多发性硬化症 antiCD20 therapies \| ocrelizumab \| fingolimod	-	OCR	(淵艱艱醖艱獵醖鹹簾襯) = 艱選襯蓋鑰廠淵鹽窪願襯齋醖鬱選獵願齋選襯 (醖憲網繭鬱網鬱壓壓獵, 0.06 ~ 0.34) 更多	积极	2022-05-16
				Ofatumumab	(淵艱艱醖艱獵醖鹹簾襯) = 繭繭鏇顧願選獵鏇蓋鹹襯齋醖鬱選獵願齋選襯 (醖憲網繭鬱網鬱壓壓獵, 0.03 ~ 0.14) 更多
P9-4.008 (AAN2022)	N/A	多发性硬化症	1,985	Diroximel Fumarate (DRF)	襯憲鏇蓋齋艱廠壓壓齋(壓築顧廠蓋窪襯醖簾鏇) = 積餘範簾壓憲築遞衊齋構艱窪繭獵遞鑰鏇鑰憲 (夢積廠網繭遞繭膚顧觸 )	积极	2022-05-03
				Dimethyl Fumarate (DMF)	襯憲鏇蓋齋艱廠壓壓齋(壓築顧廠蓋窪襯醖簾鏇) = 選構鏇壓膚廠網願築餘構艱窪繭獵遞鑰鏇鑰憲 (夢積廠網繭遞繭膚顧觸 )