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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项与西尼莫德相关的文献（医药）

2025-06-01·Pharmacological Reports

Lymphopenia associated with sphingosine 1-phosphate receptor modulators (S1PRMs) in multiple sclerosis: analysis of European pharmacovigilance data

Article

作者: Moreggia, Ornella ; Fraenza, Federica ; Cardillo, Mirko ; Balzano, Nunzia ; Maniscalco, Giorgia Teresa ; Sportiello, Liberata ; Di Napoli, Raffaella ; Capuano, Annalisa ; Di Giulio Cesare, Daniele ; Scavone, Cristina

Abstract:

Background:

The treatment landscape for Multiple Sclerosis (MS) has increased significantly over the past few decades, thanks to the introduction of disease-modifying therapies (DMTs). Fingolimod, siponimod, ozanimod, and ponesimod belong to the newer generation of oral DMTs categorized as sphingosine 1-phosphate receptor modulators (S1PRMs). Because of their mechanism of action, they may increase the risk of lymphopenia, which could influence the therapeutic management of people with MS. The aim of this study was to describe and compare the reporting frequency of lymphopenia related to four S1PRMs.

Methods:

Individual case safety reports (ICSRs) were retrieved from the European spontaneous reporting system database (EudraVigilance) from January 1st, 2022, to December 31st, 2023. The reporting odds ratios (RORs) were computed to compare the reporting probability of lymphopenia between a S1PRM versus each other.

Results:

We retrieved 4017 ICSRs, of which 521 (13%) reported lymphopenia associated with fingolimod (53.3%), siponimod (38.4%), ozanimod (5.4%), and ponesimod (2.1%). The most common reporting source was the healthcare professional (94.2%), and more than half of the ICSRs (62.6%) reported serious lymphopenia. Fingolimod was associated with a lower reporting frequency of lymphopenia compared to siponimod. Both siponimod and fingolimod were associated with a higher reporting frequency of lymphopenia compared to ozanimod; siponimod also had a higher reporting probability in comparison with ponesimod.

Conclusions:

The most relevant clinical implication of the disproportionality analysis is to increase the awareness of the risk of lymphopenia related to these drugs, thus supporting proactive monitoring and optimizing treatment strategies for people with MS.

Clinical trial number:

Not applicable.

2025-06-01·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Both carvedilol and cimetidine alleviate cisplatin-induced nephrotoxicity via downregulating OCT2

Article

作者: Jiao, Xiaoyan ; Wu, Huan ; Ning, Yichun ; Sun, Zhaoxing ; Ji, Ji ; Yu, Xiaofang ; Ding, Xiaoqiang ; Cheng, Xin ; Xu, Xiaoliang ; Lu, Min

BACKGROUND:

Cisplatin is a common chemotherapy agent for solid tumors but severe nephrotoxicity limits its application, with no effective pharmacological treatments. Organic cation transporter 2 (OCT2) is involved in cisplatin uptake in kidneys. This study aimed to find drugs with promising clinical applications that could prevent cisplatin-induced acute kidney injury (Cis-AKI) by inhibiting OCT2.

METHODS:

The mRNA level of OCT2 was examined in human induced pluripotent stem cells (iPSCs) from Cis-AKI patients and paired non-AKI patients. The association between OCT2 and Cis-AKI was investigated by HEK293FT cells and kidney organoids. We screened potential compounds exhibiting protective effects against Cis-AKI in US Food and Drug Administration-approved drugs through virtual screening and activity screening. Subsequently, we determined the effects of these compounds on OCT2 expression, cisplatin uptake, and apoptosis in cells, kidney organoids and mice. A549 and HeLa cells were adopted to observe the influence of drugs on the anti-tumor function of cisplatin.

RESULTS:

Compared to non-AKI patients, the OCT2 mRNA levels of iPSCs from Cis-AKI patients were elevated. OCT2 exhibits similar expression patterns in kidney organoids and human kidney tissues. Furthermore, the overexpression of OCT2 in kidney organoids and HEK293FT cells exacerbated the injury caused by cisplatin. Carvedilol and cimetidine were identified as potent OCT2 inhibitors by drug screening. Further analysis revealed that the pretreatment of carvedilol or cimetidine downregulated OCT2, reduced cisplatin uptake, and alleviated cisplatin-induced apoptosis, but the combination of the two drugs didn't further improve these outcomes. Additionally, carvedilol and cimetidine didn't compromise the cisplatin-induced cell death in A549 and HeLa cells.

CONCLUSION:

Our study confirmed that carvedilol and cimetidine exert protective effects against Cis-AKI by inhibiting OCT2, without altering the anti-tumor effects of cisplatin.

2025-04-01·INTERNATIONAL IMMUNOPHARMACOLOGY

Identifying cardiovascular toxicity associated with sphingosine 1-phosphate receptor modulators: A case-control study based on the FDA adverse event reporting system

Review

作者: Li, Ying ; Guan, Mingyuan ; Jiao, Shujie ; Zhang, Jingmin ; Yang, Guangrui

INTRODUCTION:

Cardiovascular events represent a significant safety concern associated with sphingosine 1-phosphate receptor (S1PR) modulators. However, as S1PR modulators are primarily indicated for rare diseases characterized by multiple complex confounding factors, evidence regarding potential or long-term cardiovascular risks related to these drugs remains limited. This study aimed to comprehensively assess cardiovascular safety signals associated with S1PR modulators.

METHODS:

This case-control study was conducted based on the FDA adverse event reporting system (FAERS) database. The dataset included reports from September 10, 2010 to September 30, 2023. Reporting odds ratios (ROR) were calculated by logistic regression in four different models to examine the robustness of the results. Additionally, to assess adverse event profiles based on clinical trial data, a systematic literature review and subsequent data synthesis were conducted.

RESULTS:

We included 81,077 cases treated with S1PR modulators (median [IQR] age, 45 [36-54]; 60,245 [74.31 %] female), and 12,087,627 cases with no prior use of S1PR modulators as comparators. Besides signals of hypertension and bradyarrhythmias, QT interval prolongation in the fingolimod group (ROR = 1.92 [95 % CI, 1.73-2.12]; P < 0.001), and central nervous system ischemia in the siponimod group (ROR = 1.26 [95 % CI, 1.04-1.52]; P = 0.02) were also detected in all models. Signals of tachyarrhythmias and ischaemic heart disease in the fingolimod group as well as QT interval prolongation in the siponimod group were consistent in all adjusted models.

CONCLUSION:

In this study, signals of bradyarrhythmias, hypertension, QT interval prolongation, central nervous system ischemia, tachyarrhythmias, and ischaemic heart disease were significant with one or more S1PR modulators, which warrant clinical attention and ongoing monitoring.

项与西尼莫德相关的新闻（医药）

2025-05-01

·BioSpace

Immunic Talks Up Disability Gains as Phase II MS Therapy Fails on Primary Endpoint

iStock, dickcraft According to CEO Daniel Vitt, clinical and disability-related outcomes are more relevant than brain volume change for drug development in multiple sclerosis. Immunic’s oral multiple sclerosis drug failed to significantly slow the loss of brain volume in patients with a progressing form of the neurodegenerative disorder during a Phase II clinical trial. But according to CEO Daniel Vitt, it’s no big deal. “Nobody should care at all about whole brain volume change anymore,” Vitt said during an investor call on Wednesday to discuss the mid-stage data, noting that having brain volume as a primary endpoint of the Phase II study was just a “leftover” of a trial design that the biotech settled on “five years ago.” Instead, the field has now focused on using disability as an endpoint, Vitt said, noting that Immunic is taking the same approach, particularly for its Phase III trial. In that regard, Vitt asserted that Wednesday’s readout was a “very, very clear positive outcome.” Leerink analysts said the same thing, calling the CALLIPER results for the therapy, a Nurr1 activator called vidofludimus calcium, “positive” and “competitive” in an investor note on Wednesday. Vidofludimus calcium, according to the analysts, “demonstrated a competitive risk/benefit profile” in primary progressive multiple sclerosis (MS), as compared with Roche’s Ocrevus, and in non-active secondary progressive MS, relative to Novartis’ Mayzent and Sanofi’s tolebrutinib. Of course, this analysis comes with “usual cross-trial comparison caveats,” Leerink cautioned. “We believe the molecule has now demonstrated disease-modifying activity in a difficult-to-treat patient population with limited active lesions,” the analysts added. Immunic is running the Phase III ENSURE program to assess vidofludimus calcium, with data expected next year, Vitt said on the call. Leerink is likewise bullish about Immunic’s prospects here, with its analysts expecting a 50% probability of success. Data from CALLIPER showed that vidofludimus calcium improved the annualized rate of brain volume change by 5% relative to placebo—an effect that failed to reach statistical significance. Immunic, however, chose to focus on the clinical outcomes. The likelihood of having disability worsening events at 24 weeks, for instance, was 20% lower in the vidofludimus calcium group, as compared with placebo. This effect remained consistent or increased even further in various patient subgroups, including in those with primary progressive MS and in those without inflammatory lesions at baseline. As for safety, there were no new signals of concern with vidofludimus calcium. Severe side effects were “rare,” according to Immunic, and occurred at similar frequencies between the treatment arms: 8.1% in patients on vidofludimus calcium and 6.5% of placebo counterparts.

临床2期临床结果临床3期

2025-04-30

·FierceBiotech

Immunic CEO says \'nobody should care at all\' about missed primary endpoint in MS study

Though the trial missed its primary endpoint, Immunic pointed to other positive results from the study to suggest that IMU-838 could succeed in phase 3.\n Immunic’s lead oral small molecule has failed to hit the primary endpoint of a phase 2 trial in patients with progressive multiple sclerosis (PMS), but the New York biotech is pointing to other measures from the study as reason to continue developing the asset.Vidofludimus calcium, called IMU-838 by Immunic, showed only a “modest benefit” of 5% over placebo at improving the yearly rate of percent brain volume change in patients with PMS after the approximately two-year treatment period, Immunic said in an April 30 press release. This measure of brain volume change is the primary endpoint of the still-ongoing phase 2 Calliper trial, which has enrolled 467 patients with PMS. The treatment period followed patients for about 120 weeks, while an open-label extension will continue for up to eight years.The company did not disclose the statistical significance of the result, but a spokesperson confirmed that the trial missed its primary goal.During an April 30 webinar about the top-line results, Immunic CEO Daniel Vitt, Ph.D., dismissed the primary endpoint, saying the measure had fallen behind current scientific advancements.\"Nobody should care at all about whole brain volume change anymore,\" Vitt said. \"This is a little bit of a leftover of our design of a study we did five years ago.\"Though IMU-838 had a marginal effect on reducing whole brain volume loss, patients receiving the drug candidate did see a 20% reduction in loss of the thalamus, Immunic said. \"Change in thalamic volume is considered a more sensitive MRI atrophy marker,\" Immunic said in the release. \"Thalamic atrophy is prevalent in PMS and data has shown strong associations with clinical disability progression.\"Daily oral 45-mg doses of IMU-838 also reduced the risk of a patient experiencing an event that worsened their disability for at least 24 weeks by 20% compared to placebo, as measured by the Expanded Disability Status Scale (EDSS) score, Immunic reported. This figure jumped to 30% when focusing on the subset of patients with primary progressive multiple sclerosis (PPMS), whose disease did not start with the more common relapsing MS (RMS).The time to 24-week confirmed disability worsening based on EDSS is a secondary endpoint of the trial. Immunic did not disclose detailed data in its communications about the top-line results. Results for another secondary endpoint, an MRI measure of change in brain parenchymal fraction, have also not been disclosed yet.\"We ourselves have not seen all data from all endpoints yet and we will continue to receive them over the next weeks and months to come,\" Vitt said in the webinar.The frequency of adverse events in the group of patients receiving treatment was similar to the rate in the placebo group, according to the company\'s release.“We are particularly thrilled to see such a clinically meaningful effect in the PPMS population,” Vitt said in the release, noting “the relative risk of 24-week confirmed disability worsening events” would be the primary endpoint of a potential future phase 3 study.“We look forward to discussing these results with healthcare authorities to determine appropriate next steps for vidofludimus calcium in PMS,” Vitt added. Analysts from William Blair wrote April 30 that \"with usual cross-trial comparison caveats, in our view, vidofludimus calcium demonstrated a competitive risk/benefit profile\" compared to Genentech\'s Ocrevus (ocrelizumab), Novartis\' Mayzent (siponimod) and Sanofi\'s experimental tolebrutinib.\"The FDA appears to be focused on confirmed disability worsening endpoints where vidofludimus compares well in the PPMS population,\" the analysts wrote.Immunic\'s stock price dropped sharply after the data reveal, from $1.41 per share in the evening of April 29 to 99 cents per share by 2 p.m. EDT on April 30.William Blair analysts attributed this stock drop to concerns about Immunic\'s ability to fund a phase 3 trial for IMU-838; the company reported $35.7 million in cash and cash equivalents as of March 31, which is expected to fund the company through the third quarter of this year.\"We acknowledge the financing overhang is material and Immunic will likely need a partner and/or additional capital to fund future phase III studies,\" the analysts wrote.Most patients with MS have relapsing MS, where symptoms like numbness, fatigue, vision changes and brain fog periodically flare up. In progressive MS, these symptoms instead gradually worsen over time; flare-ups may still happen but are less common. Relapsing MS can develop into progressive MS over time, called secondary progressive MS, but about 10% of MS patients are diagnosed with primary progressive MS without first having any relapsing symptoms.IMU-838 is also currently in a pair of phase 3 trials in RMS, after previously hitting the primary endpoint of reducing brain lesions in a phase 2 trial. The phase 3 trials are analyzing the time to first symptom relapse as the primary endpoint.Immunic’s phase 3 RMS program recently underwent an interim futility analysis, the company said in October 2024, with the independent data monitoring committee determining that no changes to the trial protocol were needed.In addition to MS, Immunic is also testing IMU-838 in a phase 2 ulcerative colitis trial. The company has two other drug candidates in development, one clinical-stage asset for celiac disease and other gastrointestinal disorders and another preclinical gastrointestinal asset.This is, however, a more narrow focus for the biotech, which in 2023 revealed that it was deprioritizing development in psoriasis and castration-resistant prostate cancer and throwing its remaining resources to multiple sclerosis and celiac disease.

$Immunic CEO says \'nobody should care at all\' about missed primary endpoint in MS study$

临床2期临床结果临床3期

2025-04-03

·药通社

12个重磅首仿药，有望获批！

根据梳理，2025年12个重磅首仿药有望获批，覆盖肿瘤、呼吸、抗感染、神经及代谢等重大疾病领域。首仿竞争激烈度存在差异，其中竞争最为激烈的当属布瑞哌唑片，已有32家仿制药企提交上市申请，还有注射用卡非佐米，申报也已超10家。而部分品种如氘丁苯那嗪片、甲磺酸贝舒地尔片、西尼莫德片等因技术壁垒、市场等因素，呈现单/双企主导格局。首仿获批后将加速进口替代进程，有望获批品种市场竞争格局简要介绍如下：1、布瑞哌唑片（32家）布瑞哌唑片是一款国内知名的“原研被围剿”的产品，原研大冢制药在2024年6月上市，国内企业就开始了首仿冲击，扎堆申报上市。布瑞哌唑片卷生卷死，甚至原研还未在国内打开市场，就已经有32家企业申请了上市申请，还有20家企业完成了BE试验等待上报，甚至有3家企业已经是被驳回后再次申报了。2、注射用卡非佐米（13家）卡非佐米是一种蛋白酶体抑制剂，是针对多发性骨髓瘤(MM)的靶向治疗药物，原研药企为安进。原研的注射用卡非佐米在2021年进入中国市场。数据显示，2023年卡非佐米全球销售额超过了14亿美元。注射用卡非佐米首仿竞争激烈，目前在审评审批中的企业已经达到13家，四川汇宇、扬子江、正大天晴等明星药企均已入局。3、非奈利酮片（9家）非奈利酮片是拜耳研发的首个非甾体类盐皮质激素受体拮抗剂，可延缓肾功能恶化并降低心血管风险。原研于21年7月FDA获批，22年在中国上市，同年进入医保。非奈利酮片市场增长非常迅猛，2023年国内销售额达1.23亿元，且2024年前两季度已超上年全年。目前国内首仿竞争激烈，已有9家仿制药企申报上市。湖南明瑞制药（2024年9月首家申报）领跑，山东朗诺、天地恒一、康恩贝、江苏德源、重庆华邦、华北制药、杨凌科森等8家药企紧随其后。其中注意到，杨凌科森生物制药正巧于今日获得受理。4、利那洛肽胶囊（8家）利那洛肽是Ironwood公司研发的全球首个鸟苷酸环化酶激动剂，可显著缓解便秘型肠易激综合征患者便秘及腹痛、腹胀等症状。2019年进入中国市场，2021年纳入医保后销售开始上涨，22、23年院内终端销售额均达到1亿元以上。目前利那洛肽胶囊一致性评价申报上市共企业8家，其中齐鲁已被驳回。5、环硅酸锆钠散（4家）阿斯利康研发的环硅酸锆钠散是高钾血症领域首个在中国获准上市的药物，填补了近60年无新药上市的空白期。此品于19年12月国内上市，前期一直不温不火，2022年被纳入医保后销量猛增，2023年医院端销售额达到2.6亿元。目前环硅酸锆钠散在审企业共4家，按申报顺序依次为杭州时森海、湖南明瑞、海南先声、河北仁和义康。最早申报时间在2023年12月。6、马立巴韦片（3家）马立巴韦片原研武田，2021年11月获FDA批准上市，用于治疗难治性巨细胞病毒感染。2023年12月19日国内获批，次年11月纳入乙类医保。2023年马立巴韦全球销售额超9亿元。马立巴韦片当前有3家药企竞争国内首仿，分别为桂林南药（2024年10月）、江苏奥赛康（2024年12月）及齐鲁制药（2025年1月）。7、诺西那生钠注射液（3家）诺西那生钠注射液原研渤健，2016年在美国上市，2019年在中国上市，第一个也是唯一一个获批治疗SMA（脊髓性肌萎缩症）的药物。原研药企为渤健，在2019年进入中国市场。诺西那生钠注射液刚刚进入中国时，价格是70万元一针，2021年底，在经过国家医保多轮谈判后，70万元一针的诺西那生钠以3.3万元每针的价格进入医保目录。数据显示，2023年诺西那生钠注射液全球销售额超过17亿美元。未来仿制药上市之后，价格有望进一步降低。截至目前，诺西那生钠注射液已有3家药企参与国内首仿争夺，分别为重庆药友制药在2024年9月首家，齐鲁第二家（2025年1月）、成都国为生物第三家（2025年3月）。8、阿贝西利片（2家）阿贝西利用于治疗早期乳腺癌的CDK4/6抑制剂，原研药企为礼来。原研的阿贝西利片在2020年获批进入中国市场，2023年国内医院终端市场达到7.5亿元。截至目前，阿贝西利片共2家药企竞争国内首仿，首家齐鲁制药于2024年12月提交4类仿制上市申请，江西科睿药业于2025年1月第二家报产。9、拉米夫定多替拉韦片（2家）拉米夫定多替拉韦片是葛兰素史克公司研发的一款抗HIV感染用药，2021年3月在中国获批上市。2022年纳入医保后，销售开始增长，2023年全医院端市场规模达到了2亿以上。目前国内仅1家药企冲击首仿：2024年12月，上海迪赛诺医药按4类仿制申报上市。另外注意到，齐鲁制药早早完成了BE试验，但不知为何没有上报。10、西尼莫德片（2家）西尼莫德片原研诺华，2020年通过优先审评审批获批上市，用于治疗成人复发型多发性硬化，23年全国院内销售市场超5700万元。当前，西尼莫德片主要有2家明星药企抢首仿，即湖南科伦2023年2月头家，齐鲁2024年1月第二家。11、甲磺酸贝舒地尔片（1家）甲磺酸贝舒地尔片是全球首个获批治疗慢性移植物抗宿主病的靶向药物，2021年在美国获批上市，2023年8月在国内上市，2024年被纳入国谈目录。此产品至今未在国内打开市场。贝舒地尔片仅齐鲁1家进行仿制申报（2024年10月23日）。另有浙江华义登记了BE试验。12、氘丁苯那嗪片（1家）氘丁苯那嗪片原研药企为梯瓦制药，2020年5月经优先审评审批后批准上市，用于治疗与亨廷顿病(HD)有关的舞蹈病及成人迟发性运动障碍(TD)。2023年，氘丁苯那嗪片院内销售额达到4800万元。氘丁苯那嗪片当前仅1家药企报产，为南京正大天晴制药于2024年5月首家提交4类仿制上市申请。本文数据来源：摩熵医药参考内容来源：制药网、药春秋↓ 扫码加入药通社交流群 ↓投稿/内容沟通：华籍美人（Ww_150525）

一致性评价上市批准医药出海

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

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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

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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	Novartis AG	2024-11-01
阿尔茨海默症	临床2期	美国	Laboratory Corp. of America Holdings	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

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


NCT04925557 (CTgov)	临床2/3期	继发进展型多发性硬化	8	Ocrevus (Ocrevus)	蓋夢鹽願顧繭壓憲觸憲(構窪鬱襯鏇醖鬱糧廠繭) = 構製襯簾構鏇廠鹽蓋願鑰觸顧窪餘壓窪遞獵窪 (遞艱齋願壓鑰獵蓋窪窪, 願淵憲壓鹽鑰顧積膚壓 ~ 醖鏇繭餘鹽顧鏇夢網觸) 更多	-	2025-05-13
				Mayzent (Mayzent)	蓋夢鹽願顧繭壓憲觸憲(構窪鬱襯鏇醖鬱糧廠繭) = 製窪築製遞醖鑰繭製淵鑰觸顧窪餘壓窪遞獵窪 (遞艱齋願壓鑰獵蓋窪窪, 糧積築選獵窪壓願夢繭 ~ 廠觸獵鬱製齋鹹夢壓顧) 更多
NCT03623243 (EXCHANGE, Pubmed \| Mult Scler)	临床3期	-	185	Siponimod	憲鑰簾廠鹹選積淵齋壓(齋積鬱憲繭選鬱夢鏇鹽) = 3.8% (n = 7) 壓餘觸鬱憲鑰願鹽憲蓋 (憲夢願製鑰糧鹹蓋鏇選 ) 更多	积极	2025-04-18
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)	觸鏇鹽簾網壓顧構願選 = 淵積鑰願鬱襯衊繭範襯襯鹽選構憲鏇遞醖繭繭 (簾醖獵築積餘壓鹽願淵, 願壓糧夢壓遞蓋顧觸淵 ~ 糧夢衊構網觸觸遞繭壓) 更多	-	2024-05-17
				BAF312+BNT162+mRNA-1273 (Siponimod- Interrupted)	觸鏇鹽簾網壓顧構願選 = 構窪餘築衊遞糧襯遞鑰襯鹽選構憲鏇遞醖繭繭 (簾醖獵築積餘壓鹽願淵, 願蓋網鹹鑰糧醖獵積簾 ~ 鏇遞糧餘廠繭構壓憲鬱) 更多
ECTRIMS2023	N/A	多发性硬化症	67	Siponimod	齋淵鏇鏇築憲遞繭範艱(鹽蓋鏇製壓窪製蓋網窪) = 構觸鑰膚鏇艱繭淵鹹製築膚夢壓醖積構顧選簾 (繭鏇鑰鏇製壓鑰醖淵鏇 )	-	2023-10-01
EAN2023	N/A	继发进展型多发性硬化	-	Siponimod	糧願範鹽簾繭網鏇願範(窪鬱艱鑰範憲鑰觸廠糧) = 選壓醖餘鏇壓淵衊範齋廠獵鹹衊窪艱繭構鏇顧 (網獵糧鬱繭鑰糧夢壓鹽 )	-	2023-06-28
ACTRIMS2023	N/A	继发进展型多发性硬化二线	29	Siponimod	憲選襯獵範選製選簾艱(膚構壓選艱遞艱廠廠窪) = 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. 願獵糧膚願鏇鑰壓廠衊 (淵顧夢齋遞鑰繭積構繭 ) 更多	积极	2023-05-30
ECTRIMS2022	N/A	继发进展型多发性硬化 CYP2C9 genotype	-	Siponimod 2mg	鏇窪艱廠齋鬱膚醖憲壓(選觸壓鏇構衊範鏇鹹夢) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure 膚繭餘顧窪壓鬱蓋鬱構 (範廠廠製糧鏇壓遞艱觸 )	-	2022-10-12
				Siponimod 1mg
ECTRIMS2022	N/A	新型冠状病毒感染	-	Fingolimod	簾遞鹹膚鬱窪製鹹遞積(醖夢繭廠範淵糧醖鑰憲) = 醖顧鑰鬱艱積醖築鹽繭鹽製艱餘觸築積鹽顧鑰 (鏇製餘蓋範構廠獵鑰構 ) 更多	-	2022-10-12
				Siponimod	簾遞鹹膚鬱窪製鹹遞積(醖夢繭廠範淵糧醖鑰憲) = 繭窪襯廠衊壓鹹鏇遞齋鹽製艱餘觸築積鹽顧鑰 (鏇製餘蓋範構廠獵鑰構 ) 更多
EAN2022	N/A	继发进展型多发性硬化	-	Siponimod	遞構製蓋襯壓齋艱構築(壓夢築衊願鑰蓋構膚獵) = 襯鬱觸鏇廠鹹壓願遞獵廠淵獵願選鹹遞鏇範積 (網廠鏇鑰蓋憲築範壓膚 )	-	2022-06-24
				Placebo	遞構製蓋襯壓齋艱構築(壓夢築衊願鑰蓋構膚獵) = 夢構鑰製壓艱構夢觸鹽廠淵獵願選鹹遞鏇範積 (網廠鏇鑰蓋憲築範壓膚 )
NCT01665144 (EXPAND, Pubmed)	临床3期	继发进展型多发性硬化	779	Siponimod	遞膚蓋鹹鏇憲窪網餘襯(觸蓋積壓糧獵範壓網糧) = 繭廠餘鬱鏇憲繭淵鏇憲窪廠獵繭鏇積顧蓋憲範 (廠顧膚鬱膚窪憲願願衊 )	积极	2022-05-31
				Placebo	遞膚蓋鹹鏇憲窪網餘襯(觸蓋積壓糧獵範壓網糧) = 憲艱衊鏇願淵簾選網獵窪廠獵繭鏇積顧蓋憲範 (廠顧膚鬱膚窪憲願願衊 )