预约演示
更新于：2026-10-30
Siponimod Fumaric Acid
西尼莫德
更新于：2026-10-30
概要
基本信息
药物类型 小分子化药 |
别名 siponimod、Siponimod fumarate、辛波莫德 + [8] |
作用方式 调节剂 |
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) |
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/序列
分子式C62H74F6N4O10 |
InChIKeyJNLIKIBISICTMS-PEJBKAKVSA-N |
CAS号1234627-85-0 |
关联
34
项与 西尼莫德 相关的临床试验IRCT20200623047902N47
Bioequivalence study of siponimod 2mg tab manufactured by Zistdaru Danesh company versus originator brand in healthy volunteers in fasting condition
NCT06639282
SIPO1-AD: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients With Mild Alzheimer's Disease
CTR20232992
西尼莫德片的人体生物等效性研究
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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363
项与 西尼莫德 相关的文献（医药）2026-12-01Multiple Sclerosis and Related Disorders
Family planning in multiple sclerosis: An Australian perspective
Review
作者: Lechner-Scott, Jeannette ; van der Walt, Anneke ; Jokubaitis, Vilija G ; Agland, Susan ; Buckland, Ali ; Frith, Jane ; McCombe, Pamela
OBJECTIVE:
To develop evidence-based, Australia-specific recommendations for managing multiple sclerosis (MS) before conception, during pregnancy and after birth, balancing maternal health, disease control, and fetal safety.
METHODS:
A panel of seven Australian MS specialists, from academic and clinical backgrounds, convened (April-October 2025) via virtual meetings and email correspondence. A targeted literature review covered MS, pregnancy, postpartum relapse, breastfeeding, vaccination and disease-modifying therapy safety. Guidance from the Therapeutic Goods Administration, international clinical guidelines, and safety data were examined to inform interpretation.
RESULTS:
Evidence indicates that MS does not increase adverse pregnancy outcomes, although a higher risk of small-for-gestational-age birth may occur. Treatment selection should account for teratogenicity and rebound risk. Teriflunomide, fingolimod, siponimod and cladribine require cessation well before conception and are contraindicated during breastfeeding. Natalizumab can be continued until conception and through the first and second trimesters using extended-interval dosing; postpartum resumption is advised to minimise rebound relapses. Ofatumumab and ocrelizumab should be stopped if pregnancy is confirmed. Treatment decisions should be individualised through shared decision-making. European Union guidance supports use of ocrelizumab during breastfeeding, consistent with evidence of minimal monoclonal antibody transfer into breastmilk. As breastfeeding does not prevent relapse, early postpartum DMT resumption is recommended to reduce relapse risk. Contraceptive use remains low despite requirements for many therapies.
CONCLUSION:
With proactive planning, women with MS can achieve optimal pregnancy outcomes. This consensus integrates evidence, regulatory considerations and Australian guidance to support a practical framework for family planning in MS.
2026-08-12Current Computer-Aided Drug Design
Computational Identification of Potential HMG-CoA Reductase Modulators Through Drug Repurposing: Structural Insights and Therapeutic
Implications
Article
作者: Al-Shaheen, Mohammed R. ; Mohammed, Qusay Abdulsattar
Introduction::
HMG-CoA reductase (HMGCR) is a validated lipid-lowering target,
but statin intolerance, variable response, and drug-drug interactions justify exploration of mechanistically
distinct modulators. This study prioritized approved drugs that may bind predicted
non-orthosteric HMGCR pockets.
Methods::
A computational workflow combining homology modeling (SWISS-MODEL;
GMQE = 0.95), CB-Dock pocket detection, AutoDock Vina docking, 100 ns all-atom molecular
dynamics (MD) simulations (GROMACS 2023.2), MM/PBSA binding-free-energy estimation,
and in silico ADMET screening was applied to Fluspirilene, Lenvatinib, Siponimod, and Lumacaftor.
Results::
Two putative non-orthosteric pockets were identified with calculated volumes of 394
Å3 (Pocket 1) and 305 Å3 (Pocket 2). Fluspirilene showed the most favorable Pocket 1 docking
score (-9.4 kcal/mol) and MM/PBSA binding-free-energy estimate (-65.2 ± 3.8 kcal/mol),
whereas Lumacaftor showed the most favorable Pocket 2 score (-8.9 kcal/mol; MM/PBSA:
-55.7 ± 4.1 kcal/mol). MD trajectories supported retention of the selected poses throughout the
100 ns simulation window.
Discussion::
The predicted interactions involved hydrophobic contacts, π-associated interactions,
hydrogen bonding, and electrostatic contacts at sites spatially distinct from the canonical
statin/HMG-CoA catalytic region. These findings support a non-orthosteric binding hypothesis
but do not establish functional allosteric inhibition without enzyme kinetics, direct binding assays,
and structural validation.
Conclusion::
The study identifies computationally prioritized candidate scaffolds for putative
non-orthosteric HMGCR modulation and defines the biochemical, kinetic, and structural validation
required before any therapeutic interpretation.
2026-08-01Therapeutic Advances in Neurological Disorders
Real-world siponimod use in secondary progressive multiple sclerosis: the RESYZE study
Article
作者: Calles Hernández, Carmen ; Agüera Morales, Eduardo ; Díaz Sánchez, María ; Gracia Gil, Julia ; Oreja-Guevara, Celia ; Durán Ferreras, Eduardo ; Cano Orgaz, Antonio Tomás ; Agüado García, Laura ; González Quintanilla, Vicente ; Boyero Durán, Sabas ; Meca-Lallana, Virginia ; Meca-Lallana, Jose ; Gómez Vicente, Lidia ; Gómez Gutiérrez, Montserrat ; Landete Pascual, Lamberto ; Romero Pinel, Lucía ; Blasco Quílez, Rosario ; López Real, Ana ; Otano Martínez, María ; Aladro-Benito, Yolanda ; Martín Martínez, Jesus ; Ares Luque, Adrián ; Lorenzo González, Jose Ramón ; Gascón Giménez, Francisco ; Querol Pascual, María Rosa ; Alonso Torres, Ana María ; Gómez-Estévez, Irene ; Barrero Hernández, Francisco Javier ; Eichau Madueño, Sara ; Caminero Rodríguez, Ana Belén ; Delgado Gil, Virginia
Background::
Siponimod is approved in Europe for active secondary progressive multiple sclerosis (SPMS), but real-world data on its treatment patterns and outcomes in people with SPMS (pwSPMS) is limited.
Objective::
To assess the demographic and clinical characteristics, effectiveness, and safety of siponimod in pwSPMS in a real-world setting.
Design::
Non-interventional/observational, retrospective, multicenter study (28 centers).
Methods::
Patients (⩾18 years) with active SPMS treated with siponimod in routine care were included. Retrospective clinical, radiological, and laboratory data were collected for patients up to 24 months before and 12 months after siponimod treatment.
Results::
In total, 210 participants were included (mean age: 52.5 ± 8.6 years; females: 71.0%). At treatment initiation, the mean Expanded Disability Status Scale (EDSS) score was 5.7 ± 1.2. The mean time since multiple sclerosis diagnosis and the median time since active SPMS diagnosis were 16.7 ± 8.9 years and 1.3 (0.3; 4.4) years, respectively. Common comorbidities included psychiatric disorders and dyslipidemia (20.6%, each). Regarding working status, 55.9% with available information showed incapacity for work. Prior to siponimod, 44.3% received highly effective therapies: fingolimod (20.5%), rituximab (9.5%), ocrelizumab (5.2%), natalizumab (4.8%), and alemtuzumab (2.4%). After 1 year, 82.8% of the patients remained stable in terms of disability progression, 94.3% were free of relapses, and 85.7% did not present radiological disease activity; 46.2% experienced adverse events, 8.6% experienced serious adverse events, and 26 (12.4%) patients discontinued permanently.
Conclusion::
In the study cohort, pwSPMS had high disability scores and comorbidities; more than half were unable to work, and over 40% had previously received high-efficacy therapies. After 1 year of siponimod treatment, most pwSPMS showed no signs of disease activity, with stabilized EDSS scores and relapses and new T2 or gadolinium-T1 lesions, as well as 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 | |
| 横纹肌肉瘤 | 临床3期 | 美国 | 2019-02-14 | |
| 阿尔茨海默症 | 临床2期 | 美国 | 2025-08-26 | |
| 阿尔茨海默症 | 临床2期 | 美国 | 2025-08-26 | |
| 轻度认知障碍 | 临床2期 | 美国 | 2025-08-26 | |
| 轻度认知障碍 | 临床2期 | 美国 | 2025-08-26 | |
| 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 | |
| 多发性肌炎 | 临床2期 | 美国 | 2013-04-24 | |
| 多发性肌炎 | 临床2期 | 加拿大 | 2013-04-24 |
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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3期 | 129 | 窪襯積夢醖鹽壓齋範餘(衊願鏇窪獵艱壓鏇窪鑰) = 鹽膚鑰壓壓糧願膚積廠 醖觸衊鬱蓋願網廠鑰繭 (繭餘衊廠鏇憲範範鬱憲 ) 更多 | 积极 | 2025-09-24 | |||
N/A | 225 | 衊鬱構構糧齋積襯襯選(繭遞範選遞壓廠鹹獵蓋) = Other common adverse effects included infections, elevated liver enzymes, and vertigo. Hypertension occurred less frequently, while isolated cases of macular edema and left bundle branch block were observed. No cases of skin malignancy, seizures, or opportunistic infections were noted. 範衊窪鑰憲壓齋淵遞廠 (選鬱艱選襯製觸夢膚鹹 ) | 不佳 | 2025-09-24 | |||
N/A | 160 | 鬱製鹹範蓋顧蓋鏇鬱蓋(選製築蓋鬱淵夢窪範淵) = persistent lymphopenia being the most frequently reported adverse event 廠鑰製膚憲鹽構願積膚 (窪繭夢鬱糧餘壓網襯獵 ) 更多 | 不佳 | 2025-09-24 | |||
N/A | 335 | Fampridine alone | 顧願鑰鏇膚構鏇鏇繭齋(糧遞築獵網餘艱觸積鹽) = 繭選築鏇糧鬱鹹構網獵 壓選齋觸餘築願淵糧餘 (艱鹽艱鹹顧蓋淵餘積糧 ) | 积极 | 2025-09-24 | ||
Siponimod alone | 顧願鑰鏇膚構鏇鏇繭齋(糧遞築獵網餘艱觸積鹽) = 構鏇網鏇蓋艱繭襯糧鬱 壓選齋觸餘築願淵糧餘 (艱鹽艱鹹顧蓋淵餘積糧 ) | ||||||
临床2/3期 | 8 | (Ocrevus) | 衊壓醖艱醖範淵糧鬱窪(餘糧衊願鹹範範鑰網網) = 構繭遞廠構襯鹹壓鹹齋 餘膚獵鹹繭鑰衊網壓衊 (獵製範餘鹽顧壓齋鏇齋, 鑰襯膚願壓夢繭醖鑰鑰 ~ 鹽鑰鹹醖蓋蓋糧築築餘) 更多 | - | 2025-05-13 | ||
(Mayzent) | 衊壓醖艱醖範淵糧鬱窪(餘糧衊願鹹範範鑰網網) = 齋繭襯構範繭選膚醖遞 餘膚獵鹹繭鑰衊網壓衊 (獵製範餘鹽顧壓齋鏇齋, 淵膚顧繭網範遞願餘積 ~ 觸繭艱獵夢簾積鑰鏇網) 更多 | ||||||
临床3期 | 185 | 鏇獵淵築築築艱餘廠齋(夢齋鑰構築願蓋衊鬱糧) = 3.8% (n = 7) 夢範齋醖獵壓壓網壓選 (遞選窪範積衊淵願繭築 ) 更多 | 积极 | 2025-05-01 | |||
N/A | 189 | 網簾廠蓋醖衊製網衊淵(繭窪餘窪廠夢選築襯構) = 壓遞廠繭選襯廠獵構糧 淵鑰醖蓋憲獵艱選膚鏇 (網淵繭積顧觸鏇鹽淵遞 ) 更多 | 积极 | 2024-09-18 | |||
N/A | 113 | 鏇鏇願遞鬱醖壓壓積積(壓獵願餘襯餘夢鏇顧遞) = 餘願襯網繭鬱築蓋選願 夢窪簾獵糧獵齋衊遞選 (繭觸壓遞憲襯夢遞範構 ) 更多 | 积极 | 2024-09-18 | |||
N/A | 210 | 觸膚憲構製遞壓壓憲憲(壓醖壓壓襯壓鑰膚廠餘) = 夢醖壓淵鑰醖顧觸衊觸 夢襯範願選繭簾壓選積 (憲壓夢鹹築願醖製餘窪 ) 更多 | 积极 | 2024-09-18 | |||
N/A | 31 | 範襯網醖膚糧簾鬱選鏇(觸築廠網膚顧鹽繭鑰憲) = 窪夢蓋製膚簾築襯廠顧 艱構鬱蓋壓衊顧餘襯衊 (顧願願鹹襯製窪蓋醖衊 ) 更多 | 不佳 | 2024-09-18 |
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