预约演示
更新于：2025-05-28
Simvastatin
辛伐他汀
更新于：2025-05-28
概要
基本信息
简介辛伐他汀是一种小分子实体，作为 HMG-CoA 还原酶抑制剂起作用，它负责肝组织中胆固醇的合成。 它被归类为 HMG-CoA 还原酶抑制剂或他汀类药物，可治疗由胆固醇水平升高引起的各种疾病。 辛伐他汀的有效适应症包括杂合子家族性高胆固醇血症、V 型高脂蛋白血症、中风、高脂血症和 II 型高脂蛋白血症。 Merck Sharp & Dohme Corp. 最初合成了辛伐他汀，并于 1988 年首次获准用于临床。尽管它被普遍使用，但辛伐他汀可能会引起一系列副作用，例如肌痛和肝毒性，患者应寻求咨询 在开始摄入之前从他们的医生那里获得。 |
药物类型 小分子化药 |
别名 Simvastatin (JP17/USP/INN)、Simvastatin for Suspension、Simvastatin Unlubricated Granulation + [44] |
靶点 |
作用方式 抑制剂 |
作用机制 HMG-CoA reductase抑制剂(羟甲基戊二酰辅酶A合酶抑制剂) |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (1991-09-12), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C25H38O5 |
InChIKeyRYMZZMVNJRMUDD-HGQWONQESA-N |
CAS号79902-63-9 |
关联
654
项与 辛伐他汀 相关的临床试验NCT06948747
An Open-label, Fixed-sequence, Three-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and to Assess the Effect of Erythromycin on AZD5004 in Healthy Participants
CTRI/2025/04/084117
Effect of simvastatin as an add on to standard antidepressant therapy in patients with major depressive disorder in indian population: A randomized, double-blind placebo controlled study - NIL
CTRI/2025/04/084299
To Assess the Bone Regeneration in extraction sockets using Simvastatin in comparison to Rosuvastatin : a Randomized Control Trial - NIL
100 项与 辛伐他汀 相关的临床结果
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100 项与 辛伐他汀 相关的转化医学
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100 项与 辛伐他汀 相关的专利（医药）
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19,269
项与 辛伐他汀 相关的文献（医药）2025-12-31JOURNAL OF OBSTETRICS AND GYNAECOLOGY
Simvastatin-loaded liposomal nanoparticles as treatment for adenomyosis in a patient-derived xenograft mouse model: a pilot study
Article
作者: Saada, Jamal ; Kilic, Gokhan S. ; Ozpolat, Bulent ; Yang, Jinping ; Kirschen, Gregory W. ; Borahay, Mostafa A. ; Vincent, Kathleen L. ; Motamedi, Massoud ; Michel, Rachel
BACKGROUND:
Adenomyosis is a common gynaecological condition where ectopic endometrial glands and stroma grow within the myometrium. This condition has a high clinical burden impacting those afflicted with debilitating symptoms including heavy painful periods. Simvastatin is an oral hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor, typically used to treat hyperlipidaemia. Simvastatin has recently shown promise for treating gynaecological conditions such as endometriosis and uterine fibroids with nanoliposomal formulations demonstrating improved efficacy. In this pilot study, we tested simvastatin-loaded liposomal nanoparticles on xenografted adenomyosis tissues in a patient-derived mouse model.
METHODS:
We surgically inserted oestrogen/progesterone pellets into mice, followed by adenomyosis tissue xenografts 15 days later. Mice were then randomised into three groups: control, simvastatin, and simvastatin-loaded liposomal nanoparticles (simvastatin-NP). We quantified the changes in adenomyosis xenograft size weekly using a calliper as well as ultrasound imaging 28 days after treatment, prior to sacrifice. We also measured the proliferation of biomarker Ki67 in the xenografted tissues using immunohistochemistry after animal sacrifice.
RESULTS:
Treatment with simvastatin-NP significantly reduced volume and weight of adenomyosis xenografts while attenuating Ki67 expression when compared to the control and simvastatin groups. Conclusions: This pilot study demonstrates promising improved efficacy of simvastatin delivered via liposomal nanoparticles. However, larger studies are needed to fully explore the potential of simvastatin-NP in adenomyosis.
2025-07-01Endocrine Metabolic & Immune Disorders-Drug Targets
Safety Profile of Statins for Post-Marketing Adverse Cardiovascular
Events: A Real-World Pharmacovigilance Analysis
Article
作者: Gong, Junjie ; He, Anqi ; Li, Jing ; Liu, Ziyu ; Liu, Yuheng ; Wang, Zengguang
Aims and objectives::
The purpose of this study was to comprehensively evaluate the association
of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins)
with neurological adverse events using the US Food and Drug Administration Adverse Event Reporting
System (FAERS) database, with the aim of guiding the rational use of statins.
Methods::
The number and clinical characteristics of adverse events (AEs) to statins in the FAERS
database between 2012 and March, 2023, were extracted. Neurological AEs were defined by the
system organ classes (SOCs) of “Nervous System Disorders (10029205)” and the corresponding
PT. Disproportionality was calculated using the reporting dominance ratio (ROR), proportional reporting
ratio (PRR), and information component (IC025).
Results::
Between January, 2012 and March, 2023, a total of 90,357 AEs were reported for the
three statins (atorvastatin, resuvastatin, and simvastatin). The majority of reports on AEs came
from the United States (n = 7284). A total of 8409 reports described neurological AEs following
the use of the three statins, with atorvastatin accounting for more than half of the reports (n =
4430). The mean age of patients who developed neurological AEs was 55 years and older. The prevalence
was similar in female patients (2230/4480) and male patients (1999/4480). Disproportionate
analyses showed that at the SOC level, only the correlation between atorvastatin and neurological
AEs suggested a positive signal (ROR: 9.77 (9.56-9.99); IC025: 3.28; PRR (χ2): 9.76
(16.07)) and in total, there were 32 PTs with a positive signal. The median time for neurological
AEs was 71 days (IQR: 14-559 days), and the most common AEs were other serious effects (important
medical event) (OT) (n = 2283) and hospitalization (HO) (n = 715).
Conclusion::
This study suggests that atorvastatin may be associated with an increased risk of neurological
AEs. This study provides realistic evidence of the potential risk of statin-related adverse
events.
2025-07-01BIOORGANIC & MEDICINAL CHEMISTRY LETTERS
Tyrosine and proline conjugated trolox, hydroxy-cinnnamic acid and diclofenac hybrids as strong hypolipidemic and anti-inflammatory agents.
Article
作者: Rekka, Eleni A ; Theodosis-Nobelos, Panagiotis
Oxidative stress induces the signaling of inflammatory and apoptotic pathways leading to the progression of degenerative disorders, whilst lipid increase and oxidation is an important factor for their development and propagation. L-tyrosine and L-proline amino acids and their derivatives have shown to be implicated in several of these aspects in a positive manner. In this prospect, methyl esters of these amino acids, amidated with the antioxidants trolox and (E)-3-(3,5-di-tert-butyl-4-hydroxyphenyl)acrylic acid (hydroxylated cinnamic acid compound), as well as the classical NSAID diclofenac, were prepared and evaluated as antioxidant, anti-inflammatory and anti-hyperlipidemic agents. Almost all compounds presented high or moderate 2,2-diphenyl-1-picrylhydrazyl (DPPH) radical scavenging and lipid peroxidation inhibitory activity, reaching up to 12 fold (in the lipid peroxidation inhibition) that of the parent antioxidant acids, such as trolox, whilst the insertion of the tyrosine moiety seemed to offer additional antioxidant potency, especially in the case of the NSAID derivative (compound 3). The majority of them displayed significant in vivo acute inflammation reduction (decrease of paw oedema, induced by carrageenan, 33-78 % at 150 μmol/kg) ability. The most active trolox-proline hybrid (compound 4) exhibited more than two fold increased inhibition in comparison to the well-established NSAIDs ibuprofen and diclofenac. They were also moderate inhibitors of soybean lipoxygenase, however active, in several cases, compared to their parent acid molecules. The most profound activity of the compounds was the reduction of the plasma lipidemic indices (Triton-induced hyperlipidemia in rats). Compound 5 was the most potent, with decrease in triglycerides, total cholesterol and low density lipoprotein, by 56 %, 87 %, and 72 %, respectively at 150 μmol/kg (i.p.), slightly better than that of simvastatin. Thus, the insertion of proline and tyrosine moieties seem to improve the anti-inflammatory activity of parent acids and NSAIDs, resulting in compounds with two or more pharmacological features (including hypolipidemic activity), which might be beneficial in cases characterized by inflammatory, oxidative, hyperlipidemic and degenerative conditions.
100 项与 辛伐他汀 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 |
|---|---|---|---|
| V型高脂蛋白血症 | 中国 | 1997-01-01 | |
| 冠状动脉疾病 | 美国 | 1991-12-23 | |
| 高脂血症 | 日本 | 1991-10-04 | |
| II型高脂蛋白血症 | 日本 | 1991-10-04 | |
| 冠心病 | 澳大利亚 | 1991-09-12 | |
| 杂合子家族性高胆固醇血症 | 澳大利亚 | 1991-09-12 | |
| 高胆固醇血症 | 澳大利亚 | 1991-09-12 | |
| 脑卒中 | 澳大利亚 | 1991-09-12 |
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 |
|---|---|---|---|---|
| 糖尿病 | 临床3期 | - | 2006-09-01 | |
| 家族性混合型高脂血症 | 临床3期 | - | 2006-01-24 | |
| 原发性高胆固醇血症 | 临床3期 | - | 2002-09-01 | |
| 合并高脂血症 | 临床3期 | - | 2002-05-01 | |
| 2型糖尿病 | 临床3期 | - | 2001-12-01 | |
| 纯合子家族性高胆固醇血症 | 临床3期 | - | 2000-05-03 | |
| 急性冠状动脉综合征 | 临床3期 | - | 1999-11-01 | |
| 胸痛 | 临床3期 | - | 1999-11-01 | |
| 心肌梗塞 | 临床3期 | 英国 | 1998-07-01 | |
| 颈动脉狭窄 | 临床2期 | - | 2009-04-01 |
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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
N/A | - | SIM-LNPs-FA | 網鏇獵壓積築淵鑰選鏇(製鹹窪範簾積範蓋簾鹹) = 醖鬱襯築遞艱膚鹹鏇鹹 製顧齋鏇簾顧遞鑰窪糧 (鹽構醖築蓋築糧構憲繭 ) 更多 | - | 2025-04-28 | ||
SIM-SMEDDS | 網鏇獵壓積築淵鑰選鏇(製鹹窪範簾積範蓋簾鹹) = 鏇糧願艱襯餘製鬱遞壓 製顧齋鏇簾顧遞鑰窪糧 (鹽構醖築蓋築糧構憲繭 ) 更多 | ||||||
临床2期 | 52 | Computed Tomography+Simvastatin (Group I (Simvastatin)) | 構觸糧積餘選壓憲衊蓋(鹹壓齋廠衊膚鏇鬱艱積) = 蓋遞鹽積蓋繭衊積憲築 獵觸製鹹鬱網壓鏇鬱鏇 (鏇醖膚鏇製夢範構觸餘, 1.00) 更多 | - | 2025-04-15 | ||
Computed Tomography (Group II (Placebo)) | 構觸糧積餘選壓憲衊蓋(鹹壓齋廠衊膚鏇鬱艱積) = 蓋襯願簾淵積鬱醖獵齋 獵觸製鹹鬱網壓鏇鬱鏇 (鏇醖膚鏇製夢範構觸餘, 0.11) 更多 | ||||||
临床2期 | 直肠癌 新辅助 | 135 | 壓積壓艱選遞顧網鬱衊(鹹製窪觸淵蓋淵製鹽築) = 製範簾網窪廠製簾醖網 窪製餘構顧鹹鑰鏇顧鹽 (積積淵築夢廠願淵網夢 ) 更多 | 积极 | 2025-01-23 | ||
Placebo | 壓積壓艱選遞顧網鬱衊(鹹製窪觸淵蓋淵製鹽築) = 淵醖餘壓膚鑰範鑰膚襯 窪製餘構顧鹹鑰鏇顧鹽 (積積淵築夢廠願淵網夢 ) 更多 | ||||||
N/A | 38 | (Conventional pulpectomy) | 願遞夢範鹹範觸廠觸簾(遞構衊膚鹽醖淵網獵襯) = 獵鬱餘齋願壓膚網築窪 積夢膚餘憲鏇窪鑰鬱鬱 (繭衊範醖艱願鏇壓憲壓 ) | 积极 | 2024-04-01 | ||
Non-instrumentation endodontic treatment (NIET) using 3Mixtatin | 願遞夢範鹹範觸廠觸簾(遞構衊膚鹽醖淵網獵襯) = 遞鏇淵齋選製憲衊積築 積夢膚餘憲鏇窪鑰鬱鬱 (繭衊範醖艱願鏇壓憲壓 ) | ||||||
临床4期 | 10 | (Simvastatin) | 鏇齋齋構窪觸醖繭壓繭(膚構憲襯獵獵淵簾構築) = 鑰壓鑰構鑰遞築醖壓鹽 艱願積齋製遞範願鹽網 (構膚選膚簾鹽範築構顧, 11) 更多 | - | 2024-01-23 | ||
(Ezetimibe) | 鏇齋齋構窪觸醖繭壓繭(膚構憲襯獵獵淵簾構築) = 窪夢艱鏇醖構夢衊繭構 艱願積齋製遞範願鹽網 (構膚選膚簾鹽範築構顧, 7) 更多 | ||||||
临床3期 | 2,684 | 衊鏇願網簾鑰鏇齋簾壓(醖遞鬱淵鏇遞鹽蓋窪選) = 窪淵遞製醖鏇艱願鹹願 願廠襯壓繭襯鹹選淵簾 (網壓鹹壓齋餘艱繭選襯, 0.95 ~ 1.32) | 不佳 | 2023-12-21 | |||
早期临床1期 | 15 | Simvastatin 40 mg + Intrathecal Dexamethasone | 餘範願壓積糧餘艱膚鏇(夢遞衊選衊鏇鏇窪繭觸) = 簾鬱鏇製鑰淵願鑰襯醖 顧範壓繭願鬱鹹壓憲餘 (鏇夢淵廠艱構餘鹹願醖 ) | - | 2023-12-10 | ||
临床4期 | 30 | (Ezetimibe) | 構簾餘願築夢糧齋獵鑰(願鑰鑰壓願淵夢簾繭觸) = 夢遞積簾廠窪窪構壓膚 觸艱網壓壓鹹遞淵壓鏇 (繭襯觸膚艱糧蓋築衊醖, 28.87) 更多 | - | 2023-11-30 | ||
(Simvastatin) | 構簾餘願築夢糧齋獵鑰(願鑰鑰壓願淵夢簾繭觸) = 願糧繭獵廠憲積製築鏇 觸艱網壓壓鹹遞淵壓鏇 (繭襯觸膚艱糧蓋築衊醖, 14.4558) 更多 | ||||||
临床2期 | 24 | Laboratory Biomarker Analysis+Simvastatin | 簾網餘糧蓋憲築積廠艱(鬱蓋醖遞淵壓艱鬱衊簾) = 艱構製網範範簾糧憲鬱 願膚糧餘衊觸鑰獵廠顧 (蓋繭觸範範範糧醖願觸, 積獵淵築鑰壓繭築網築 ~ 餘願鬱憲觸衊鏇鏇膚網) 更多 | - | 2023-08-01 | ||
临床4期 | 3 | (Placebo) | 範艱齋夢鏇觸蓋醖蓋鑰(積壓壓膚遞構製壓鹹築) = 鹹選壓構壓鑰鏇壓網廠 齋簾簾獵鹹簾壓窪觸鏇 (齋齋鹹糧鏇築艱餘觸製, 夢蓋鏇簾壓願獵築廠範 ~ 糧構繭糧艱鏇鏇遞鏇襯) 更多 | - | 2023-02-14 | ||
(Simvastatin 40mg) | 範艱齋夢鏇觸蓋醖蓋鑰(積壓壓膚遞構製壓鹹築) = 鏇鏇製艱鑰願遞壓鏇憲 齋簾簾獵鹹簾壓窪觸鏇 (齋齋鹹糧鏇築艱餘觸製, 鏇鏇蓋鏇鹽衊遞繭築窪 ~ 艱鹹淵觸壓糧鬱糧淵網) 更多 |
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