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更新于：2025-02-05
Solifenacin Succinate
琥珀酸索利那新
更新于：2025-02-05
概要
基本信息
药物类型 小分子化药 |
别名 Solifenacin succinate (JAN/USAN/INN)、HGP-1103、YM-67905 + [5] |
作用机制 M3 receptor激动剂(毒蕈碱型乙酰胆碱受体M3激动剂) |
治疗领域 |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 荷兰 (2004-06-08), |
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C27H32N2O6 |
InChIKeyRXZMMZZRUPYENV-VROPFNGYSA-N |
CAS号242478-38-2 |
关联
147
项与 琥珀酸索利那新 相关的临床试验NCT06803030
A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
CTRI/2024/11/077322
Comparative study of solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy in neurogenic overactive bladder among supra-sacral spinal cord injury patients: An open label randomized clinical trial. - IRB
NCT06489951
Efficacy and Safety of Short-term High-dose Vitamin D Supplementation Combined With Standard Behavioral Therapy for the Treatment of Dry Overactive Bladder in Children: a Prospective, Randomized Controlled, Multicentre Clinical Study
100 项与 琥珀酸索利那新 相关的临床结果
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100 项与 琥珀酸索利那新 相关的转化医学
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100 项与 琥珀酸索利那新 相关的专利（医药）
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162
项与 琥珀酸索利那新 相关的文献（医药）2024-11-01BMJ medicine
Risk of dementia associated with anticholinergic drugs for overactive bladder in adults aged ≥55 years: nested case-control study
Article
作者: Ashcroft, Darren M ; Dening, Tom ; Orrell, Martin William ; Iyen, Barbara ; Coupland, Carol ; Bell, Brian Gregory ; Bishara, Delia ; Avery, Anthony J
Objective:
To investigate whether different anticholinergic drug treatments for overactive bladder have differential risks for incident dementia, in a large representative population of older adults in England.
Design:
Nested case-control study.
Setting:
General practices in England providing data to the Clinical Practice Research Datalink (CPRD) GOLD database, with linked patient admission records from secondary care (Hospital Episode Statistics), 1 January 2006 and 16 February 2022
Participants:
170 742 patients aged ≥55 years, with a first reported diagnosis of dementia during the study period, matched by age, sex, and general practice with 804 385 individuals without dementia (controls).
Interventions:
Cumulative drug use (defined using total standardised daily dose) of different anticholinergic drugs used for the treatment of an overactive bladder, and a non-anticholinergic drug, mirabegron, in the period 3-16 years before a diagnosis of dementia (or equivalent date in matched controls).
Main outcome measures:
Odds ratios for onset of dementia associated with the different anticholinergic drugs used for the treatment of an overactive bladder, adjusted for sociodemographic characteristics, clinical comorbidities, and use of other anticholinergic drug treatments.
Results:
The study population comprised 62.6% women, and median age was 83 (interquartile range 77-87) years. 15 418 (9.0%) patients with dementia and 63 369 (7.9%) controls without dementia had used anticholinergic drugs for the treatment of an overactive bladder in the 3-16 years before diagnosis (or equivalent date for controls). The adjusted odds ratio for dementia associated with the use of any anticholinergic drug used to treat an overactive bladder was 1.18 (95% confidence interval (CI) 1.16 to 1.20), and was higher in men (1.22, 1.18 to 1.26) than women (1.16, 1.13 to 1.19). The risk of dementia was substantially increased with the use of oxybutynin hydrochloride (adjusted odds ratio 1.31, 95% CI 1.21 to 1.42 and 1.28, 1.15 to 1.43 for use of 366-1095 and >1095 total standardised daily doses, respectively), solifenacin succinate (1.18, 1.09 to 1.27 and 1.29, 1.19 to 1.39), and tolterodine tartrate (1.27, 1.19 to 1.37 and 1.25, 1.17 to 1.34). No significant increases in the risk of dementia associated with darifenacin, fesoterodine fumarate, flavoxate hydrochloride, propiverine hydrochloride, and trospium chloride were found. The association between mirabegron, a non-anticholinergic drug, and dementia was variable across the dose categories and might be caused by previous use of anticholinergic drugs for the treatment of an overactive bladder in these individuals.
Conclusions:
Of the different anticholinergic drugs used to treat an overactive bladder, oxybutynin hydrochloride, solifenacin succinate, and tolterodine tartrate were found to be most strongly associated with the risk of dementia in older adults. This finding emphasises the need for clinicians to take into account the possible long term risks and consequences of the available treatment options for an overactive bladder in older adults, and to consider prescribing alternative treatments that might be associated with a lower risk of dementia.
2024-10-01SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Diaryl pyrrolone fluorescent probing strategy for Mirabegron determination through condensation with ninhydrin and phenylacetaldehyde: Application to dosage forms, human urine and plasma
Article
作者: Ahmed, Ahmed S ; Abdelshakour, Mohamed A ; Oraby, Mohamed ; Derayea, Sayed M ; Badr El-Din, Khalid M
Mirabegron (MRB) is a β3-adrenoceptor agonist used for managing overactive bladder syndrome. A cost-effective, environmentally friendly, and highly sensitive spectrofluorimetric method was suggested to serve the purpose of quantifying MRB in its pure state, pharmaceutical tablets, spiked human plasma and urine, and testing content uniformity. In the present study, ninhydrin and phenylacetaldehyde react with the amino group moiety of MRB in Teorell-Stenhagen buffer (pH 7.5) to generate a strongly fluorescent diaryl pyrrolone compound that emits fluorescence at a wavelength of 477 nm upon excitation at 385 nm. The obtained calibration curve showed a linear relationship with a high correlation coefficient (r = 0.9997) in the concentration range of 0.25 to 5.0 µg mL-1. Limits of detection (LOD) and quantitation (LOQ) were 0.082 and 0.248 µg mL-1 respectively. The procedure was verified in accordance with the ICH guidelines. The suggested approach could be utilized for the selective analysis of MRB in its pharmaceuticals, either containing a single drug or co-formulated with solifenacin succinate. The greenness of the suggested method was confirmed using different green analytical metrics.
2024-10-01Heliyon
Disproportionality analysis of drug-induced dry mouth using data from the United States food and drug administration adverse event reporting system database
Article
作者: Wu, Meng ; Zhu, Hong ; Xu, Dan
Background:
Drug-induced dry mouth is an adverse reaction that can significantly affect the quality of life and mental state of patients. In this study, we aimed to identify the most common drugs associated with dry mouth using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
We accessed data from the FAERS database between the first quarter of 2004 and the first quarter of 2024. The Medical Dictionary for Regulatory Activities was used to identify reports of dry mouth, and disproportionality analyses (reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker) were performed to examine the risk signals for dry mouth and its causative drugs.
Results:
A total of 75,899 adverse event reports were related to dry mouth. Tiotropium bromide monohydrate (2080 cases) was associated with the majority of dry mouth cases. Disproportionality analysis revealed that the top five drugs with the highest reporting odds ratio (ROR) were darifenacin, solifenacin succinate, fesoterodine fumarate, tolterodine tartrate, and niraparib. Moreover, eight of the top 19 drugs that caused dry mouth were not identified as having major side effects in the package inserts.
Conclusion:
Tiotropium bromide monohydrate was the most frequently reported drug for dry mouth, whereas darifenacin had the highest ROR. Collectively, our findings emphasize the necessity for improved recognition and management of drug-induced dry mouth, particularly for medications not adequately flagged for this side effect in their labels.
100 项与 琥珀酸索利那新 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 |
|---|---|---|---|
| 神经源性逼尿肌过度活动 | 美国 | 2020-05-26 | |
| 膀胱过度活动症 | 日本 | 2006-04-20 | |
| 尿频 | 美国 | 2004-11-19 | |
| 急迫性尿失禁 | 美国 | 2004-11-19 | |
| 膀胱过度活动症综合征 | 荷兰 | 2004-06-08 |
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 |
|---|---|---|---|---|
| 尿急 | 临床3期 | 比利时 | 2004-04-01 | |
| 尿急 | 临床3期 | 捷克 | 2004-04-01 | |
| 尿急 | 临床3期 | 埃及 | 2004-04-01 | |
| 尿急 | 临床3期 | 法国 | 2004-04-01 | |
| 尿急 | 临床3期 | 德国 | 2004-04-01 | |
| 尿急 | 临床3期 | 希腊 | 2004-04-01 | |
| 尿急 | 临床3期 | 匈牙利 | 2004-04-01 | |
| 尿急 | 临床3期 | 意大利 | 2004-04-01 | |
| 尿急 | 临床3期 | 波兰 | 2004-04-01 | |
| 尿急 | 临床3期 | 葡萄牙 | 2004-04-01 |
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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
临床3期 | 77 | Pelvic floor muscle exercise-based behavioral therapy (Behavioral Therapy) | 鑰積觸遞衊觸衊構鏇衊(憲淵糧願網獵願願餘繭) = 鏇顧鏇憲鏇鬱窪範醖齋 淵範鹹觸廠襯醖蓋築壓 (鬱範網網膚餘壓餘壓壓, 夢蓋襯鹽壓壓鹽鑰獵獵 ~ 構鑰簾構壓築淵鏇顧積) 更多 | - | 2024-09-24 | ||
(Drug Therapy) | 鑰積觸遞衊觸衊構鏇衊(憲淵糧願網獵願願餘繭) = 製鬱鬱衊糧醖憲鬱繭鏇 淵範鹹觸廠襯醖蓋築壓 (鬱範網網膚餘壓餘壓壓, 遞蓋願獵觸繭淵鹽製鑰 ~ 糧餘築鹽夢鑰願遞築憲) 更多 | ||||||
临床4期 | 20 | 憲獵艱餘壓願廠鹹網簾(醖製襯遞鏇糧齋範鏇積) = 廠鏇壓製醖餘淵繭築壓 構積鑰簾範積艱廠廠衊 (壓艱鏇鬱顧簾餘齋觸壓, 糧範鏇鑰衊繭積繭衊蓋 ~ 醖齋憲餘願觸餘鹽製製) 更多 | - | 2022-10-03 | |||
临床3期 | - | Solifenacin oral suspension | 餘鏇鏇獵鹹範鏇範蓋壓(簾憲繭鏇觸觸鏇膚鏇艱) = 夢鑰衊鹽糧簾製艱網艱 膚窪鬱鏇衊積鹽蓋遞觸 (醖壓鏇糧鹽鏇淵簾鏇夢 ) | - | 2020-04-01 | ||
临床3期 | 76 | 襯窪鏇鑰鬱範構積選選(選繭鹹淵築鬱鑰蓋餘遞) = 餘鏇蓋獵齋顧艱鹽壓觸 網獵願艱艱衊夢簾淵淵 (齋鏇鹹廠糧積顧艱壓鑰, 繭鏇願齋鏇範餘餘鹹構 ~ 顧構觸襯膚蓋構顧鏇鏇) 更多 | - | 2019-05-06 | |||
临床2期 | 28 | (Cohort 1) | 顧鏇廠鹹夢鑰鑰夢遞積(範鏇遞憲鑰淵鬱願築鹽) = 鏇鬱夢餘鏇鹹網壓積窪 鑰獵構艱構構窪網餘繭 (遞範膚願醖糧窪積鹽築, 窪齋願網築鹽顧觸淵襯 ~ 築膚艱選鏇繭衊觸齋範) 更多 | - | 2019-03-05 | ||
(Cohort 2) | 顧鏇廠鹹夢鑰鑰夢遞積(範鏇遞憲鑰淵鬱願築鹽) = 醖積廠願淵廠餘糧觸淵 鑰獵構艱構構窪網餘繭 (遞範膚願醖糧窪積鹽築, 鑰製淵窪顧獵膚廠鹽壓 ~ 齋壓選鏇觸鑰淵醖蓋簾) 更多 | ||||||
临床4期 | 649 | (Mirabegron + Solifenacin) | 糧鑰衊夢製簾膚願憲醖(憲糧繭淵憲憲齋遞鑰範) = 膚顧糧餘夢壓構築襯鹹 鬱鬱鹹網艱鏇蓋顧繭襯 (鏇觸醖憲襯餘蓋蓋膚鑰, 鹽廠範顧窪製膚簾膚壓 ~ 簾選積艱範壓糧壓襯衊) 更多 | - | 2018-12-24 | ||
(Mirabegron + Propiverine) | 糧鑰衊夢製簾膚願憲醖(憲糧繭淵憲憲齋遞鑰範) = 簾繭憲鏇網蓋蓋願醖糧 鬱鬱鹹網艱鏇蓋顧繭襯 (鏇觸醖憲襯餘蓋蓋膚鑰, 鏇獵鏇憲獵淵鬱範鏇夢 ~ 壓構鹹齋築膚鹹簾築窪) 更多 | ||||||
临床3期 | 23 | 鬱齋網構醖鹽憲艱獵糧(蓋鑰製襯襯選觸鹹鏇顧) = 繭醖壓鏇窪壓鹹積鹽獵 餘壓積夢獵鹽廠廠鹹獵 (簾簾糧衊簾獵積觸網襯, 遞壓蓋膚餘簾衊鏇淵範 ~ 襯膚餘夢夢淵窪觸簾顧) 更多 | - | 2018-06-21 | |||
临床3期 | 3,527 | placebo (Placebo) | 顧膚齋鹹選糧壓壓膚遞(網襯壓鹽淵遞範構獵構) = 鏇構選蓋襯壓夢艱鬱壓 獵顧觸膚鹹糧膚餘鹽製 (壓廠願膚夢顧範積餘鏇, 構憲衊築獵衊鏇範廠鬱 ~ 憲選蓋壓壓淵鹽鏇製艱) 更多 | - | 2018-06-12 | ||
(Mirabegron 25 mg) | 顧膚齋鹹選糧壓壓膚遞(網襯壓鹽淵遞範構獵構) = 艱觸鏇鹽衊簾蓋鬱窪艱 獵顧觸膚鹹糧膚餘鹽製 (壓廠願膚夢顧範積餘鏇, 範鏇餘鹹製廠餘獵蓋衊 ~ 艱餘膚願願製鏇觸網積) 更多 | ||||||
临床3期 | 1,829 | Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg) | 餘遞繭顧醖窪窪糧鏇觸(餘鬱觸蓋鹹醖築艱鏇製) = 鬱繭鹹構積網壓製壓網 鏇齋選廠鹽遞廠淵蓋餘 (膚願製鏇繭憲構壓鬱遞, 憲廠構範遞獵蓋願醖餘 ~ 鬱膚繭蓋觸製簾憲築鬱) 更多 | - | 2018-06-06 | ||
Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg) | 餘遞繭顧醖窪窪糧鏇觸(餘鬱觸蓋鹹醖築艱鏇製) = 觸簾鑰範鏇餘網餘願築 鏇齋選廠鹽遞廠淵蓋餘 (膚願製鏇繭憲構壓鬱遞, 淵艱選齋範鹽夢觸壓顧 ~ 網齋廠糧獵醖鬱繭鬱鏇) 更多 | ||||||
临床2/3期 | 94 | Placebo | 選艱蓋繭夢醖鹽積構衊(構範壓繭鏇鹹艱鑰憲糧): AMD = -1.179 (95% CI, -1.98 ~ -0.38) 更多 | 积极 | 2018-05-01 | ||
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