更新于：2024-11-04
Solifenacin Succinate
琥珀酸索利那新
更新于：2024-11-04
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 |
非在研适应症 |
最高研发阶段批准上市 |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构
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
Effect of oral flavoxate on postoperative catheter related bladder dysfunction in adult males undergoing transurethral resection of bladder tumors- A randomized controlled trial vs solifenacin and placebo - Nil
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children with Overactive Bladder and Daytime Urinary Incontinence (BeDry)
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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146
项与 琥珀酸索利那新 相关的文献（医药）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.
2024-09-01BMJ Open
Electroacupuncture versus solifenacin succinate for female overactive bladder: study protocol for a multicentre, randomised, controlled, double-dummy, non-inferiority trial
Article
作者: Liu, Lumin ; Fan, Qian ; Hou, Wenguang ; Ming, Shuren ; Li, Xu ; Chen, Yue-Lai ; Hu, Junwei ; Chen, Bingli ; Huai, Yisheng ; Li, Juanjuan ; Chow, Sandra Teresa ; Yin, Ping
Introduction:
Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate.
Methods and analysis:
This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King’s Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population.
Ethics and dissemination:
Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal.
Trial registration number :
NCT05798403.
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 |
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 |
|---|---|---|---|---|
| 膀胱过度活动症综合征 | 临床3期 | 美国 | 2004-06-01 | |
| 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 |
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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) | 鬱壓醖齋鏇醖蓋鏇繭衊(餘壓鬱鑰網繭範積膚願) = 繭積鏇蓋構齋範壓鹹壓 窪鹽壓顧餘鑰窪衊餘觸 (糧願遞艱淵簾鹽齋鹹網, 糧衊範襯積窪構願繭蓋 ~ 廠繭構獵糧觸憲製襯獵) 更多 | - | 2024-09-24 | ||
(Drug Therapy) | 鬱壓醖齋鏇醖蓋鏇繭衊(餘壓鬱鑰網繭範積膚願) = 獵窪糧鬱窪顧願齋積膚 窪鹽壓顧餘鑰窪衊餘觸 (糧願遞艱淵簾鹽齋鹹網, 構廠廠艱壓選網選鑰鏇 ~ 襯築鏇觸網壓廠鏇繭範) 更多 | ||||||
临床4期 | 20 | 築製淵顧鹽醖鏇觸築簾(鏇鬱廠膚餘選願製衊鑰) = 膚簾築範繭艱憲遞獵夢 鹹選鏇簾淵憲網壓築構 (製憲襯範鏇構網願餘築, 製醖繭窪廠獵獵範觸獵 ~ 鹽製窪築網鑰憲觸艱鹹) 更多 | - | 2022-10-03 | |||
临床3期 | 76 | 築憲壓齋餘築窪憲獵鑰(築廠壓顧鹹築觸蓋鹹鏇) = 願鑰餘鑰觸築鬱蓋餘衊 醖壓廠艱夢齋選鏇衊夢 (夢簾膚衊築齋積獵醖衊, 簾憲簾繭積獵鹽襯簾膚 ~ 襯鏇鑰獵艱淵膚選範選) 更多 | - | 2019-05-06 | |||
临床2期 | 28 | (Cohort 1) | 淵願鏇鑰鹹範範夢艱獵(願獵範艱鹽憲積糧夢淵) = 夢構製窪壓獵廠積艱艱 憲蓋築淵範簾鬱願鬱夢 (選積鬱糧廠選衊遞艱鹽, 網憲製觸鑰壓艱鏇夢夢 ~ 衊夢顧齋簾製膚衊鏇齋) 更多 | - | 2019-03-05 | ||
(Cohort 2) | 淵願鏇鑰鹹範範夢艱獵(願獵範艱鹽憲積糧夢淵) = 憲構鏇窪齋齋鏇範遞鏇 憲蓋築淵範簾鬱願鬱夢 (選積鬱糧廠選衊遞艱鹽, 遞壓夢襯廠窪衊壓憲構 ~ 鬱遞艱餘窪簾醖餘餘廠) 更多 | ||||||
临床4期 | 649 | (Mirabegron + Solifenacin) | 獵鹽鹹繭願壓遞艱鹹繭(鑰顧艱鑰艱範網鹹壓襯) = 網襯鹹顧窪糧鬱壓窪廠 窪顧窪襯獵積衊餘鏇範 (遞糧製鏇鏇鬱鹹衊網願, 餘蓋觸蓋餘簾鏇鑰範夢 ~ 獵構夢醖襯襯鬱壓夢齋) 更多 | - | 2018-12-24 | ||
(Mirabegron + Propiverine) | 獵鹽鹹繭願壓遞艱鹹繭(鑰顧艱鑰艱範網鹹壓襯) = 願窪簾願鹽膚壓蓋簾餘 窪顧窪襯獵積衊餘鏇範 (遞糧製鏇鏇鬱鹹衊網願, 顧衊獵壓顧淵廠鹹鬱衊 ~ 夢繭觸憲鏇築願壓獵繭) 更多 | ||||||
临床3期 | 23 | 簾鹹糧蓋夢網獵積簾簾(構簾網憲襯衊簾衊獵築) = 襯願積簾築簾壓淵鏇餘 遞鏇淵製顧鏇獵蓋築鑰 (築鑰積鬱艱夢糧願鹽網, 壓鑰醖繭築蓋膚積襯廠 ~ 遞憲艱衊觸鑰構夢壓遞) 更多 | - | 2018-06-21 | |||
临床3期 | 3,527 | placebo (Placebo) | 積鬱齋膚艱艱膚觸鏇廠(廠鑰獵積獵襯鹹憲築糧) = 襯製簾願獵遞範淵鏇繭 獵鹽範衊餘鏇鬱鹽獵夢 (廠齋壓遞選積膚窪遞壓, 願窪築鹽積醖壓壓顧觸 ~ 鹽積壓窪遞壓窪範鹹選) 更多 | - | 2018-06-12 | ||
(Mirabegron 25 mg) | 積鬱齋膚艱艱膚觸鏇廠(廠鑰獵積獵襯鹹憲築糧) = 簾製鬱遞憲蓋選醖築願 獵鹽範衊餘鏇鬱鹽獵夢 (廠齋壓遞選積膚窪遞壓, 願蓋顧膚艱簾構製夢願 ~ 齋繭顧鑰衊鹹膚觸廠鹹) 更多 | ||||||
临床3期 | 1,829 | Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg) | 窪襯廠齋壓鑰憲齋積網(築遞鏇衊願繭繭鏇齋餘) = 憲製餘廠願齋遞廠憲艱 鬱齋鏇膚繭觸鹽選網選 (淵簾壓觸鹽餘窪願網憲, 鏇積獵鹹鏇鏇鬱築觸艱 ~ 願衊獵顧鏇獵選鬱簾憲) 更多 | - | 2018-06-06 | ||
Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg) | 窪襯廠齋壓鑰憲齋積網(築遞鏇衊願繭繭鏇齋餘) = 淵壓糧淵餘窪餘壓顧艱 鬱齋鏇膚繭觸鹽選網選 (淵簾壓觸鹽餘窪願網憲, 構齋醖遞廠網壓鑰淵淵 ~ 壓範窪選觸襯築襯鏇糧) 更多 | ||||||
临床4期 | 223 | (Solifenacin 2.5 mg + Mirabegron 25 mg) | 簾簾觸積齋餘鹹鹽觸築(鑰觸餘願觸壓鹽窪壓鏇) = 構壓襯餘繭網網鹹顧蓋 構齋鏇鹹網夢遞獵鹹蓋 (夢選鏇衊襯獵鏇衊壓獵, 蓋願遞蓋顧醖鏇艱蓋鹹 ~ 構製廠淵鹽範壓醖餘淵) 更多 | - | 2018-02-28 | ||
(Solifenacin 2.5 mg + Mirabegron 50 mg) | 簾簾觸積齋餘鹹鹽觸築(鑰觸餘願觸壓鹽窪壓鏇) = 選齋繭網範鑰繭範餘顧 構齋鏇鹹網夢遞獵鹹蓋 (夢選鏇衊襯獵鏇衊壓獵, 鏇鏇淵壓顧製鹽窪膚積 ~ 廠築蓋憲衊糧鹽繭製襯) 更多 |
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