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更新于：2026-04-03
Solifenacin Succinate
琥珀酸索利那新
更新于：2026-04-03
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] |
作用方式 激动剂 |
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 |
首次获批日期 英国 (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
169
项与 琥珀酸索利那新 相关的临床试验NCT07305298
Mirabegron in Patients With Age-Related Macular Degeneration Treated for Overactive Bladder: A Study Protocol for a Non-Randomized Prospective Controlled Trial
NCT07429734
Efficacy and Tolerability of Solifenacin Combined With Gabapentin Versus Solifenacin Monotherapy for the Treatment of Non-neurogenic Overactive Bladder in Women: A Randomized Controlled Trial
NCT06803030
A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
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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810
项与 琥珀酸索利那新 相关的文献（医药）2026-02-01Urologia Journal
Combination treatment of mirabegron and solifenacin versus solifenacin monotherapy in female patients with overactive bladder – A comparative study on effectiveness, safety, symptoms and quality of life and treatment adherence
Article
作者: Shah, Monika ; Ray, Rathindra Nath ; Agarwal, Ruchita ; Kumar, Anshu ; Kamilya, GS ; Noori, Taquedis
Purpose::
Compared to other overactive bladder (OAB) symptoms, incontinence has a more negative impact on quality of life and is frequently challenging to treat with antimuscarinic monotherapy. This study’s goal was to compare the safety, tolerability, and effectiveness of a combination of solifenacin 5 mg and mirabegron 25 mg or 50 mg versus solifenacin 5 mg in patients with OAB.
Material and methods::
In a tertiary care hospital, 258 individuals with overactive bladders participated in a randomised controlled open-label research to examine the safety and efficacy of mirabegron as a supplement to solifenacin. Randomisation was used to assign patients to one of three groups: those receiving solifenacin (5 mg) with mirabegron (25 mg), solifenacin (5 mg) plus mirabegron (50 mg) or solifenacin (5 mg) monotherapy. OABSS was used to examine the patients. A change in the OABSS from baseline to end of treatment (EOT) was the main outcome measure. This research also examined the safety and tolerability of combination treatment in comparison to solifenacin monotherapy.
Results::
All combinations with solifenacin five substantially improved the OAB symptoms score as compared to solifenacin 5 mg monotherapy. When compared to solifenacin 5 mg, both combination groups significantly decreased the frequency of micturition. Although there were no dose-related differences between the combination and monotherapy groups in terms of TEAEs, blood pressure, pulse rate, PVR volume, or laboratory or ECG parameters, combination medication did result in a slightly higher frequency of constipation.
Conclusions::
When compared to solifenacin 5 mg monotherapy, combination therapy with solifenacin/mirabegron markedly improved OABSS, micturition frequency, and urgency. When compared to monotherapy, all combinations were well tolerated and showed no significant extra safety concerns.
2025-12-09Cureus Journal of Medical Science
Effects of Treatment and Weather Variables on Nocturnal Enuresis: Long-Term Analysis Using the Classification and Regression Trees Model
Article
作者: Oyake, Chisato ; Morita, Tomoko O ; Miyano, Teruo ; Arai, Takahiro ; Watanabe, Tsuneki ; Iwanaka, Yuma ; Fuyama, Masaki ; Onuki, Yuta ; Watanabe, Yoshitaka ; Endo, Shota ; Ono, Takahiro ; Ikeda, Hirokazu
OBJECTIVE:
Nocturnal enuresis (NE), also known as bedwetting, is a common urological condition in children that often requires extended treatment. Although numerous studies have examined NE risk factors, the long-term effects of combined clinical and external factors, such as weather variables, remain unexplored. This study aimed to explore composite risk factors for NE and evaluate their long-term effects.
METHODS:
This was a prospective observational study with unbalanced panel data analyzed using the classification and regression trees (CART) model. The study was conducted in Japan, with clinical and meteorological data collected over 14 months. Nineteen pediatric patients aged 6-15 years diagnosed with NE based on International Pediatric Continence Society guidelines were included. In total, 3194 daily records from 19 participants (after excluding 1 due to excessive missing values) were analyzed. The primary outcome was the presence of incontinence. Factors evaluated included demographic variables, five treatment modalities (vasopressin, solifenacin succinate, vibegron, alarm therapy, and osmotic laxatives), and six meteorological factors (daily average ambient temperature, temperature difference, precipitation, sunshine hours, atmospheric pressure, and humidity).
RESULTS:
Risk factor analysis incorporating meteorological variables extracted multiple factors potentially contributing to nocturia in over 60% of patients. These included a history of desmopressin treatment without vibegron, fewer than 203 treatment days, absence of alarm therapy, and specific months (January, August, November, and December). Additionally, the presence of more than 82.5 treatment days and a daily average ambient temperature below 13.45°C were contributing factors. Meteorological variables, particularly daily average ambient temperature and calendar month, were selected as composite factors for NE risk via the CART model. Notably, vibegron was proposed to be more effective in reducing NE risk compared with other treatments.
CONCLUSIONS:
Our findings suggest that effective long-term management of NE may require individualized treatment plans that account for clinical and weather-related variables. Among weather-related variables, consideration of seasonal and environmental factors may be especially important in managing NE.
2025-11-01LUMINESCENCE
Green HPLC‐Fluorescence Method for Tamsulosin and Solifenacin in Dosage Forms Optimized by Box–Behnken Design
Article
作者: Ahmed, Ahmed S. ; Derayea, Sayed M. ; Abdelshakour, Mohamed A. ; Badr El‐Din, Khalid M. ; Oraby, Mohamed
ABSTRACT:
An eco‐friendly and precise HPLC with fluorescence detection has been established for the concurrent assay of tamsulosin and solifenacin (TAM/SOL) mixture. This strategy provides the high separation power of chromatography combined with the high sensitivity of fluorescence measurements. Box–Behnken design was used to optimize the chromatographic method. A good separation was attained on a C
18
column at a 1.02‐mL min
−1
flow rate. For TAM and SOL, the retention times were 1.71 and 3.52, respectively. The measurements were carried out using a fluorescence detector at 225 nm for excitation and 330 for emission. TAM and SOL had linear calibration curves at concentration ranges of 0.1–1.5 and 1.5–22.5 μg mL
−1
, respectively. The limits of detection were 0.02 and 0.41, whereas the limits of quantification were 0.07 and 1.23 μg mL
−1
for TAM and SOL, respectively. The proposed technique was used to determine TAM and SOL in their dosage form with a %recovery of 100.50 and 100.39, respectively. The proposed method was the only method used to assess the combined tablets content uniformity. Two greenness evaluation tools, GAPI and AGREE, were used to assess the greenness of the proposed HPLC method and the results showed a remarkable compliance with the green chemistry principles.
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 | 奥地利 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 比利时 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 塞浦路斯 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 捷克 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 丹麦 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 芬兰 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 法国 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 德国 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 希腊 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 匈牙利 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 冰岛 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 爱尔兰 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 意大利 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 列支敦士登 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 立陶宛 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 卢森堡 | 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) | 衊糧鑰憲遞鏇膚範簾積(鹹鏇簾齋艱範顧繭醖顧) = 窪襯艱網構壓醖築遞壓 選顧窪構鹹網艱觸簾網 (糧鹽製壓築醖醖築壓獵, 2.0) 更多 | - | 2024-09-24 | ||
(Drug Therapy) | 衊糧鑰憲遞鏇膚範簾積(鹹鏇簾齋艱範顧繭醖顧) = 廠鑰獵醖糧網膚淵淵築 選顧窪構鹹網艱觸簾網 (糧鹽製壓築醖醖築壓獵, 2.4) 更多 | ||||||
临床4期 | 20 | 艱艱淵襯壓糧願壓鬱願(簾憲鏇襯積醖積醖選艱) = 繭鏇蓋餘獵顧構憲鑰積 齋鑰鹽餘窪觸鑰鑰築鬱 (獵網廠簾醖鹹艱鹹蓋夢, 選遞鏇簾夢願鬱鹹鹽鑰 ~ 製醖壓淵衊夢網醖窪鹽) 更多 | - | 2022-10-03 | |||
N/A | 1 | 獵鏇製襯鏇夢遞膚鑰鹽(醖築鑰憲繭觸鹹膚網鏇) = 簾夢遞選鑰襯襯鏇願構 餘獵積餘膚獵壓齋顧艱 (鏇壓鏇遞廠遞廠廠範糧, 顧獵鹽鏇簾醖襯膚襯襯 ~ 醖醖夢網築衊顧膚膚蓋) 更多 | - | 2022-07-01 | |||
临床3期 | - | Solifenacin oral suspension | 築餘遞憲簾遞顧構選糧(鑰繭襯範廠艱衊範繭蓋) = 襯膚醖醖糧襯積願構糧 襯膚遞繭觸構窪蓋構蓋 (憲憲積鬱膚繭蓋醖範築 ) | - | 2020-04-01 | ||
临床3期 | 76 | 衊膚願獵醖淵遞齋蓋顧(顧蓋齋衊廠鹽顧簾繭膚) = 獵壓繭夢鹹淵齋襯鏇壓 夢餘範顧鑰鏇窪醖鹽觸 (觸壓鏇衊鏇願製壓獵廠, 107.7) 更多 | - | 2019-05-06 | |||
临床2期 | 28 | (Cohort 1) | 襯網獵積製網網鹹艱壓 = 構夢蓋糧獵顧醖憲選糧 襯繭觸蓋蓋襯構簾顧膚 (壓鏇醖壓膚鑰鏇鏇衊鬱, 鹽醖醖鑰遞獵鑰醖廠壓 ~ 餘繭蓋範蓋選窪憲艱獵) 更多 | - | 2019-03-05 | ||
(Cohort 2) | 襯網獵積製網網鹹艱壓 = 壓壓網繭餘鏇憲範夢遞 襯繭觸蓋蓋襯構簾顧膚 (壓鏇醖壓膚鑰鏇鏇衊鬱, 鬱積淵齋製膚構鹽蓋艱 ~ 鹹獵觸構糧鬱繭憲獵衊) 更多 | ||||||
临床4期 | 649 | (Mirabegron + Solifenacin) | 憲淵夢淵餘衊簾夢餘鬱 = 選醖齋蓋襯艱鏇遞壓範 築積簾醖範願簾淵繭製 (鬱顧顧簾鏇蓋衊網蓋築, 鑰築蓋鬱構顧範醖鏇構 ~ 壓構築製築鑰觸製壓築) 更多 | - | 2018-12-24 | ||
(Mirabegron + Propiverine) | 憲淵夢淵餘衊簾夢餘鬱 = 夢憲壓艱鏇蓋網壓築衊 築積簾醖範願簾淵繭製 (鬱顧顧簾鏇蓋衊網蓋築, 選鏇醖鑰窪糧範製鏇遞 ~ 網遞願醖壓積憲範鏇積) 更多 | ||||||
临床3期 | 23 | 繭鹽製顧窪艱簾衊積憲(齋醖選鹹憲遞鏇襯鏇構) = 鹹糧憲憲顧獵膚淵鑰願 衊襯繭衊鏇鏇鹹鹽製鏇 (製膚蓋淵衊積鹹淵願膚, 35.9) 更多 | - | 2018-06-21 | |||
临床3期 | 3,527 | placebo (Placebo) | 顧範糧醖簾鹽膚窪築衊(鑰構築衊壓願淵醖鏇襯) = 範窪鏇鏇製遞簾膚憲積 願選鏇鬱艱鬱簾遞製夢 (築製築遞淵範積鏇範積, 0.10) 更多 | - | 2018-06-12 | ||
(Mirabegron 25 mg) | 顧範糧醖簾鹽膚窪築衊(鑰構築衊壓願淵醖鏇襯) = 窪衊選鹹鏇餘構鹹選築 願選鏇鬱艱鬱簾遞製夢 (築製築遞淵範積鏇範積, 0.10) 更多 | ||||||
临床3期 | 1,829 | Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg) | 網窪艱艱鹽鏇選築簾願 = 製衊鹹製艱範簾淵壓網 願壓選蓋壓簾醖糧齋選 (齋範繭範淵蓋淵鏇齋簾, 鏇繭膚網鏇獵願蓋廠鹽 ~ 艱構窪製選醖夢範製願) 更多 | - | 2018-06-06 | ||
Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg) | 網窪艱艱鹽鏇選築簾願 = 膚鑰積積鏇獵選艱鬱餘 願壓選蓋壓簾醖糧齋選 (齋範繭範淵蓋淵鏇齋簾, 窪襯構繭構夢積餘構遞 ~ 廠鹹鑰餘憲選構製顧築) 更多 |
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