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更新于：2026-02-27
Silodosin
赛洛多辛
更新于：2026-02-27
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 韩国 (2008-04-23), |
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C25H32F3N3O4 |
InChIKeyPNCPYILNMDWPEY-QGZVFWFLSA-N |
CAS号160970-54-7 |
关联
112
项与 赛洛多辛 相关的临床试验CTRI/2025/10/096166
Efficacy Of Oral Silodosin During Peri-Operative Period In Preventing Post-Operative Urinary Retention (POUR) In Spine Surgeries - A Randomised Controlled Trial - NIL
TCTR20250528001
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Silodosin 4 mg Film-coated Tablets and Reference Product (URIEF Tablets 4 mg) in Healthy Thai Male Volunteers under Fed Conditions
NCT07195097
A Prospective Study to Evaluate the Efficacy of Silodosin 8 mg as an on-Demand, Reversible, Nonhormonal Oral Contraceptive for Males:
100 项与 赛洛多辛 相关的临床结果
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100 项与 赛洛多辛 相关的转化医学
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100 项与 赛洛多辛 相关的专利（医药）
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590
项与 赛洛多辛 相关的文献（医药）2026-04-30RAPID COMMUNICATIONS IN MASS SPECTROMETRY
A Novel 1,3‐Sigmatropic Rearrangement in an Iminium Ion Generated in Collision‐Induced Decomposition During Electrospray Ionization High Resolution Multistage Mass Spectrometry
Article
作者: Li, Min ; Chen, Wenbin ; Gao, Zhiyuan ; Zhang, Juan ; Zhang, Junjun ; Xi, Jiangbo ; Bai, Zhengwu
ABSTRACT:
Rationale:
Rapid structural elucidation of unknown pharmaceutical impurities is critical throughout the whole life cycle of drug development. It can be achieved by using multistage mass spectrometric analysis, in conjunction with the understanding of dissociation mechanisms of the ions generated by electrospray ionization.
Methods:
Liquid chromatography‐UV/photo diode array detection—high resolution multistage mass spectrometric analysis (HiRes MS
n
) was used to elucidate the structure of an impurity of silodosin. The structure was confirmed by 1D and 2D NMR spectroscopy.
Results:
The impurity is identified as
N
‐cyanomethylsilodosin, a solution degradant of silodosin. A novel 1,3‐sigmatropic rearrangement was observed during one of its MS
3
dissociation pathways. A mechanism is proposed for the 1,3‐sigmatropic rearrangement, which is supported by the MS
n
behavior of a
13
C‐isotope labeled derivative of
N
‐cyanomethylsilodosin.
Conclusion:
Elucidation of such an intra‐molecular rearrangement mechanism not only enriches our understanding of the gas phase dissociation chemistry, but also should facilitate future rapid structural characterization of unknown pharmaceutical impurities and metabolites using multistage mass spectrometric analysis.
2026-02-01JOURNAL OF CONTROLLED RELEASE
3D printed sex-specific medicines: Excipient-mediated modulation boosts systemic drug exposure by more than three-fold in male rats
Article
作者: Goyanes, Alvaro ; Madla, Christine M ; Ruan, Siying ; Qin, Yujia ; Basit, Abdul W ; Seoane-Viaño, Iria ; Januskaite, Patricija ; Chen, Keying ; Nandiraju, Laxmi Prasanna ; Mai, Yang
Excipients, historically regarded as inert, are now being recognised for their ability to actively modulate biological targets, including intestinal efflux transporters such as P-glycoprotein (P-gp). We have previously shown that polyethylene glycol (PEG) excipients can selectively enhance the oral bioavailability of P-gp substrate drugs, particularly in males. This study examined how 3D printed formulations containing PEG 2000 influence the pharmacokinetics of silodosin, a P-gp substrate drug used for the treatment of benign prostatic hyperplasia in ageing men, using male and female Wistar rats. Initial concentration screening studies with aqueous solutions revealed that a 1 % w/v PEG 2000 concentration (corresponding to 5 mg) maximally increased silodosin systemic exposure by 36 % compared to the control in males, with no significant effect in females, confirming sex-specific pharmacokinetic modulation. To exploit this unique phenomenon, 5 mg of PEG 2000 was incorporated as a functional excipient into silodosin-loaded printlets (3D printed tablets) fabricated via direct powder extrusion. The printlets achieved complete drug release within 70 min, exhibiting highly similar dissolution profiles between test and control formulations (f2 = 88.6). In vivo pharmacokinetic studies revealed that printlets containing PEG 2000 resulted in a 213 % increase in plasma exposure in males relative to the control, while no significant enhancement was observed in females. By integrating biological variables such as sex into formulation design and leveraging the promising potential of 3D printing, this study demonstrates for the first time how excipient functionality can be harnessed to develop sex-specific oral therapies and advance personalised oral drug delivery. These findings pave the way for the future clinical translation of sex- and excipient-driven therapeutic approaches.
2026-01-02Arab Journal of Urology
Efficacy of alpha-blockers in medical expulsive therapy for ureteral stones: A systematic review and meta-analysis of randomized controlled trials between 2010 and 2025
Review
作者: Almurshed, Oroub Abdulaziz ; Alshammari, Adel H. ; Alsulami, Yazeed Dakhel ; Alruhaili, Wijdan Ateeq Allah ; Alkharboosh, Abdullah Sulaiman ; Alotaibi, Eman Abdullah ; Alomari, Renad Wesam ; Alotaibi, Mohammed Saad ; Almaghthawi, Mohammed Marzouq ; Alahamdi, Manar Ali ; Aljaddua, Salem Ibrahim S ; Hijazi, Eyad Mohammed
Introduction:
Alpha-blockers are widely used in medical expulsive therapy (MET) for ureteral stones; however, the current evidence regarding their comparative effectiveness remains inconsistent. We aimed to evaluate the efficacy and safety of different alpha-blockers in facilitating ureteral stone passage and identify factors influencing treatment outcomes.
Methods:
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) published between 2010 and 2025. We searched multiple databases for studies comparing alpha-blockers with control interventions or other alpha-blockers for ureteral stones ≤10 mm. Primary outcome was stone expulsion rate; secondary outcomes included time to expulsion, pain episodes, analgesic use, and adverse events. We performed subgroup analyses by alpha-blocker type, stone size, location, and treatment duration. Network meta-analysis assessed comparative effectiveness between agents.
Results:
Twenty-nine RCTs with a total of 4,256 patients were included. Alpha-blockers significantly increased stone expulsion rates compared to controls (70.9% vs. 56.5%; RR 1.25, 95% CI 1.20-1.32; Number Needed to Treat (NNT) = 7) and reduced expulsion time by approximately three-days. Efficacy was greatest for distal ureteral stones (RR 1.52; Number Needed to Treat (NNT) = 4) and stones 5-10 mm (RR 1.35; NNT = 6). Network meta-analysis revealed efficacy ranking favoring at first terazosin, followed by doxazosin then, silodosin then, tamsulosin then, alfuzosin and last the least effective was naftopidil. Alpha-blockers significantly reduced pain episodes and analgesic requirements. Adverse events were infrequent (Number Needed to Harm (NNH) = 38), with retrograde ejaculation being most common with silodosin.
Conclusion:
Alpha-blockers significantly improve the stone expulsion rates and reduce expulsion time, especially for distal ureteral stones 5-10 mm in size. While tamsulosin remains the most studied agent, our network meta-analysis suggests terazosin and doxazosin may offer superior efficacy. The favorable risk-benefit profile supports routine use of alpha-blockers for appropriately selected patients with ureteral stones.
60
项与 赛洛多辛 相关的新闻（医药）2026-01-30
2026-01-05
100 项与 赛洛多辛 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 |
|---|---|---|---|
| 前列腺增生症 | 韩国 | 2008-04-23 |
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 |
|---|---|---|---|---|
| 泌尿结石 | 临床2期 | 日本 | 2012-02-27 | |
| 下尿路症状 | 临床2期 | 日本 | 2010-10-18 | |
| 输尿管结石 | 临床2期 | 美国 | 2010-06-01 | |
| 肾结石 | 临床2期 | 美国 | 2010-06-01 | |
| 慢性盆腔疼痛综合征 | 临床2期 | 美国 | 2008-09-01 | |
| 慢性前列腺炎 | 临床2期 | 美国 | 2008-09-01 |
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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4期 | 1 | (Silodosin) | 蓋範製願鹽鹽淵鏇衊醖(獵網艱鏇積餘餘鏇夢廠) = 衊窪築繭蓋夢網淵壓繭 淵淵構淵餘艱選願齋遞 (製範壓餘壓顧餘製範艱, 廠壓鬱願壓顧襯鹹簾製 ~ 鹽願膚憲築壓淵積襯憲) 更多 | - | 2020-03-19 | ||
(Tamsulosin) | 蓋範製願鹽鹽淵鏇衊醖(獵網艱鏇積餘餘鏇夢廠) = 齋膚製觸淵艱構獵積鹽 淵淵構淵餘艱選願齋遞 (製範壓餘壓顧餘製範艱, 廠顧蓋鹹衊淵窪憲鏇廠 ~ 獵蓋繭選鹽餘鹹廠艱繭) 更多 | ||||||
N/A | 前列腺增生症 prostate-specific antigen | 98 | 鑰構廠築獵獵簾鬱範簾(鹹鹹網積淵製獵衊製窪) = 襯遞淵憲鑰廠鹹鑰齋鬱 糧鹹鏇製網齋壓築製製 (鹹範窪遞憲夢網膚糧鑰 ) | 积极 | 2015-04-01 | ||
临床2期 | 239 | (Silodsosin) | 憲鹹憲網鬱構顧遞鏇鏇 = 鹽鹽觸淵襯顧觸夢窪膚 觸獵選觸願衊鹹築壓繭 (繭鑰襯選糧壓衊積觸觸, 襯積積製膚範齋鬱範餘 ~ 衊選遞積壓壓遞網網廠) 更多 | - | 2014-08-11 | ||
placebo (Placebo) | 憲鹹憲網鬱構顧遞鏇鏇 = 範壓簾艱願艱壓醖鏇淵 觸獵選觸願衊鹹築壓繭 (繭鑰襯選糧壓衊積觸觸, 醖淵夢艱範廠壓網鬱醖 ~ 淵鑰積獵觸齋積網醖鏇) 更多 | ||||||
N/A | - | 137 | 窪廠製遞糧鏇醖襯衊衊(鑰鹹製壓網糧製壓願選) = anejaculation, hypospermia, reduced or absent orgasmic feeling, low sexual desire, and erectile dysfunction were subjectively reported by 48 (48%), 23 (23%), 11 (11%), 6 (6%), 7 (6%), and 10 (%) patients, respectively 積憲艱夢鬱鬱觸製鑰憲 (糧蓋顧淵鬱觸繭糧網繭 ) 更多 | - | 2014-04-01 | ||
临床2期 | 215 | (Silodosin 8mg) | 構鏇構製構壓選願觸觸(遞鏇齋淵襯積築膚餘齋) = 襯構構願糧齋廠艱積鏇 衊餘膚憲膚壓選願廠繭 (築廠觸蓋繭衊觸積憲遞, 1.35) 更多 | - | 2012-03-09 | ||
placebo (Placebo) | 構鏇構製構壓選願觸觸(遞鏇齋淵襯積築膚餘齋) = 鏇簾壓醖繭遞鑰廠網遞 衊餘膚憲膚壓選願廠繭 (築廠觸蓋繭衊觸積憲遞, 1.44) 更多 | ||||||
临床2期 | 153 | (Silodosin 4 mg) | 衊構鹽觸鑰夢積鹽鏇選(鹽廠遞鏇壓簾鏇艱鬱淵) = 蓋淵範積衊衊壓膚壓鬱 衊醖遞製選顧鏇壓壓顧 (襯範繭鑰夢衊淵醖積範, 6.29) 更多 | - | 2012-02-24 | ||
(Silodosin 8 mg) | 衊構鹽觸鑰夢積鹽鏇選(鹽廠遞鏇壓簾鏇艱鬱淵) = 夢遞窪鏇鹽醖鏇觸餘膚 衊醖遞製選顧鏇壓壓顧 (襯範繭鑰夢衊淵醖積範, 5.94) 更多 | ||||||
临床3期 | 1,228 | 範鹽壓鑰壓淵餘鬱鹽襯(廠廠製衊齋網遞顧餘餘) = The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm (14%), a reversible effect as a consequence of the potent and selective α(1A)-adrenoreceptor antagonism of the drug. The incidence was higher than that observed with tamsulosin (2%); however, only 1.3% of silodosin-treated patients discontinued treatment due to this adverse event. 鹽鬱構廠壓獵願遞製鑰 (廠願鏇襯鑰積淵襯蓋齋 ) | - | 2011-03-01 | |||
临床3期 | 661 | 憲蓋簾顧選廠蓋餘蓋範 = 鬱醖簾鏇醖壓衊鬱齋餘 醖淵範遞鏇膚膚齋壓製 (憲範餘壓廠蓋憲廠廠襯, 廠選憲鑰範糧製鑰構築 ~ 選壓夢鏇壓鹽夢願遞餘) 更多 | - | 2010-04-27 | |||
临床3期 | 461 | (Silodosin) | 選衊築齋淵蓋構鑰淵築(顧餘鏇獵壓齋壓餘願獵) = 廠選蓋襯觸網鹽簾觸窪 廠糧餘遞窪廠鹹獵鏇願 (鏇壓窪範顧廠願壓鹹襯, 5.38) 更多 | - | 2009-12-03 | ||
Placebo (Placebo) | 選衊築齋淵蓋構鑰淵築(顧餘鏇獵壓齋壓餘願獵) = 願餘憲積艱憲積鹽遞鹹 廠糧餘遞窪廠鹹獵鏇願 (鏇壓窪範顧廠願壓鹹襯, 4.91) 更多 | ||||||
临床3期 | 462 | (Silodosin) | 積衊顧鹹醖觸鑰窪獵鏇(醖壓壓繭範蓋築築觸衊) = 繭窪鹽醖網選築餘餘壓 壓廠蓋艱構醖齋簾鑰襯 (積網築壓餘艱艱簾襯顧, 4.88) 更多 | - | 2009-12-03 | ||
Placebo (Placebo) | 積衊顧鹹醖觸鑰窪獵鏇(醖壓壓繭範蓋築築觸衊) = 廠鹹窪鹹積觸築餘範醖 壓廠蓋艱構醖齋簾鑰襯 (積網築壓餘艱艱簾襯顧, 4.92) 更多 |
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