预约演示
更新于：2025-08-17
Dapoxetine Hydrochloride
盐酸达泊西汀
更新于：2025-08-17
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 英国 (2008-12-17), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C21H24ClNO |
InChIKeyIHWDIQRWYNMKFM-BDQAORGHSA-N |
CAS号129938-20-1 |
关联
122
项与 盐酸达泊西汀 相关的临床试验CTR20251768
国药控股星鲨制药（厦门）有限公司研制的盐酸达泊西汀片与参比制剂在中国健康受试者中进行的单中心、随机、开放、两制剂、空腹和餐后、单次给药、两周期、双交叉设计的生物等效性研究
CTR20251864
盐酸达泊西汀片（60 mg）在健康研究参与者空腹及餐后状态下随机、开放、两周期、两序列、交叉设计的生物等效性试验
CTR20251666
盐酸达泊西汀片在健康受试者中单中心、随机、开放、单剂量、两周期、双交叉、餐后状态下的生物等效性试验
100 项与 盐酸达泊西汀 相关的临床结果
登录后查看更多信息
100 项与 盐酸达泊西汀 相关的转化医学
登录后查看更多信息
100 项与 盐酸达泊西汀 相关的专利（医药）
登录后查看更多信息
394
项与 盐酸达泊西汀 相关的文献（医药）2025-08-01Drug Delivery and Translational Research
Development and in vitro/in vivo evaluation of taste-masked orodispersible films of dapoxetine hydrochloride using ion exchange resins
Article
作者: Yan, Peng ; Zhang, Hailong ; Ding, Jinsong ; Zhou, Ying ; Zhao, Xiangcheng ; Yang, Yan
Dapoxetine hydrochloride tablets are the most commonly used drug for the treatment of premature ejaculation (PE). However, the tablets must be taken with water 1-3 h before sexual activity, which makes the medication intake conspicuous and inconvenient. This study aimed to develop taste-masked orodispersible films (ODFs) of dapoxetine hydrochloride using ion exchange resins. It was found that the based-Kyron T-134 resin complex achieved a high drug loading of 75.9 ± 1.4%, establishing the mass ratio of dapoxetine hydrochloride to Kyron T-134 at 2:1, and adjusting the solution pH to 5.4 ± 0.05. The effect of pH on the drug loading of the resin was initially characterized by SEM, while the binding mechanism between dapoxetine hydrochloride and the resin was investigated by XRD, DSC, and FTIR. The ODFs exhibited favorable mechanical properties and palatability. Meanwhile, the drug release in both the ODFs and commercially available tablets Priligy® could reach 100.8% of the drug over 15 min in a simulated gastric fluid with pH 1.2 HCl. Furthermore, pharmacokinetic studies conducted in healthy volunteers demonstrated that the ODFs were bioequivalent to Priligy®. Therefore, this ODFs, characterized by its pleasant taste and water-free administration, offer a novel and convenient oral formulation for patients with PE, thereby enhancing patient compliance.
2025-06-29Journal of Sexual Medicine
A prospective and comparative evaluation of a male masturbation device for premature ejaculation—functional outcomes, safety, and satisfaction assessment: a pilot study
Article
作者: García-Rojo, Esther ; Romero-Otero, Javier ; Calzas-Montalvo, Cristina ; Juste-Álvarez, Silvia ; Alonso-Isa, Manuel ; Peña-Vallejo, Elena ; Rodríguez-Antolín, Alfredo ; Sopeña-Sutil, Raquel ; Caro-González, Maria del Prado ; García-Gómez, Borja
Abstract:
Background:
Premature ejaculation (PE) is a common sexual dysfunction that negatively impacts the quality of life and relationships for men.
Aim:
To compare the effectiveness, side effects, and satisfaction between a novel cognitive-behavioral therapy based on sphincter control training (SCT) supported by a mechanical masturbation device and dapoxetine, a pharmacological treatment for PE.
Methods:
A crossover study with 20 male patients diagnosed with PE was designed. Participants were randomly assigned to start with an 8-week cognitive-behavioral therapy program supported by a masturbation device or an 8-week treatment with dapoxetine (60 mg). After a 2-week washout time, treatments were crossed. Effectiveness was measured through intravaginal ejaculation latency time (IELT), Premature Ejaculation Diagnostic Tool (PEDT) scores, and the International Index of Erectile Function. Satisfaction rates were measured using the Erectile Dysfunction Inventory of Treatment Satisfaction scale and Likert scale. Adverse effects were recorded for both treatments.
Outcomes:
Changes in IELT, PEDT scores, satisfaction rates, and side effects.
Results:
In the randomized phase, SCT + device demonstrated superior outcomes compared to dapoxetine for PEDT scores: 15.2 (SD = 1.7) vs 18.4 (SD = 2.6), P = .01; though IELT improvements were comparable: 111.7 (SD = 56.7) seconds vs 91.8 (SD = 77.8) seconds, P = .20. After crossover, patients switching from dapoxetine to SCT + device achieved significantly greater IELT 171.8 (SD = 148.8) seconds vs 76.7 (SD = 37.1) seconds, P = .02; and better PEDT scores: 14.6 (SD = 2.7) vs 17.7 (SD = 2.7), P = .04. Notably, dapoxetine underperformed relative to historical data. Treatment satisfaction was markedly higher with SCT + device: 64.9% (SD = 9.3) vs 33.3% (SD = 20.7), P = .003; with fewer adverse effects (25% vs 60%).
Clinical Implications:
This pilot study suggests a potential role for cognitive-behavioral therapy supported by a mechanical masturbation device in managing PE, but further research is needed to confirm its effectiveness and comparative advantages.
Strengths and Limitations:
The main strengths of the study is its crossover design, which minimizes the influence of individual patient variability. Limitations include the small sample size, the lack of long-term follow-up to assess the durability of treatment effects, and the absence of a sham arm using masturbation alone, which makes it unclear whether the observed improvements are due to the device itself or the act of masturbating.
Conclusion:
This pilot study suggests that the cognitive-behavioral therapy program supported by the male masturbation device may offer potential benefits for managing PE, but further research with larger samples is needed to confirm these preliminary findings.
2025-06-17ANGEWANDTE CHEMIE-INTERNATIONAL EDITION
Excited‐State Basicity Diverts the Site‐Selectivity of Aromatic Deuteration: Application to the Late‐Stage Labeling of Pharmaceuticals
Article
作者: Ruffoni, Alessandro ; Corpas, Javier ; Rivera‐Chao, Eva ; Derdau, Volker ; Leonori, Daniele ; Lonardi, Giovanni
Abstract:
Isotope labeling, particularly with deuterium (2H), plays a critical role in drug discovery due to its ease of incorporation and its potential to switch unwanted metabolic transformations. Deuterium incorporation can enhance drug stability, affect pharmacokinetics, and alter metabolism pathways. Current deuterium labeling methods focus on hydrogen isotope exchange (HIE), and typically rely on the use of transition metal catalysis. Herein, we present a metal‐free approach for aromatic HIE, utilizing photoexcitation in deuterated hexafluoroisopropanol (HFIP‐d1). By exploiting the enhanced basicity of excited‐state aromatics, this method achieves selective deuteration at positions often inaccessible by traditional methods. The approach is efficient and was demonstrated across a broad number of complex drug molecules. Transient absorption spectroscopy confirms the formation of deuterated arenium ions.
100 项与 盐酸达泊西汀 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 早泄 | 奥地利 | 2008-12-17 | |
| 早泄 | 比利时 | 2008-12-17 | |
| 早泄 | 保加利亚 | 2008-12-17 | |
| 早泄 | 克罗地亚 | 2008-12-17 | |
| 早泄 | 塞浦路斯 | 2008-12-17 | |
| 早泄 | 捷克 | 2008-12-17 | |
| 早泄 | 爱沙尼亚 | 2008-12-17 | |
| 早泄 | 芬兰 | 2008-12-17 | |
| 早泄 | 法国 | 2008-12-17 | |
| 早泄 | 德国 | 2008-12-17 | |
| 早泄 | 希腊 | 2008-12-17 | |
| 早泄 | 匈牙利 | 2008-12-17 | |
| 早泄 | 爱尔兰 | 2008-12-17 | |
| 早泄 | 意大利 | 2008-12-17 | |
| 早泄 | 立陶宛 | 2008-12-17 | |
| 早泄 | 卢森堡 | 2008-12-17 | |
| 早泄 | 马耳他 | 2008-12-17 | |
| 早泄 | 荷兰 | 2008-12-17 | |
| 早泄 | 波兰 | 2008-12-17 | |
| 早泄 | 葡萄牙 | 2008-12-17 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 勃起功能障碍 | 临床3期 | - | 2004-12-01 | |
| 性功能障碍 | 临床3期 | - | 2004-11-01 | |
| 血精症 | 临床3期 | - | 2003-06-01 |
登录后查看更多信息
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 | 495 | Placebo | 築鏇鬱構積鹽糧範艱鹽(網憲顧膚壓餘衊艱廠壓) = Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135) 繭鏇選衊膚窪艱築艱醖 (蓋壓衊夢糧願鏇簾範壓 ) 更多 | 积极 | 2013-09-01 | ||
临床3期 | 495 | Placebo (PDE5I + Placebo (Baseline)) | 膚衊願積鹽蓋積鏇製鑰(構齋膚鏇築繭糧壓鑰製) = 鏇鑰鏇製構鹽製築製積 憲齋廠鹹製齋製淵鑰製 (遞繭鏇製鏇窪鏇鹽淵壓, 0.53) | - | 2012-11-04 | ||
Placebo (PDE5I + Placebo (Week 12)) | 膚衊願積鹽蓋積鏇製鑰(構齋膚鏇築繭糧壓鑰製) = 鹹蓋構獵網憲襯糧壓鹽 憲齋廠鹹製齋製淵鑰製 (遞繭鏇製鏇窪鏇鹽淵壓, 3.54) | ||||||
临床3期 | - | 艱膚選糧糧築廠壓構醖(憲觸積選選窪糧衊衊築) = no akathisia 鏇製築齋窪糧鬱齋夢鏇 (製衊窪鑰構鹹製廠觸鹹 ) 更多 | 积极 | 2011-02-01 | |||
临床3期 | 1,162 | 襯鑰願壓窪遞遞簾獵願(襯鏇衊觸顧憲壓獵鹽獵) = 鬱艱築衊獵夢窪蓋網憲 築蓋鏇選遞餘醖夢襯淵 (鬱顧衊網衊襯蓋鏇願衊 ) | 积极 | 2009-04-01 | |||
襯鑰願壓窪遞遞簾獵願(襯鏇衊觸顧憲壓獵鹽獵) = 鏇糧範積鏇製鑰選襯憲 築蓋鏇選遞餘醖夢襯淵 (鬱顧衊網衊襯蓋鏇願衊 ) | |||||||
临床3期 | 870 | Placebo | 齋積遞獵淵顧淵憲製網(鹽鏇廠製夢醖餘鏇鑰鑰) = 夢範製夢簾齋淵積製窪 鹽鏇範製鏇鬱網選鏇醖 (願製鏇齋淵窪夢襯選蓋 ) | 积极 | 2006-09-09 | ||
齋積遞獵淵顧淵憲製網(鹽鏇廠製夢醖餘鏇鑰鑰) = 鏇繭築築夢艱製構觸鏇 鹽鏇範製鏇鬱網選鏇醖 (願製鏇齋淵窪夢襯選蓋 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用