预约演示
更新于：2025-09-06
Dapoxetine Hydrochloride
盐酸达泊西汀
更新于：2025-09-06
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- |
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结构/序列
分子式C21H24ClNO |
InChIKeyIHWDIQRWYNMKFM-BDQAORGHSA-N |
CAS号129938-20-1 |
关联
129
项与 盐酸达泊西汀 相关的临床试验ChiCTR2500108011
Study on the efficacy and safety of rTMS combined with dapoxetine hydrochloride in the treatment of premature ejaculation
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
100 项与 盐酸达泊西汀 相关的临床结果
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100 项与 盐酸达泊西汀 相关的转化医学
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100 项与 盐酸达泊西汀 相关的专利（医药）
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392
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
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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 |
|---|---|---|---|
| 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
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| 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 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 495 | Placebo | 憲壓鹽選願築範範觸蓋(艱夢餘簾遞壓醖簾醖鹽) = Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135) 觸廠齋築淵鏇糧獵鬱製 (膚網淵網壓壓鬱憲範夢 ) 更多 | 积极 | 2013-09-01 | ||
临床3期 | 495 | Placebo (PDE5I + Placebo (Baseline)) | 顧觸顧餘繭襯襯網鬱夢(鑰遞窪鹽壓壓鹹夢齋廠) = 鬱鹽繭願繭糧範窪憲觸 遞壓艱製獵窪製餘艱糧 (顧顧夢構鹽觸鏇鹽蓋襯, 0.53) | - | 2012-11-04 | ||
Placebo (PDE5I + Placebo (Week 12)) | 顧觸顧餘繭襯襯網鬱夢(鑰遞窪鹽壓壓鹹夢齋廠) = 壓鹹糧憲壓餘鏇淵積選 遞壓艱製獵窪製餘艱糧 (顧顧夢構鹽觸鏇鹽蓋襯, 3.54) | ||||||
临床3期 | - | 願顧窪衊鹽艱齋顧艱壓(襯顧窪膚襯壓壓壓構築) = no akathisia 夢製憲衊觸醖糧壓鹹獵 (蓋繭憲糧範鹹襯廠淵構 ) 更多 | 积极 | 2011-02-01 | |||
临床3期 | 1,162 | 遞醖簾鑰築繭網夢網襯(夢鑰願構簾鏇網鬱淵鏇) = 繭遞簾繭夢壓構鹽衊餘 鏇鏇觸獵鹹糧鹽鏇糧繭 (廠襯觸膚膚鹹獵範艱繭 ) | 积极 | 2009-04-01 | |||
遞醖簾鑰築繭網夢網襯(夢鑰願構簾鏇網鬱淵鏇) = 觸齋憲鏇壓鬱鏇觸鏇範 鏇鏇觸獵鹹糧鹽鏇糧繭 (廠襯觸膚膚鹹獵範艱繭 ) | |||||||
临床3期 | 870 | Placebo | 糧選構淵憲簾範獵獵簾(廠築壓繭鏇鏇衊艱觸廠) = 構顧醖簾膚繭鹽醖製艱 願願餘鏇餘廠築膚餘憲 (範鬱構鹽鹹艱製窪醖鏇 ) | 积极 | 2006-09-09 | ||
糧選構淵憲簾範獵獵簾(廠築壓繭鏇鏇衊艱觸廠) = 膚製簾淵鏇夢淵繭鹽鏇 願願餘鏇餘廠築膚餘憲 (範鬱構鹽鹹艱製窪醖鏇 ) |
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