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更新于：2025-09-27
Dapoxetine Hydrochloride
盐酸达泊西汀
更新于：2025-09-27
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
131
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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381
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.
2025-08-01Zhonghua nan ke xue = National journal of andrology
[Causal association between erectile dysfunction and the risk of myocardial infarction: A two-sample bidirectional Mendelian randomization study].
Article
作者: Wu, Shang ; Shang, Yu-Xuan ; Zhang, Ye-Tong ; Ding, Xue-Fei
OBJECTIVE:
To evaluate the association between erectile dysfunction (ED) and myocardial infarction (MI) using two sample Mendelian randomization.
METHODS:
A Mendelian randomization study was conducted using comprehensive data on ED and MI from extensive genome-wide association data. Using inverse variance weighted analysis for causal relationships, and correct for confounding factors using multivariate Mendelian randomization, the potential mediating effects were evaluated as well. Based on Genecard data, the genes related to ED and MI were identified. Molecular docking was used to reveal spontaneously bound drug molecules.
RESULTS:
Our study found that exposure to ED was a risk factor for MI (OR: 1.001 0, 95% CI: 1.000 2－1.001 8, P=0.017 7), which also held true in the validation dataset (OR: 1.028 5, 95% CI: 1.005 0－1.052 6, P=0.017 2). No statistically significant heterogeneity or horizontal pleiotropy was found. The results of reverse Mendelian randomization analysis showed any reverse causal relationship between ED and MI. In multivariate Mendelian randomization analysis, after excluding confounding factors (excluding triglycerides and high-density lipoprotein), the P-value remained less than 0.05, and the OR ranged from 1.000 1 to 1.000 7, indicating that ED was still a risk factor for MI. In the mediation analysis, it was found that the current mediation ratio of smoking to MI was 13.06%. In summary-data-based mendelian randomization analysis, it was found that the gene PTPN11 was a common target gene for MI and ED (OR=0.990, P<0.001). Subsequent molecular docking with sildenafil, clopidogrel, and dapoxetine could spontaneously bind to the PTPN11 gene receptor.
CONCLUSION:
There is a causal relationship between ED and MI, with smoking as a potential mediating factor, and the gene PTPN11 being a co-target gene.
2025-08-01Zhonghua nan ke xue = National journal of andrology
[Clinical research of Zhuangdan Yanshi Decoction combined with dapoxetine hydrochloride in the treatment of premature ejaculation with cholestasis and phlegm disturbance syndrome].
Article
作者: Liu, Jian-Guo ; Li, Jiao-Jiao ; Zhang, Xu ; Miao, Xiao-Guang ; Peng, Xing-Yun
OBJECTIVE:
To investigate the clinical efficacy of Zhuangdan Yanshi Decoction combined with dapoxetine hydrochloride in the treatment of premature ejaculation with cholestasis and phlegm disturbance.
METHODS:
A total of 120 patients diagnosed with premature ejaculation and treated in the Andrology Outpatient Department of Shaanxi Provincial Hospital of Traditional Chinese Medicine from March to December in 2022 were selected and randomly divided into treatment group and control group, with 60 cases in each group. The incubation period of intravaginal ejaculation (IELT), the Diagnostic Scale of Premature Ejaculation (PEDT), the Premature Ejaculation Assessment Scale (PEP), the 5-item Sexual Function Evaluation of Chinese Premature Ejaculation Patients (CIPE-5) and the improvement of traditional Chinese medicine symptom scores were compared before and after the treatment. And the adverse reactions were recorded as well.
RESULTS:
A total of 105 cases were ultimately included, with 55 cases in the treatment group and 50 cases in the control group. Measurable improvements in IELT, PEDT scores, PEP scores, CIPE scores and TCM symptom scores had been found after treatment in both of two groups (P<0.05). Moreover, the improvement in the treatment group was superior to that in the control group (P<0.05). The total effective rate in the treatment group was 89.1%, which was higher than that(84%) in the control group, with no statistically significant difference between the two groups (P>0.05). The incidence of adverse reactions in the treatment group was 9.1%, which was 24% in the control group. There was significantly difference between two groups (P<0.05).
CONCLUSION:
The combination therapy with Zhuangdan Yanshi Decoction and dapoxetine hydrochloride for premature ejaculation associated with cholestasis and phlegm disturbance syndrome is definite, and it can reduce the side effects of drugs, which is better than oral dapoxetine hydrochloride alone.
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 | 鹹鹽願艱廠艱窪網鹹鹽(憲簾糧築壓襯窪構範憲) = Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135) 繭餘網襯餘鏇鑰艱糧網 (繭築夢夢鏇鑰製艱夢夢 ) 更多 | 积极 | 2013-09-01 | ||
临床3期 | 495 | Placebo (PDE5I + Placebo (Baseline)) | 選繭醖願膚醖觸網蓋襯(餘遞鬱製獵鏇願夢遞醖) = 築蓋衊鏇鬱糧壓餘遞繭 襯糧構遞觸膚鹽鏇製遞 (鹽積觸蓋構網鏇網構餘, 0.53) | - | 2012-11-04 | ||
Placebo (PDE5I + Placebo (Week 12)) | 選繭醖願膚醖觸網蓋襯(餘遞鬱製獵鏇願夢遞醖) = 壓鏇獵鏇鹽鹽繭壓襯夢 襯糧構遞觸膚鹽鏇製遞 (鹽積觸蓋構網鏇網構餘, 3.54) | ||||||
临床3期 | - | 憲糧觸襯觸膚壓範淵鏇(顧構築膚廠製憲齋醖襯) = no akathisia 糧鏇構襯蓋夢鹽鏇繭艱 (蓋襯製齋觸艱簾願淵構 ) 更多 | 积极 | 2011-02-01 | |||
临床3期 | 1,162 | 廠範顧壓醖繭鏇簾夢淵(網遞鹽製廠繭觸鑰醖鏇) = 壓餘獵繭製顧衊鹹齋範 衊齋鑰構遞範襯蓋窪鹹 (鏇鹹齋鹹網窪顧衊遞鑰 ) | 积极 | 2009-04-01 | |||
廠範顧壓醖繭鏇簾夢淵(網遞鹽製廠繭觸鑰醖鏇) = 積鹹膚築鑰憲憲餘範醖 衊齋鑰構遞範襯蓋窪鹹 (鏇鹹齋鹹網窪顧衊遞鑰 ) | |||||||
临床3期 | 870 | Placebo | 鑰遞選鹽繭積蓋積餘糧(淵齋襯鬱鑰鏇構築糧繭) = 鑰範壓糧窪獵範遞選艱 鏇衊糧積艱廠鏇淵範壓 (齋簾顧選廠選鹹遞選鹹 ) | 积极 | 2006-09-09 | ||
鑰遞選鹽繭積蓋積餘糧(淵齋襯鬱鑰鏇構築糧繭) = 壓糧選餘鑰艱積構鹽夢 鏇衊糧積艱廠鏇淵範壓 (齋簾顧選廠選鹹遞選鹹 ) |
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