Delving into the Latest Updates on Dapoxetine Hydrochloride with Synapse

[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of dapoxetine hydrochloride tablets developed by Sinopharm Xingsha Pharmaceutical (Xiamen) Co., Ltd. and the reference preparation in healthy Chinese subjects

以国药控股星鲨制药（厦门）有限公司研制的盐酸达泊西汀片（规格：60 mg）为受试制剂，持证商为Berlin-Chemie AG的盐酸达泊西汀片（商品名：必利劲®/PRILIGY®，规格：60 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两制剂在健康人体中的安全性和耐受性。

[Translation]

Dapoxetine hydrochloride tablets (specification: 60 mg) developed by Sinopharm Holdings Xingsha Pharmaceutical (Xiamen) Co., Ltd. were used as the test preparation, and dapoxetine hydrochloride tablets (trade name: Priligy®/PRILIGY®, specification: 60 mg) from Berlin-Chemie AG were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date06 Jun 2025

Sponsor / Collaborator

Sinopharm Xingsha Pharmaceuticals Xiamen Co., Ltd.

CTR20251864

/ RecruitingNot Applicable

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

[Translation] A randomized, open-label, two-period, two-sequence, crossover bioequivalence study of dapoxetine hydrochloride tablets (60 mg) in healthy study participants in the fasting and fed state

主要研究目的研究空腹及餐后状态下单次口服受试制剂盐酸达泊西汀片（60 mg；正大天晴药业集团股份有限公司生产）与参比制剂盐酸达泊西汀片（必利劲®，规格：60 mg；Menarini Von Heyden GmbH生产）在健康研究参与者体内的药代动力学，评价两种制剂的生物等效性。次要研究目的观察受试制剂盐酸达泊西汀片（60 mg）与参比制剂必利劲®（60 mg）在健康研究参与者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation dapoxetine hydrochloride tablets (60 mg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and the reference preparation dapoxetine hydrochloride tablets (Priligy®, specification: 60 mg; manufactured by Menarini Von Heyden GmbH) in healthy study participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives To observe the safety of the test preparation dapoxetine hydrochloride tablets (60 mg) and the reference preparation Priligy® (60 mg) in healthy study participants.

Start Date04 Jun 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20251666

/ CompletedNot Applicable

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

[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover, fed-state bioequivalence study of dapoxetine hydrochloride tablets in healthy subjects

主要研究目的: 评价中山可可康制药有限公司研发并由中山可可康制药有限公司生产的盐酸达泊西汀片与持证商为 Berin-Chemie AG的盐酸达泊西汀片餐后单次口服给药在中国健康男性成年受试者中的生物等效性。次要目的: 评价受试制剂和参比制剂在中国健康男性成年受试者中的安全性。

[Translation]

Primary study objective: To evaluate the bioequivalence of dapoxetine hydrochloride tablets developed and produced by Zhongshan Kekekang Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets from Berin-Chemie AG after a single oral administration in healthy Chinese male adult subjects. Secondary objective: To evaluate the safety of the test formulation and the reference formulation in healthy Chinese male adult subjects.

Start Date12 May 2025

Sponsor / Collaborator

Zhongshan Cococon Pharmaceutical Co., Ltd.

100 Clinical Results associated with Dapoxetine Hydrochloride

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100 Translational Medicine associated with Dapoxetine Hydrochloride

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100 Patents (Medical) associated with Dapoxetine Hydrochloride

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441

Literatures (Medical) associated with Dapoxetine Hydrochloride

01 Aug 2025·Drug Delivery and Translational Research

Development and in vitro/in vivo evaluation of taste-masked orodispersible films of dapoxetine hydrochloride using ion exchange resins

Article

Author: Yan, Peng ; Ding, Jinsong ; Zhang, Hailong ; 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.

29 Jun 2025·Journal 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

Author: García-Rojo, Esther ; Romero-Otero, Javier ; Juste-Álvarez, Silvia ; Calzas-Montalvo, Cristina ; Peña-Vallejo, Elena ; Alonso-Isa, Manuel ; 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.

17 Jun 2025·ANGEWANDTE CHEMIE-INTERNATIONAL EDITION

Excited‐State Basicity Diverts the Site‐Selectivity of Aromatic Deuteration: Application to the Late‐Stage Labeling of Pharmaceuticals

Article

Author: 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.

1

News (Medical) associated with Dapoxetine Hydrochloride

19 Oct 2005

·www.biospace.com

New Drug Delays Male Orgasms

The first drug formulated to treat premature ejaculation delays climax and also increases reported satisfaction, researchers said on Monday.The drug, called dapoxetine, helped men delay their orgasms significantly and doubled the numbers of men and their female partners reporting “good” sexual satisfaction, they told a conference."Premature ejaculation is a really common problem, affecting between 10 and 30 percent of all men. Here is something for the first time that we have that works,” said Dr. Jon Pryor, chairman of the Department of Urologic Surgery at the University of Minnesota, who led the study.He said the drug worked quickly and with few side-effects."It gets in rapidly. It gets out rapidly. You can take it one to three hours before intercourse,” Pryor said in a telephone interview.The drug is being co-developed by Mountain View, California-based Alza Corp. and Johnson & Johnson Pharmaceutical Services LLC. Ortho Pharmaceutical will market the drug in the United States if it receives U.S. Food and Drug Administration approval. All three companies are units of Johnson & Johnson.

Drug Approval

100 Deals associated with Dapoxetine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D03649	Dapoxetine Hydrochloride	G04BX14	DB04884

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Premature Ejaculation	Austria	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Belgium	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Bulgaria	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Croatia	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Cyprus	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Czechia	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Estonia	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Finland	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	France	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Germany	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Greece	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Hungary	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Ireland	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Italy	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Lithuania	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Luxembourg	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Malta	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Netherlands	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Poland	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Portugal	BERLIN-CHEMIE AG	17 Dec 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Erectile Dysfunction	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2004
Sexual Dysfunction	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Nov 2004
Hemospermia	Phase 3	-	ALZA Corp.	01 Jun 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AUA2024	Not Applicable	Premature Ejaculation	-	Dapoxetine 30 mg+mirodenafil 50 mg	zowycfmwtp(euzorkbagn) = xixbymqmwa qwdgusiflc (pecryyddnf, 23.0 - 400.0)	Positive	01 May 2024
				OLNP-05	zowycfmwtp(euzorkbagn) = sxeqxevnqy qwdgusiflc (pecryyddnf, 140.0 - 410.0)
NCT01063855 (Pubmed \| J Sex Med)	Phase 3	Premature Ejaculation \| Erectile Dysfunction	495	Placebo	xbrdxfxbav(fecluqyhxn) = Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135) tguxvlgzmi (wlgtmeirgi ) View more	Positive	01 Sep 2013
				Dapoxetine 30mg
NCT01063855 (COUPLE, CTgov)	Phase 3	Premature Ejaculation \| Sexual Dysfunction \| Erectile Dysfunction	495	Placebo (PDE5I + Placebo (Baseline))	givppbqhio(kgdnfzufwj) = getimtvwvn tipilucsdx (wertvrpley, 0.53)	-	04 Nov 2012
				Placebo (PDE5I + Placebo (Week 12))	givppbqhio(kgdnfzufwj) = wwlsrmrjcg tipilucsdx (wertvrpley, 3.54)
NCT00211094 \| NCT00210704 \| NCT00210613 \| NCT00229073 \| NCT02572037 \| NCT00211107 (Pubmed \| J Sex Med)	Phase 3	Premature Ejaculation	-	Dapoxetine 30 mg	hlqwexpucg(mooyvhvilr) = no akathisia dmzvdavwhj (svzeeliost ) View more	Positive	01 Feb 2011
				Dapoxetine 60 mg
NCT00229073 (Pubmed \| Eur Urol)	Phase 3	Premature Ejaculation	1,162	Dapoxetine 30 mg	idrobrhwvs(inbaizpomp) = ysozpvcbjb mpclugmyet (pdpqmnpewc )	Positive	01 Apr 2009
				Dapoxetine 60 mg	idrobrhwvs(inbaizpomp) = xucezejvhp mpclugmyet (pdpqmnpewc )
NCT00211094 \| NCT00211107 (Pubmed \| Lancet)	Phase 3	Premature Ejaculation	870	Placebo	vysolqtcbl(entskxtbpp) = iomtiztbpq yglxbmdeig (qtludgvhmg )	Positive	09 Sep 2006
				30 mg dapoxetine	vysolqtcbl(entskxtbpp) = vnykzyshxq yglxbmdeig (qtludgvhmg )