Delving into the Latest Updates on Dapoxetine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Dapoxetine, Dapoxetine hydrochloride (USAN), Priligy

+ [2]

Target

SERT

Action

inhibitors

Mechanism

SERT inhibitors(Serotonin transporter inhibitors)

Therapeutic Areas

Urogenital Diseases

Active Indication

Premature Ejaculation

Inactive Indication

Erectile DysfunctionSexual Dysfunction

Originator Organization

Eli Lilly & Co.

Johnson & Johnson

Active Organization

A. Menarini Australia Pty Ltd.BERLIN-CHEMIE AGJanssen-Cilag AB

+ [4]

Inactive Organization

Johnson & Johnson Pharmaceutical Research & Development LLCJanssen Research & Development LLC

License Organization-

Drug Highest PhaseApproved

First Approval Date

United Kingdom (17 Dec 2008),

Premature Ejaculation

Regulation-

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Structure/Sequence

Molecular FormulaC21H24ClNO

InChIKeyIHWDIQRWYNMKFM-BDQAORGHSA-N

CAS Registry129938-20-1

View All Structures (2)

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Berlin-Chemie AG的盐酸达泊西汀片空腹及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]

Main study objectives: To evaluate the bioequivalence of dapoxetine hydrochloride tablets developed and produced by Zhongshan Kekekang Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets licensed by Berlin-Chemie AG in healthy Chinese male adult subjects after single oral administration on an empty stomach or after meals. Secondary objectives: To evaluate the safety of the test formulation and the reference formulation in healthy Chinese male adult subjects.

Start Date24 Feb 2025

Sponsor / Collaborator

Zhongshan Cococon Pharmaceutical Co., Ltd.

CTR20250171

/ CompletedNot Applicable

盐酸达泊西汀片在中国成年健康男性受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of dapoxetine hydrochloride tablets in healthy Chinese adult male subjects

主要研究目的：考察单次单剂量口服 60 mg（空腹/餐后）受试制剂盐酸达泊西汀片（规格： 60 mg ，海南赛立克药业有限公司生产）与参比制剂盐酸达泊西汀片（商品名： Priligy® , 规格：60 mg，Berlin-Chemie AG 持证，Menarini-Von Heyden GmbH 生产），在中国成年健康男性受试者中的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康男性受试者中的安全性。

[Translation]

Main study objectives: To investigate the relative bioavailability of a single oral dose of 60 mg (fasting/after meals) of the test preparation dapoxetine hydrochloride tablets (specification: 60 mg, produced by Hainan Celic Pharmaceutical Co., Ltd.) and the reference preparation dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 60 mg, licensed by Berlin-Chemie AG, produced by Menarini-Von Heyden GmbH) in healthy adult male subjects in China, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of a single oral dose of the test preparation and the reference preparation in healthy adult male subjects in China on an empty stomach/after meals.

Start Date17 Feb 2025

Sponsor / Collaborator

Hainan Selection Pharmaceutical Co. Ltd.

CTR20250263

/ CompletedNot Applicable

山东济坤生物制药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

[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 Shandong Jikun Biopharmaceutical Co., Ltd. and the reference preparation in healthy Chinese subjects

以山东济坤生物制药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 Shandong Jikun Biopharmaceutical Co., Ltd. were used as the test preparation, and dapoxetine hydrochloride tablets (trade name: Priligy®/PRILIGY®, specification: 60 mg) of 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 Date14 Feb 2025

Sponsor / Collaborator

Shandong Jikun Bio-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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435

Literatures (Medical) associated with Dapoxetine Hydrochloride

01 Apr 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Identification of Phosphodiesterase type 5 inhibitors (PDE5is) analogues using surface-enhanced Raman scattering and machine learning algorithm

Article

Author: Luan, Yujing ; Huang, Jiadong ; Li, Yujing ; He, Hongyuan

Phosphodiesterase type 5 inhibitors (PDE5is), primarily used for the treatment of erectile dysfunction, have been severely misused in recent years, posing a threat to public health and safety. This study developed a method that combines Surface-enhanced Raman spectroscopy (SERS) with machine learning algorithms to rapidly identify different PDE5is types. A total of 948 SERS spectra from 79 PDE5is were collected using gold nanoparticles (AuNPs) as the enhancement agent, and dimensionality reduction was performed through principal component analysis (PCA). Subsequently, six traditional machine learning models, partial least squares discriminant analysis (PLS-DA), orthogonal partial least squares discriminant analysis (OPLS-DA), support vector machines (SVM), k-nearest neighbors (KNN), random forest (RF), and multilayer perceptron (MLP) were applied for data classification and identification. Results showed that the MLP model achieved the highest classification accuracy of 99.65 %, with only 1.82 % of the samples misclassified from thiosildenafil to sildenafil analogues, significantly outperforming the other models. This method offers a rapid, cost-effective, and accurate alternative for the detection of PDE5is in health foods, with implications for improving regulatory oversight and public health safety.

07 Mar 2025·Organic Letters

Manganese(I)-Catalyzed Enantioselective Formal Anti-Markovnikov Hydroalkoxylation of Racemic Allylic Alcohols: A Borrowing Hydrogen Access

Article

Author: Liu, Shuai-Hu ; Li, Faju ; He, Yan-Mei ; Fan, Qing-Hua

An enantioselective manganese(I)-catalyzed formal anti-Markovnikov hydroalkoxylation of racemic allylic alcohols has been developed using a chiral N₆-type macrocyclic ligand, affording a wide range of chiral γ-alkoxypropyl alcohols in high isolated yields with excellent enantioselectivities. The synthetic utility of this protocol was further proven by gram-scale synthesis of chiral γ-alkoxypropanol 3n and derivatization of chiral γ-alkoxypropanol 3a to a drug molecule, (S)-dapoxetine, for the treatment of premature ejaculation and erectile dysfunction. Mechanistic studies support that the reaction proceeds via a hydrogen-borrowing cascade reaction pathway.

01 Mar 2025·Chem

Excited-state protonation and reduction enable the umpolung Birch reduction of naphthalenes

Author: Rivera-Chao, Eva ; Echeverria, Pierre-Georges ; Leonori, Daniele ; Gomez-Mendoza, Miguel ; Bouchel, Celine ; Katayama, Yuri ; Ruffoni, Alessandro ; de la Pena O'Shea, Victor A. ; Arpa, Enrique M. ; Jacob, Clement ; Corpas, Javier

The Birch reaction is a classical process used for the partial reduction of aromatics into non-conjugated cyclohexadienes that can be further functionalized.This strategy and its more modern variants are all based on an initial single-electron transfer event converting the arene into the corresponding radical anion for either protonation or hydrogen-atom transfer.Herein, we demonstrate an umpolung approach where the aromatic is first protonated to its corresponding carbocation and then reduced using the Lewis acid-base complex Et₃N-BH₃.This strategy requires aromatic photoexcitation so that protonation is favored by charge-transfer and driven by excited-state antiaromaticity relief.This means that aromatic excited-state basicity rather than ground-state redox potential needs to be considered when approaching reaction development.The mild conditions and the avoidance of strong reductants have enabled tolerance of functionalities generally not compatible under standard Birch conditions.

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	Poland	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Czechia	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Croatia	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Austria	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Germany	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	United Kingdom	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Lithuania	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Belgium	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Spain	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Estonia	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Netherlands	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Hungary	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Greece	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Romania	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Slovakia	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	France	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Portugal	BERLIN-CHEMIE AG	17 Dec 2008
Premature Ejaculation	Cyprus	BERLIN-CHEMIE AG	17 Dec 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sexual Dysfunction	Phase 2	Malaysia	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	Poland	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	South Korea	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	France	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	Australia	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	United Kingdom	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	Canada	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	Belgium	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	Russia	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Sexual Dysfunction	Phase 2	Argentina	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01063855 (Pubmed \| J Sex Med)	Phase 3	Premature Ejaculation \| Erectile Dysfunction	495	Placebo	ovytmedxza(xnaobhgdip) = Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135) wcnguittms (gvfrfxdpmo ) View more	Positive	01 Sep 2013
				Dapoxetine 30mg
NCT01063855 (COUPLE, CTgov)	Phase 3	Premature Ejaculation \| Sexual Dysfunction \| Erectile Dysfunction	495	Placebo (PDE5I + Placebo (Baseline))	aphuuvwkey(waqujirgww) = kgdpyxuggm xswwzswknn (soztgawovp, otgjoxrsgn - gckcaprdtv)	-	04 Nov 2012
				Placebo (PDE5I + Placebo (Week 12))	aphuuvwkey(waqujirgww) = hzckfyujgj xswwzswknn (soztgawovp, lrouurlrbp - cxfhqbwadn)