Last update 28 May 2025

Dapoxetine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dapoxetine, Dapoxetine hydrochloride (USAN), Priligy
+ [2]
Target
Action
inhibitors
Mechanism
SERT inhibitors(Serotonin transporter inhibitors)
Therapeutic Areas
Active Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United Kingdom (17 Dec 2008),
Regulation-
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Structure/Sequence

Molecular FormulaC21H24ClNO
InChIKeyIHWDIQRWYNMKFM-BDQAORGHSA-N
CAS Registry129938-20-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Premature Ejaculation
Austria
17 Dec 2008
Premature Ejaculation
Belgium
17 Dec 2008
Premature Ejaculation
Bulgaria
17 Dec 2008
Premature Ejaculation
Croatia
17 Dec 2008
Premature Ejaculation
Cyprus
17 Dec 2008
Premature Ejaculation
Czechia
17 Dec 2008
Premature Ejaculation
Estonia
17 Dec 2008
Premature Ejaculation
Finland
17 Dec 2008
Premature Ejaculation
France
17 Dec 2008
Premature Ejaculation
Germany
17 Dec 2008
Premature Ejaculation
Greece
17 Dec 2008
Premature Ejaculation
Hungary
17 Dec 2008
Premature Ejaculation
Ireland
17 Dec 2008
Premature Ejaculation
Italy
17 Dec 2008
Premature Ejaculation
Lithuania
17 Dec 2008
Premature Ejaculation
Luxembourg
17 Dec 2008
Premature Ejaculation
Malta
17 Dec 2008
Premature Ejaculation
Netherlands
17 Dec 2008
Premature Ejaculation
Poland
17 Dec 2008
Premature Ejaculation
Portugal
17 Dec 2008
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Sexual DysfunctionPhase 3
United States
01 Apr 2010
Sexual DysfunctionPhase 3
Argentina
01 Apr 2010
Sexual DysfunctionPhase 3
Australia
01 Apr 2010
Sexual DysfunctionPhase 3
Belgium
01 Apr 2010
Sexual DysfunctionPhase 3
Canada
01 Apr 2010
Sexual DysfunctionPhase 3
France
01 Apr 2010
Sexual DysfunctionPhase 3
Malaysia
01 Apr 2010
Sexual DysfunctionPhase 3
Mexico
01 Apr 2010
Sexual DysfunctionPhase 3
Poland
01 Apr 2010
Sexual DysfunctionPhase 3
Russia
01 Apr 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
locqzeqjrx(evuzhhpcfh) = oeacjryhyt jahgovlpln (osnoqtnpsj, 23.0 - 400.0)
Positive
01 May 2024
OLNP-05
locqzeqjrx(evuzhhpcfh) = dpbfokdchi jahgovlpln (osnoqtnpsj, 140.0 - 410.0)
Phase 3
495
Placebo
byqybvqlik(euocqfpyty) = Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135) uqqofkkjvk (egsdxwlery )
Positive
01 Sep 2013
Phase 3
495
Placebo
(PDE5I + Placebo (Baseline))
sykiknuovo(xzypdwunfg) = qugrpdcnhg qreyvprdym (lofzxkfmsl, 0.53)
-
04 Nov 2012
Placebo
(PDE5I + Placebo (Week 12))
sykiknuovo(xzypdwunfg) = eifoypqbcj qreyvprdym (lofzxkfmsl, 3.54)
Phase 3
-
qwlfzahsqu(zlqvxbiqcb) = no akathisia wqymyecetm (uabhqcnksh )
Positive
01 Feb 2011
Phase 3
870
Placebo
mcbuuvynpx(uyacgynmhx) = kqfnielzbj zhuhwsfdgf (vtpmrddhah )
Positive
09 Sep 2006
mcbuuvynpx(uyacgynmhx) = ptksonfwnb zhuhwsfdgf (vtpmrddhah )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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