Dapoxetine

Generic Name
Dapoxetine
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C21H23NO
CAS Number
119356-77-3
Unique Ingredient Identifier
GB2433A4M3
Background

Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.

Indication

For the treatment of premature ejaculation.

Associated Conditions
Premature Ejaculation
Associated Therapies
-

A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation

Phase 3
Completed
Conditions
First Posted Date
2005-09-21
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
199
Registration Number
NCT00210613

A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation.

Phase 3
Completed
Conditions
First Posted Date
2005-09-21
Last Posted Date
2011-05-19
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
1294
Registration Number
NCT00211107

A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

Phase 3
Completed
Conditions
First Posted Date
2005-09-21
Last Posted Date
2011-02-11
Lead Sponsor
Alza Corporation, DE, USA
Target Recruit Count
1320
Registration Number
NCT00211094
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