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Dapoxetine hydrochloride
Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) that increases serotonin levels in the central nervous system to delay ejaculation.
Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) that increases serotonin levels in the central nervous system to delay ejaculation. Used for Premature ejaculation in men aged 18-64 years.
At a glance
| Generic name | Dapoxetine hydrochloride |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | Selective serotonin reuptake inhibitor (SSRI) |
| Target | Serotonin transporter (SERT) |
| Modality | Small molecule |
| Therapeutic area | Urology / Sexual Health |
| Phase | Phase 3 |
Mechanism of action
Dapoxetine works by inhibiting the reuptake of serotonin at the synaptic cleft, thereby increasing serotonin availability in neural pathways that regulate ejaculation. The drug has a rapid onset and short half-life, making it suitable for on-demand dosing prior to sexual activity. Enhanced serotonergic neurotransmission in the brain regions controlling ejaculation results in prolonged time to ejaculation and improved control.
Approved indications
- Premature ejaculation in men aged 18-64 years
Common side effects
- Nausea
- Dizziness
- Headache
- Diarrhea
- Insomnia
- Syncope
Key clinical trials
- Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation (PHASE4)
- On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation (PHASE2, PHASE3)
- Comparison of the Efficacy and Safety of Dapoxetine, Kegel Exercises, and Acupuncture in the Treatment of Premature Ejaculation: A Randomized, Double-Blind, Placebo-Controlled Trial (NA)
- The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy (PHASE3)
- Effectiveness and Safety of TENS Therapy for Premature Ejaculation (PHASE3)
- Brain Networks Implicated in Lifelong Premature Ejaculation Patients (PHASE1, PHASE2)
- Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) (PHASE2)
- The Safety of Dapoxetine/Tadalafil Combination Therapy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |