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Priligy (DAPOXETINE)
Priligy (generic name: DAPOXETINE) is a dapoxetine drug. It is currently in Phase 3 development for Premature ejaculation.
Dapoxetine works by blocking the reuptake of serotonin in the brain, allowing it to stay in the synaptic cleft for longer and increasing the time it takes to ejaculate.
Priligy, also known as dapoxetine, is a small molecule that inhibits the sodium-dependent serotonin transporter, a mechanism that affects serotonin levels in the body. It is primarily used to treat premature ejaculation, a condition where a man ejaculates earlier than he or his partner would like during sexual activity.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | DAPOXETINE |
|---|---|
| Drug class | dapoxetine |
| Target | Sodium-dependent serotonin transporter |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Imagine serotonin as a messenger that helps you feel pleasure and relaxation. When you ejaculate, serotonin is quickly taken back into the brain, making it harder to control your body's response. Dapoxetine helps keep serotonin in the brain for longer, giving you more time to enjoy sex before ejaculation.
Approved indications
- Premature ejaculation
Common side effects
- Nausea
- Dizziness
- Headache
- Somnolence
- Palpitations
- Dry Mouth
- Aspartate Aminotransferase Increased
- Hot Flush
- Vomiting
- Fatigue
- Back Pain
- Insomnia
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Priligy CI brief — competitive landscape report
- Priligy updates RSS · CI watch RSS
Frequently asked questions about Priligy
What is Priligy?
How does Priligy work?
What is Priligy used for?
What is the generic name of Priligy?
What drug class is Priligy in?
What development phase is Priligy in?
What are the side effects of Priligy?
What does Priligy target?
Related
- Drug class: All dapoxetine drugs
- Target: All drugs targeting Sodium-dependent serotonin transporter
- Therapeutic area: All drugs in Other
- Indication: Drugs for Premature ejaculation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing