Dapoxetine
As of the edition of 20 October 2026, Dapoxetine is a small molecule: marketed, first approved in 2009 (ES); acts on SLC6A4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Priligy
- First approved
- 28 April 2009 (ES)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Curatis AG; 3 holders in all
- Registered trials
- 19, 0 stopped early
- Disease areas
- Mental health; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Dapoxetine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A4 | Sodium-dependent serotonin transporter | P31645 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 3 | 2 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 9 | 8 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 19 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Lead sponsor of trials | 2004 to now |
| Yuhan | Lead sponsor of trials | 2011 to now |