Vardenafil
As of the edition of 20 October 2026, Vardenafil is a small molecule: marketed, first approved in 2003 (EU); acts on PDE5A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Small molecule
- Brand name
- Levitra
- First approved
- 6 March 2003 (EU)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- Bayer; 2 holders in all
- Registered trials
- 62, 2 stopped early
- Disease areas
- Urinary and reproductive; Mental health; Heart and blood vessels; Lungs and airways; Nutrition and metabolism; Hormones
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 Vardenafil.
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 |
|---|---|---|
| PDE5A | cGMP-specific 3',5'-cyclic phosphodiesterase | O76074 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 6 | 0 | 1 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 8 | 8 | 0 | 0 |
| Phase 3 | 21 | 20 | 0 | 0 |
| Phase 4 | 22 | 18 | 0 | 0 |
| All trials | 62 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant, Later holder and Lead sponsor of trials | 2002 to now |