Udenafil
As of the edition of 20 October 2026, Udenafil is a small molecule: marketed, first approved in 2017 (BR); acts on PDE5A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Zydena
- First approved
- 3 July 2017 (BR)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Eurofarma Laboratorios
- Registered trials
- 26, 1 stopped early
- Disease areas
- Urinary and reproductive; Mental health; Heart and blood vessels; Lungs and airways; Cancer; Digestive system
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PDE5A | cGMP-specific 3',5'-cyclic phosphodiesterase | O76074 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 6 | 4 | 0 | 0 |
| Phase 2 | 5 | 4 | 0 | 1 |
| Phase 3 | 12 | 11 | 1 | 0 |
| Phase 4 | 3 | 1 | 0 | 0 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eurofarma Laboratorios | Applicant | 2017 to now |