Tadalafil
As of the edition of 20 October 2026, Tadalafil is a small molecule: marketed, first approved in 2002 (EU); acts on PDE5A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Cialis
- First approved
- 12 November 2002 (EU)
- Approvals on record
- 27 in 7 regions
- Holder of the most recent approval
- GRÜNENTHAL DO BRASIL FARMACÊUTICA LTDA.; 12 holders in all
- Registered trials
- 163, 17 stopped early
- Disease areas
- Urinary and reproductive; Mental health; Lungs and airways; Heart and blood vessels; Cancer; Nervous 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.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Tadalafil.
See the 3 companies 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 | 27 | 16 | 4 | 2 |
| Phase 1 | 31 | 26 | 0 | 3 |
| Phase 2 | 31 | 20 | 5 | 5 |
| Phase 3 | 39 | 23 | 8 | 3 |
| Phase 4 | 35 | 19 | 8 | 4 |
| All trials | 163 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant and Lead sponsor of trials | 2002 to now |
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 2015 to now |
| Cmp | Applicant | 2022 to now |
| B Better | Later holder | 2024 to now |