Pirfenidone
As of the edition of 20 October 2026, Pirfenidone is a small molecule: marketed, first approved in 2008 (JP).
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
- Esbriet
- First approved
- 16 October 2008 (JP)
- Approvals on record
- 10 in 6 regions
- Holder of the most recent approval
- TEVA FARMACĂUTICA LTDA.; 6 holders in all
- Registered trials
- 109, 4 stopped early
- Disease areas
- Lungs and airways; Skin and connective tissue; Cancer; Digestive system; Immune system; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 11 | 1 | 1 |
| Phase 1 | 21 | 17 | 2 | 0 |
| Phase 2 | 49 | 28 | 10 | 3 |
| Phase 3 | 16 | 5 | 5 | 0 |
| Phase 4 | 9 | 5 | 1 | 0 |
| All trials | 109 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Shionogi | Applicant | 2008 to now |
| H.A.C. Pharma | Applicant | 2011 to now |
| Roche | Applicant, Later holder and Lead sponsor of trials | 2012 to now |
| InterMune | Applicant | 2014 to now |
| Legacy Pharma Inc Sezc | Acquired holder | 2026 to now |