Difluprednate
As of the edition of 20 October 2026, Difluprednate is a small molecule: marketed, first approved in 1995 (FR); acts on NR3C1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Durezol
- First approved
- 7 September 1995 (FR)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Novartis; 3 holders in all
- Registered trials
- 19, 1 stopped early
- Disease areas
- Eye
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 Difluprednate.
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 |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 13 | 12 | 1 | 0 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sirion Therapeutics | Originator and Lead sponsor of trials | 2007 to now |
| Novartis | Applicant | 2013 to now |
| Sandoz | Acquired holder | 2023 to now |