Fluorometholone acetate
As of the edition of 20 October 2026, Fluorometholone acetate is a small molecule: marketed, first approved in 1986 (US); acts on NR3C1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1986
- Kind
- Small molecule
- Brand name
- Flarex
- First approved
- 11 February 1986 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Harrow Eye
- Registered trials
- 2, 0 stopped early
- Disease areas
- Eye
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
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 Fluorometholone acetate.
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 4 | 2 | 1 | 1 | 0 |
| All trials | 2 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Harrow Eye | Acquired holder | 2023 to now |
| Alcon | Originator | 1986 to 2023 |