Fluocinolone acetonide
As of the edition of 20 October 2026, Fluocinolone acetonide is a small molecule: marketed, first approved in 1982 (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 1996
- Kind
- Small molecule
- Brand name
- Synalar
- First approved
- 1 January 1982 (US)
- Approvals on record
- 18 in 3 regions
- Holder of the most recent approval
- ANI Pharmaceuticals; 7 holders in all
- Registered trials
- 33, 4 stopped early
- Disease areas
- Eye; Skin and connective tissue; Heart and blood vessels; Cancer; Ear, nose and throat; Hormones
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 Fluocinolone acetonide.
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 not stated | 5 | 2 | 2 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 2 |
| Phase 3 | 10 | 8 | 0 | 1 |
| Phase 4 | 12 | 6 | 3 | 1 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Galderma | Later holder | 1990 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 1996 to now |
| Hill Dermaceuticals | Acquired holder | 2003 to now |
| ANI Pharmaceuticals | Later holder and Lead sponsor of trials | 2007 to now |
| EyePoint Pharmaceuticals | Later holder and Lead sponsor of trials | 2015 to now |
| Eurofarma | Acquired holder | 2026 to now |
| Medicis Pharmaceutical | Earlier holder |