Prednisolone acetate
As of the edition of 20 October 2026, Prednisolone acetate is a small molecule: marketed, first approved in 1968 (CH); acts on NR3C1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Metimyd
- First approved
- 4 November 1968 (CH)
- Approvals on record
- 16 in 3 regions
- Holder of the most recent approval
- Sun Pharma; 7 holders in all
- Registered trials
- 31, 3 stopped early
- Disease areas
- Eye; Hormones; Immune system; Heart and blood vessels; Infections; Nutrition and metabolism
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Prednisolone acetate.
See the 2 companies 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 | 2 | 2 | 0 | 0 |
| Phase 2 | 7 | 3 | 3 | 0 |
| Phase 3 | 8 | 4 | 0 | 2 |
| Phase 4 | 14 | 10 | 0 | 1 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Applicant, Later holder and Lead sponsor of trials | 1968 to now |
| Taro Pharmaceuticals | Later holder | 2008 to now |
| Alcon | Later holder and Lead sponsor of trials | 2008 to now |
| Sandoz | Acquired holder | 2023 to now |
| Harrow Eye | Acquired holder | 2023 to now |
| Sun Pharma | Acquired holder | 2025 to now |
| Merck & Co. | Applicant | |
| Pfizer | Later holder |