Prednisolone
As of the edition of 20 October 2026, Prednisolone is a small molecule: marketed, first approved in 1969 (ES); acts on NR3C1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Hydeltrasol
- First approved
- 1 March 1969 (ES)
- Approvals on record
- 35 in 6 regions
- Holder of the most recent approval
- COSMED INDUSTRIA DE COSMETICOS E MEDICAMENTOS S.A.; 18 holders in all
- Registered trials
- 373, 40 stopped early
- Disease areas
- Immune system; Cancer; Blood and lymph; Lungs and airways; Urinary and reproductive; Skin and connective tissue
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
6 companies on route B because of this drug.
Companies on route B for this drug
In the product6 companies are on route B because of Prednisolone.
See the 6 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 | 52 | 21 | 5 | 7 |
| Phase 1 | 26 | 15 | 1 | 6 |
| Phase 2 | 105 | 52 | 26 | 9 |
| Phase 3 | 120 | 57 | 34 | 14 |
| Phase 4 | 70 | 44 | 7 | 4 |
| All trials | 373 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Applicant, Later holder and Lead sponsor of trials | 1974 to now |
| Fisons | Later holder | 1986 to now |
| Bausch Health | Later holder and Lead sponsor of trials | 1995 to now |
| Merck & Co. | Later holder and Lead sponsor of trials | 2006 to now |
| Amicus Therapeutics | Later holder | 2006 to now |
| Taro Pharmaceuticals | Later holder | 2008 to now |
| Sandoz | Acquired holder | 2023 to now |
| Harrow Eye | Acquired holder | 2023 to now |
| Advanz Pharma | Acquired holder | 2025 to now |
| Sun Pharma | Acquired holder | 2025 to now |
| Pharmaceutical Associates | Acquired holder | 2026 to now |
| Alcon | Later holder | |
| Asahi Kasei Therapeutics | Applicant | |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | |
| Shionogi | Later holder | |
| Takeda | Later holder |