Prednisone
As of the edition of 20 October 2026, Prednisone is a small molecule: marketed, first approved in 1955 (ES); acts on NR3C1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Deltasone
- First approved
- 1 October 1955 (ES)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- ORGANON FARMACĂUTICA LTDA.; 9 holders in all
- Registered trials
- 1,291, 195 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Urinary and reproductive; Heart and blood vessels; Infections
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 Prednisone.
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 | 92 | 35 | 14 | 13 |
| Phase 1 | 147 | 73 | 42 | 26 |
| Phase 2 | 615 | 306 | 151 | 98 |
| Phase 3 | 318 | 167 | 68 | 44 |
| Phase 4 | 119 | 57 | 21 | 14 |
| All trials | 1,291 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Later holder and Lead sponsor of trials | 1998 to now |
| Amgen | Later holder and Lead sponsor of trials | 1999 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2008 to now |
| Hikma Pharmaceuticals | Later holder |