Hydrocortisone acetate
As of the edition of 20 October 2026, Hydrocortisone acetate 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 1998
- Kind
- Small molecule
- Brand name
- Cortef Acetate
- First approved
- 1 January 1982 (US)
- Approvals on record
- 16 in 3 regions
- Holder of the most recent approval
- LEO Pharma; 10 holders in all
- Registered trials
- 5, 1 stopped early
- Disease areas
- Digestive system; Ear, nose and throat; Heart and blood vessels; Hormones; Lungs and airways; Nervous system
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
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 Hydrocortisone 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 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| UCB | Later holder | 1982 to now |
| LEO Pharma | Applicant | 1998 to now |
| Epic Pharma | Acquired holder | 2023 to now |
| Viatris | Acquired holder | 2025 to now |
| Akorn | Later holder | |
| Merck & Co. | Applicant | |
| Pfizer | Later holder |