Hydrocortisone
As of the edition of 20 October 2026, Hydrocortisone is a small molecule: marketed, first approved in 1954 (ES); acts on NR3C1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Cortril
- First approved
- 1 June 1954 (ES)
- Approvals on record
- 74 in 7 regions
- Holder of the most recent approval
- Eton Pharmaceuticals; 25 holders in all
- Registered trials
- 267, 42 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Infections; Urinary and reproductive; Hormones
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
5 companies on route B because of this drug.
Companies on route B for this drug
In the product5 companies are on route B because of Hydrocortisone.
See the 5 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 | 43 | 29 | 1 | 7 |
| Phase 1 | 39 | 21 | 11 | 7 |
| Phase 2 | 85 | 49 | 15 | 17 |
| Phase 3 | 66 | 42 | 13 | 6 |
| Phase 4 | 34 | 19 | 5 | 5 |
| All trials | 267 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Later holder | 1954 to now |
| UCB | Later holder and Lead sponsor of trials | 1982 to now |
| LEO Pharma | Later holder and Lead sponsor of trials | 1998 to now |
| Panray Corp Sub Ormont Drug And Chemical | Acquired holder | 2003 to now |
| Takeda | Applicant and Lead sponsor of trials | 2007 to now |
| ANI Pharmaceuticals | Acquired holder | 2008 to now |
| Bayer | Applicant, Later holder and Lead sponsor of trials | 2009 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 2012 to now |
| Bausch Health | Acquired holder | 2013 to now |
| Immedica Pharma | Later holder | 2018 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2018 to now |
| Eton Pharmaceuticals | Later holder | 2020 to now |
| Merck & Co. | Later holder and Lead sponsor of trials | 2023 to now |
| Epic Pharma | Acquired holder | 2023 to now |
| Akorn | Later holder | |
| Solvay Pharmaceuticals | Later holder | |
| Westwood Squibb Pharmaceuticals | Later holder |