Hydrocortisone butyrate
As of the edition of 20 October 2026, Hydrocortisone butyrate 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 2020
- Kind
- Small molecule
- Brand name
- Locoid
- First approved
- 31 March 1982 (US)
- Approvals on record
- 9 in 2 regions
- Holder of the most recent approval
- SMARTPRACTICE DENMARK (DANEMARK); 4 holders in all
- Registered trials
- 5, 0 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive
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
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 Hydrocortisone butyrate.
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 | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 4 | 2 | 0 | 0 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Earlier holder | 1982 to now |
| Galderma | Later holder | 1984 to now |
| Triax Pharmaceuticals | Later holder | 2007 to now |
| PreCision Dermatology | Acquired holder | 2012 to now |
| Bausch Health | Acquired holder | 2019 to now |