Hydrocortisone probutate
As of the edition of 20 October 2026, Hydrocortisone probutate is a small molecule: marketed, first approved in 1997 (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 1997
- Kind
- Small molecule
- Brand name
- Pandel
- First approved
- 28 February 1997 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- ANI Pharmaceuticals
- Registered trials
- 1, 0 stopped early
- Disease areas
- Immune system; Inherited and neonatal; Skin and connective tissue
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| ANI Pharmaceuticals | Acquired holder | 2021 to now |