Fludrocortisone
As of the edition of 20 October 2026, Fludrocortisone is a small molecule: marketed, first approved in 1970 (ES); acts on NR3C2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Florinef
- First approved
- 1 March 1970 (ES)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- ZAMBON FRANCE; 3 holders in all
- Registered trials
- 30, 5 stopped early
- Disease areas
- Infections; Hormones; Urinary and reproductive; Heart and blood vessels; Nervous system; Nutrition and metabolism
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| NR3C2 | Mineralocorticoid receptor | P08235 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 1 | 1 |
| Phase 1 | 7 | 6 | 0 | 1 |
| Phase 2 | 8 | 2 | 4 | 2 |
| Phase 3 | 6 | 3 | 1 | 1 |
| Phase 4 | 4 | 0 | 2 | 0 |
| All trials | 30 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Casper Pharma | Acquired holder | 2016 to now |