Fludrocortisone acetate
As of the edition of 20 October 2026, Fludrocortisone acetate 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 1995
- Kind
- Small molecule
- Brand name
- Florinef
- First approved
- 1 March 1970 (ES)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Knight Therapeutics; 4 holders in all
- Registered trials
- 13, 0 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Nervous system; Heart and blood vessels; Infections; Lungs and airways
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
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 Fludrocortisone acetate.
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 |
|---|---|---|
| NR3C2 | Mineralocorticoid receptor | P08235 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 2 | 0 | 2 | 0 |
| Phase 3 | 3 | 1 | 2 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Knight Therapeutics | Applicant | 1995 to now |
| Casper Pharma | Acquired holder | 2016 to now |