Spironolactone
As of the edition of 20 October 2026, Spironolactone is a small molecule: marketed, first approved in 1961 (CH); acts on NR3C2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Aldactone
- First approved
- 20 April 1961 (CH)
- Approvals on record
- 11 in 6 regions
- Holder of the most recent approval
- Lipomed; 3 holders in all
- Registered trials
- 156, 18 stopped early
- Disease areas
- Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Hormones; Nutrition and metabolism; Inherited and neonatal
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Spironolactone.
See the 3 companies 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 | 33 | 15 | 5 | 4 |
| Phase 1 | 12 | 6 | 3 | 2 |
| Phase 2 | 38 | 21 | 10 | 3 |
| Phase 3 | 28 | 17 | 3 | 1 |
| Phase 4 | 45 | 21 | 3 | 8 |
| All trials | 156 |