Eplerenone
As of the edition of 20 October 2026, Eplerenone is a small molecule: marketed, first approved in 2002 (US); acts on NR3C2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Inspra
- First approved
- 27 September 2002 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- VIATRIS FARMACEUTICA DO BRASIL LTDA; 5 holders in all
- Registered trials
- 70, 14 stopped early
- Disease areas
- Heart and blood vessels; Hormones; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive; Eye
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Eplerenone.
See the 2 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 | 13 | 11 | 0 | 0 |
| Phase 1 | 12 | 6 | 3 | 2 |
| Phase 2 | 9 | 1 | 2 | 4 |
| Phase 3 | 11 | 6 | 3 | 1 |
| Phase 4 | 25 | 12 | 3 | 7 |
| All trials | 70 |