Raloxifene
As of the edition of 20 October 2026, Raloxifene is a small molecule: marketed, first approved in 1997 (US); acts on ESR1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Evista
- First approved
- 9 December 1997 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Eli Lilly; 3 holders in all
- Registered trials
- 49, 3 stopped early
- Disease areas
- Cancer; Nutrition and metabolism; Bones, joints and muscles; Mental health; Skin and connective tissue; Urinary and reproductive
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
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 Raloxifene.
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 |
|---|---|---|
| ESR1 | Estrogen receptor | P03372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 8 | 1 | 2 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 10 | 7 | 2 | 1 |
| Phase 3 | 12 | 10 | 1 | 0 |
| Phase 4 | 9 | 8 | 0 | 0 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Originator, Later holder and Lead sponsor of trials | 1994 to now |
| Substipharm | Applicant | 1998 to now |