Estradiol valerate
As of the edition of 20 October 2026, Estradiol valerate is a small molecule: marketed, first approved in 1982 (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 2001
- Kind
- Small molecule
- Brand name
- Delestrogen
- First approved
- 1 January 1982 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Bayer; 3 holders in all
- Registered trials
- 47, 2 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Mental health; Nutrition and metabolism; Bones, joints and muscles
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ESR1 | Estrogen receptor | P03372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 23 | 10 | 5 | 1 |
| Phase 1 | 6 | 3 | 0 | 0 |
| Phase 3 | 5 | 4 | 0 | 0 |
| Phase 4 | 13 | 8 | 0 | 1 |
| All trials | 47 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ph Health | Acquired holder | 2025 to now |
| Bristol Myers Squibb | Earlier holder |