Ospemifene
As of the edition of 20 October 2026, Ospemifene is a small molecule: marketed, first approved in 2013 (US); acts on ESR1 and ESR2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Osphena
- First approved
- 26 February 2013 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Shionogi; 2 holders in all
- Registered trials
- 9, 1 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Mental health
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Ospemifene.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 6 | 6 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 9 |