Drug Profile
Ospemifene - Shionogi
Alternative Names: FC-1271a; Ophena; Osphena; SenshioLatest Information Update: 10 Jun 2019
Price :
$50
*
At a glance
- Originator Hormos Medical
- Developer QuatRx Pharmaceuticals; Shionogi
- Class Anti-inflammatories; Calcium regulators; Osteoporosis therapies; Small molecules; Stilbenes
- Mechanism of Action Selective estrogen receptor modulators
-
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Atrophic vaginitis; Dyspareunia
- Discontinued Menopausal syndrome; Postmenopausal osteoporosis
Most Recent Events
- 29 Jan 2019 The US FDA approves sNDA for ospemifene to include moderate to severe vaginal dryness for the treatment of Atrophic vaginitis
- 23 Oct 2018 FDA assigns PDUFA action date of January 26, 2019 to Ospemifene for Vaginal dryness in postmenopausal women with Atrophic vaginitis in USA
- 24 Jun 2018 Biomarkers information updated