Ospemifene - Shionogi

Drug Profile

Ospemifene - Shionogi

Alternative Names: FC-1271a; Ophena; Osphena; Senshio

Latest Information Update: 04 Nov 2018

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At a glance

  • Originator Hormos Medical
  • Developer QuatRx Pharmaceuticals; Shionogi
  • Class 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

  • 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
  • 23 Oct 2018 Duchesnay files supplemental NDA of ospemifene for vaginal dryness in postmenopausal women with Atrophic vaginitis in USA (Shionogi pipeline, May 2018)
  • 24 Jun 2018 Biomarkers information updated
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