Ospemifene - Shionogi

Drug Profile

Ospemifene - Shionogi

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

Latest Information Update: 30 Apr 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

  • 17 Apr 2018 Pharmbio Korea in-licenses ospemifene from Shionogi for development and marketing in South Korea
  • 01 Mar 2018 Duchesnay files NDA of ospemifene for treatment vaginal dryness in postmenopausal women with Atrophic vaginitis in USA (Shionogi pipeline, May 2018)
  • 05 Jul 2017 Shionogi completes a phase III trial for Atrophic vaginitis (in women with vaginal dryness) in USA (PO) (NCT02638337)
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