Ospemifene

Drug Profile

Ospemifene

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

Latest Information Update: 12 Nov 2016

Price : $50

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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Atrophic vaginitis; Dyspareunia
  • Discontinued Menopausal syndrome; Postmenopausal osteoporosis

Most Recent Events

  • 02 Dec 2015 Shionogi initiates a phase III trial for Atrophic vaginitis (in women with vaginal dryness) in USA
  • 19 Jan 2015 Registered for Atrophic vaginitis in European Union (PO)
  • 31 May 2013 Launched for Dyspareunia caused by postmenopausal vulvovaginal atrophy in USA (PO) - first global launch
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