Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Ospemifene - Shionogi

Drug Profile

Ospemifene - Shionogi

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

Latest Information Update: 10 Jun 2019

Price : $50 *
  • Adis is an information provider. We do not sell or distribute actual drugs.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
  • A link to download a PDF version of the drug profile will be included in your email receipt.

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.

    No
  • 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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top