Drug Profile


Alternative Names: LUM002; SAR-548304; SHP626; Volixibat potassium

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator sanofi-aventis
  • Developer Sanofi; Shire
  • Class Antihyperlipidaemics; Benzothiepins; Hepatoprotectants; Urea compounds
  • Mechanism of Action Sodium-bile acid cotransporter-inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • 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.

    Non-alcoholic steatohepatitis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Non-alcoholic steatohepatitis
  • No development reported Cholestasis
  • Discontinued Hypercholesterolaemia

Most Recent Events

  • 29 Jul 2016 Volixibat receives Fast Track designation for Non-alcoholic steatohepatitis [PO,od] in USA
  • 29 Jul 2016 Adverse events data from phase I trials in healthy volunteers released by Shire
  • 16 Jul 2016 No recent reports of development identified for phase-I development in Cholestasis in USA (PO)
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