Lopixibat chloride

Drug Profile

Lopixibat chloride

Alternative Names: LUM-001; Maralixibat; SD-5613; SHP 625

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Pfizer
  • Developer Childhood Liver Disease Research and Education Network; Pfizer; Shire
  • Class Azabicyclo compounds; Benzothiepins; Dioxoles; Hepatoprotectants; Onium compounds; Small molecules
  • 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.

    Yes - Primary biliary cirrhosis; Alagille syndrome; Primary sclerosing cholangitis; Intrahepatic cholestasis
  • 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

  • Phase II Alagille syndrome; Intrahepatic cholestasis; Primary biliary cirrhosis; Primary sclerosing cholangitis
  • Discontinued Hypercholesterolaemia

Most Recent Events

  • 13 Jun 2016 Lopixibat chloride receives Breakthrough Therapy status for Intrahepatic cholestasis (In children, In infants, In adolescents) in USA
  • 16 Apr 2016 Adverse events and efficacy data from the phase II CLARITY trial in Primary biliary cirrhosis released by Shire
  • 01 Dec 2015 Shire completes a phase II trial in Primary sclerosing cholangitis in USA, United Kingdom and Canada (NCT02061540)
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