Lopixibat chloride

Drug Profile

Lopixibat chloride

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

Latest Information Update: 14 Dec 2017

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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; Intrahepatic cholestasis; Primary sclerosing cholangitis
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 14 Dec 2017 Shire plans a phase III trial for Alagille syndrome (Shire pipeline, December 2017)
  • 27 Nov 2017 Shire plans a phase III trial for Intrahepatic Cholestasis in USA , (NCT03353454)
  • 24 Oct 2017 Additional efficacy data from a phase II trial in Intrahepatic cholestasis presented at the 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2017)
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