Lopixibat chloride

Drug Profile

Lopixibat chloride

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

Latest Information Update: 10 Sep 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; Primary sclerosing cholangitis; Intrahepatic cholestasis
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 15 Dec 2016 Biomarkers information updated
  • 01 Nov 2016 Shire completes the ITCH trial in Alagille syndrome (In children, In adolescents) in USA and Canada (PO) (NCT02057692)
  • 13 Jun 2016 Lopixibat chloride receives Breakthrough Therapy status for Intrahepatic cholestasis (In children, In infants, In adolescents) in USA
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