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Lopixibat chloride - Mirum Pharmaceuticals

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Drug Profile

Lopixibat chloride - Mirum Pharmaceuticals

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

Latest Information Update: 16 Nov 2019

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At a glance

  • Originator Pfizer
  • Developer Childhood Liver Disease Research and Education Network; Mirum Pharmaceuticals; Pfizer; Takeda
  • Class Anti-inflammatories; Antihyperlipidaemics; 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 III Intrahepatic cholestasis
  • Phase II Alagille syndrome; Primary biliary cirrhosis; Primary sclerosing cholangitis
  • Discontinued Hypercholesterolaemia

Most Recent Events

  • 04 Dec 2019 Mirum Pharmaceuticals plans an open-label extension phase III trial in Intrahepatic cholestasis in North America, Europe, Asia, and South America (NCT04185363; MRX-503)
  • 19 Nov 2019 Mirum Pharmaceuticals plans a phase II trial for Intrahepatic cholestasis (In childrens, In adolescents, In adults) in December 2019 (NCT04168385)
  • 07 Nov 2019 Mirum Pharmaceuticals announces intention to launch Lopixibat chloride for Alagille syndrome and progressive familial intrahepatic cholestasis
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