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Maralixibat - Mirum Pharmaceuticals

Drug Profile

Maralixibat - Mirum Pharmaceuticals

Alternative Names: CAN 108; GC-2127A; LIVMARLI; Lopixibat - Mirum Pharmaceuticals; Lopixibat chloride - Mirum Pharmaceuticals; LUM-001; Maralixibat chloride - Mirum Pharmaceuticals; SD-5613; SHP 625; TAK-625

Latest Information Update: 12 Jul 2024

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At a glance

  • Originator Pfizer
  • Developer CANbridge Pharmaceuticals; GC Biopharma; Mirum Pharmaceuticals; Pfizer; Takeda
  • Class Amines; 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 - Biliary atresia; Primary biliary cirrhosis; Alagille syndrome; Intrahepatic cholestasis; Primary sclerosing cholangitis
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 08 Jul 2024 Registered for Intrahepatic cholestasis (In infants, In adolescents, In children, In adults, In the elderly) in Iceland, Norway, Liechtenstein, European Union (PO)
  • 31 May 2024 EMA's Committee for Orphan Medicinal Products (COMP) recommends maintenance of Orphan Drug Designation for maralixibat in Intrahepatic cholestasis
  • 31 May 2024 Mirum Pharmaceuticals announces its intention receive final decision of CHMP and COMP opinions for Intrahepatic cholestasis (In adolescents, In children, In infants) in the third quarter of 2024
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