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Maralixibat - Mirum Pharmaceuticals

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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: 13 Aug 2025

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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; Pruritus; Primary biliary cirrhosis; Intrahepatic cholestasis; Primary sclerosing cholangitis
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 01 Jun 2025 Launched for Intrahepatic cholestasis in USA (PO)
  • 01 Jun 2025 Launched for Pruritus in USA (PO)
  • 23 Apr 2025 Mirum Pharmaceuticals completes a phase III trial in Intrahepatic cholestasis (In infants, In children, In adolescents) in Argentina, Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Italy, Lebanon, Mexico, Poland, Singapore, Turkey, United Kingdom, USA (PO) (NCT04185363)

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