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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: 10 Feb 2026

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At a glance

  • Originator Pfizer
  • Developer CANbridge Pharmaceuticals; GC Biopharma; Mirum Pharmaceuticals; Pfizer; Takeda
  • Class Amines; Anti-inflammatories; Antihyperlipidaemics; Antipruritics; Azabicyclo compounds; Benzothiepins; Dioxoles; Hepatoprotectants; Onium compounds; Skin disorder therapies; 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

  • 05 Feb 2026 Launched for Pruritus (In adolescents, In children, In infants) in Canada (PO)
  • 05 Feb 2026 The Health Canada approves maralixibat oral solution and tablet formulation for cholestatic pruritus in patients aged 12 months or older with progressive familial intrahepatic cholestasis (PFIC)
  • 25 Jul 2025 Takeda completes a phase III trial in Pruritus (In infants, In children, In adolescents, In adults, In the elderly) in Japan (PO) (NCT05543174)

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