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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: 26 Mar 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

  • 17 Mar 2026 Mirum Pharmaceuticals completes enrollment in a phase-III EXPAND trial in Pruritus (In children, In infants, In adults, In adolescents) in US, France, Italy, Poland, Spain, United Kingdom, Brazil, Canada, Lebanon, Spain, Saudi Arabia and Germany (PO) (NCT06553768)
  • 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)

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