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Volixibat - Mirum Pharmaceuticals

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Drug Profile

Volixibat - Mirum Pharmaceuticals

Alternative Names: LUM-002; SAR-548304; SHP-626; Volixibat - Takeda; Volixibat potassium

Latest Information Update: 12 Sep 2025

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At a glance

  • Originator sanofi-aventis
  • Developer Mirum Pharmaceuticals; Sanofi; Shire
  • Class Anti-inflammatories; Antihyperlipidaemics; Benzothiepins; Hepatoprotectants; Urea compounds
  • 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
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Primary biliary cirrhosis
  • Phase II Intrahepatic cholestasis; Primary sclerosing cholangitis
  • No development reported Cholestasis
  • Discontinued Hypercholesterolaemia; Non-alcoholic steatohepatitis

Most Recent Events

  • 08 Sep 2025 Mirum Pharmaceuticals completes enrollment in the phase II VISTAS trial in Primary sclerosing cholangitis in US, Argentina, Belgium, Italy, Germany, Canada, Israel, the Netherlands, the United Kingdom, Australia, Brazil, France, Spain and Switzerland (PO) (NCT04663308)
  • 12 May 2025 Updated efficacy data from the phase IIb VANTAGE trial in Primary biliary cirrhosis released by Mirum Pharmaceuticals
  • 07 May 2025 Interim efficacy and adverse events data from the phase IIb VANTAGE trial in Primary biliary cirrhosis presented at the European Association for the Study of the Liver Congress 2025 (EASL-2025)

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