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Odevixibat - Albireo Pharma

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Drug Profile

Odevixibat - Albireo Pharma

Alternative Names: A-4250; Bylvay; Kayfanda; Kayfanda®; Odevixibat sesquihydrate - Alberio Pharma; ODEVIXIBAT1

Latest Information Update: 23 Oct 2025

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At a glance

  • Originator Albireo AB
  • Developer Albireo AB; Albireo Pharma; Ipsen
  • Class Acetamides; Butyric acids; Hepatoprotectants; Small molecules; Sulfones; Thiazepines
  • 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 - Intrahepatic cholestasis; Primary biliary cirrhosis; Biliary atresia; Alagille syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Alagille syndrome; Intrahepatic cholestasis
  • Phase III Biliary atresia
  • Phase II Cholestasis
  • Discontinued Non-alcoholic steatohepatitis; Primary biliary cirrhosis; Primary sclerosing cholangitis

Most Recent Events

  • 19 Sep 2025 Registered for Intrahepatic cholestasis (In adolescents, In adults, In children, In infants) in Japan (PO)
  • 09 Sep 2025 Preregistration for Alagille syndrome (In adults, In infants, In adolescents, In children) in Canada (PO) prior to September
  • 09 Sep 2025 Registered for Alagille syndrome (In adolescents, In children, In adults, In infants) in Canada (PO)

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