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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: 30 Jan 2026

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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

  • 02 Dec 2025 Albireo completes a phase III trial for Intrahepatic cholestasis (In infants, In children, In adolescents, In adults) in the US, Australia, Belgium, Canada, France, Germany, Israel, Italy, the Netherlands, Poland, Spain, Sweden, Turkey, Saudi Arabia, the UK (PO) (NCT03659916)
  • 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

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