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Odevixibat - Ipsen

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Drug Profile

Odevixibat - Ipsen

Alternative Names: A-4250; BYLVAY; KAYFANDA; Odevixibat sesquihydrate - Alberio Pharma; ODEVIXIBAT1

Latest Information Update: 17 Jul 2026

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At a glance

  • Originator Albireo AB
  • Developer Albireo Pharma; Ipsen
  • Class Acetamides; Anti-inflammatories; Butyric acids; Hepatoprotectants; Skin disorder therapies; 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

  • 22 Jun 2026 Albireo completes phase III trial in Biliary atresia (In infants, In neonates) in the US, the Netherlands, Hungary, the UK, France, Germany, Belgium, Malaysia, Spain, South Korea, Poland, New Zealand, Canada, Taiwan, Australia, Italy, Isarel and Turkey, China and Denmark (PO) (NCT04336722)
  • 13 Apr 2026 Ipsen plans a observational trial for Alagille Syndrome (In infants, In children, In adolescents, In adults, In the elderly) in September 2026 (PO) (NCT07585097)
  • 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)

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