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Odevixibat - Albireo Pharma

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Drug Profile

Odevixibat - Albireo Pharma

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

Latest Information Update: 13 Feb 2024

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At a glance

  • Originator Albireo AB
  • Developer Albireo AB; Albireo Pharma
  • 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

  • 08 Feb 2024 Ipsen anticipates regulatory approval for Alagille syndrome in the EU, in the second half of 2024
  • 08 Jan 2024 Updated efficacy and safety data from a phase III PEDFIC 1 and PEDFIC 2 trial in Intrahepatic cholestasis presented at the 74th Annual Meeting of the American Association for the Study of Liver Diseases
  • 30 Nov 2023 Discontinued - Phase-I for Primary sclerosing cholangitis in USA (PO) before November 2023 (Ipsen pipeline, November 2023)
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