A 4250

Drug Profile

A 4250

Alternative Names: A-4250

Latest Information Update: 12 Jul 2018

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At a glance

  • Originator Albireo AB
  • Developer Albireo AB; Albireo Pharma
  • Class Antipruritics
  • 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; Intrahepatic cholestasis; Alagille syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Intrahepatic cholestasis
  • Phase II Primary biliary cirrhosis; Pruritus
  • Phase I Alagille syndrome
  • Preclinical Non-alcoholic steatohepatitis

Most Recent Events

  • 12 Jun 2018 US FDA grants Rare pediatric disease designation to A 4250 for Intrahepatic cholestasis in USA
  • 06 Jun 2018 Albireo AB plans a phase III trial for Progressive familial intrahepatic vholestasis types 1 and 2 (PEDFIC 2) (In children) in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Saudi Arabia, Spain, Sweden, Turkey, United Kingdom and USA (PO) (EudraCT 2017-002325-38)
  • 16 May 2018 Phase-III clinical trials in Intrahepatic cholestasis in United Kingdom (PO) (EudraCT2017-002338-21)
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