A 4250

Drug Profile

A 4250

Alternative Names: A-4250

Latest Information Update: 12 Jan 2017

Price : $50

At a glance

  • Originator Albireo
  • Developer 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Intrahepatic cholestasis; Primary biliary cirrhosis; Pruritus
  • Phase I Alagille syndrome

Most Recent Events

  • 15 Nov 2016 The EMA designates PRIME status to A 4250 for Intrahepatic cholestasis in the EU
  • 15 Nov 2016 Albireo plans a pivotal phase III trial for Intrahepatic cholestasis in USA and European Union
  • 15 Oct 2016 Albireo terminates a phase-II clinical trial for Primary biliary cirrhosis and Cholestatic pruritus in Sweden (PO) (NCT02360852; EudraCT2014-004070-42)
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