Aripiprazole lauroxil

Drug Profile

Aripiprazole lauroxil

Alternative Names: ALKS-9070; ALKS-9072; ARISTADA

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Alkermes
  • Developer Alkermes plc
  • Class Antipsychotics; Piperazines; Quinolines; Small molecules
  • Mechanism of Action Dopamine D2 receptor agonists; Serotonin 1A receptor agonists; Serotonin 2A receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Schizophrenia

Most Recent Events

  • 20 Mar 2017 FDA assigns PDUFA action date of 05/06/2017 for aripiprazole lauroxil (bi-monthly) for Schizophrenia
  • 17 Feb 2017 US FDA accepts sNDA for aripiprazole lauroxil (bi-monthly) for Schizophrenia for review (Alkermes plc 10-K, February 2017)
  • 08 Aug 2016 Alkermes receives patent allowance for Patent application 14/663 042 for aripiprazole lauroxil in USA
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