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Brexpiprazole - Lundbeck/Otsuka

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Drug Profile

Brexpiprazole - Lundbeck/Otsuka

Alternative Names: Lu-AF41156; OPC-34712; OPC-34712 FUM; OPDC-34712; Rexulti; REXULTIOD; Rxulti

Latest Information Update: 25 Dec 2024

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At a glance

  • Originator Otsuka Pharmaceutical Development & Commercialization
  • Developer Lundbeck A/S; Otsuka Beijing Research Institute; Otsuka Pharmaceutical Development & Commercialization; University of Chicago
  • Class Antidepressants; Antipsychotics; Behavioural disorder therapies; Piperazines; Quinolines; Sleep disorder therapies; Small molecules; Thiophenes
  • Mechanism of Action Dopamine D2 receptor partial agonists; Serotonin 1A receptor partial agonists; Serotonin 5-HT2A receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Agitation; Major depressive disorder; Schizophrenia
  • Preregistration Post-traumatic stress disorders
  • Phase III Bipolar disorders; Pervasive child development disorders; Sleep disorders
  • Discontinued Attention-deficit hyperactivity disorder; Borderline personality disorders

Most Recent Events

  • 18 Dec 2024 Efficacy and adverse events data from the phase III trial in Post-traumatic stress disorder released by Otsuka Pharmaceutical Development & Commercialization
  • 30 Jun 2024 Registered for Schizophrenia in China (PO) before June 2024 (Otsuka Pharmaceutical pipeline, August 2024)
  • 25 Jun 2024 Preregistration for Post-traumatic stress disorders (Combination therapy) in USA (PO) prior to June 2024

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