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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: 14 Jan 2025

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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

  • 10 Jan 2025 Otsuka Pharmaceutical plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting with US FDA to seek input on issues related to the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder in first half of 2025
  • 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)

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