Brexpiprazole - Lundbeck/Otsuka

Drug Profile

Brexpiprazole - Lundbeck/Otsuka

Alternative Names: Lu-AF41156; OPC-34712; OPDC-34712; Rexulti; RXULTI

Latest Information Update: 01 Feb 2018

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At a glance

  • Originator Otsuka Pharmaceutical Development & Commercialization
  • Developer Duke University; Lundbeck A/S; Otsuka Pharmaceutical Development & Commercialization
  • Class Antidepressants; Antipsychotics; Behavioural disorder therapies; Piperazines; Quinolines; Small molecules; Thiophenes
  • Mechanism of Action Alpha 1 adrenergic receptor antagonists; Alpha 2c adrenergic receptor antagonists; Dopamine D2 receptor partial agonists; Norepinephrine plasma membrane transport protein modulators; Serotonin 1A receptor partial 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Major depressive disorder; Schizophrenia
  • Phase III Agitation; Bipolar disorders; Post-traumatic stress disorders; Sleep disorders
  • Discontinued Attention-deficit hyperactivity disorder

Most Recent Events

  • 19 Jan 2018 Registered for Schizophrenia in Japan (PO)
  • 12 Jan 2018 Otsuka Pharmaceutical Development & Commercialization terminates a phase I trial in Schizophrenia as Part A of study was completed per protocol and conduct of Part B of the study (confirmatory phase) was not necessary in USA (IM, SC, Controlled release) (NCT02968121)
  • 01 Nov 2017 Lundbeck and Otsuka plan a phase III trial for Agitation (in patients with dementia of the Alzheimer's type) in USA (PO) during the first half of 2018
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