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Confirmatory study of DSP-5423 in pediatric patients with schizophrenia

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Trial Profile

Confirmatory study of DSP-5423 in pediatric patients with schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Mar 2022

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At a glance

  • Drugs Blonanserin (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Sumitomo Dainippon Pharma

    • Most Recent Events

    • 01 Feb 2022 Results published in the Journal of Child and Adolescent Psychopharmacology
    • 22 Jul 2019 According to a Sumitomo Dainippon Pharma media release, based on the results of the study, the company plans to submit a supplemental new drug application in the first half of fiscal 2020 for approval of an additional indication of LONASEN in the treatment of adolescent patients with schizophrenia in Japan.
    • 22 Jul 2019 Primary endpoint has not been met. (PANSS total score change from baseline [8 mg/day]), according to a Sumitomo Dainippon Pharma media release.

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