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A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

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Trial Profile

A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2024

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At a glance

  • Drugs Olanzapine/samidorphan (Primary) ; Olanzapine
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ENLIGHTEN-1
  • Sponsors Alkermes plc

    • Most Recent Events

    • 08 Apr 2024 According to Alkermes plc media release , company announced the oral presentation of clinical data at the 2024 Congress of the Schizophrenia International Research Society (SIRS), which took place April 3-7, 2024 in Florence, Italy.
    • 03 Jan 2024 According to Alkermes plc media release, topline result is announced
    • 01 Jun 2021 According to Alkermes plc media release, the U.S. Food and Drug Administration (FDA) has approved LYBALVI™ (olanzapine and samidorphan) for the treatment of adults with schizophrenia results from this study are included in the approved labeling for LYBALVI.
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