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A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of iloperidone for 4 weeks in the treatment of patients with acute manic episodes associated with Bipolar I Disorder

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Trial Profile

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of iloperidone for 4 weeks in the treatment of patients with acute manic episodes associated with Bipolar I Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 May 2024

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At a glance

  • Drugs Iloperidone (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Vanda Pharmaceuticals

    • Most Recent Events

    • 08 May 2024 According to a Vanda Pharmaceuticals media release, in April 2024 that the U.S. Food and Drug Administration (FDA) approved Fanapt as a first line treatment of acute bipolar I disorder in adults.
    • 19 Apr 2024 Status changed from active, no longer recruiting to completed.
    • 07 Feb 2024 According to a Vanda Pharmaceuticals media release, findings from this study have been submitted to the FDA as part of Vanda's sNDA for Fanapt in the treatment of bipolar I disorder in adults.

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