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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization

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Trial Profile

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Dec 2025

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At a glance

  • Drugs Direclidine (Primary)
  • Indications Bipolar depression
  • Focus Adverse reactions
  • Sponsors Nxera Pharma

Most Recent Events

  • 17 Dec 2025 Planned number of patients changed to 150.
  • 17 Dec 2025 Status changed from planning to not yet recruiting.
  • 20 Jan 2025 New trial record

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