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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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 02 Aug 2026

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At a glance

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

Most Recent Events

  • 24 Mar 2026 Status changed from not yet recruiting to recruiting.
  • 17 Dec 2025 Planned number of patients changed to 150.
  • 17 Dec 2025 Status changed from planning to not yet recruiting.

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