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Clinical trial

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

NCT07288320 is registered in ClinicalTrials.gov with Neurocrine Biosciences as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Neurocrine Biosciences
Phase
Phase 2
Overall status
Recruiting
Start date
December 24, 2025
Completion date
February 29, 2028
Enrollment
150 (estimated)
Sites
11

Conditions

As the registry lists them; a condition with its own page is linked.

bipolar i disorder, mania