Neurocrine Biosciences Launches Phase 2 Trial for Bipolar I Disorder Treatment

Neurocrine Biosciences (NBIX) announced an update on their ongoing clinical study.

Neurocrine Biosciences (NBIX) has initiated a Phase 2 clinical study titled 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. The study aims to evaluate the effectiveness and safety of NBI-1117568 in alleviating manic symptoms in people with bipolar I disorder, a condition with significant unmet therapeutic needs.

The study will test the oral drug NBI-1117568 in comparison to a placebo. NBI-1117568 is a novel treatment designed to help manage acute manic episodes or mixed features in patients with bipolar I disorder, potentially offering a new option in this challenging therapeutic area.

The design of the trial includes random assignment to treatment groups, a parallel intervention model, and double-blinding to ensure unbiased results. This interventional study focuses on treatment efficacy, with key assessments planned during the trial.

The study, still listed as Not Yet Recruiting, was first submitted to the database on December 15, 2025, and has the same date marked as its last update. Timely updates on start, primary completion, and estimated end dates are expected to follow.

For Neurocrine Biosciences, positive outcomes in this trial could strengthen its portfolio and foster investor confidence, potentially driving stock performance. With bipolar I disorder treatments being a competitive space, success in this trial could provide the company an edge over larger players.

This study is ongoing, with more details available on the ClinicalTrials portal.

To learn more about NBIX’s potential, visit the Neurocrine Biosciences drug pipeline page.