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An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

Name: An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania — clinical trial record (NCT07288320)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 2

SponsorNeurocrine Biosciences

Started2025-12-24

View on ClinicalTrials.gov ↗

Amendment history

2026-07-29

Study Status, Contacts/Locations v2

Trial sites expanded: 6 → 9 locations

2026-03-20

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-12→confirmed 2025-12-24

Study sites0→6

2025-12-15

Original filing

Neurocrine Biosciences

25 trials monitored

See 1 trial at risk

Bipolar Disorder

384 trials monitored

See 22 trials at risk

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.

Trial Details

NCT Number	NCT07288320
Lead Sponsor	Neurocrine Biosciences
Conditions	Bipolar I Disorder, Mania
Enrollment	150 participants
Start Date	2025-12-24
Primary Completion	2028-02 (estimated)
Study Completion	2028-02 (estimated)
Updated on ClinicalTrials.gov	2026-09-29