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NCT07288320 · ClinicalTrials.gov registry record · Phase 2
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
A Phase 2 study, sponsored by Neurocrine Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT07288320: Recruiting Phase 2 study, sponsored by Neurocrine Biosciences.
NCT07288320 is a Phase 2 study that is actively recruiting participants, run by Neurocrine Biosciences. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07288320, a Phase 2 study, is actively recruiting participants, sponsored by Neurocrine Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG NBI-1117568
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-12-24 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What NCT07288320 shows while recruiting
NCT07288320 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07288320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07288320 about?
NCT07288320 is a clinical study titled "An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania". 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.
What is the current status of trial NCT07288320?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-12-24. Estimated completion is 2028-02.
What interventions are being tested in trial NCT07288320?
The interventions under investigation include: Placebo (DRUG), NBI-1117568 (DRUG).
Who is sponsoring clinical trial NCT07288320?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07288320's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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