An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
← catalyst calendarNCT07288320 · readout ≤ 559 d
Sponsored by Neurocrine Biosciences (industry) · NBIX — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
150estimated
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-24 | actual | When the study began enrolling |
| Primary completion | Feb 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bipolar I Disorder
- Mania
Interventions
- Drug: NBI-1117568
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21
measured Baseline, Day 21
Permalink · NBIX's whole pipeline · Catalyst calendar · Every registered study · What changed