A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
← catalyst calendarNCT06929273 · readout in 663 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
450estimated
Sites
174
Countries
Argentina, Australia, Bulgaria +17
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 | 2025-07-18 | actual | When the study began enrolling |
| Primary completion | 2028-06-13 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-13 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Bipolar Disorder Type I With Mania
Interventions
- Drug: KarXT — also filed as BMS-986510, Xanomeline and trospium chloride
- Drug: Lithium
- Drug: Valproate
- Drug: Lamotrigine
Primary outcome
what the primary-completion date above is the date OFNumber of participants with treatment emergent adverse events (TEAEs)
measured Up to week 54
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