Trial intelligence / Profile preview

Adjunctive KarXT for Treatment of Bipolar I Mania

2025-521845-26-00Phase 3Authorised

Sponsor
Bristol Myers Squibb
Start
Mar 2026
Modality
Small Molecules
Countries
11
01

Overview

Phase 3, randomised, double-blind trial in bipolar I disorder comparing KarXT adjunctive arm with Placebo adjunctive arm (2 arms). Primary endpoint: Change from baseline in Young Mania Rating Scale (YMRS) score at Week 5. Planned start Mar 2026; status: authorised.

02

Drugs

xanomeline
03

Conditions

bipolar I disorder

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