Trial intelligence / Profile preview

BALSAM-1: KarXT in manic episodes of bipolar I disorder

jRCT2041250071Phase 3Recruiting

Sponsor
Bristol Myers Squibb
Start
Aug 2025
Modality
Small Molecules
01

Overview

Phase 3, randomised, double-blind trial in bipolar I disorder comparing KarXT with Placebo (2 arms). Primary endpoint: Change from baseline in Young Mania Rating Scale (YMRS) score at Week 3. Started Aug 2025; status: recruiting.

02

Drugs

xanomeline
03

Conditions

bipolar I disorder

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