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BALSAM-2 Phase 3 study of KarXT for manic episodes in bipolar I disorder
2024-520195-94-00Phase 3Authorised
- Sponsor
- Bristol Myers Squibb
- Start
- Sep 2025
- Modality
- Small Molecules
- Countries
- 8
01
Overview
Phase 3, randomised, double-blind trial in bipolar I disorder comparing KarXT with KarXT Matching Placebo (2 arms). Primary endpoint: Change from baseline in Young Mania Rating Scale score at Week 3. Planned start Sep 2025; status: authorised.
02
Drugs
xanomeline
03
Conditions
bipolar I disorder
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