# A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

> **NCT06951711** · PHASE3 · RECRUITING · sponsor: **Bristol-Myers Squibb** · enrollment: 274 (estimated)

## Conditions studied

- Bipolar Disorder Type I With Mania or Mania With Mixed Features

## Interventions

- **DRUG:** KarXT
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT06951711
- **Lead sponsor:** Bristol-Myers Squibb
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-06-13
- **Primary completion:** 2026-11-02
- **Final completion:** 2026-11-02
- **Target enrollment:** 274 (ESTIMATED)
- **Last updated:** 2026-04-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06951711

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06951711, "A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT06951711. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*