Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Study Overview: Bristol-Myers Squibb is conducting a Phase 3 study titled ‘A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer’s Disease (ADAGIO-3)’. The study aims to assess the long-term efficacy and safety of the combined formulation of xanomeline tartrate/trospium chloride (KarXT) and xanomeline enteric capsules (KarX-EC) in patients with Alzheimer’s-related agitation who have completed previous studies.
Intervention/Treatment: The study tests two drugs: KarXT, an immediate-release capsule, and KarX-EC, an enteric capsule. Both are designed to manage agitation symptoms in Alzheimer’s patients.
Study Design: This is an interventional study with a single-group assignment. It is non-randomized and open-label, meaning all participants receive the treatment and both researchers and participants know what treatment is being administered. The primary purpose is treatment-focused.
Study Timeline: The study is not yet recruiting, with an estimated start date of November 21, 2025. It was first submitted on April 15, 2025, and last updated on June 24, 2025. These dates are crucial for tracking the study’s progress and potential market entry.
Market Implications: The successful development of KarXT and KarX-EC could significantly impact Bristol-Myers Squibb’s stock performance by addressing a critical need in Alzheimer’s treatment. This development could also influence investor sentiment positively, as the market for Alzheimer’s therapies is competitive and growing.
The study is ongoing, with further details available on the ClinicalTrials portal.