Bristol-Myers Squibb’s KarXT Safety Study: What Long-Term Urological Data Could Mean for BMY Investors

Bristol-Myers Squibb Company (BMY) announced an update on their ongoing clinical study.

Study Overview: Bristol-Myers Squibb is running a 12‑month, phase 4 safety study titled “A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety.” The goal is to understand how KarXT affects bladder function and general urinary safety in people with schizophrenia, an area that can limit long‑term use of many psychiatric drugs and directly influence real‑world adoption and market potential.

Intervention/Treatment: The study tests KarXT, also known as xanomeline/trospium chloride or BMS‑986510. It is an oral drug combo designed to treat schizophrenia symptoms while reducing common side effects seen with older drugs, especially those tied to the urinary system. The focus here is not on how well it works on symptoms, but on how safe it is for everyday use over a year.

Study Design: This is an interventional, phase 4 trial with a single treatment group; all participants receive KarXT. There is no random assignment to different drugs or a placebo. The study is open‑label, meaning both doctors and patients know they are taking KarXT. The main purpose is treatment safety, with close tracking of urinary symptoms and any problems that could limit long‑term prescribing.

Study Timeline: The study was first submitted on October 13, 2025, marking the start of formal regulatory tracking and site setup. It is currently listed as “recruiting,” so active enrollment is under way but primary completion and final completion dates are still ahead and not yet reported. The most recent update was submitted on January 20, 2026, signaling that the sponsor is actively maintaining the record and that the protocol or operational details were recently refreshed.

Market Implications: For investors, this update highlights Bristol-Myers Squibb’s push to de‑risk KarXT’s long‑term safety profile in schizophrenia, a market with strong demand but heavy side‑effect concerns. Clear urological safety over 12 months would support broader physician confidence, better persistence on therapy, and potential premium pricing, which could be a meaningful long‑term revenue driver. Conversely, any safety red flags could slow uptake or invite tighter labeling. The study also matters in the context of competing therapies from large players in neuropsychiatry that often carry metabolic or neurological burdens; a cleaner urinary and overall side‑effect profile could help KarXT stand out. While this is an early safety‑focused step and not yet a revenue inflection point, the fresh update and recruiting status are modest positives for sentiment around BMY’s neuroscience pipeline and its ability to compete in the evolving schizophrenia drug landscape.

The study is currently ongoing and recently updated, with further details available on the ClinicalTrials portal.

To learn more about BMY’s potential, visit the Bristol-Myers Squibb Company drug pipeline page.