Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Bayer AG has initiated a post-marketing surveillance study titled ‘Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients.’ The study aims to evaluate the safety of darolutamide, a treatment for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in Korean patients. This observational study is significant as it provides insights into the real-world safety profile of darolutamide, enhancing understanding of its effects in a specific population.
The intervention being tested is darolutamide, marketed as Nubeqa, which is designed to delay cancer growth by blocking androgens from attaching to androgen receptors in prostate cells. It is already approved for use in nmCRPC and mHSPC, making this study crucial for monitoring its safety post-approval.
The study is observational with a cohort model and a prospective time perspective. Participants will be monitored for adverse events over a one-year period, with data collected from their medical records. The study’s primary purpose is to gather safety data on darolutamide in a real-world setting.
The study began on September 25, 2024, with an estimated completion timeline of six years. The last update was submitted on August 21, 2025. These dates are critical as they mark the study’s progress and ongoing data collection phases.
For investors, this update could influence Bayer AG’s stock performance positively by reinforcing the safety profile of darolutamide, potentially increasing its market adoption. In the competitive landscape of prostate cancer treatments, maintaining a strong safety record is vital for sustaining market share and investor confidence.
The study is currently recruiting, and further details can be accessed on the ClinicalTrials portal.