Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG is conducting a Phase 4 clinical study titled A Single-arm, Open-label Phase 4 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy for Participants in India With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC). The study aims to evaluate the safety and efficacy of darolutamide, a drug used to treat prostate cancer, in Indian patients with high-risk nmCRPC. This study is significant as it seeks to provide insights into the treatment’s performance in a real-world setting specifically for Indian participants.
Intervention/Treatment: The intervention being tested is darolutamide, marketed as Nubeqa, which is a drug designed to block androgens from attaching to proteins in prostate cancer cells. Participants will take 600 mg tablets orally twice a day, totaling a daily dose of 1200 mg, alongside standard androgen deprivation therapy (ADT).
Study Design: This is an interventional study with a single-group assignment. There is no allocation or masking involved, meaning all participants receive the treatment, and the study is open-label. The primary purpose of the study is treatment-focused, aiming to assess the safety and effectiveness of darolutamide in the specified patient group.
Study Timeline: The study began on August 3, 2022, with the primary completion and estimated study completion dates yet to be specified. The last update was submitted on July 25, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might be available.
Market Implications: The study’s findings could impact Bayer AG’s stock performance by potentially expanding the market for darolutamide in India, enhancing investor confidence. Given the competitive landscape in prostate cancer treatments, positive results could position Bayer favorably against competitors, potentially influencing market dynamics and investor sentiment.
The study is ongoing, with further details available on the ClinicalTrials portal.