Bayer AG ((BAYRY)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG is conducting an observational study titled ‘Special Drug Use Investigation of Rivaroxaban in Pediatric Patients With Congenital Heart Disease (CHD) Who Had Undergone the Fontan Procedure.’ The study aims to assess the safety and effectiveness of rivaroxaban, an anticoagulant, in preventing blood clots in children with CHD post-Fontan surgery. This research is significant due to the limited data available, especially among Japanese patients, regarding the drug’s safety profile in this demographic.
Intervention/Treatment: The study focuses on rivaroxaban, marketed as Xarelto, which is used to prevent blood clot formation. It works by inhibiting a protein that causes blood to clot, thereby reducing the risk of thrombosis, a common complication post-Fontan procedure.
Study Design: This is a prospective, observational cohort study. It involves collecting data from regular health visits without requiring additional tests or visits. Researchers will gather information from medical records or interviews with the children and their guardians.
Study Timeline: The study began in December 2023 and is expected to conclude in June 2026. The primary completion date aligns with the end of data collection, while the last update was submitted in October 2025, indicating ongoing progress.
Market Implications: This study could influence Bayer’s stock performance by potentially expanding the market for rivaroxaban in pediatric use, especially if results demonstrate favorable safety and efficacy. Competitors in the anticoagulant market may also feel pressure to conduct similar studies to validate their products for pediatric use.
The study is currently ongoing, with further details available on the ClinicalTrials portal.