Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG, in collaboration with Janssen Research & Development, LLC, is conducting an observational study titled ‘Xarelto Paediatric VTE PASS Drug Utilization Study.’ The study aims to evaluate the drug use patterns and safety of Rivaroxaban oral suspension in children under two years old with venous thromboembolism (VTE). This research is significant as it seeks to fill the gap in knowledge regarding the safety and efficacy of Rivaroxaban in this young demographic.
Intervention/Treatment: The study focuses on two interventions: Rivaroxaban (Xarelto, BAY59-7939) and the standard of care (SOC) treatments, which include heparins, Vitamin K antagonists (VKAs), and other direct oral anticoagulants (DOACs). These treatments aim to manage VTE in pediatric patients.
Study Design: This is a retrospective, observational cohort study. It will utilize data from national health registers and health insurance claims across several European countries. The primary purpose is to observe and collect data on the safety and usage patterns of the treatments without any additional tests or interventions.
Study Timeline: The study is set to start on December 31, 2025, with data collection continuing until 2026. The last update was submitted on August 19, 2025. These dates are crucial as they mark the phases of data collection and analysis, which are vital for timely insights into the treatment’s safety and efficacy.
Market Implications: This study could significantly impact Bayer AG’s stock performance and investor sentiment. Positive results may enhance the company’s reputation in pediatric care and increase the market share of Rivaroxaban. However, investors should also consider the competitive landscape, including other anticoagulants in the market.
The study is ongoing, and further details are available on the ClinicalTrials portal.