Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Bayer AG, in collaboration with Janssen Research & Development, LLC, 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 efficacy of rivaroxaban, an anticoagulant, in preventing blood clots in children with CHD who have undergone the Fontan procedure. This research is significant due to the limited data available, particularly in Japanese patients, and seeks to better understand the occurrence of major and non-major bleeding events in this population.
The intervention being tested is rivaroxaban, marketed as Xarelto, which is designed to prevent blood clot formation by inhibiting a specific protein. It is already approved for use but carries a risk of increased bleeding.
This study follows a cohort observational model with a prospective time perspective. It involves collecting data from regular health visits without requiring additional tests or visits, focusing on real-world usage of rivaroxaban in pediatric patients.
The study began in December 2023, with primary data collection expected to complete by June 2026. The last update was submitted in July 2025. These dates are crucial for tracking the study’s progress and anticipating results.
For investors, this study could influence Bayer’s stock performance by potentially expanding the market for rivaroxaban if the results are favorable. It also highlights Bayer’s commitment to addressing unmet medical needs in pediatric populations, which could positively affect investor sentiment. Competitors in the anticoagulant market may also be impacted depending on the study’s outcomes.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.