Bayer AG ((BAYRY)) announced an update on their ongoing clinical study.
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Bayer AG is conducting an observational study titled ‘Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant.’ The study aims to assess the safety of nifurtimox, a drug used for over 50 years to treat Chagas disease, when administered during pregnancy. The primary focus is on understanding the risk of birth defects, pregnancy outcomes, and health issues in children up to 12 months old, as well as maternal complications.
The intervention being tested is the drug nifurtimox (BAYA2502), which is administered to pregnant women diagnosed with Chagas disease. The study seeks to gather data on its effects on both the mother and the developing child.
This observational study follows a cohort model with a prospective time perspective. It does not involve any specific allocation or masking, as it is designed to collect data from women who have already been exposed to the drug during pregnancy.
The study was first submitted on May 19, 2022, and is currently not yet recruiting. The last update was submitted on October 3, 2025. These dates are crucial as they indicate the study’s progression and timeline for data collection and analysis.
The update on this study could influence Bayer’s stock performance and investor sentiment, especially given the potential market implications of successfully addressing safety concerns related to nifurtimox use during pregnancy. The study’s findings could also impact the broader pharmaceutical industry, particularly companies involved in treating Chagas disease.
The study is ongoing, with further details available on the ClinicalTrials portal.