Ipsen’s Odevixibat Study: A Closer Look at Pregnancy and Lactation Safety

Ipsen ((GB:0MH6)) announced an update on their ongoing clinical study.

In a significant update, Ipsen has announced the continuation of its Odevixibat Pregnancy and Lactation Surveillance Program. Officially titled ‘Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study,’ the study aims to assess the safety of Odevixibat during pregnancy and lactation. The focus is on evaluating risks of pregnancy complications and adverse effects on infants exposed to the drug, highlighting its importance for maternal and infant health.

The study investigates Odevixibat, a treatment designed to manage specific pregnancy-related conditions. The drug’s safety profile during pregnancy and lactation is under scrutiny, aiming to ensure it does not adversely affect mothers or their infants.

This observational study is designed to collect data from various sources, including healthcare providers and pharmacovigilance records. It follows a prospective time perspective, meaning it will monitor participants over time without altering their treatment plans. The study is purely observational, with no additional tests required beyond routine medical care.

Key dates for the study include its start on February 2, 2024, with the latest update submitted on August 28, 2025. These timelines are crucial for tracking the study’s progress and ensuring timely data collection and analysis.

For investors, this study could impact Ipsen’s market position by potentially enhancing the safety profile of Odevixibat, thereby influencing stock performance positively. As the study progresses, it may also affect investor sentiment towards Ipsen, especially if the results support the drug’s safety during critical periods of pregnancy and lactation.

The study is currently ongoing, with further details available on the ClinicalTrials portal.