Regeneron and Sanofi Complete Key Dupilumab Pregnancy Safety Study With Fresh Data Update
Regeneron Pharmaceuticals (REGN), Sanofi (SNYNF) announced an update on their ongoing clinical study.
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The post-authorization safety study NCT04173442 tracks pregnancy and infant outcomes after exposure to Dupilumab, co-developed by Regeneron (REGN) and Sanofi (SNYNF). It compares women on the drug with similar patients not taking it and with healthy pregnant women, providing key real-world safety data that can shape long-term demand and labeling confidence.
Dupilumab (Dupixent) is an injectable biologic drug used for conditions like atopic dermatitis and asthma. This study focuses on its use in women who are pregnant, aiming to show whether use during pregnancy affects the baby or mother compared with no exposure.
The study is observational and uses a prospective cohort design that follows groups of pregnant women over time. There is no random assignment or blinding; researchers only observe outcomes in Dupilumab-exposed patients, disease-matched controls, and healthy controls to spot any differences in birth or infant health.
The trial began after submission on November 20, 2019, marking the start of patient tracking in routine care. The overall status is listed as completed, and the most recent update was filed on March 2, 2026, showing that final data review or reporting is still in progress even though follow-up is over.
For investors, a completed pregnancy safety study with recent updates is important because it can remove a key overhang on Dupixent’s broad use. Positive or neutral findings versus controls would support sustained sales growth and may improve physician comfort, which is bullish for REGN and SNYNF compared with other biologic competitors.
The latest ClinicalTrials.gov update confirms that this large North American pregnancy safety study of Dupilumab is completed and recently updated, and further details are available on the ClinicalTrials portal.
To learn more about REGN’s potential, visit the Regeneron Pharmaceuticals drug pipeline page.
