Phathom Pharmaceuticals, Inc. ((PHAT)) announced an update on their ongoing clinical study.
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Phathom Pharmaceuticals, Inc. is conducting an observational study titled ‘Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring.’ The primary objective is to assess the safety of vonoprazan exposure in pregnant women by comparing maternal, fetal, and infant outcomes with those of a cohort not exposed to the drug. This study is significant as it aims to provide crucial safety data for vonoprazan, a treatment for conditions like erosive esophagitis and heartburn, during pregnancy.
The intervention being tested is the drug vonoprazan, administered as an oral tablet. It is intended to treat conditions such as erosive esophagitis, heartburn, and gastroesophageal reflux disease.
The study is designed as a prospective cohort observational study. It involves two groups: pregnant women exposed to vonoprazan and those who are not. The primary purpose is to observe and compare outcomes between these groups.
The study began on October 22, 2024, with an estimated primary completion date of 12 months from the start. The latest update was submitted on May 21, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
This study update could impact Phathom Pharmaceuticals’ stock performance and investor sentiment, as positive safety data might enhance vonoprazan’s market potential. In the competitive pharmaceutical industry, demonstrating drug safety during pregnancy can provide a significant market advantage.
The study is currently recruiting, with further details available on the ClinicalTrials portal.