FDA Mandates Additional Phase III Trial for Apraglutide in Short Bowel Syndrome Treatment

The Food and Drug Administration (FDA) will require an additional Phase III clinical trial for apraglutide, a drug candidate developed for the treatment of short bowel syndrome. This decision means the company developing apraglutide must conduct another large-scale study to further evaluate the drug’s safety and efficacy before the FDA considers it for approval. Specifically, the FDA’s requirement stipulates that the company must initiate and complete a new Phase III trial. Phase III trials are typically large, randomized controlled studies that provide substantial evidence about a drug’s benefits and risks in a patient population. The trial will focus on apraglutide’s performance in treating short bowel syndrome, a condition where the small intestine is unable to absorb enough nutrients. The company will need to design and execute the trial, enroll patients, collect data, and analyze the results to meet the FDA’s requirements.

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Date: April 15, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後