Adial Pharmaceuticals announced on May 8, 2025, that the U.S. Food and Drug Administration (FDA) has granted its request for an End of Phase 2 (EOP2) meeting. This meeting is scheduled to take place on July 25, 2025.
The purpose of the EOP2 meeting is to discuss Adial’s proposed clinical development plan and protocol designs for its lead investigational drug, AD04. AD04 is a genetically targeted, serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD).
This meeting represents a crucial step in aligning with the FDA on the design of the Phase 3 clinical trial for AD04. Clarity and validation from the FDA on the clinical development path are expected to strengthen Adial’s position in discussions with potential partners.
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