Adial Gains FDA Meeting To Finalise Phase 3 Design Of AD04 For Genetically Targeted AUD Treatment

Adial Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted the company an End of Phase 2 meeting to review and discuss the proposed development strategy for AD04, its lead investigational therapy for Alcohol Use Disorder (AUD). The meeting is scheduled for July 25, 2025, and will focus on the design of a planned Phase 3 trial using an adaptive with enrichment approach.

Cary Claiborne, President and Chief Executive Officer of Adial, stated, “We recently announced the successful results of our Type D Meeting with FDA, confirming Adial’s 505(b)(2) regulatory bridging strategy. Concurrently, we have made strong progress in developing the design of our Phase 3 trial and look forward to aligning with the FDA on key requirements to move AD04 forward. Our recent analyses have reinforced the selection of our target patient population and continue to support AD04’s potential to treat AUD and related conditions effectively. We remain confident in the path ahead and look forward to sharing a comprehensive update following our FDA meeting in July.”

AD04 is a genetically targeted serotonin-3 receptor antagonist being developed for the treatment of AUD in heavy drinking patients, specifically those who consume fewer than 8 drinks per drinking day. This targeted approach is based on genetic markers that may help identify patients more likely to benefit from treatment, supporting a precision medicine model in addiction therapy.