Adial Pharmaceuticals announced on August 6, 2025, the successful completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). The FDA provided input into the AD04 Phase 3 adaptive design clinical trial and the overall clinical program.
The objective of the EOP2 meeting was to align with the FDA on key elements of the planned adaptive study design, including population, endpoints, inclusion/exclusion criteria, dose regime, and affirmation of biomarker positive and biomarker negative groups. This prepares Adial to advance AD04 into its Phase 3 clinical development program for Alcohol Use Disorder (AUD) in individuals with heavy drinking and select genotypes, specifically the AG+ genotype.
Clarity and validation from the FDA on the clinical development path are expected to strengthen Adial’s position in discussions with potential partners. This regulatory momentum is viewed as a key de-risking milestone in the decision-making process for collaborators.
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