Adial Pharmaceuticals receives FDA alignment on Phase 3 trial design for AD04 in alcohol use disorder

ADIAL PHARMACEUTICALS, INC.

• FDA End-of-Phase 2 meeting held July 29, 2025; final minutes received confirming alignment on adaptive Phase 3 design.
• FDA confirmed primary endpoint of zero heavy drinking days during months 5 and 6 of efficacy observation.
• FDA supported biomarker stratification (AG+ subgroup, ~14% of general population) and adaptive enrichment strategy.
• FDA advised pre-specifying key secondary endpoints in protocol for potential future product labeling.
• CEO highlights new patent filing that may extend AD04 market exclusivity to 2045.