Trial Profile

A Phase 3 trial of AD04

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 15 May 2025

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At a glance

08 May 2025 According to Adial Pharmaceuticals media release, the FDA has granted request for an End of Phase 2 meeting to discuss Adial's proposed clinical development plan and seek FDA guidance on the Phase 3 adaptive with enrichment design of the upcoming clinical trial for AD04. The meeting will take place on July 25, 2025.
25 Feb 2025 According to Adial Pharmaceuticals media release, Adial moves forward with manufacturing of clinical supplies for upcoming Phase 3 clinical program in 2025
23 Aug 2023 New trial record

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