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A Phase 3 trial of AD04

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Trial Profile

A Phase 3 trial of AD04

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2025

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At a glance

  • Drugs Ondansetron (Primary)
  • Indications Alcoholism
  • Focus Therapeutic Use

Most Recent Events

  • 11 Jun 2025 According to Adial Pharmaceuticals media release, post-hoc analyses of historical clinical trial data identified genotype-defined patient subgroups likely to benefit most from AD04. This supports Adial's precision medicine approach in the upcoming Phase 3 trial- targeting higher efficacy and commercial differentiation. The precision-focused Phase 3 trial is expected to begin in late 2025, with potential for interim analysis data, supporting regulatory submission.
  • 11 Jun 2025 According to Adial Pharmaceuticals media release, as a part of its Phase 3 trial preparation, Adial engaged Cytel Inc., a global leader in data science and advanced statistical methodologies for clinical trials, to provide expert support on trial design and data interrogation.
  • 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.

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