---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-087925"
form_type: "8-K"
ticker: "ADIL"
cik: "0001513525"
company_name: "ADIAL PHARMACEUTICALS, INC."
filed_at: "2025-09-16T23:59:59+00:00"
generated_at: "2026-05-17T06:29:34.181983+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-087925
- form_type: 8-K
- ticker: ADIL
- cik: 0001513525
- company_name: ADIAL PHARMACEUTICALS, INC.
- filed_at: 2025-09-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1513525/000121390025087925/0001213900-25-087925-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1513525/000121390025087925/ea0257511-8k_adial.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-087925
- JSON: https://secwatch.observer/filing/0001213900-25-087925.json
- Plain text: https://secwatch.observer/filing/0001213900-25-087925.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.