---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-016826"
form_type: "8-K"
ticker: "ADIL"
cik: "0001513525"
company_name: "ADIAL PHARMACEUTICALS, INC."
filed_at: "2025-02-25T23:59:59+00:00"
generated_at: "2026-05-26T04:44:17.290840+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Adial gets FDA nod for AD04 in vitro bridging strategy; Phase 3 path clear

## Summary
- FDA agreed with proposed 505(b)(2) bridging strategy for AD04, leveraging AD04-103 study and in vitro data.
- Adial to manufacture clinical supplies for Phase 3 program in 2025 following FDA confirmation.
- Submission was made on Nov 19, 2024; FDA feedback received Feb 25, 2025.
- AD04 is a genetically targeted therapy for Alcohol Use Disorder; ONWARD Phase 3 trial completed.
- CEO Cary Claiborne says milestone brings AD04 closer to regulatory approval.

## SEC filing metadata
- accession: 0001213900-25-016826
- form_type: 8-K
- ticker: ADIL
- cik: 0001513525
- company_name: ADIAL PHARMACEUTICALS, INC.
- filed_at: 2025-02-25T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1513525/000121390025016826/0001213900-25-016826-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1513525/000121390025016826/ea0231982-8k_adial.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-016826
- JSON: https://secwatch.observer/filing/0001213900-25-016826.json
- Plain text: https://secwatch.observer/filing/0001213900-25-016826.txt

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