---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-099633"
form_type: "8-K"
ticker: "ADIL"
cik: "0001513525"
company_name: "ADIAL PHARMACEUTICALS, INC."
filed_at: "2024-11-18T23:59:59+00:00"
generated_at: "2026-05-29T23:00:19.773483+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Adial Pharmaceuticals Announces Positive Topline Results from AD04 Pharmacokinetics Study for Alcohol Use Disorder

## Summary
- Study enrolled 30 healthy volunteers in two cohorts: Cohort 1 (n=6) evaluated PK variability; Cohort 2 (n=24) assessed relative bioavailability, dose proportionality, and food effect.
- Results showed AD04 0.33mg delivered lower ondansetron PK exposure than marketed 4mg tablet; exposure increased proportionally across 3-fold dose range; no food effect observed.
- Completion of the study satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04 and supports 505(b)(2) regulatory pathway.
- Company plans to engage with FDA in Q4 2024 to discuss study design for Phase 3, aiming to enhance likelihood of success and advance partnership discussions.
- Continued excellent safety and tolerability findings consistent with extensive human use experience with ondansetron.

## SEC filing metadata
- accession: 0001213900-24-099633
- form_type: 8-K
- ticker: ADIL
- cik: 0001513525
- company_name: ADIAL PHARMACEUTICALS, INC.
- filed_at: 2024-11-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1513525/000121390024099633/0001213900-24-099633-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1513525/000121390024099633/ea022169101-8k_adialpharm.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-099633
- JSON: https://secwatch.observer/filing/0001213900-24-099633.json
- Plain text: https://secwatch.observer/filing/0001213900-24-099633.txt

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