First Patient Dosed in Pharmacokinetics Study of AD04 for Alcohol Use Disorder


The study aims to collect data to optimize the design of the treatment’s upcoming phase 3 clinical trial.



Adial Pharmaceuticals Inc announced that the first patient has been dosed in its pharmacokinetics study of AD04 for the treatment of alcohol use disorder (AUD).

“Dosing our first patient is an important milestone, marking the beginning of clinical activity in this previously planned and pre-budgeted study,” said Cary Claiborne, president and CEO of Adial Pharmaceuticals, in a press release. “Our goal is to obtain data we need to design a more precise and informed phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Completion of this study is in accord with previous guidance provided by the US Food and Drug Administration (FDA) and is intended to enhance the likelihood of success in our upcoming phase 3 trial.”

The pharmacokinetics study, which is expected to take 6 months to complete, will provide critical data to optimize the design of the upcoming phase 3 clinical trial of AD04, an investigational, genetically targeted, serotonin-3 receptor agonist being developed for the treatment of AUD in heavy drinking patients, defined as those who consume fewer than 10 drinks per drinking day. The trial is designed to assess the drug’s efficacy and safety in treating the disorder, with the aim of enhancing the likelihood of its success.1

“This relatively short and low-cost study is also a key element of our strategy to advance ongoing partnership discussions,” Claiborne said in a press release. “The study will also provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA.”

The pharmacokinetics study will be conducted in a single center and will involve up to 30 healthy adult volunteers. It will compare the pharmacokinetic profile of AD04, administered as an oral dose of 0.33 mg taken twice daily with or without food, against a reference standard product. This open-label study aims to provide valuable information on how AD04 is absorbed, distributed, metabolized, and excreted in the body.1

“Looking ahead, we plan to engage with the FDA in Q4 2024 to discuss the results of this pharmacokinetics study and obtain feedback to refine the phase 3 study design,” Claiborne said in a press release. “This meeting will help establish the final protocol and ensure that it aligns with FDA expectations, further advancing AD04 toward regulatory approval.”

According to Adial Pharmaceuticals, topline results from the study are expected to be reported in the early fourth quarter of 2024.1

According to the World Health Organization, harmful alcohol consumption causes 3 million deaths—or 5.3% of all deaths—globally every year, and 5.1% of the global burden of injury and disease is attributable to alcohol.2 Explore the latest expert discussions on and treatment updates for AUD and harmful alcohol consumption in Psychiatric Times®:

An Update on GLP-1 Receptor Agonists as Pharmacotherapies for AUD

The Role of Alcohol and Substances in Suicide

Abstinence vs Drinking in Moderation

Understanding Alcohol Misuse in Women

Nonabstinent Recovery From Alcohol Use Disorder

Survey Finds 1 in 7 Physicians Uses Alcohol or Drugs on the Job to Cope With Stress

Exploring the Link Between Neuroticism-Depression and College Drinking

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Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of other psychiatric disorders at


1. Adial Pharmaceuticals achieves important milestone of first patient dosed in pharmacokinetics study of AD04 for the treatment of alcohol use disorder. Adial Pharmaceuticals. News release. June 5, 2024. Accessed June 5, 2024.

2. Alcohol. World Health Organization. May 9, 2022. Accessed June 5, 2024.

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