FDA Events for Adial Pharmaceuticals (ADIL)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Adial Pharmaceuticals (ADIL).
Over the past two years, Adial Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AD04. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AD04 - FDA Regulatory Timeline and Events
AD04 is a drug developed by Adial Pharmaceuticals for the following indication: Alcohol Use Disorder (AUD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AD04
- Announced Date:
- June 25, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, Inc. announced the recent execution of agreements for the production of AD04 (0.33 mg ondansetron tablets), supporting both the completion of upcoming clinical trials and the planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the treatment of Alcohol Use Disorder (AUD) in the US.
AI Summary
Adial Pharmaceuticals recently announced new agreements for the production of AD04, a 0.33 mg ondansetron tablet designed as an investigational treatment for Alcohol Use Disorder (AUD). These agreements support the completion of upcoming clinical trials and pave the way for the planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). AD04 is a genetically targeted serotonin-3 receptor antagonist meant to help heavy drinking patients overcome AUD. The company is working with Thermo Fisher Scientific for manufacturing and validation of clinical batches, while Cambrex is providing the essential ondansetron drug substance. Together, these contract manufacturing organizations will produce the required demonstration batches and ensure the necessary Chemistry, Manufacturing, and Controls (CMC) documentation is in place. This strategic collaboration is critical in advancing AD04 through its Phase 3 clinical trials and meeting all FDA regulatory requirements.
Read Announcement- Drug:
- AD04
- Announced Date:
- June 16, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, Inc. announced the submission of the required briefing package for the upcoming End of Phase 2 meeting (EOP2M) with the Food and Drug Administration (FDA).
AI Summary
Adial Pharmaceuticals, Inc. has submitted the required briefing package for its upcoming End of Phase 2 meeting (EOP2M) with the FDA. The meeting, now set for July 29th, is an important milestone as it allows the FDA to review detailed data ahead of discussions. The briefing package includes comprehensive data such as historical safety information and efficacy studies related to the company’s lead investigational drug, AD04, which is being developed for Alcohol Use Disorder treatment. The objective of the meeting is to agree on key aspects of the planned Phase 3 Clinical Development program, including study design, patient selection, dosing, and endpoints. A successful dialogue with the FDA is expected to strengthen the company’s position and support its ongoing strategic partnership efforts, ultimately helping move AD04 closer to future clinical and marketing goals.
Read Announcement - Drug:
- AD04
- Announced Date:
- June 11, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, Inc announced progress in the design and planning of its upcoming Phase 3 trial evaluating AD04, the company's lead investigational genetically targeted, serotonin-3 receptor antagonist, a therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/day).
AI Summary
Adial Pharmaceuticals, Inc. recently announced progress in designing its upcoming Phase 3 trial to evaluate AD04, a genetically targeted serotonin-3 receptor antagonist. AD04 is being explored as a treatment for Alcohol Use Disorder in heavy drinking patients, defined as less than eight drinks per day. The trial’s design and planning have been enhanced by a collaboration with Cytel Inc., a company specializing in advanced data science and statistical methods for clinical trials.
Cytel’s contributions have helped identify genetic subpopulations that may benefit the most from AD04. This strategic insight supports a precision medicine approach, aiming to increase treatment efficacy while providing a streamlined path for future regulatory submission. The refined design is set to maximize efficiency, improve cost-effectiveness, and enhance the overall likelihood of success as the trial moves forward.
Read Announcement- Drug:
- AD04
- Announced Date:
- May 8, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
ADIL on Thursday announced that the FDA has granted the company's request for an End of Phase 2 meeting to discuss its proposed clinical development plan and seek the U.S. Food and Drug Administration (FDA) guidance on the Phase 3 clinical trial for AD04.
AI Summary
Adial Pharmaceuticals announced on Thursday that the FDA has approved its request for an End of Phase 2 meeting. The meeting, set for July 25, 2025, will allow the company to review its clinical development plan for AD04 and receive guidance on the design of its upcoming Phase 3 trial. AD04 is being developed as a new treatment for Alcohol Use Disorder, particularly targeting heavy drinking patients.
This milestone meeting will give Adial a clear path forward by helping to shape the requirements and design of the Phase 3 trial with direct input from the FDA. The discussions are expected to address important factors related to the trial’s safety and effectiveness, reinforcing the company’s commitment to advancing AD04 as a potential new therapeutic option for those struggling with alcohol use challenges.
Read Announcement- Drug:
- AD04
- Announced Date:
- May 1, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
EXCLUSIVE: Adial Pharmaceuticals Tells Benzinga 'New patent covers a treatment method for a broad spectrum of alcohol-related disorders, including additional conditions associated with alcohol use'
AI Summary
Adial Pharmaceuticals has secured a new patent that covers a broad treatment method for alcohol-related disorders, including additional conditions linked with alcohol use. According to the company, the new patent protects the use of its investigational drug AD04 to treat a wide range of issues beyond just alcohol use disorder. The method involves administering a specific dose of AD04 to patients who have certain genetic markers, potentially helping not only with alcohol dependence but also with related conditions such as anxiety, sleep disturbances, and other complications that can arise from alcohol consumption.
This strategic move aims to broaden the scope of treatment options available for patients with alcohol-related problems while strengthening Adial’s intellectual property portfolio. By covering this wide spectrum of conditions, the company hopes to offer more comprehensive solutions to those affected by alcohol use.
Read Announcement - Drug:
- AD04
- Announced Date:
- May 1, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
EXCLUSIVE: Adial Pharmaceuticals Tells Benzinga Co. Expands Intellectual Property Portfolio With New US Patent Granted For Genetic-Based Treatment Of Alcohol And Opioid Use Disorders
AI Summary
Adial Pharmaceuticals has strengthened its intellectual property portfolio by receiving a new US patent for a genetic-based treatment using its investigational drug, AD04. The patent, issued by the USPTO, covers a method for treating both alcohol-related diseases and opioid use disorders. It is designed for patients with specific serotonin-related gene variations, which could help tailor treatment based on individual genetic profiles. This new patent outlines dosing regimens and targeted genetic profiles to increase the drug’s treatment effectiveness. By expanding the covered methods, the patent promises a more personalized approach in fighting addiction, potentially addressing a wider range of alcohol-related conditions, including anxiety, sleep disorders, and withdrawal symptoms. This milestone marks an important step for the company as it develops AD04 to target genetic markers linked to substance use disorders, reinforcing its commitment to innovative, precision-based healthcare solutions.
Read Announcement- Drug:
- AD04
- Announced Date:
- February 25, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, announced a positive response from the U.S. Food and Drug Administration (FDA) regarding its proposed in vitro bridging strategy for AD04. Inc.
AI Summary
Adial Pharmaceuticals recently received good news from the U.S. Food and Drug Administration (FDA) about its proposed in vitro bridging strategy for AD04. The FDA agreed with Adial’s plan, which is based on using existing clinical data and lab tests to confirm that the new AD04 product works similarly to its established reference. This positive response boosts the company’s confidence as it plans to move the drug into the next development phase, Phase 3 trials. The bridging strategy uses results from a previous study along with lab data showing that the new commercial formulation is equivalent to the original version.
This regulatory feedback marks a key step forward for Adial, paving the way for further clinical testing and potential new treatment options for patients.
Read Announcement- Drug:
- AD04
- Announced Date:
- January 29, 2025
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals Tells Benzinga Co. Announces Clinical Study Results From The AD04-103 Pharmacokinetics Study Of AD04 For The Treatment Of Alcohol Disorder
AI Summary
Adial Pharmaceuticals recently announced positive results from the AD04-103 pharmacokinetics study, which looked at how AD04 behaves in the body for treating alcohol use disorder. The study confirmed that AD04 has predictable and proportional absorption, works the same with or without food, and shows a safety profile similar to that of ondansetron, a well-known drug.
These findings are an important step for the company as they prepare for an End-of-Phase 2 meeting with the FDA to discuss the design of a future Phase 3 trial. AD04 is specifically aimed at patients with certain genetic markers linked to better drug response. This targeted approach, supported by a Companion Diagnostic Test developed by the company, may help in identifying those who will benefit the most from this treatment.
Read Announcement- Drug:
- AD04
- Announced Date:
- September 19, 2024
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, Inc. announced that database lock for the pharmacokinetics study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 10 drinks/drinking day).
AI Summary
Adial Pharmaceuticals, Inc. announced that the database lock for its pharmacokinetics study of AD04 has been completed. AD04 is the company’s lead investigational agent, a genetically targeted serotonin‐3 receptor antagonist developed for treating Alcohol Use Disorder in heavy drinking patients (defined as consuming fewer than 10 drinks per drinking day).
With the database lock finalized, the study data has now been transferred to independent statisticians who will start the analysis process ahead of the next FDA interaction. Topline results from this study are expected to be announced in the fourth quarter of 2024. The insights gained will be essential in guiding the clinical strategy for a Phase 3 study and will support the company’s efforts as it prepares to re-engage with the FDA.
Read Announcement- Drug:
- AD04
- Announced Date:
- September 19, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, Inc. announced that Topline results are expected to be announced during the fourth quarter of 2024.
AI Summary
Adial Pharmaceuticals has announced that the topline results from its pharmacokinetics study of AD04 are expected in the fourth quarter of 2024. The company, which is developing therapies for addiction and related disorders, recently locked the study database, and the data is now being analyzed by independent statisticians. This milestone is a key step as the company prepares for its next FDA interaction, which will help shape its clinical strategy for an upcoming Phase 3 study. AD04, a genetically targeted serotonin-3 receptor antagonist, is being developed to treat Alcohol Use Disorder in heavy drinking patients. The forthcoming results are expected to play a crucial role in furthering the clinical development of AD04 and may also support potential strategic collaborations in the future.
Read Announcement- Drug:
- AD04
- Announced Date:
- August 7, 2024
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, Inc announced that the final patient completed the last dose in the pharmacokinetics study of AD04 for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as <10 drinks/drinking day).
AI Summary
Adial Pharmaceuticals, Inc. recently reached an important milestone in its clinical program for AD04, a therapeutic agent designed to treat Alcohol Use Disorder (AUD) in heavy drinking patients—those consuming fewer than 10 drinks per drinking day. The company announced that the final patient has completed the last dose in the pharmacokinetics study for AD04. This study is a key part of their efforts to understand how the body processes the drug and to support its safe development. In addition, Adial has filed a new patent application for AD04, which, if granted, will protect the company's core assets until at least 2044. This progress builds confidence in the potential of AD04 to not only treat AUD but possibly other addictive disorders, marking a significant advancement in the company’s ongoing research and development efforts.
Read Announcement- Drug:
- AD04
- Announced Date:
- July 23, 2024
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals Inc announced the progression to the second cohort in the pharmacokinetics study of AD04.
AI Summary
Adial Pharmaceuticals Inc. announced progress in its pharmacokinetics study of AD04 for treating Alcohol Use Disorder in heavy drinkers. The study, which meets FDA guidance requirements for the upcoming Phase 3 clinical trial, is designed to gather key data on the drug’s behavior in the body. After dosing the first patient in the initial cohort, the company is now set to move to the second cohort, a step that will help refine details for future larger trials.
The trial is a single-center, open-label study comparing the bioavailability of AD04, taken with and without food, against a reference product. Up to 30 healthy adult volunteers will be enrolled, and the study is expected to last six months, with topline results available by early Q4 2024. This progression is a critical part of Adial's strategy to advance their application for AD04 approval under a 505(b)(2) regulatory pathway with the FDA.
Read Announcement- Drug:
- AD04
- Announced Date:
- June 20, 2024
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals, Inc. announced the publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, "Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes." The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company's lead asset, AD04 (low-dose ondansetron), and the placebo group among heavy drinking patients with Alcohol Use Disorder (AUD) and specific genotypic variants.
AI Summary
Adial Pharmaceuticals recently announced the publication of findings from its Phase 3 ONWARD study in the European Journal of Internal Medicine. The study, titled “Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes,” focuses on the company’s lead asset, AD04, which is low-dose ondansetron. The results demonstrated that, after six months of treatment, heavy drinking patients with Alcohol Use Disorder (AUD) who had certain genetic variants experienced a significant decrease in the monthly percentage of heavy drinking days compared to those receiving placebo.
The study highlights the promise of using a precision medicine approach, utilizing a companion diagnostic to identify patients who may benefit most from AD04. Importantly, the adverse events reported for AD04 were similar to those seen with placebo, suggesting a favorable safety profile while targeting specific genotypic markers associated with AUD.
Read Announcement- Drug:
- AD04
- Announced Date:
- June 5, 2024
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals Inc announced that the first patient had been dosed in a pharmacokinetics study of AD04 for Alcohol Use Disorder in heavy drinking patients.
AI Summary
Adial Pharmaceuticals Inc. recently announced an important milestone as the first patient was dosed in a pharmacokinetics study of AD04. This study focuses on treating Alcohol Use Disorder in heavy drinking patients and is designed to gather key data on how the drug is absorbed, distributed, metabolized, and excreted by the body. The information collected will help optimize the study design for the upcoming Phase 3 clinical trial, including determining the best dosing regimen to ensure both efficacy and safety.
The trial, expected to last about six months, aims to support both the refinement of the Phase 3 protocol and ongoing partnership discussions. Topline results are anticipated in early Q4 2024, which could provide the necessary guidance to further advance AD04 through its regulatory pathway and potentially offer a new treatment option for patients with Alcohol Use Disorder.
Read Announcement- Drug:
- AD04
- Announced Date:
- April 10, 2024
- Indication:
- Alcohol Use Disorder (AUD)
Announcement
Adial Pharmaceuticals announced the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 (low-dose ondansetron), the Company's lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD).
AI Summary
Adial Pharmaceuticals recently published a peer-reviewed article highlighting the encouraging clinical results of its lead investigational drug, AD04 (low-dose ondansetron). The study, focused on treating Alcohol Use Disorder (AUD), showed that AD04 had a strong safety profile and high patient compliance. Researchers found that the treatment did not significantly change key biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin, nor did it affect elevated GGT levels typically seen in patients with AUD.
The article underscores that AD04 was well tolerated with few adverse events, suggesting it could offer a safe and effective treatment option for individuals with AUD. The findings support the potential of AD04 to become a precision treatment, particularly for patients with a specific genetic profile, and mark an important step forward in addressing the challenges of alcohol-related liver disease and addiction.
Read Announcement
Adial Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Adial Pharmaceuticals (ADIL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Adial Pharmaceuticals (ADIL) has reported FDA regulatory activity for AD04.
The most recent FDA-related event for Adial Pharmaceuticals occurred on June 25, 2025, involving AD04. The update was categorized as "Provided Update," with the company reporting: "Adial Pharmaceuticals, Inc. announced the recent execution of agreements for the production of AD04 (0.33 mg ondansetron tablets), supporting both the completion of upcoming clinical trials and the planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the treatment of Alcohol Use Disorder (AUD) in the US."
Currently, Adial Pharmaceuticals has one therapy (AD04) targeting the following condition: Alcohol Use Disorder (AUD).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ADIL) was last updated on 7/13/2025 by MarketBeat.com Staff
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