Trial Profile
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of AD04 (Ondansetron) in Adults With Alcohol Use Disorder (AUD) and Selected Polymorphisms in the Serotonin Transporter and Receptor Genes
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 11 Mar 2026
Price :
$35
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At a glance
- Drugs Ondansetron (Primary)
- Indications Alcoholism
- Focus Registrational; Therapeutic Use
- Acronyms ONWARD
- Sponsors ADial Pharmaceuticals
Most Recent Events
- 23 Feb 2026 According to an ADial Pharmaceuticals media release, the company highlighted recent U.S. Food and Drug Administration (FDA) policy direction. The policy that may reduce pivotal trial burden from two studies to one. The Company is preparing for the next stage of clinical development and intends to engage closely with the FDA regarding the appropriate evidentiary strategy for AD04 consistent with current regulatory standards and policy considerations.
- 14 Aug 2025 According to an ADial Pharmaceuticals media release, company announced successful completion of our End of Phase 2 meeting with the Food and Drug Administration (FDA) and received critical input from the FDA on the clinical and statistical design of our upcoming Phase 3 trial for AD04. Expect to receive the official meeting minutes from the FDA within 30 days of the meeting date.
- 20 Jun 2024 Results published in the ADial Pharmaceuticals Media Release, company 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."