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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

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: 05 Nov 2023

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At a glance

  • Drugs Ondansetron (Primary)
  • Indications Alcoholism
  • Focus Registrational; Therapeutic Use
  • Acronyms ONWARD
  • Sponsors ADial Pharmaceuticals
  • Most Recent Events

    • 31 Oct 2023 According to an ADial Pharmaceuticals media release, the company will present the overview of trial results at The Annual International Society of Addiction Medicine Conference taking place November 2-4, 2023, in Marrakesh, Morocco.
    • 11 Jul 2023 According to an ADial Pharmaceuticals media release, the company received feed back from the US and EU regulators after reviewing data the safety data from study they did not express any concerns with the data. They requested additional data to support an NDA or MA submission and approval for AD04. The company to conducting two phase 3 trials in parallel to minimize risk, optimize timing and costs, as well as improve the regulatory authority acceptance and approval in the US and Europe.
    • 06 Mar 2023 According to an ADial Pharmaceuticals media release, based on results from this and ONWARD trial and after discussions with its regulatory advisors and key opinion leaders (KOLs), the company believes there is a clear, cost-effective path toward FDA approval that it plans to aggressively pursue.
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