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Also known as AD04 (ondansetron)
AD04 · 1 trial · 1 indication
Change from baseline in the percentage of monthly HDDs, where (heavy) drinking is defined as the consumption of ≥ 60 g alcohol/day (if male) or ≥ 40 g alcohol/day (if female).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | AD04 (ondansetron) |
| Placebo Arm | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| AD04 (ondansetron) | DRUG | AD04 (ondansetron) 0.33 mg, orally (p.o.) twice a day (BID) |
| Matching placebo | DRUG | Matching placebo to AD04 (ondansetron), orally (p.o.) twice a day (BID) |
| Companion Diagnostic for Genetic Testing | DEVICE | Companion Diagnostic for Genetic Testing |
| Brief Psychological Counseling | BEHAVIORAL | Brief Psychological Counseling |
Inclusion Criteria: 1. The subject has signed the Informed Consent Form. 2. The subject has breath alcohol concentration (BAC) of 0.00% at the Screening and \< 0.02 % at the Baseline visit. 3. The subject has moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Me...
AD04 is being developed for the treatment of alcohol use disorder (AUD) in adults. It is a small molecule studied in a Phase 3 trial that enrolled adults aged 18 years and older with AUD across sites in Bulgaria, Croatia, Estonia, Finland, Latvia, Poland, and Sweden.
AD04 targets the serotonin-3 receptor, a receptor target. Its mechanism is directed at this serotonin receptor subtype, and the Phase 3 study also enrolled patients selected for serotonin transporter polymorphisms, linking the drug's serotonin pathway focus to the trial population.
AD04 is being developed by Azora Therapeutics, Inc., which trades under the ticker AZR. The company is advancing the small molecule as a treatment for alcohol use disorder in adults through Phase 3 clinical development.
AD04 is in Phase 3 development for alcohol use disorder. It is investigational and has not been approved by the FDA. One Phase 3 trial has been completed, and no trials are currently active according to available tracking.
AD04 has been studied in the Phase 3 trial NCT04101227, titled Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms. The trial was randomized, double-blind, and placebo-controlled, enrolled 302 participants, and is completed.
Yes, AD04 is also known as AD04 (ondansetron). Ondansetron is the underlying drug name, and AD04 is the development designation used by Azora Therapeutics for its alcohol use disorder program. Readers searching either name are looking at the same small molecule asset.