Drug intelligence / Profile preview

AD04

Development stage
Phase 2
Lead developer
Adial Pharmaceuticals
Modality
Small Molecules, Vaccines & Immunotherapeutics
Administration
Oral, Subcutaneous
01

Overview

AD04 is a code name used for two distinct drug candidates in clinical development. Primarily, it refers to a genetically targeted, ultra-low-dose formulation of **ondansetron**, a serotonin-3 (5-HT3) receptor antagonist, developed by **Adial Pharmaceuticals** for the treatment of **Alcohol Use Disorder (AUD)**. This precision medicine candidate is designed to treat patients with specific genetic biomarkers (e.g., the AG+ genotype) that predict a favorable response to 5-HT3 antagonism in reducing alcohol cravings and heavy drinking. Separately, AD04 is also the name of a subcutaneous injectable **immunomodulator** (comprising an aluminum-based adjuvant) developed by **ADvantage Therapeutics** for **Alzheimer's disease**. This version is intended to stimulate the innate immune system, improve lipid metabolism, and enhance microglial phagocytosis of amyloid plaques to reduce neuroinflammation. The Adial candidate is entering Phase 3 trials, while the ADvantage candidate has completed Phase 2 trials.

Other names
ultra-low-dose ondansetrongenetically targeted ondansetron
02

Targets

HTR3A (5-hydroxytryptamine receptor 3A)

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