Drug intelligence / Profile preview

GXV813

Development stage
Phase 2
Lead developer
Novartis
Modality
Small Molecules
Administration
Oral
01

Overview

GXV813 is an investigational, orally active small molecule developed by Novartis for the treatment of schizophrenia. It functions as an agonist of the Trace Amine-Associated Receptor 1 (TAAR1), a G protein-coupled receptor that modulates the activity of dopaminergic, serotonergic, and glutamatergic neurotransmission. Unlike traditional antipsychotics that primarily function through dopamine D2 receptor antagonism, TAAR1 agonists like GXV813 aim to alleviate both positive and negative symptoms of schizophrenia without the motor-related side effects or prolactin elevation typically associated with D2 blockade. The compound is currently being evaluated in the Phase 2a STAR-1 clinical trial, which focuses on the safety, tolerability, and efficacy of the drug in hospitalized adults experiencing acute exacerbations of schizophrenia.

02

Targets

CHRM4 (M4)

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