Itruvone is an odorless synthetic investigational neuroactive pherine nasal spray designed with a novel, rapid-onset proposed mechanism of action (MOA) for the potential treatment of major depressive disorder (MDD). Itruvone’s proposed MOA is fundamentally differentiated from the MOA of all currently approved treatments for depression disorders. Itruvone, which is administered at microgram-level doses, is designed to engage and activate chemosensory neurons in the nasal cavity, which activate neural circuits in the brain that produce antidepressant effects. Specifically, itruvone’s proposed MOA involves the regulation of the olfactory-amygdala neural circuits believed to increase the activity of the sympathetic autonomic nervous system and the release of catecholamines from the midbrain. Importantly, unlike all currently approved oral antidepressants and rapid-onset ketamine-based therapy (KBT), including both intravenous ketamine and intranasal ketamine, Vistagen believes itruvone does not require systemic absorption or direct activity on neurons in the brain to produce antidepressant effects, avoiding side effects and safety concerns potentially associated with rapid-onset KBT and longer acting oral antidepressants.

Based on positive Phase 2A results, itruvone has the potential to change the current treatment paradigm for major depressive disorder (MDD), with rapid-onset efficacy and a differentiated safety profile from all current FDA-approved antidepressant therapies. Vistagen is planning to advance Phase 2B development of itruvone as a standalone treatment for MDD.

The FDA has granted Fast Track designation for investigation of itruvone as a potential treatment for MDD.