MDD is characterized by persistent disturbances in mood and interest, accompanied by reduced energy, impaired concentration, and other emotional and physical symptoms that negatively affect day‑to‑day functioning. Cognitive symptoms are common, often persistent, and can remain even when mood symptoms improve; these deficits are a key barrier to achieving full functional recovery.

Although many antidepressants are available, important limitations remain. Traditional therapies often require 4–8 weeks to exert meaningful effects, and tolerability challenges can restrict long‑term adherence. More than half of patients do not achieve adequate symptom improvement, and approximately one‑third meet criteria for treatment‑resistant depression (TRD). This group represents a major unmet need and a disproportionate share of the total economic and clinical burden. 

These limitations highlight the continued need for new antidepressant approaches that can deliver reliable, fast‑acting relief, address cognitive dysfunction, and provide broader accessibility than currently available options