Delix Therapeutics reported positive Phase Ib efficacy and biomarker data for zalsupindole (DLX‑001), a non‑hallucinogenic oral neuroplastogen, in adults with major depressive disorder (MDD). The company said translational markers of plasticity (qEEG and polysomnography) and rapid, durable antidepressant effects were observed across dosing regimens in the small Phase Ib cohort. The U.S. Food and Drug Administration cleared Delix’s Investigational New Drug application for a Phase II trial that explicitly permits at‑home self‑administration, a regulatory validation of the compound’s tolerability and Delix’s outpatient development model. Zalsupindole is engineered as an orally available analog of 5‑MeO‑DMT aimed at promoting neuroplasticity without perceptible hallucinatory effects. Delix will present more detailed biomarker and safety readouts at upcoming conferences. The at‑home administration design, if successful, could alter trial logistics for rapid‑acting neuropsychiatric drugs and expand outpatient access models.