Delix Therapeutics reported positive Phase Ib biomarker and efficacy signals for zalsupindole (DLX‑001) in adults with major depressive disorder and said the FDA cleared its Phase II trial design that permits at‑home self‑administration. The company presented qEEG and polysomnography biomarker improvements alongside rapid, durable antidepressant effects in the Phase Ib cohort. Zalsupindole is a non‑hallucinogenic neuroplastogen designed to promote structural and functional neuroplasticity without psychedelic effects; preclinical work showed plasticity comparable to ketamine and serotonergic psychedelics. FDA clearance of a Phase II protocol that includes outpatient dosing lowers operational barriers for broader efficacy testing and validates Delix’s development approach, potentially accelerating clinical readouts and de‑risking commercialization assumptions for an oral neuroplasticity platform.