Delix Therapeutics Announces Positive Efficacy Data for DLX-001 Zalsupindole and FDA Clearance of Phase II At-Home Trial Design

Zalsupindole (DLX-001), described as a first-in-class non-hallucinogenic neuroplastogen, is reported to show rapid, robust, and potentially durable antidepressant effects in adults with major depressive disorder (MDD) in a Phase Ib study. In 18 enrolled participants, dosing was given either once daily for seven consecutive days or twice during the first week. Depression severity improved quickly on the Montgomery-Åsberg Depression Rating Scale (MADRS), with effects reported around Day 8, and improvements were maintained through Day 36, suggesting lasting benefit after a short course. Similar symptom and tolerability signals were described across the daily versus intermittent dosing regimens. The company also states the FDA cleared the Phase II trial design for a multi-site, randomized, double-blind, placebo-controlled study that includes at-home self-administration, intended to validate safety and outpatient feasibility as the program moves toward determining an optimal dosing paradigm.