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

Zalsupindole (DLX-001), a non-hallucinogenic neuroplastogen, showed positive Phase Ib efficacy and biomarker results in adults with major depressive disorder (MDD) from a short dosing course. In 18 enrolled patients, DLX-001 was given either once daily for seven days or twice during the first week. The study targeted translational neuroplasticity markers using qEEG and polysomnography, and also assessed depressive symptom change with the MADRS, reporting a rapid reduction by Day 8 and durability of benefit out to Day 36. Delix also reported favorable safety and tolerability, with no serious adverse events and no reported hallucinatory, dissociative, or psychotomimetic effects. In parallel, the FDA cleared the Investigational New Drug application for a Phase II MDD protocol that includes at-home self-administration, using randomized, double-blind, placebo-controlled arms and both once-daily and twice-weekly dosing.