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Delix Therapeutics Reports Strong Phase Ib Results

2025-11-26 • Microdose (industry)

Article summary

Delix Therapeutics recently announced compelling data from a Phase Ib trial of DLX-001 (zalsupindole), a non-hallucinogenic neuroplastogen. According to the company’s release, DLX-001 produced robust biomarker signals (quantitative EEG and polysomnography) consistent with engagement of neuroplasticity pathways, while delivering rapid and durable antidepressant effects in adults with major depressive disorder (MDD). The average reduction of 12 points on the MADRS scale by Day 8 — sustained through Day 36 — suggests both fast onset and lasting benefit. Importantly, DLX-001 was well tolerated, with no observed hallucinatory or psychotomimetic effects. Regulatory progress has followed: the U.S. Food and Drug Administration cleared Delix’s IND submission and approved a Phase II trial design that includes at-home self-administration. That feature bodes well for scalability and ease of use in real-world outpatient settings. The post Delix Therapeutics Reports Strong Phase Ib Results appear...

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