Delix Therapeutics Reports Strong Phase Ib Results

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.

Preclinical evidence further strengthens DLX-001’s credentials. In head-to-head models, DLX-001 reportedly promoted structural and functional neuroplasticity comparable to classic agents such as ketamine, psilocybin, or DMT — but critically, without triggering the hallucinogenic or dissociative side effects often associated with such compounds.

Taken together, these findings position DLX-001 as a leading candidate among the emerging class of “non-psychedelic psychoplastogens,” and suggest that we may be approaching a paradigm shift in how we treat neuropsychiatric disorders.

At the same time, Enveric Biosciences — which you know well — strengthened its own intellectual property foundation. On November 26, 2025, the company announced it received a fourth Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its EVM401 series of neuroplastogenic molecules — broadening its portfolio of potential drug candidates for non-hallucinogenic treatment of neuropsychiatric and addiction disorders.

The new patent is titled “Substituted Ethylamine Fused Heterocyclic Mescaline Derivatives.” Once issued, it will further expand Enveric’s patent estate covering non-hallucinogenic, neuroplastogenic small molecules likely designed for scalable, outpatient-friendly use. The issuance of a fourth patent for EVM401 underscores Enveric’s commitment to building a deep pipeline of next-generation compounds beyond its lead candidate, EB-003. In Enveric’s own words, this latest patent “demonstrates the Company’s ability to develop next-generation, non-hallucinogenic neuroplastogens intended for potential treatment of neuropsychiatric conditions.”

This milestone comes on the heels of several other patent allowances this year — including for aminated tryptamine derivatives and other mescaline-inspired compounds — reflecting an aggressive push to protect novel chemical structures engineered to promote neuroplasticity without hallucinogenic effects.

Validation for the entire class: The clinical progress of DLX-001 at Delix acts as a powerful proof-of-concept for non-hallucinogenic neuroplastogens. Demonstrating rapid, durable antidepressant effects — along with favorable safety and home-dosing feasibility — helps validate the concept of small-molecule psychoplastogens as genuinely therapeutic agents rather than “psychedelic curiosities.” For Enveric, that matters: as regulatory and investor confidence builds around the class, the broader spotlight may boost interest in its own pipeline for EB-003 and EVM401 candidates.

Regulatory and commercial template: Delix’s clearance for at-home administration establishes a model for how neuroplastogens might be deployed at scale — moving beyond clinic-bound, supervised dosing. This could significantly lower barriers to adoption and pave the way for broad commercial deployment. Enveric’s compounds, many of which seem optimized for outpatient convenience, may benefit from this emerging regulatory and commercialization template.

IP strength becomes strategic advantage: Enveric’s growing patent portfolio — now with multiple issued patents covering distinct chemical series — gives it important flexibility. As the neuroplastogen space expands, having strong IP coverage across different molecular scaffolds may position Enveric as a licensing or partnership-friendly player, or as a potential consolidator of advantage if competition intensifies.

Diverse pipeline beyond a single candidate: Rather than depending solely on EB-003, Enveric now has a deeper portfolio of EVM401 series molecules. That reduces execution risk at the single-molecule level and increases the odds that at least one candidate will advance successfully to clinic and beyond.

The simultaneous rise of clinical evidence (via Delix) and intellectual-property expansion (via Enveric) suggests we’re entering a critical inflection point in the neuroplastogen/neurostabilogen revolution. For Enveric — which combines novel chemistry, receptor targeting insight, and a growing IP estate — this could be a moment to accelerate IND filings, advance EB-003, and explore strategic partnerships to leverage its broader chemical library.

Viewed in the context of recent developments, Enveric stands not just as a hopeful contender but as a versatile platform potentially capable of delivering a range of next-generation, scalable treatments for depression, anxiety, PTSD, addiction or other neuropsychiatric conditions.