Enveric secures US patent for non-hallucinogenic psilocybin derivatives treating psychiatric disorders

Enveric Biosciences (Nasdaq: ENVB), headquartered in Cambridge, Massachusetts, announced receipt of US Patent No. 12,605,361 from the USPTO on April 21, 2026, covering methods of treating psychiatric disorders using the company’s EVM301 series of carboxylated tryptamine-based drug candidates. The issuance extends protection established under the earlier composition-of-matter patent, US Patent No. 11,752,130, by adding method claims that govern how the novel molecular structures may be used therapeutically. The patent’s core commercial relevance lies in the dual-layer protection it creates for the EVM301 series, combining structural and use-based exclusivity across a family of compounds designed to promote neuroplasticity without producing the hallucinogenic effects associated with classical psychedelic agents.

The patent psychiatric mechanism and asset profile

The EVM301 series, and its lead candidate EB-003, are built around a dual-receptor pharmacology targeting both 5-HT2A and 5-HT1B serotonin receptors. The 5-HT2A receptor is the primary mediator of classical psychedelic pharmacology, including the perceptual distortions produced by psilocybin, and is also implicated in the downstream neuroplasticity signaling that has drawn clinical interest to psilocybin-derived compounds as potential antidepressants. Enveric’s design approach involves carboxylation of the tryptamine scaffold, a structural modification intended to alter the receptor engagement profile relative to unmodified psilocybin, with the stated goal of retaining plasticity-promoting activity while reducing hallucinogenic liability. The additional 5-HT1B component is positioned as contributing to anxiolytic and antidepressant activity, with the receptor having established disease relevance in preclinical and clinical literature on mood disorders.

The company describes EB-003 as the first known compound designed to engage both receptor subtypes in this configuration. Development stage information beyond preclinical characterization was not disclosed in the available source material. No IND filing date, Phase I initiation, or clinical data have been publicly confirmed as of the patent issuance date. The practical implication is that while the IP position is being constructed in advance of clinical milestones, the therapeutic differentiation claim — that EB-003 separates neuroplasticity from hallucinations — remains to be validated in human studies. The company has stated it anticipates that eliminating the requirement for supervised administration would enhance both the clinical utility and commercial profile of EVM301-based therapies, a positioning argument that depends on the hallucinogen-free profile being confirmed in trials.

For EVM301 psychiatric disorders coverage, the issued claims extend across depression, anxiety, and the broader category of difficult-to-treat psychiatric conditions, providing a wide indication footprint that could support multiple development paths from a single patent family.

Competitive context

The broader field of serotonergic neuroplastogen development has attracted multiple companies pursuing structurally modified or functionally differentiated psilocybin derivatives treatment strategies, and the Enveric Biosciences patent psychiatric filing enters a competitive IP environment.

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COMPASS Pathways (Nasdaq: CMPS), headquartered in the United Kingdom, holds composition-of-matter patents on COMP360, a synthetic crystalline psilocybin formulation. COMPASS is the most advanced company in the psilocybin-derived space, currently in Phase III study for treatment-resistant depression. Notably, COMP360 is a conventional psilocybin formulation and retains full hallucinogenic activity, requiring supervised administration in a clinical setting. Its development model depends on the therapeutic value of the psychedelic experience itself, which is mechanistically distinct from Enveric’s non-hallucinogenic design thesis.

Usona Institute, a nonprofit organization based in the United States, is advancing psilocybin under a Breakthrough Therapy designation from the US FDA for major depressive disorder, also as a full agonist at 5-HT2A with intact hallucinogenic properties. Usona’s program similarly relies on supervised dosing sessions, reinforcing the operational and commercial distinction Enveric is attempting to establish.

More directly relevant as a mechanistic peer is ITI-1549, a compound described in recent preclinical literature as a non-hallucinogenic 5-HT2A agonist neuroplastogen, under investigation by Intra-Cellular Therapies (Nasdaq: ITCI), headquartered in the United States. ITI-1549 represents the closest publicly documented analog to Enveric’s stated design strategy, targeting the same mechanistic goal of dissociating plasticity from hallucinogenesis at the 5-HT2A receptor.


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