Enveric’s Patent Win Targets New Frontiers in Sleep Medicine

With U.S. Patent No. 12,187,679 now granted, Enveric Biosciences has secured more than intellectual property—it’s staked a claim on the future of neurotherapeutics. The Cambridge-based biotech firm announced this week that its latest patent covers a class of hydroxylated psilocybin derivatives that selectively target melatonin MT1 receptors, key regulators of sleep-wake cycles and circadian rhythms.

“This newly issued patent adds to the growing body of intellectual property that underpins our pipeline of next-generation neuroplastogenic therapeutics,” said Dr. Joseph Tucker, CEO of Enveric Biosciences. “The inclusion of selective melatonin receptor-binding compounds broadens our ability to target sleep disorders, a prevalent category representing a multi-billion-dollar annual market.”

This is not your average pharma announcement. At its core is a story of convergence: psychedelic chemistry meeting circadian biology, with the goal of developing targeted therapeutics for CNS disorders that afflict tens of millions globally.

Melatonin signaling has long been an attractive target for drug development. The hormone regulates sleep onset and circadian rhythms, and synthetic analogs have become staple prescriptions for sleep and mood disorders.

Two leading examples underscore the credibility of this pathway:• Ramelteon (Rozerem®), a selective MT1/MT2 agonist approved by the U.S. Food and Drug Administration in 2005, treats insomnia by mimicking the body’s natural melatonin.• Agomelatine (Valdoxan®), authorized in Europe in 2009, is both an MT1/MT2 agonist and a 5-HT₂C antagonist. It’s approved for major depressive disorder and may offer benefits beyond sleep regulation, including mood stabilization and circadian re-entrainment.

Both drugs validate the melatonergic mechanism of action and suggest untapped therapeutic potential. Enveric’s twist? Novel compounds that preferentially bind the MT1 receptor, potentially leading to cleaner pharmacodynamics and fewer off-target effects.

What makes Enveric’s patent meaningful isn’t just its novelty—it’s the platform it plugs into.

These compounds were not stumbled upon. They emerged from Enveric’s proprietary Psybrary™ platform, a digital-chemical hybrid combining AI-driven screening with synthetic neurochemistry. The platform maps structure-activity relationships of both classic and novel molecules to known psychiatric and neurological targets.

Through this effort, Enveric has developed a pipeline of non-hallucinogenic neuroplastogens—molecules designed to promote neuroplasticity without inducing altered states of consciousness. Their lead candidate, EB-003, exemplifies this approach. While EB-003 is still preclinical, it’s designed to treat anxiety and depressive disorders where conventional antidepressants often fall short or take weeks to become effective.

By adding MT1-selective molecules to this ecosystem, Enveric is expanding the reach of Psybrary™ beyond affective disorders and into sleep and circadian-related dysfunction—an area often neglected in CNS R&D.

The newly patented molecules are not one-trick ponies. Several exhibit complex pharmacological profiles, binding not only to melatonin receptors but also interacting with other CNS-relevant targets. This polypharmacology could offer differentiated profiles for treating comorbid conditions such as insomnia with anxiety, or depression with circadian misalignment.

“These are structurally diverse molecules, and some demonstrate multivalent engagement,” said Tucker. “That gives us optionality—not just to optimize for sleep, but to explore therapeutic use across a spectrum of psychiatric and neurological disorders.”

Indeed, CNS disorders rarely travel alone. Up to 90% of patients with depression experience sleep disturbances, and circadian rhythm disorders often exacerbate neurodegeneration and mood dysregulation. Therapies that can address multiple axes may offer better outcomes and greater market uptake.

The sleep therapeutics market is vast—and deeply unsatisfied. According to market research firm Grand View Research, global insomnia drug sales were valued at over $4 billion in 2023 and are projected to reach $6 billion by 2030. Yet the most commonly prescribed agents—benzodiazepines and Z-drugs—carry risks of dependence, cognitive impairment, and next-day sedation.

Melatonin receptor agonists offer a non-sedative alternative, but current drugs like ramelteon have modest efficacy. What the field lacks are next-generation therapies with the selectivity, safety, and CNS-penetrant profiles to be both potent and well-tolerated.

By patenting molecules that target MT1 with greater specificity, Enveric is addressing this need. Selectivity matters. MT1 plays a more central role in initiating sleep onset, while MT2 is implicated in phase-shifting circadian rhythms. Targeting MT1 alone could result in faster-acting, more focused therapeutics.

The commercial implications are clear. Sleep medicine intersects multiple market verticals—from CNS and primary care to wellness and digital therapeutics. While Enveric’s current pipeline is preclinical, its patent and discovery strategy suggest a business model built around out-licensing.

The company’s stated aim is to move EB-003 into human trials while partnering or licensing out other assets from its Psybrary™ platform. This could appeal to larger pharma firms hungry for CNS innovation but wary of untested psychedelic scaffolds. By offering non-hallucinogenic, receptor-specific candidates backed by patents, Enveric is lowering the perceived risk.

“We view this as a milestone that reinforces our CNS strategy,” said Tucker. “Sleep disorders remain underserved, and this IP expands our toolkit for pursuing high-value indications where traditional approaches fall short.”

Closing Kicker

In a sector where sleep often plays second fiddle to depression and anxiety, Enveric’s new patent underscores a simple truth: restful nights may hold the key to resilient minds.