Cybin backs FDA’s call to fast-track psychedelic therapeutics as CYB003 advances in Phase 3 trials

In a notable shift reflecting growing acceptance of alternative therapies in psychiatry, the U.S. Food and Drug Administration (FDA), under the leadership of Commissioner Dr. Martin Makary, has publicly endorsed the acceleration of research into psychedelic-based therapeutics. Dr. Makary’s remarks, which framed psychedelic medicine as a high-priority “frontier area” for regulatory focus, mark a pivotal moment in the U.S. government’s approach to tackling persistent and complex mental health challenges. Clinical-stage neuropsychiatry company Cybin Inc., which is at the forefront of this emerging field, has welcomed this stance as validation of its mission and its drug development strategy.

Cybin’s support follows the FDA’s growing willingness to consider innovative treatments that may not align with traditional pharmacological models but show compelling clinical promise. Commissioner Makary’s comments signal the agency’s readiness to expedite review processes for psychedelic compounds demonstrating efficacy in controlled trials, particularly for major depressive disorder (MDD), generalized anxiety disorder (GAD), and other mental health conditions with high unmet need.

What Does This Mean for Cybin’s Lead Candidate CYB003?

Cybin Inc., which is publicly listed on the NYSE American and Cboe Canada under the ticker CYBN, is developing its proprietary psychedelic compounds through a rigorous clinical framework. The company’s lead asset, CYB003—a deuterated psilocin analog—is currently undergoing dosing in the pivotal Phase 3 APPROACH study. The trial forms part of Cybin’s broader PARADIGM development program, which includes a second randomized Phase 3 trial (EMBRACE) and a long-term extension study (EXTEND), all focused on evaluating CYB003 for use in adjunctive treatment of MDD.

CYB003 has already been granted Breakthrough Therapy Designation by the FDA, a regulatory status designed to expedite development and review of drugs showing substantial improvement over existing therapies. This designation underscores the FDA’s confidence in CYB003’s potential and aligns with Dr. Makary’s call for a more agile review process when considering treatments addressing the mental health crisis.

According to data shared by Cybin from its earlier Phase 2 trials, CYB003 has delivered compelling efficacy in patients with MDD. All participants who received two doses of 16 mg responded to treatment, with 71% achieving clinical remission. The mean improvement in MADRS (Montgomery–Åsberg Depression Rating Scale) scores was approximately 23 points—a significant reduction by industry standards.

What Is the Broader Significance of Psychedelic Therapeutics in Mental Health Care?

The FDA’s increasing interest in psychedelics stems from mounting clinical evidence that these compounds can offer rapid and durable relief from psychiatric symptoms that are often resistant to conventional antidepressants and anxiolytics. With U.S. mental health indicators worsening post-pandemic and suicide rates remaining stubbornly high, there is growing consensus that a paradigm shift in psychiatric treatment is overdue.

Psychedelic-based treatments such as those being developed by Cybin, Compass Pathways, and MAPS PBC aim to introduce intermittent dosing regimens that achieve longer-lasting therapeutic benefits than currently available options. The most studied compounds in this space include psilocybin (the active metabolite of which is psilocin), DMT (N,N-dimethyltryptamine), and MDMA, among others. By developing proprietary formulations of these substances, companies like Cybin aim to improve the safety, predictability, and therapeutic index of psychedelic-assisted therapy.

Cybin’s emphasis on deuterated analogs—molecular variants that incorporate deuterium to enhance metabolic stability—positions the company uniquely within the competitive field. The firm argues that such compounds may offer more consistent absorption and efficacy compared to traditional psilocybin, which can vary significantly in onset and intensity.

What Are the Next Milestones for CYB003 and CYB004?

Following the ongoing Phase 3 APPROACH study, Cybin anticipates launching its second pivotal trial, EMBRACE, by mid-2025. This will further support regulatory submissions for CYB003, potentially paving the way for commercial approval if results remain positive. In parallel, the company continues to progress CYB004, a proprietary deuterated DMT analog, through a Phase 2 trial targeting generalized anxiety disorder.

CYB004 represents another innovative step, as DMT offers a much shorter duration of psychedelic experience compared to psilocybin, raising the possibility of more practical outpatient-based therapeutic models. Cybin expects to complete the Phase 2 study for CYB004 by mid-2025, aligning both development programs within a timeframe conducive to regulatory coordination.

How Is Cybin Positioning Itself Within the Industry?

Founded in 2019 and operational across North America and Europe—including Canada, the U.S., the U.K., the Netherlands, and Ireland—Cybin is seeking to lead the next generation of mental health treatment development. The company continues to invest in novel drug discovery, formulation technology, and delivery platforms designed specifically for neuropsychiatric use cases.

Unlike earlier wave psychedelic advocates focused on access and destigmatization, Cybin is taking a biotechnology-centric approach. Its strategy relies on clinical data, proprietary molecules, and intellectual property to create scalable, regulatory-compliant solutions. With over 200 preclinical and clinical patents in play, Cybin aims to defend its competitive position as the psychedelic sector moves into formal medical adoption.

The company has also worked proactively with regulators and stakeholders, engaging frequently with the FDA and other agencies to ensure clinical transparency and compliance. CEO Doug Drysdale has emphasized the importance of scientific rigor and public trust in psychedelic drug development, particularly in an area so often misunderstood by mainstream medicine.

What Risks and Challenges Remain for Psychedelic Drug Developers Like Cybin?

Despite recent regulatory encouragement, psychedelic developers continue to face considerable uncertainty. Longstanding social stigma, patchy federal and state laws, and the limited availability of certified psychedelic therapists all contribute to a challenging commercialization pathway.

Moreover, the clinical trial designs for psychedelic therapies often require complex settings, including integration with psychotherapy sessions, which adds to costs and regulatory scrutiny. Cybin and its peers must also compete for investor attention in a capital-intensive biotech environment, where funding cycles can be volatile.

Another critical concern is scalability. Even if CYB003 and CYB004 receive approval, deploying them across large populations will require massive infrastructure investment in trained personnel, clinical networks, and patient education.

Finally, efficacy data—though promising—is still relatively early-stage compared to established antidepressants. Long-term safety, durability of benefit, and potential for misuse remain areas regulators are keenly monitoring.

Why Does FDA Recognition of Psychedelic Innovation Matter Now More Than Ever?

Commissioner Makary’s remarks represent a crucial turning point in the U.S. government’s relationship with psychedelic medicine. His recognition that psychedelic drugs are not only scientifically promising but essential to addressing the mental health epidemic gives developers like Cybin a tailwind in both public perception and institutional support.

For Cybin, this validation arrives at a strategically important time. With Phase 3 trials already underway and multiple regulatory touchpoints ahead, the company is navigating a critical path toward becoming one of the first to commercialize a next-generation psychedelic treatment for depression. FDA leadership backing could influence payers, health systems, and policymakers to accelerate ecosystem readiness—making real-world deployment of these therapies more viable in the near term.