Clairvoyant Therapeutics
Clairvoyant on target for potential commercialization of psilocybin treatment in 2025
VANCOUVER, BC / ACCESSWIRE / April 3, 2024 / Clairvoyant Therapeutics Inc. (www.clairvoyantrx.com), the private clinical-stage pharmaceutical company developing psilocybin treatment for alcohol use disorder (AUD), today announced that it is on target to potentially become the first in the world to commercialize clinically validated psilocybin treatment. Clairvoyant believes it may achieve this milestone in H2 2025.
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.Clairvoyant's randomized controlled trial, CLA-PSY-201, has dosed more than 90 per cent of the expected 128 subjects for its 24-week Phase 2b clinical trial of synthetic psilocybin treatment for AUD (two dosing sessions of a 25 mg oral capsule over 8 weeks) at 12 active clinical sites in Canada and Europe. A top line read out from the clinical trial is expected in Q3 2024 and a Series A financing round is currently underway.
"We are quickly approaching a critical and exciting moment for psilocybin and its potential use as a recognized treatment," said Damian Kettlewell, CEO, Clairvoyant. "We have the compelling efficacy and safety data on psilocybin treatment for AUD from a phase 2a study previously published in JAMA Psychiatry[i] in 2022 and earlier data published in 2015. Assuming our trial has similar results, we believe there is a regulatory pathway to conditional market authorization in Canada in 2025 and in the EU in 2026."
Conditional marketing authorization of psilocybin would be based on recognition of AUD as a serious, life-threatening or severely debilitating disease for which psilocybin demonstrates a significant increase in efficacy in relation to existing AUD drugs. Conditional authorization of a new medicine, known as NOC/c in Canada and CMA in Europe, allows the marketing of a new drug with the condition that the sponsor undertake additional studies to verify the clinical benefit. Under NOC/c and CMA, companies are required to conduct confirmatory studies to validate the initial efficacy evidence. Clairvoyant intends to launch a pivotal confirmatory trial in H2 2025, with a read out in 2027, to support full approval of psilocybin treatment in Canada, the EU and UK.
About Patient Safety
Clairvoyant is committed to ensuring the safety and well-being of participants. Participants are supported by two therapists in preparation for, and during, the psychedelic experience induced by psilocybin. Clairvoyant has trained over 50 therapists in its 35-hour training program. Therapists are monitored for adherence to the trial protocol and ethics under Clairvoyant's industry leading therapist adherence monitoring program. No ethical concerns have been identified to date.
About Alcohol Use Disorder
Alcohol is the leading risk factor for overall burden of disease among men and a significant risk factor among women.[ii] A regional study recently reported that fewer than 5 per cent of patients diagnosed with moderate to severe alcohol use disorder receive recommended medications.[iii]
About Clairvoyant Therapeutics
Clairvoyant Therapeutics is a Canadian biotechnology company trailblazing a path to global mental health through psilocybin treatment. Clairvoyant's speed-to-market clinical strategy is designed to enable psilocybin treatment in Canada, EU & the UK for patients living with Alcohol Use Disorder (AUD) beginning in 2025.
The company's exceptional team, with deep clinical development experience, has made Clairvoyant the most advanced company developing psilocybin for the treatment of AUD. Clairvoyant is a member of Life Sciences BC.
Additional information about Clairvoyant's clinical trial may be found at ClinicalTrials.gov
-30-
For more information:
Damian Kettlewell
damian@clairvoyantrx.com
[i] Bogenschutz, MP et al. (2022) JAMA Psychiatry. 2022;79(10):953-962. doi:10.1001/jamapsychiatry.2022.2096
[ii] World Health Organization. Global Status Report on Alcohol and Health 2014 Accessed March 2024 at WHO Global Status Report on Alcohol and Health 2014
[iii] Maria Eugenia Socias, Frank Xavier Scheuermeyer, Zizhan Cui, Wing Yin Mok, Alexis Crabtree, Nadia Fairbairn, Seonaid Nolan, Amanda Slaunwhite, Lianping Ti. (2023) Addiction. 2023; Volume118, Issue11: 2128-2138. doi.org/10.1111/add.16273
SOURCE: Clairvoyant Therapeutics
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
AI and Cybersecurity Leader, SecureAuth, Appoints Geoffrey Mattson to Help Enterprises Secure Complex Human, Machine, and AI-agent Identities10.12.2025 17:30:00 CET | Press release
IRVINE, CALIFORNIA / ACCESS Newswire / December 10, 2025 / SecureAuth, a leader in AI-driven identity security, today announced the appointment of Geoffrey Mattson as Chief Executive Officer. Mattson's appointment marks the beginning of the company's next phase of growth as enterprises confront a rapid rise in AI agents with real authority, a shift that is increasing the complexity of business relationships and driving urgent demand for modern identity security. The Board of Directors thanks outgoing CEO Joseph Dhanapal, who will remain as a strategic advisor. During his tenure, SecureAuth invested heavily in creating a next generation security platform, featuring our market leading, AI-driven risk engine. With this platform in place, SecureAuth is positioned to capture accelerating demand for identity and access management as agentic AI transforms identity from a static access check into a dynamic control plane for managing complex human, machine, and AI-driven relationships. Mattson
Nasdaq Verafin Joins Global Anti-Scam Alliance10.12.2025 15:00:00 CET | Press release
THE HAGUE, NL / ACCESS Newswire / December 10, 2025 / The Global Anti-Scam Alliance (GASA) is pleased to announce that Nasdaq Verafin has joined GASA as a Foundation Member, strengthening the global effort to combat scams, financial crime, and digital fraud. As fraud tactics continue to evolve across borders and digital channels, cross-sector collaboration has become essential to protecting consumers and building safer financial ecosystems. Nasdaq Verafin's participation marks a meaningful step forward in the shared mission to advance trust, transparency, and resilience across the globe. In addition to joining the global effort, Nasdaq Verafin will join both the Brazil and Mexico chapters of GASA to partner with stakeholders across the financial ecosystem in Latin America, bolstering regional initiatives to combat financial crime. "Criminals are innovating at an unprecedented rate, taking advantage of information siloes and the shortcomings of legacy technology to avoid detection. We a
TIS Helps Treasury Teams Navigate the Ongoing ISO 20022 Transition After the 2025 Banking Deadline10.12.2025 14:00:00 CET | Press release
BERLIN, DE / ACCESS Newswire / December 10, 2025 / Treasury Intelligence Solutions (TIS), a leading cloud-based platform for payments and cash management, is future-proofing organizations with specialized translation services in the wake of the recent November 2025 ISO 20022 deadline. A major turning point for the financial industry, SWIFT now requires banks to move their cross-border payment messages to ISO 20022. As a result, treasury teams are already seeing differences in how their banks send and receive payment information. Adapting to these changes will require a strategic approach to modernizing systems and processes. ISO 20022 replaces a patchwork of older standards with a single approach to structuring payment data. The new universal standard is designed to reduce confusion across markets, improve data quality, and support the level of transparency that regulators around the globe now expect. Moving to ISO 20022 payments takes time and strategic vision, especially when legacy
Majority of Australian Parents (65%) and U.S. Parents 58% Support Social Media Ban for Under 16s, but Kids Say It Risks Cutting Them Off from Key Connections9.12.2025 15:00:00 CET | Press release
New survey of 4,000 parents and children in the U.S. and Australia reveals sharp generational divides in support, fears, mental health expectations, and belief in government enforcement. WASHINGTON, DC / ACCESS Newswire / December 9, 2025 / The Family Online Safety Institute (FOSI) released new research today examining how parents and children in the United States and Australia view social media bans for anyone under 16. The findings reveal strong parental support for such bans, in contrast with widespread concern from children who fear losing friendships and support systems that exist primarily online. The research arrives as Australia implements a national under 16 social media ban, placing global attention on how the policy will affect youth and their families. FOSI's study surveyed 4,000 parents and children ages 10 to 17 to understand how both groups feel about restrictions, enforcement, and the broader impact of social media on daily life. Support for the Ban: Parents vs Children
Techmer PM Joins Formerra's Portfolio in North America9.12.2025 15:00:00 CET | Press release
Formerra will distribute Techmer PM color masterbatches, high-performance additives, and pre-colored compounds across the U.S., Canada, and Mexico. ROMEOVILLE, ILLINOIS / ACCESS Newswire / December 9, 2025 / Formerra, a leader in performance materials distribution, today announced the addition of Techmer PM color masterbatches, high-performance additives, and pre-colored compounds to its expansive portfolio of materials. With this partnership, Formerra advances its application-specific lineup, aligning its material portfolio to customers' evolving needs across North America. A U.S.-based plastics compounder, Techmer PM specializes in value-added color and additive masterbatches and engineered compounds for high-performance plastics and fibers. These products are used in various industries such as medical, automotive, packaging, and consumer goods applications. Techmer PM has consistently invested in its optical and color capabilities, including the recent acquisition of OptiColor Inc.
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom