Cybin Inc., a company in the early stages of clinical development that focuses on creating new treatments for mental health using psychedelic-based approaches, has announced that it has finished enrolling patients in its ongoing Phase 2 clinical trial for CYB004. This experimental drug is a special form of dimethyltryptamine (DMT) that includes deuterium atoms and is being studied for its potential to treat Generalized Anxiety Disorder (GAD). The company also confirmed that it remains on track to release the primary results from the trial in the first quarter of 2026.
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Eric So, the Interim Chief Executive Officer of Cybin, emphasized the importance of reaching this point in the trial. He stated that completing patient enrollment represents a meaningful step forward in the effort to deliver a new and effective treatment for GAD. He highlighted the global scale of anxiety disorders, which affect over 300 million people, and pointed out that GAD is the most frequently diagnosed anxiety disorder in primary care settings. In the United States alone, approximately 6.8 million adults live with GAD, and many of them do not respond well to the standard treatments like SSRIs and SNRIs. According to So, CYB004 has the potential to meet this unmet need, not only because of its unique pharmacological profile but also due to its intramuscular delivery method, which could offer patients a more convenient treatment option. He added that the company is encouraged by the progress made so far and values the strong patent protections surrounding the CYB004 program.
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The CYB004-002 study is a randomized, double-blind Phase 2 trial designed to evaluate both the safety and efficacy of CYB004 in adults with moderate to severe GAD. All participants entered the study with a GAD-7 score of 10 or above and were allowed to continue using their current antidepressant or anti-anxiety medications. The study also accepted participants with co-occurring depression. The primary goal is to assess changes in the Hamilton Anxiety Rating Scale (HAM-A) scores from the beginning of the trial to six weeks after the initial dose. Secondary and exploratory endpoints include further changes in HAM-A over a 12-week period, as well as additional evaluations using depression scales, safety metrics, quality of life assessments, and a psychedelic experience questionnaire.
A total of 36 participants were enrolled and randomized into two treatment arms. The majority of participants received two doses of CYB004 at 20 milligrams each, given three weeks apart—this dose is believed to have therapeutic potential. The other group received the same dosing schedule but at a significantly lower 2 milligram dose, which is expected to be sub-therapeutic. Both groups remain unaware of their assigned dosing for the duration of the 12-week double-blind period. Additionally, an optional follow-up period of up to 12 months has been included to track any long-term outcomes.
Now that the enrollment phase is complete, Cybin will proceed with collecting and analyzing data from the study. The company continues to view CYB004 as a promising candidate for addressing the unmet treatment needs in GAD. This trial plays a central role in Cybin’s broader clinical strategy, and the company remains committed to advancing safe, effective, and innovative therapies in the field of mental health.
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