Definium Therapeutics has scored another phase 3 success with its LSD-based therapy, this time demonstrating positive results in generalized anxiety disorder just months after reporting strong findings in depression.
The 214-patient Voyage study compared a single psychoactive treatment session using Definium’s DT120 ODT with a placebo. At the 12th week, anxiety symptoms had declined by an average of 11.6 points among patients receiving DT120, versus 6.2 points in the placebo group. Researchers measured symptom severity using the Hamilton Anxiety Rating Scale (HAM-A).
The CEO’s Response
Definium Chief Executive Officer Robert Barrow said the study produced a placebo-adjusted improvement of 5.4 points on the HAM-A, noting that pivotal studies had not previously demonstrated more than a five-point placebo-adjusted change on the scale. He also emphasized that the benefit was still evident 12 weeks after a single dose.
Barrow described the 5.4-point advantage as a major shift in the treatment outlook for people with generalized anxiety disorder, arguing that the results could establish a new benchmark for what patients should expect from therapy.
The CEO expressed similar enthusiasm in June when Definium announced Phase 3 results for DT120 in major depressive disorder. At the time, he characterized the candidate’s efficacy as unprecedented in a pivotal depression study.
Anxiety Treatment Options
Treatment options for anxiety have seen relatively little innovation in nearly two decades, with Eli Lilly’s Cymbalta receiving approval for generalized anxiety disorder in 2007. Barrow said existing approaches have significant shortcomings, pointing to the long-term addiction concerns associated with benzodiazepines and noting that serotonin reuptake inhibitors are generally more effective for depression.
Brian Barnett, vice chair of psychiatry at Cleveland Clinic and main investigator of the Voyage study, said many patients he treats continue to experience inadequate relief despite trying several different therapies. He added that a single-dose treatment capable of producing meaningful benefits for 12 weeks could represent a significant advance and, if approved, would give physicians and patients an option that works through a mechanism distinct from currently available treatments.
What the Future Holds For DT120
DT120 now has another Phase 3 test ahead, with results from the next anxiety study expected next month. Known as Panorama, the trial includes a second control group receiving a lower dose of the LSD-derived therapy.
Barrow explained that the lower-dose group is intended to make it difficult for participants to determine whether they received the full therapeutic dose based on the subjective effects of the treatment.
Although Barrow expects the Panorama results to provide additional support for DT120’s regulatory prospects, he believes the existing Phase 3 findings already provide substantial evidence of the therapy’s effectiveness. He said the company now has two compelling studies spanning anxiety and depression, both of which represent areas with significant unmet medical need and high treatment priority.
Barrow also said Definium has had positive discussions with the FDA and feels optimistic about the regulatory path ahead.
The company’s latest results arrive amid renewed interest in psychedelic medicines, supported in part by backing from the Trump administration and Eli Lilly’s nearly $3 billion buyout of AtaiBeckley last month.
Definium Therapeutics has reported positive Phase 3 results for DT120 ODT, its pharmaceutical formulation of lysergide, or LSD, in generalized anxiety disorder. The 214-patient Voyage study met its primary endpoint, with patients receiving a single dose showing a larger reduction in anxiety symptoms than those receiving placebo.
The results represent the second major Phase 3 success for Definium in 2026. Earlier, the company’s Emerge Phase 3 study of DT120 in major depressive disorder also met its primary and key secondary endpoints.
Definium’s DT120 Shows Sustained Anxiety Benefits
In the Voyage trial, Definium reported an 11.6-point reduction in Hamilton Anxiety Rating Scale scores after 12 weeks among patients receiving DT120, compared with a 6.2-point reduction for placebo. This produced a 5.4-point placebo-adjusted difference.
According to Definium, the treatment effect appeared as early as two days after dosing and remained measurable through the 12-week assessment. The company is developing DT120 as a single-dose, supervised treatment rather than a daily medication.
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