Key Summary:
- DT120 significantly reduced anxiety symptoms versus placebo at Week 12.
- DT120 achieved a placebo-adjusted HAM-A difference of 5.4 points.
- Results supported further investigation of DT120 for generalized anxiety disorder.
An LSD-based investigational treatment has shown positive results in a phase 3 study of generalised anxiety disorder (GAD), adding to growing interest in psychedelic-derived medicines for mental health conditions.
Definium Therapeutics’ DT120 is a pharmaceutical formulation of lysergide (LSD) delivered as an orally disintegrating tablet. In the Voyage study, a single 100 µg dose significantly reduced anxiety symptoms compared with placebo after 12 weeks.
The results add to growing clinical research into whether psychedelic compounds can be developed into regulated medicines for psychiatric conditions, with companies investigating these approaches across depression, anxiety and other mental health disorders.
Positive phase 3 results
The study included 214 adults with GAD. DT120 met its primary endpoint, with a placebo-adjusted difference of 5.4 points (-11.6 for DT120 ODT 100 µg group vs -6.2 for placebo group) on the Hamilton Anxiety Rating Scale. Improvements were also reported across key secondary measures, with benefits seen early in the study and maintained over 12 weeks.
DT120 was generally well tolerated, with the company reporting no new safety signals. Further data will be needed to assess the consistency of the findings across the wider development programme and to build a clearer picture of the treatment’s safety profile.
DT120 advances in psychiatric development
The Voyage results are the second positive phase 3 readout for DT120 this year, following results from the Emerge study in major depressive disorder announced in June.
Definium is also conducting Panorama, a second phase 3 study of DT120 in GAD, with results expected later this year. Further findings will help determine whether the treatment can progress towards regulatory submission and potentially become a new option for people with anxiety.
The results also add to the broader development of LSD-derived medicines. While LSD has historically been associated with recreational and experimental use, pharmaceutical developers are increasingly exploring whether its effects can be translated into controlled treatments for mental health conditions.
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