Definium Therapeutics has notched another late-stage win for DT120 in generalised anxiety disorder (GAD) – further bolstering the drug’s market potential as the buzz around psychedelic medicines grows.
The therapies latest success stems from Definium’s Voyage study (NCT06741228), which pitted a single, orally disintegrating dose of DT120, which is a formulation of lysergide (LSD), against placebo in patients with GAD for an initial 12 weeks.
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During the trial, patients treated with DT120 experienced a statistically significant 5.4-point average decrease in anxiety scores as per the Hamilton Anxiety Rating Scale (HAM-A) from baseline over placebo, with these effects setting in as early as day two and remaining throughout the 12-week initial treatment period. The HAM-A score was -11.6 in the DT120 cohort compared with -6.2 for patients who received placebo.
Patients saw benefit as early as day two, with DT120’s effects sustaining through all time points throughout the study.
Key secondary endpoints, including HAM-A at week one and Clinical Global Impression – Severity (CGI-S) at week one and week 12 were also statistically significant.
Patients also tolerated the drug well, with treatment-emergent adverse events (TEAEs) generally occurring on the day of dosing, while remaining mild-to-moderate in severity. Researchers identified no new safety signals linked to treatment with DT120.
The 12-week period will be followed by a 40-week open-label extension, in which patients could receive up to four more doses of the drug based on their symptom severity.
With a first successful late-stage GAD readout for DT120 in the bag, Definium will now await the results of Panorama, its other Phase III GAD study, which could further solidify the drug’s case for potential approval in the indication, if positive. Definium expects this second trial will read out in September.
DT120’s role in mental health treatment
While the GAD readout marks the latest step forward for Definium, this mental health condition is not the only one DT120 has demonstrated potential in. Back in June 2026, Definium posted a Phase III win for the drug in major depressive disorder (MDD) – a result which GlobalData neurology analyst Philippa Salter noted would be pertinent for patients who don’t want to rely on long-term maintenance treatment.
At the time the MDD results debuted, study investigator and CSO at TRIP Clinics at Psychedelic Science Institute, Dr Keith Heinzerling, told Clinical Trials Arena the data was particularly impactful because it highlighted the drug’s rapid onset of action. This trait, he said, would differentiate DT120 from current MDD offerings, which generally rely on a prolonged adjustment period before they begin to take effect.
Currently, psychedelic medicines are garnering significant attention for their potential to treat mental health conditions, with compounds derived from Schedule I controlled substances like psilocybin, LSD and N, N-Dimethyltryptamine (DMT) currently all making their way through late-stage studies in conditions like GAD, MDD and treatment-resistant depression (TRD).
The regulated psychedelic movement is also seemingly backed by the US government, with President Donald Trump previously inking an executive order (EO) awarding expedited regulatory timelines to psychedelics that are either breakthrough therapy-designated or have completed a Phase III trial.
In a previous conversation with Clinical Trials Arena, Dr Hans Eriksson, CMO at HMNC Brain Health, compared the current surge in psychedelic medicines to the “first golden age of neuropsychopharmacology” in the 1950s, driven by their high efficacy.
However, experts warn that systems must play catch-up to ensure that psychedelic medicines can be safely and effectively administered to patients requiring treatment, as long supervised treatment periods remain a key hurdle to overcome.
