FDA awarded DT120 Breakthrough Therapy designation for MDD based on phase 3 data showing rapid, sustained improvement after one 100 μg dose.
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DT120 (lysergide) orally disintegrating tablets (ODT) for the treatment of
DT120 is the tartrate salt form of lysergide, an ergoline derivative and classic serotonergic psychedelic that acts as a partial agonist at serotonin 2A receptors. The ODT formulation is designed to provide faster absorption and onset of transient cognitive, perceptual, and affective effects, improve bioavailability, and reduce gastrointestinal adverse effects.¹
“Securing our second Breakthrough Therapy designation, closely following the unprecedented results from our phase 3 Emerge study, underscores the potential of DT120 to meaningfully transform the treatment landscape for people living with serious mental health disorders,” Rob Barrow, chief executive officer of Definium Therapeutics, said in a statement.¹
“This recognition of DT120’s promise, first in GAD and now in MDD, reinforces the urgency to advance and deliver rapid, durable benefit across multiple indications,” Barrow added.¹
The regulatory action marks the second Breakthrough Therapy designation awarded to the DT120 development program. The FDA previously granted the designation for the treatment of
Voyage enrolled 214 adults aged 18 to 74 years across 35 US sites. Eligible participants had a diagnosis of GAD confirmed according to DSM-5 criteria through clinical assessment and the Mini-International Neuropsychiatric Interview, as well as a baseline Hamilton Anxiety Rating Scale score of 20 or higher.²
Participants were randomly assigned in a 1:1 ratio to receive a single 100 μg dose of DT120 ODT or placebo during a 12-week double-blind period. This was followed by a 40-week open-label extension in which participants could receive up to 4 additional doses of DT120 based on symptom severity.²
The trial met its primary and all key secondary endpoints, according to Definium. Improvements emerged within days after dosing and were maintained through the 12-week double-blind period.² Detailed peer-reviewed findings, including complete safety and tolerability data, will be important for assessing the therapy’s potential clinical role.
Definium is also evaluating DT120 for other psychiatric conditions, including
Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious or life-threatening conditions when preliminary clinical evidence suggests substantial improvement over available treatment. The designation does not constitute FDA approval, and DT120 is not currently authorized for routine clinical use in MDD.
