Three consecutive Phase 3 wins with lysergide ODT across GAD and MDD; approval of a novel psychedelic therapy hinges on FDA's regulatory posture at the NDA

Definium Therapeutics is a clinical-stage company developing a psychedelic therapy for generalized anxiety disorder and major depressive disorder, neither of which is yet approved with this treatment.

DT120 ODT, an orally disintegrating lysergide tablet, has now won three consecutive Phase 3 trials across two indications, with Breakthrough Therapy designations in both GAD and MDD. The GAD NDA filing anticipated in the first half of 2027 will determine whether FDA accepts psychedelic-class efficacy data as sufficient for approval without additional conditions. The central risk is an unconventional approval path: no approved lysergide therapy exists, and FDA's willingness to approve on single-dose psychedelic mechanism data remains untested at the NDA stage.