Definium’s Oral Film Achieves Second Phase III Win in GAD

Definium Therapeutics has reported that DT120 oral disintegrating tablet (ODT), an LSD-derived, 5-HT2A partial agonist formulated with Catalent’s Zydis rapid-dissolve technology, met the primary endpoint in the Phase III PANORAMA study in generalised anxiety disorder (GAD), with the 100 µg arm cutting Hamilton Anxiety Rating Scale scores by 9.8 points versus 4.7 for placebo, a 5.1-point separation (p<0.0001), onset by day two, and response rates of 32% versus 14% at week 12.

The 245-patient, placebo-controlled trial follows the August 2026 VOYAGE win, and Definium now plans a pre-NDA meeting in the fourth quarter and a 2027 first-half submission, targeting a US market of roughly 26 million adults where the last novel GAD approval was duloxetine in 2007.

DT120’s pitch is infrequent dosing and rapid symptom relief rather than daily SSRI or SNRI maintenance, but the safety label will define the launch: hallucination rates were 61% to 68% and nausea 26% to 37% across active arms, even though discontinuation matched placebo at about 10% to 12%.

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