Definium Advances DT120 Toward Regulatory Submission After Positive Phase III Results
核心洞察
Definium Therapeutics (搜索) will file an NDA for its LSD-based medicine DT120 (搜索) in generalised anxiety disorder (搜索) after a third positive Phase III readout.
The open-label Panorama study met its primary endpoint with a 5.1-point placebo-adjusted improvement in anxiety scores at week 12 on the 100µg dose.
Definium plans a pre-NDA meeting with the FDA in the fourth quarter of 2026 and a GAD filing in the first half of 2027.
Definium Therapeutics (搜索) is preparing a New Drug Application to US regulators for DT120 (搜索), its lysergic acid diethylamide (LSD)-based medicine also known as lysergide, after a third positive Phase III readout. The open-label Panorama study (NCT06809595) compared 50µg and 100µg doses of DT120 with placebo over 12 weeks in patients with generalised anxiety disorder (搜索), followed by a 40-week extension phase offering optional open-label treatment.
The 100µg dose produced a 5.1-point placebo-adjusted improvement from baseline in anxiety scores at week 12, meeting the primary endpoint. Score changes appeared as early as day two and were maintained through the first portion of the trial. Most treatment-related adverse events were mild to moderate and occurred on the day of dosing, with no new safety signals and discontinuation rates consistent between treatment and placebo arms.
Panorama follows positive results from the Emerge (NCT06941844) and Voyage (NCT06741228) studies in major depressive disorder (搜索) and GAD respectively; Voyage showed a 5.4-point improvement in anxiety scores. DT120 (搜索) is in development for MDD, GAD and post-traumatic stress disorder (搜索). Definium plans a pre-NDA meeting with the FDA in the fourth quarter of 2026 and a GAD filing in the first half of 2027. The FDA also held a hearing on how psychedelic therapies should be rolled out, monitored and studied outside clinical trials, with access and administration models, including supervised treatment sessions versus psychotherapy-based approaches, as central topics.