Definium Therapeutics to Report Phase 3 Panorama Topline Results for LSD-Based Anxiety Drug DT120
核心洞察
Definium Therapeutics (搜索) will host a webcast on September 14, 2026, to present topline results from Panorama, its second Phase 3 trial of DT120 (搜索) in generalized anxiety disorder (搜索).
Panorama randomized 245 adults with DSM-5-confirmed GAD to a single dose of DT120 (搜索) ODT 100 µg, 50 µg, or placebo, with HAM-A change at Week 12 as the primary endpoint.
Anticipation follows positive Phase 3 Emerge depression (搜索) data in which a single 100-microgram DT120 (搜索) dose produced an 8.1-point placebo-adjusted improvement at Week 6, sustained through Week 12.
Definium Therapeutics (搜索) is set to disclose topline results from Panorama (MM120-301), its second Phase 3 study of DT120 (搜索) (lysergide) Orally Disintegrating Tablet in adults with generalized anxiety disorder (搜索), during a live webcast scheduled for September 14, 2026, at 8:00 a.m. EDT. The New York-based late-stage biopharmaceutical company announced the event on September 13, 2026, with analysts able to participate in a question-and-answer session and a replay archived for at least 30 days on the company's investor relations site.
Panorama Trial Design and Endpoints
Panorama is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of DT120 (搜索) ODT in adults with GAD. The trial enrolled 245 participants across approximately 32 study centers, recruiting individuals 18 to 74 years of age with a DSM-5-confirmed primary diagnosis of GAD and a minimum Hamilton Anxiety Rating Scale (HAM-A) total score of 20 at both screening and baseline.
Eligible participants were randomized 2:1:2 to receive a single dose of DT120 (搜索) ODT 100 µg, DT120 ODT 50 µg, or matching placebo. According to the company, the 50 µg arm was included to help mitigate functional unblinding. The study comprises a 12-week double-blind treatment period (Part A) followed by a 40-week open-label extension (Part B), during which participants may be eligible to receive up to four additional doses of DT120 ODT 100 µg based on symptom severity, for a total study duration of approximately 56 weeks.
The primary endpoint is change from baseline in HAM-A total score at Week 12. Key secondary multiplicity-controlled endpoints include change from baseline in Clinical Global Impression-Severity (CGI-S) scale score at Week 12, change from baseline in HAM-A total score at Week 1, and change from baseline in CGI-S score at Day 2.
Depression Data Underpin Anxiety Readout Expectations
Anticipation around Panorama follows positive results from Definium's Phase 3 Emerge depression (搜索) trial. A single 100-microgram DT120 (搜索) dose produced an 8.1-point improvement over placebo on a widely used depression scale at Week 6, with the benefit lasting through Week 12. The result was described as highly statistically significant.
Those findings helped DT120 (搜索) secure FDA Breakthrough Therapy designation for depression (搜索) earlier in September 2026 — its second such designation after anxiety.
Broader Phase 3 Program to Be Presented
Definium will present findings from its broader Phase 3 program at Psych Congress 2026, held September 15–19 in New Orleans. Its six posters will cover anxiety and depression (搜索) results, DT120 (搜索)'s safety, trial design and suicidal ideation, while Emerge will feature in a session on emerging trends in depression.
Definium describes its mission as forging a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments intended to address underlying causes of psychiatric and neurological disorders. The company trades on Nasdaq under the symbol DFTX.