Definium’s DT120 Posts Positive Phase 3 Results in Generalized Anxiety Disorder

Key Points

• Definium Therapeutics said its Phase 3 Panorama trial met its main goal and all key secondary efficacy endpoints in adults with generalized anxiety disorder, or GAD.
• A single 100-microgram dose of DT120 ODT improved anxiety scores by 5.1 points more than placebo after 12 weeks.
• The company said improvements appeared by Day 2 and continued through the 12-week study.
• Panorama is Definium’s second positive Phase 3 GAD trial and its third positive Phase 3 readout for DT120 ODT.
• Definium expects a pre-NDA meeting with the FDA in the fourth quarter of 2026 and plans to file for approval in the first half of 2027.

Definium Therapeutics (NASDAQ: DFTX) reported positive topline results from Panorama, its second Phase 3 study of DT120 orally disintegrating tablets in adults with generalized anxiety disorder. The company said the single-dose treatment improved anxiety symptoms more than placebo and was generally well tolerated.

Single 100-Microgram DT120 Dose Reduced Anxiety Scores More Than Placebo

Patients who received a single 100-microgram dose of DT120 saw their anxiety scores decline by an average of 9.8 points after 12 weeks. Patients receiving placebo improved by 4.7 points.

In other words, DT120 produced an additional 5.1-point improvement over placebo. Definium said the result was statistically significant and that benefits appeared as early as two days after dosing, continuing through the 12-week study period.

More DT120 Patients Achieved Major Symptom Improvement and Remission

Definium said DT120 also met all key secondary endpoints, including measures of overall clinical severity.

At Week 12, 32% of patients receiving DT120 achieved at least a 50% reduction in anxiety symptoms, compared with 14% of placebo patients. Fifteen percent of DT120 patients reached remission, compared with 4% in the placebo group.

The company also reported that 35% of patients receiving DT120 reached a mild-or-better anxiety level at Week 12, compared with 17% of patients who received placebo.

Lower 50-Microgram DT120 Dose Produced a Smaller Anxiety Benefit

The Panorama study also included a 50-microgram DT120 dose group. Definium said this group was not designed for formal statistical comparisons.

Still, the lower dose showed a smaller improvement than the 100-microgram dose, with placebo-adjusted reductions in anxiety scores of 3.5 points at Week 4 and 3.6 points at Week 12.

Most Reported DT120 Side Effects Were Temporary and Occurred on Dosing Day

Definium said DT120 was generally well tolerated. Most side effects were mild to moderate, temporary, and occurred mainly on the day of dosing.

The most commonly reported effects were illusion, nausea, and headache. The company reported no drug-related serious adverse events, no new safety signals, and no suicidality signal or suicidal behavior. Discontinuation rates were similar across the 100-microgram, 50-microgram, and placebo groups.

Definium Plans FDA Meeting in Late 2026 and NDA Submission in 2027

Panorama follows positive Phase 3 Voyage results in GAD and positive Phase 3 Emerge results in major depressive disorder.

Definium plans to meet with the FDA in the fourth quarter of 2026 before submitting a New Drug Application for DT120 ODT in the first half of 2027.