The Effect Size Is 0.81. The Number That Decides the Business Is 6.4 Hours.
- Definium Therapeutics (Nasdaq: DFTX) reported positive topline results on 12 August 2026 from Voyage, its first Phase 3 of DT120 (lysergide) orally disintegrating tablet at 100 µg in generalized anxiety disorder. It is the second positive DT120 Phase 3, after Emerge in major depressive disorder in June.
- Voyage randomised 214 adults aged 18 to 74 across roughly 35 US sites, all with a HAM-A score of at least 20 at screening and baseline. Effect size was d=0.81, and every key secondary endpoint was met, with separation from placebo visible at Day 2.
- On dosing day, participants were assessed hourly from hour 5 on a structured end-of-session checklist. Mean time to meeting criteria was 6.4 hours, median 6.1, with 92% clearing by hour 8.
- The 12-week double-blind period is followed by a 40-week open-label extension in which participants may receive up to four additional doses. DT120 holds Breakthrough Therapy designation for GAD. Second Phase 3, Panorama, reads out in September. GAD affects roughly 26 million US adults and the last new approval was in 2007.
Voyage · Week 12 · DT120 ODT 100 µg against placebo
| Endpoint | DT120 (n=107) | Placebo (n=107) | Difference |
|---|---|---|---|
| HAM-A, LS mean change | -11.6 | -6.2 | -5.4 (p<0.0001) |
| CGI-S, LS mean change | -1.0 | -0.4 | -0.6 (p<0.0001) |
| HAM-A response, 50% or more | 43% | 16% | +27 pts (p<0.0001) |
| HAM-A remission, 7 or below | 14% | 4% | +10 pts (p=0.0222) |
| HAM-A mild or better, under 16 | 51% | 23% | +28 pts (p<0.0001) |
Baseline HAM-A was 28.4 on DT120 and 27.4 on placebo. Onset was rapid: HAM-A difference at Week 1 was -7.7 and CGI-S difference at Day 2 was -0.8, both p<0.0001. Adverse events were mild to moderate, transient and mostly confined to dosing day, with no suicidality signal.
CI read
Efficacy is settled. Effect size 0.81, second positive Phase 3, every key secondary met. The figure that decides the commercial case is 6.4 hours, because each dose occupies a supervised chair for most of a working day.
- Definium names the constraint in its own risk factors: finding treatment sites and training qualified practitioners. Monitoring runs from hour 5 to hour 8. 92% cleared by then, so 8% did not, and the FDA writes discharge rules off that tail.
- Single dose describes Part A, not the regimen. The 40-week extension allows up to four further doses. Model up to five supervised days per patient per year against 26 million US adults with GAD.
- The DEA holds the launch date. Lysergide is Schedule I, and rescheduling sits in Definium’s risk factors. Takeda’s Orzeyful cleared the FDA on 5 August and still cannot be sold for the same reason.
Read the original source (Definium Therapeutics) →
CompaniesDefinium Therapeutics
GeographyUnited States