Definium Therapeutics announced successful results from its third Phase 3 trial of 2026 for DT120, an oral LSD-based tablet. In a 245-patient study, a single 100-microgram dose significantly reduced generalized anxiety disorder symptoms over 12 weeks. The company plans to file for FDA approval in the first half of 2027, targeting a market of 26 million U.S. adults who have lacked new treatment options for nearly two decades.
DT120 Phase 3 trial results
- ▪In a Phase 3 clinical trial of 245 patients, a single 100-microgram dose of Definium Therapeutics' DT120 reduced generalized anxiety disorder scores by 9.8 points after 12 weeks, compared to a 4.7-point decline for placebo
- ▪The therapeutic benefits of Definium Therapeutics' DT120 emerged by day 2 of the clinical trial and persisted through week 12
- ▪The September 14, 2026 readout represents Definium Therapeutics' third successful Phase 3 trial for DT120 in 2026, following an anxiety trial in August 2026 and a depression trial in June 2026
- ▪Definium Therapeutics reported that DT120 demonstrated higher efficacy at the 100-microgram dose compared to the 50-microgram dose in its clinical trial
- ▪Definium Therapeutics added a 50-microgram dose arm to its DT120 clinical trial of 245 patients to address functional unblinding
LSD psychedelic therapy enthusiasm
- ▪Regulatory and investor enthusiasm for psychedelic-based therapies contributed to Definium Therapeutics' shares nearly tripling in 2026
- ▪Definium Therapeutics' stock price rose 5% on September 14, 2026, following the announcement of the successful DT120 Phase 3 trial results
- ▪Evercore ISI analyst Gavin Clark-Gartner stated that seeing three back-to-back trials with highly consistent benefits is unusual in the neuropsychiatry field
FDA approval timeline
- ▪Definium Therapeutics plans to submit a marketing application for DT120 to the United States Food and Drug Administration in the first half of 2027
- ▪Definium Therapeutics CEO Robert Barrow stated that having two successful studies for generalized anxiety disorder helps address regulatory questions regarding what drives the drug's therapeutic effect
Commercial treatment strategy
- ▪Definium Therapeutics is pursuing a broad regulatory label to treat both generalized anxiety disorder and depression with DT120, featuring no fixed dosing intervals
- ▪Definium Therapeutics CEO Robert Barrow projected that if half of the approximately 8,000 interventional psychiatry sites in the United States treated two DT120 patients monthly, annual treatment volume would reach about 100,000 patients
Generalized anxiety disorder epidemiology
- ▪Generalized anxiety disorder is commonly treated with antidepressants, anti-anxiety medications, and psychotherapy, with no new treatments approved for the condition in nearly two decades as of September 2026
- ▪Generalized anxiety disorder affects approximately 26 million adults in the United States
Debatable claims
- ▪Functional unblinding compromises the clinical trial results of psychedelic therapies
- ▪The FDA should approve Definium's LSD-based drug DT120
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