The FDA has granted breakthrough therapy designation to Definium Therapeutics' DT120 ODT, an optimized lysergide (LSD) formulation, for treating major depressive disorder. The decision follows positive phase 3 Emerge trial results, where a single dose showed rapid, durable improvements in depression scores through 12 weeks. DT120 ODT also holds a breakthrough designation for generalized anxiety disorder based on positive phase 3 Panorama trial data. Definium plans to submit a new drug application in the first half of 2027.
FDA breakthrough therapy designation
- ▪Definium Therapeutics previously received an FDA breakthrough therapy designation for DT120 Orally Disintegrating Tablet for the treatment of generalized anxiety disorder.
- ▪The FDA granted breakthrough therapy designation to DT120 Orally Disintegrating Tablet for the treatment of major depressive disorder based on preliminary clinical evidence.
DT120 ODT lysergide formulation
- ▪DT120 Orally Disintegrating Tablet acts as a partial agonist at serotonin-2A (5-HT2A) receptors and is designed to be fast-absorbing with improved bioavailability and lower gastrointestinal side effects.
- ▪DT120 Orally Disintegrating Tablet is a pharmaceutically optimized formulation of lysergide (LSD) developed by Definium Therapeutics.
Major depressive disorder trial
- ▪Clinical data from the Emerge study demonstrated that a single dose of DT120 Orally Disintegrating Tablet produced significant antidepressant effects starting at week 1 that were sustained through week 12.
- ▪Definium Therapeutics' phase 3 Emerge study of DT120 Orally Disintegrating Tablet in adults with major depressive disorder showed significant improvement in Montgomery-Åsberg Depression Rating Scale scores at week 6 compared to placebo.
Generalized anxiety disorder trial
- ▪Definium Therapeutics' phase 3 Panorama study of DT120 Orally Disintegrating Tablet for generalized anxiety disorder met its primary endpoint, showing significant improvements in Hamilton Anxiety Rating Scale scores.
- ▪In the Panorama study of 245 adults, the DT120 Orally Disintegrating Tablet group showed a least squares mean change of -9.8 points on the Hamilton Anxiety Rating Scale at week 12, compared to -4.7 points for the placebo group.
Safety tolerability profile
- ▪In both the Emerge and Panorama clinical trials, DT120 Orally Disintegrating Tablet was generally well tolerated, with most adverse effects being mild to moderate and occurring primarily on the day of dosing.
- ▪Clinical trials of DT120 Orally Disintegrating Tablet showed no new safety signals, including no increase in suicidal ideation or behavior across more than 1,000 administered sessions.
Regulatory timeline future trials
- ▪Definium Therapeutics plans to submit a new drug application to the FDA for DT120 Orally Disintegrating Tablet in the first half of 2027.
- ▪Definium Therapeutics is currently recruiting for Ascend, a second study of DT120 Orally Disintegrating Tablet in major depressive disorder, and plans to launch a phase 3 study for post-traumatic stress disorder in 2027.
Debatable claims
- ▪The FDA should approve Definium's lysergide-based DT120 for depression
- ▪Lysergide-based DT120 is superior to traditional SSRI antidepressants
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