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FDA grants Breakthrough Therapy designation to Definium's DT120 for major depressive disorder, following prior approval for anxiety
DFTXDefinium Therapeutics, Inc.
On September 8, 2026, Definium Therapeutics announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for its DT120 ODT program to treat major depressive disorder (MDD). This is the second such designation for DT120, following an earlier grant for generalized anxiety disorder. The FDA decision was supported by Phase 3 Emerge study results showing a statistically significant 8.1-point placebo-adjusted improvement in MADRS scores at Week 6 with durable efficacy through Week 12 after a single 100 µg dose. Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-inspired therapeutics for psychiatric and neurological disorders.