Definium Therapeutics announced it has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its DT120 ODT (lysergide) program for the treatment of major depressive disorder (MDD). This designation is intended to expedite the development and review process for promising new drugs targeting serious conditions.

Key Details

  • Designation: The FDA granted Breakthrough Therapy designation to DT120 ODT for MDD, marking the drug's second such designation, following a previous one for generalized anxiety disorder (GAD).
  • Supporting Data: The decision was based on positive results from the Phase 3 Emerge study, which showed a single 100 µg dose of DT120 demonstrated a statistically significant 8.1-point placebo-adjusted improvement on the MADRS depression scale at Week 6.
  • Regulatory Impact: The designation provides access to more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling and priority review.