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Jan 5, 2026 Psychedelics
FDA Clears the Way for a Global Phase 3 Trial of Inhaled 5-MeO-DMT
GH Research PLC's (NASDAQ: GHRS) GH001 — inhaled, synthetic 5-MeO-DMT — posted some of the strongest Phase 2b data in the field for treatment-resistant depression: 57.5% of patients in remission within a week, 73% still in remission at six months. In January, the FDA lifted a clinical hold on the drug's IND, clearing the way for a global Phase 3 program. As of now, the company hasn't confirmed the trial has actually started enrolling.
Read at GlobeNewswire / GH Research