GH Research to Announce IND Status for GH001

Core Viewpoint - GH Research PLC is set to provide an update on its Investigational New Drug Application (IND) for GH001 and its global pivotal Phase 3 program in treatment-resistant depression (TRD) on January 5, 2026 [1] Company Overview - GH Research PLC is a clinical-stage biopharmaceutical company focused on developing transformative treatments for depression, specifically targeting treatment-resistant depression (TRD) [2] Product Information - GH001 is the lead product candidate of the company, utilizing a proprietary inhalation method for mebufotenin administration. The Phase 2b GH001-TRD-201 trial demonstrated significant clinical activity, achieving a mean reduction of 15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo on Day 8 (p<0.0001), indicating its potential to change TRD treatment [3]