US Executive Order Boosts GH Research’s GH001 Phase 3 Launch After 15.5-Point Drop
GH Research welcomed a U.S. Executive Order directing coordinated federal action to accelerate development and patient access to psychedelic medical treatments for serious mental illness. GH001, its inhaled mebufotenin candidate, achieved a 15.5-point MADRS reduction versus placebo (p<0.0001) and is advancing to a global pivotal Phase 3 program in 2026.
1. Executive Order Expands Support for Mental Illness Treatments
The U.S. Executive Order signed April 18, 2026 mandates cross-agency coordination to accelerate development and patient access to innovative therapies for serious mental illness, explicitly including psychedelic medical treatments. This directive aims to streamline regulatory processes and funding pathways for companies developing practice-changing therapies.
2. GH001 Advances to Global Phase 3 Following Strong Phase 2b Results
GH Research is progressing GH001, its proprietary inhaled mebufotenin candidate, toward a global pivotal Phase 3 program in treatment-resistant depression slated for 2026. The product demonstrated a 15.5-point MADRS reduction versus placebo on Day 8 (p<0.0001) in its Phase 2b trial, underscoring its potential practice-changing impact.