GH Research announces FDA lifts clinical hold on GH001, clearing U.S. IND and enabling global Phase 3 initiation targeted for 2026

GH Research announced that the FDA lifted the clinical hold on its IND for GH001, allowing the company to enroll U.S. subjects and proceed with alignment of its development plans across major jurisdictions. The company plans a global Phase 3 program with initiation targeted for 2026 and says it will seek FDA alignment on a Phase 3 design intended to replicate its previously reported Phase 2b structure. GH001 is being developed for treatment-resistant depression (TRD) as an inhaled, mebufotenin-based candidate. GH Research highlights Phase 2b results including a MADRS primary endpoint met at Day 8, ultra-rapid remission figures, short psychoactive experience, infrequent dosing, and a favorable safety profile with no serious treatment-related adverse events.