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GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026
GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollmentCompany to seek FDA alignment on global Phase 3 program replicating
About this update from Gh Research Plc
[{"type":"text","content":"GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollmentCompany to seek FDA alignment on global Phase 3 program replicating Phase 2b designPhase 3 initiation targeted for 2026 DUBLIN, Jan. 05, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug Application (IND) for GH001. This clearance enables U.S. subject enrollment and progresses the company toward alignment of its development across major jurisdictions. “The FDA clearance is a major milestone and positions us to advance GH001 as a potential ultra-rapid and durable treatment option for TRD patients,” said Dr. Velichka Valcheva, Chief Executive Officer. “We continue to expect initiation of our global pivotal program in 2026. We look forward to meeting with the FDA to align on the design for the pivotal Phase 3 program.” GH001 Phase 2b Profile Highlights from the Previously Reported Phase 2b trial (GH001-TRD-201): Primary endpoint met: -15.5 point placebo-adjusted MADRS reduction on Day 8 (p","length":1928,"tagName":"div"}]