GH Research submits response to clinical hold of IND for GH001 inhaled mebufotenin

GH Research announced that it has submitted its response to a clinical hold of an IND for the company’s GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. The FDA cited “Insufficient information to assess risks to human subjects” when it placed the hold on the IND in 2023. Earlier this year, GH Research announced that it had completed inhalation toxicology studies designed to produce data for its response.

In February 2025, the company announced that a European Phase 2 trial of GH001 in patients with treatment-resistant depression met its primary endpoint.

GH Research CEO Velichka Valcheva commented, “We are thrilled to have submitted our response to the FDA ahead of schedule, addressing their clear requests with comprehensive data and completed toxicology studies. We remain fully committed to working closely with the agency to bring GH001 to patients.”

Read the GH Research press release