> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Clinical Hold Lifted on GH Research Antidepressant
- URL: https://www.fdaweb.com/clinical-hold-lifted-on-gh-research-antidepressant/
- Published: 2026-01-16T12:00:00.000Z
- Updated: 2026-09-14T15:30:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160509

FDA has lifted a clinical hold against GH Research’s investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing plans for a global late-stage development program. The action allows the clinical-stage biotechnology company to resume U.S. trials under its IND and aligns development of GH001 across major regulatory jurisdictions, the company says.

Company CEO **Velichka Valcheva** says GH001 is being positioned as a potential ultra-rapid and durable treatment for patients with treatment-resistant depression. The company expects to initiate a global pivotal Phase 3 program in 2026 and plans to meet with FDA to align on trial design, he adds.

GH001 is the lead candidate of GH Research PLC, which is developing mebufotenin-based therapies for depression. The drug is administered through a proprietary inhalation approach, the company says.

Previously reported results from a Phase 2b trial showed that the drug met its primary endpoint. The company had reported that more than half of treated patients achieved remission by Day 8, rising to 73% at six months with infrequent dosing. According to the company, GH001’s effects were accompanied by a short psychoactive experience, with a median duration of about 11 minutes, and did not require adjunct psychotherapy. Nearly all patients were deemed ready for discharge within an hour of dosing, and no serious treatment-related adverse events were reported, it adds.