GH Research PLC GHRS
GH Research PLC (Nasdaq: GHRS) is a CNS/neurology/psychiatry drug developer. Its lead program, GH001, is in Phase 2 for Treatment-resistant depression (TRD).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| GH001 (inhaled mebufotenin) - TRD | Treatment-resistant depression | small molecule | Phase 2 |
| GH001 - bipolar II disorder (GH001-BD-202) | Bipolar II disorder, current depressive episode | small molecule | Phase 2 |
| GH001 - postpartum depression (GH001-PPD-203) | Postpartum depression | small molecule | Phase 2 |
| GH002 (intravenous mebufotenin) | Psychiatric/neurological disorders (TRD focus) | small molecule | Phase 1 |
Recent results and decisions
- Aug 6, 2026n/a FDA (July 2026 written responses) confirmed GH001 CMC and device plans appear Phase 3 ready; discussions on pivotal program design continue.
In July 2026, we received written responses from the FDA confirming that our CMC and device plans appear Phase 3 ready.
Filing - Mar 5, 2026hold lifted GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment (earlier clinical hold resolved); exact clearance date not given.
GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment
Filing - Jan 8, 2026positive Open-label Phase 2a (n=6): GH001 cut MADRS by a mean 16.8 points at Day 8 (p=0.0099), 33.3% in remission, no serious AEs and no mania emergence.
The primary endpoint was achieved, with a significant reduction from baseline to Day 8 in mean (standard deviation [SD]) MADRS total score of −16.8 (12.2) (P=0.0099)
Filing
For subscribers
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Other phase 2 CNS/neurology/psychiatry companies
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