drugset
Drugs / GH001
last change Mar 2026 re-read 3 minutes ago

GH001

Developed for
bipolar II disorder
Investigated by
GH Research Ireland Limited

Trials 2

today NCT05800860 · Ph 2 NCT05839509 · Ph 2
202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT05800860 May 2023 → Oct 2024 — GH Research Ireland Limited Completed Met primary
Phase 2 NCT05839509 Apr 2023 → Nov 2024 bipolar II disorder GH Research Ireland Limited Terminated Met primary Stop: Enrollment

Press releases naming this drug 8 releases

DateIssuerRelease
2026-03-25 GH Research Ireland Limited GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD ghres.com ↗
2026-01-05 GH Research Ireland Limited GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026 ghres.com ↗
2026-01-02 GH Research Ireland Limited GH Research to Announce IND Status for GH001 ghres.com ↗
2025-02-03 GH Research Ireland Limited GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placebo-adjusted MADRS Reduction ghres.com ↗
2025-01-31 GH Research Ireland Limited GH Research to Provide Update on Phase 2b Trial with GH001 in TRD ghres.com ↗
2023-09-29 GH Research Ireland Limited GH Research Provides Updates and Guidance on its Clinical Development Program for GH001 in Treatment-Resistant Depression ghres.com ↗
2021-12-06 GH Research Ireland Limited GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression ghres.com ↗
2020-11-19 GH Research Ireland Limited GH Research Ltd. Announces Completion of Phase 1 Clinical Study with GH001 (5-Methoxy-N,N-Dimethyltryptamine) in Healthy Volunteers and Updates on Further Progress ghres.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as GH001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05800860 ↗
1

NCT05839509 ↗
Route Inhaled “The study drug is administered as an aerosol via pulmonary inhalation.” NCT05800860 ↗