GH ResearchNASDAQ: GHRS
GH Research plc (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company founded in 2018 and headquartered in Dublin, Ireland, developing novel mebufotenin (5-MeO-DMT) therapeutics for treatment-resistant depression, bipolar II disorder, and postpartum depression. Its lead asset GH001 — an inhaled mebufotenin formulation — met the primary endpoint of its Phase 2b TRD trial in February 2025 with striking results: -15.5 point MADRS reduction vs placebo (p<0.0001) and 57.7% remission vs 0%. With a single-day dosing paradigm requiring no structured psychotherapy, GH001 is positioned as a differentiated asset; Phase 3 global initiation is planned for 2026 following FDA clinical hold lift. GH002 (IV mebufotenin) completed Phase 1 in healthy volunteers.
Development Programmes
4GH001
5-MeO-DMTMebufotenin (5-MeO-DMT) delivered via a proprietary vaporization inhaler. Single or few inhalation sessions in a clinical setting. Phase 2b (NCT05800860) met primary endpoint: −15.2-point MADRS reduction vs +0.3 for placebo (p<0.0001); 57.7% remission. FDA clinical hold (Sep 2023) lifted Jan 5, 2026. Global Phase 3 program planned for 2026.
Programme Tracker
Treatment-Resistant Depression (TRD)
Forecast
Phase III started - Approval eventual: 50%
Phase 3 global pivotal program planned for 2026 initiation following FDA clinical hold lift (Jan 5, 2026) and positive Phase 2b results
Milestones
Phase II topline
CompletedActual: Feb 3, 2025
Phase 2b (NCT05800860) primary endpoint met: GH001 reduced MADRS by 15.2 points vs +0.3 for placebo (p<0.0001); 57.7% remission at Day 8
Why it matters: Largest placebo-adjusted antidepressant effect seen in a controlled psychedelic trial; validated 5-MeO-DMT as a rapid-acting antidepressant in TRD
Watch next: FDA clinical hold resolution, Phase 3 programme initiation
Phase III started
PlannedLikely: Q3 2026
GH Research announced plans to initiate global pivotal Phase 3 programme in 2026
Why it matters: Pivotal trials needed to support NDA/MAA regulatory submissions for TRD
Watch next: Phase 3 ClinicalTrials.gov registration and first patient dosing announcement
Regulatory review accepted
CompletedActual: Jan 5, 2026
FDA lifted clinical hold on GH001 IND (hold placed September 2023 for additional inhalation toxicology data)
Why it matters: Clears path for U.S. patient enrollment in Phase 3; non-rodent inhalation tox studies showed no respiratory toxicity
Watch next: Phase 3 programme initiation and first patient dosing
Recorded Events
Jan 5, 2026: Regulatory review accepted
Feb 3, 2025: Phase II topline
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
Publication - PMC / Neuropsychopharmacology - Jul 1, 2023 - Verified
company-website - GH Research - Verified
GH001
5-MeO-DMTInhaled GH001 for bipolar II disorder with a current major depressive episode. Phase 2a proof-of-concept (GH001-BD-202) met primary endpoint: MADRS reduction −16.8 points (51.9%) at Day 8 (p=0.0099; n=6). No further development announced.
Programme Tracker
Bipolar Disorder
Phase 2a completed Q4 2024; no further development in BDII announced. Recruitment challenges led to small n=6 treated sample.
Milestones
Phase II topline
CompletedActual: Dec 1, 2024
Phase 2a (GH001-BD-202) met primary endpoint: MADRS −16.8 pts (51.9%) at Day 8 (p=0.0099); 33% patients in remission
Why it matters: Proof-of-concept signal in BDII; however, small n=6 and recruitment difficulties limit conclusions
Watch next: No further BDII development currently announced
Recorded Events
Dec 1, 2024: Phase II topline
GH001
5-MeO-DMTInhaled GH001 for postpartum depression. Phase 2a proof-of-concept (GH001-PPD-203; n=10): all 10 patients in remission at Day 8 (mean MADRS 1.3). No further development announced.
Programme Tracker
Peripartum
Phase 2a completed Q4 2024. All 10 patients in remission — striking result. No further PPD development announced; resources focused on TRD Phase 3.
Milestones
Phase II topline
CompletedActual: Dec 1, 2024
Phase 2a (GH001-PPD-203) met primary endpoint: all 10 patients in remission at Day 8 (mean MADRS 1.3)
Why it matters: 100% remission rate is an extraordinary clinical signal; PPD is an under-served indication with growing regulatory interest
Watch next: No further PPD programme currently announced; resources focused on TRD
Recorded Events
Dec 1, 2024: Phase II topline
GH002
5-MeO-DMTIntravenous formulation of mebufotenin (5-MeO-DMT) — distinct from GH001's inhaled route. Phase 1 healthy volunteer trial (GH002-HV-105; n=64) completed Q4 2023. Well tolerated, no serious adverse events. No patient indication announced.
Programme Tracker
Healthy Volunteers
Phase 1 HV study complete (Q4 2023). Safety, tolerability, and PK characterised for IV route. Next steps not yet announced.
Milestones
Phase I completed
CompletedActual: Dec 31, 2023
GH002-HV-105 Phase 1 trial completed in 64 healthy volunteers; IV 5-MeO-DMT characterised for safety and PK at single and multiple doses
Why it matters: IV route may offer more precise dosing control than inhalation; validates GH002 for potential patient trials
Watch next: Patient indication selection and Phase 2 planning
Recorded Events
Dec 31, 2023: Phase I completed
Evidence Links
company-website - GH Research - Verified
Quick Facts
- Type
- Public Biotech
- Founded
- 2018
- Ticker
- NASDAQ: GHRS
- Lead Stage
- Phase III
- HQ
- 28 Baggot Street Lower, Dublin 2, Ireland, Ireland
- Website
- Visit