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GH ResearchNASDAQ: GHRS

Data updated

28 Baggot Street Lower, Dublin 2, Ireland, Ireland
4 Drug Candidates8 Trials2 Papers

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.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
4

All tracked candidates active

Active programmes
3

4 total in tracker

Lead stage
Phase III

Multiple active stages

Forecast coverage
1 of 3

1 active programme with forecast fields

Latest sourced update

GH Research Pipeline Page

Jun 27, 2026 - company-website - GH Research - GH001

Next known catalyst

Phase III started

Timing not specified - GH001 / GH001 TRD — Global Phase 3 - Confidence: 45%

15 sources4 pipeline-linked trials1 pipeline-linked paper1 Phase III2 Phase II1 Phase I

Development Programmes

4
Phase III
Treatment-Resistant Depression (TRD)

Mebufotenin (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)

Primary: US (FDA)
Phase IIIActive

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

Completed

Actual: 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

GH Research — Phase 2b Primary Endpoint Met (GH001-TRD-201)(Press release)[Verified]

Phase III started

Planned

Likely: 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

GH Research — Global Pivotal Phase 3 Programme Plans and Business Update(Press release)[Verified]

Regulatory review accepted

Completed

Actual: 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

GH Research — FDA Lifts Clinical Hold on GH001, Clearing Path for Phase 3(Press release)[Verified]

Recorded Events

Jan 5, 2026: Regulatory review accepted

Feb 3, 2025: Phase II topline

Evidence Links

NCT05800860 — GH001-TRD-201 Phase 2b Trial

trial-registry - ClinicalTrials.gov - May 31, 2025 - Verified

GH001 Phase 1/2 TRD Publication (PMC)

Publication - PMC / Neuropsychopharmacology - Jul 1, 2023 - Verified

GH Research Pipeline Page

company-website - GH Research - Jun 27, 2026 - Verified

Phase II
Bipolar Disorder

Inhaled GH001 / mebufotenin for bipolar II disorder with a current major depressive episode. Phase 2a proof-of-concept met its endpoint in a small n=6 treated sample, but the BDII registry is terminated and no BDII-specific follow-on study was found. GH001 parent-programme development is now focused on TRD, where FDA lifted the IND clinical hold in January 2026 and Phase 2b results were published in JAMA Psychiatry in March 2026.

Programme Tracker

Bipolar Disorder

Primary: US (FDA)
Phase IIpaused

BDII-specific development remains quiet: the NCT05839509 registry is terminated and no follow-on BDII study was found. GH001 as a parent programme is advancing in TRD after FDA lifted the U.S. clinical hold on 2026-01-05 and the Phase 2b TRD results were published in JAMA Psychiatry on 2026-03-25, with global pivotal initiation targeted for 2026.

Milestones

Phase II topline

Completed

Actual: 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

GH Research — Phase 2a POC Results Met in BDII and PPD(Press release)[Verified]ClinicalTrials.gov NCT05839509 - GH001 in Bipolar II Disorder(Registry update)[Verified]GH Research Announces Primary Endpoint Met in Two GH001 Phase 2a POC Trials(Press release)[Verified]

Recorded Events

Dec 1, 2024: Phase II topline

Evidence Links

GH Research - Pipeline

company-website - GH Research - Jun 26, 2026 - Verified

Pipeline lists GH001 Phase 2a trials in bipolar II disorder and postpartum depression, plus the current GH001 programme structure.

ClinicalTrials.gov NCT05839509 - GH001 in Bipolar II Disorder

Registry update - ClinicalTrials.gov - Feb 18, 2025 - Verified

ClinicalTrials.gov registry for GH001 in bipolar II disorder; status terminated, last update posted 2025-02-18.

GH Research Announces Primary Endpoint Met in Two GH001 Phase 2a POC Trials

Press release - GH Research - Jan 10, 2025 - Verified

Company reported primary endpoint met in GH001 Phase 2a POC trials in both postpartum depression and bipolar II disorder.

GH Research announces FDA lift of GH001 clinical hold and Phase 3 path

Press release - GH Research - Jan 5, 2026 - Verified

Company release says FDA lifted the GH001 IND clinical hold and that global Phase 3 initiation in TRD is targeted for 2026.

GH Research announces JAMA Psychiatry publication of GH001 Phase 2b TRD results

Press release - GH Research - Mar 25, 2026 - Verified

Company release says GH001 Phase 2b TRD results were published in JAMA Psychiatry and supports global pivotal development.

Phase II
Peripartum

Inhaled 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

Primary: US (FDA)
Phase IIpaused

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

Completed

Actual: 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

GH Research — Phase 2a POC Results Met in BDII and PPD(Press release)[Verified]ClinicalTrials.gov NCT05804708 - GH001 in Postpartum Depression(Registry update)[Verified]GH Research Announces Primary Endpoint Met in Two GH001 Phase 2a POC Trials(Press release)[Verified]Inhaled Mebufotenin (GH001) for Adult Patients With Postpartum Depression(Publication)[Verified]

Recorded Events

Dec 1, 2024: Phase II topline

Evidence Links

GH Research - Pipeline

company-website - GH Research - Jun 26, 2026 - Verified

ClinicalTrials.gov NCT05804708 - GH001 in Postpartum Depression

Registry update - ClinicalTrials.gov - Feb 18, 2025 - Verified

Registry identifies GH Research Ireland as sponsor of the Phase 2 GH001 postpartum depression trial.

GH Research Announces Primary Endpoint Met in Two GH001 Phase 2a POC Trials

Press release - GH Research - Jan 10, 2025 - Verified

Inhaled Mebufotenin (GH001) for Adult Patients With Postpartum Depression

Publication - The Journal of Clinical Psychiatry - Jun 3, 2026 - Verified

Peer-reviewed Phase 2a open-label trial publication reported rapid and significant improvement and remission in postpartum depression.

Phase I
Healthy Volunteers

Intravenous 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

Primary: US (FDA)
Phase ICompleted

GH002 Phase 1 healthy-volunteer study is complete. GH Research clinical-trials materials describe the IV mebufotenin study as n=64 with no severe or serious adverse events, and the FY2025 update continues to list GH002 as an IV mebufotenin product candidate. No patient-indication next step has been publicly announced.

Milestones

Phase I completed

Completed

Actual: 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

ClinicalTrials.gov NCT05753956 - GH002 Phase 1 healthy-volunteer study(clinical-trial-registry)[Verified]

Recorded Events

Dec 31, 2023: Phase I completed

Evidence Links

GH Research — Clinical Trials Overview

company-website - GH Research - Jun 27, 2026 - Verified

GH Research FY2025 update confirms GH002 Phase 1 completion

Press release - GH Research / GlobeNewswire - Mar 5, 2026 - Verified

Company update continues to list GH002 as an intravenous mebufotenin product candidate and states the GH002 Phase 1 healthy-volunteer trial is complete.

ClinicalTrials.gov NCT05753956 - GH002 Phase 1 healthy-volunteer study

clinical-trial-registry - ClinicalTrials.gov - Jan 25, 2024 - Verified

Registry lists GH002-HV-105 as completed with 64 actual participants and completion date 2023-11-29.

Similar Developers

Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.

View landscape
AtaiBeckley
Phase II4 active candidates2 trials1 paper
shared compound: 5-MeO-DMTsame indication: Treatment-Resistant Depression (TRD)also active in Phase IIsame regulator: US FDA
Reunion Neuroscience
Phase III4 active candidates
same indication: PeripartumPhase III peer2 overlapping stagessame regulator: US FDA
Usona Institute
Phase III2 active candidates23 trials
shared compound: 5-MeO-DMTPhase III peersame regulator: US FDAboth have forecast coverage

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

Sponsored Trials

8
Not yet recruitingI

Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects

Start Date
Compounds
DMT
CompletedII

A Trial of GH001 in Patients With Treatment-resistant Depression

Start Date
Compounds
5-MeO-DMT, Placebo
TerminatedII

Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

Start Date
Compounds
5-MeO-DMT
TerminatedII

Phase 2 Clinical Trial of GH001 in Postpartum Depression

Start Date
Compounds
5-MeO-DMT
CompletedI

Safety and Pharmacokinetics of GH002 in Healthy Volunteers

Start Date
Compounds
5-MeO-DMT, Placebo
CompletedI

Pharmacokinetics of GH001 in Healthy Volunteers

Start Date
Compounds
5-MeO-DMT, Placebo
CompletedI, II

Clinical Study of GH001 in Depression

Start Date
Compounds
5-MeO-DMT
CompletedI

Safety of GH001 in Healthy Volunteers

Start Date
Compounds
5-MeO-DMT

Research Papers

2
PaywallindividualPrimary

Inhaled Mebufotenin (GH001) for Adult Patients With Postpartum Depression: A Phase 2a Open-Label Clinical Trial

This Phase IIa open-label proof-of-concept trial (n=10) investigated GH001, an inhaled formulation of 5-MeO-DMT (up to 6, 12, and 18 mg), in women with postpartum depression. All patients responded and achieved remission by day 8, with effects first seen two hours after the final dose. It was well tolerated, with headache the most common mild to moderate side effect.

Published
Journal
Journal of Clinical Psychiatry
Authors
Johnson, M., Baldo, P. A., Arbe, E., Brennan, B., Cohen, S. E., Doolin, K., Gann, W., Gregory, D., Keady, S., Kriger, K., MacIsaac, R., Ratcliffe, S., Rubinow, D. R., Svendsen, C. B., Terwey, T. H., Tully, D., Valcheva, V., Zantvoord, J. B., Deligiannidis, K. M.
Open AccessindividualPrimary

GH001 vs Placebo in Patients With Treatment-Resistant Depression A Randomized Clinical Trial

This randomised, double-blind, placebo-controlled Phase IIb trial (n=81) found that a single-day inhaled synthetic mebufotenin treatment (GH001; 5-MeO-DMT) reduced depression symptoms more than placebo in adults with treatment-resistant depression, with remission in over half of those treated. No severe or serious adverse events were reported during the placebo-controlled period.

Published
Journal
JAMA Psychiatry
Authors
Cubała, W. J., Bajbouj, M., Bauer, M., Baune, B. T., Cardoner, N., Devlin, F., Doolin, K., Dueñas Herrero, R. M., Elices, M., Feeney, A., Gałuszko-Węgielnik, M., Jakuszkowiak-Wojten, K., Janů, L., Kelly, J. R., Ledden, K., Maclsaac, R., Madero, S., McInerney, S. J., Montejo, A. L., Nawka, A., Páleníček, T., Pérez Solà, V., Ramaekers, J. G., Reif, A., Ritter, P., Ryan, F., Svendsen, C. B., Sweeney, C., Terwey, T. H., Trivedi, M. H., Valcheva, V., Vieta, E., Thase, M. E.