GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD
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Therapies to transform the treatment of psychiatric and neurological disorders
GH Research is a clinical-stage pharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders.
With its novel and proprietary mebufotenin (5-methoxy-N,N-dimethyltryptamine, 5-MeO-DMT) products and current clinical development programs in treatment-resistant depression (TRD), bipolar II disorder with a depressive episode (BDII) and postpartum depression (PPD), GH Research is aiming to provide improved treatments for difficult-to-treat depression with increased remission rates, faster onset of action, durable effects, and improved tolerability and convenience.
Increased Remission Rates
Early clinical data from a Phase 1/2 trial in 16 patients with TRD have shown that administration of GH001, our pulmonary inhalation formulation of mebufotenin, has the potential to induce remission of depressive symptoms after a single dosing day. Remission at day 8 of the trial was achieved in 25% to 50% when using a single dose of GH001 and in 87.5% of patients when using an individualized dosing regimen (IDR) of GH001. For more recent clinical trial results, see the latest News Release.
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Faster Onset of Action and Durable Effects
Early clinical data from a Phase 1/2 trial in 16 patients with TRD have shown that anti-depressive effects of GH001 can have an ultra-rapid onset within only 2 hours of administration and were durable for the 7-day duration of the trial. Longer follow-up of 6 months is currently being investigated in a randomized, double-blind, placebo-controlled Phase 2b trial of GH001. For more recent clinical trial results, see the latest News Release.
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Favorable Tolerability Profile
In three completed phase 1 clinical trials to date with a total of 78 participants, administration of GH001 was well-tolerated and no severe or serious adverse events occurred. For more recent clinical trial results, see the latest News Release.
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Convenient Administration
It is anticipated that the therapeutic paradigm for our mebufotenin-based therapies will require only a single day for initial administration, reducing the overall treatment burden for patients and healthcare providers; single day dosing and the absence of further structured psychotherapy or psychological support interventions (as commonly required in programs with other psychoactive compounds) contribute towards a more convenient, less time-consuming treatment option.
Learn MoreOur proprietary mebufotenin programs
GH Research is currently developing mebufotenin-based product candidates, with GH001, a pulmonary inhalation formulation of mebufotenin, and its development in TRD, being the lead program.
We own a growing intellectual property portfolio
We own a growing intellectual property portfolio comprising applications for several patent families that relate to various aspects of mebufotenin use in a therapeutic context. These include but are but not limited to, novel uses of mebufotenin for the treatment of various disorders when administered by inhalation, nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes, novel manufacturing methods, high purity mebufotenin and novel salt forms, novel aerosol compositions of matter, and novel device-related aspects.
Latest press releases
GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD
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GH Research Reports Full Year 2025 Financial Results and Provides Business Update
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GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026
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