GH Research Plc operates as a holding company, which engages in the provision of biopharmaceutical products and services. It develops therapeutic products for patients of psychiatric and neurological disorders. The firm develops novel and proprietary 5-Methoxy-N and N-Dimethyltryptamine, or 5-MeO-DMT, therapies. The company was founded by Theis Terwey, Florian Sch?nharting, and Magnus Halle in 2018 and is headquartered in Dublin, Ireland.
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- GH Research PLC will provide an update on January 5, 2026, regarding the FDA IND status for GH001 and its global pivotal Phase 3 program in treatment-resistant depression. - GH001 is a novel mebufotenin therapy administered via proprietary inhalation approach, representing a potential practice-changing treatment for depression patients. - The drug candidate demonstrated significant efficacy in Phase 2b trials with a MADRS reduction of -15.5 points compared to placebo on Day 8 (p<0.0001). - The company's focus on mebufotenin therapies positions it to potentially transform treatment approaches for patients with treatment-resistant depression.
- GH Research's lead candidate GH001 achieved a highly significant 15.5-point reduction in depression scores compared to placebo on Day 8 in its Phase 2b trial (p<0.0001). - The open-label extension demonstrated a 73% remission rate at 6 months with no treatment-related serious adverse events or suicidal behaviors during the full trial duration. - The company continues to work with FDA to resolve the remaining clinical hold issue and expects to initiate global pivotal trials in 2026. - GH Research reported $293.9 million in cash and securities as of September 30, 2025, providing financial runway for continued development.
- GH Research PLC submitted its complete response to the FDA's clinical hold on GH001 ahead of schedule in June 2025, addressing regulatory concerns with comprehensive data and completed toxicology studies. - The company's lead candidate GH001 is formulated for mebufotenin administration via proprietary inhalation for treatment-resistant depression (TRD). - Phase 2b trial results showed GH001 met its primary endpoint with a statistically significant MADRS reduction of -15.5 points compared to placebo on Day 8 (p<0.0001). - The company believes GH001 has potential to transform current TRD treatment approaches based on observed clinical activity.
- GH Research's inhaled mebufotenin (GH001) demonstrated significant efficacy in a Phase 2b trial for treatment-resistant depression, achieving a 15.5-point reduction in MADRS scores compared to placebo (p<0.0001). - A Phase 2a proof-of-concept trial for postpartum depression showed remarkable results with all ten participants achieving remission by Day 8, offering new hope for this underserved condition. - In bipolar II disorder patients with major depressive episodes, GH001 produced a 52% mean reduction in depressive symptoms by Day 8, with no serious adverse events or signs of treatment-emergent mania.
• GH Research's GH001, an inhaled 5-MeO-DMT, met its primary endpoint in a Phase IIb trial for treatment-resistant depression, showing a significant reduction in MADRS scores. • The trial demonstrated ultra-rapid responses, with substantial reductions in MADRS scores observed as early as two hours post-treatment with GH001. • GH001 led to a high remission rate at six months in the open-label extension portion of the trial, indicating a sustained therapeutic effect. • The company reported no serious adverse events, suggesting a favorable safety profile for GH001 in treating TRD.
• GH Research's inhalable mebufotenin demonstrated significant efficacy in a mid-stage clinical trial, reducing depression scores by 15.5 points more than placebo in treatment-resistant patients. • The drug showed an impressive 58% remission rate within eight days of treatment, with no serious adverse events reported and patients being discharge-ready within an hour of dosing. • Long-term efficacy was maintained with 78% of patients achieving remission at the six-month mark in the extension study, suggesting potential as a practice-changing treatment for depression.
- GH Research's GH001 met its primary endpoint in a Phase 2b trial for treatment-resistant depression, showing a significant -15.5 point placebo-adjusted reduction in MADRS scores. - The majority of patients treated with GH001 achieved remission, with a 57.5% remission rate on Day 8, compared to 0% in the placebo group, demonstrating a statistically significant improvement. - GH001 was well-tolerated during the double-blind phase, with no serious adverse events reported, and 77.8% of open-label extension completers were in remission at the 6-month visit. - All secondary endpoints were met, showing clinically and statistically significant improvements on various scales, positioning GH001 as a potential practice-changing treatment for TRD.
- GH Research anticipates topline data from its Phase 2b trial of GH001, an inhaled formulation of mebufotenin (5-MeO-DMT), for treatment-resistant depression by early 2025. - GH001 is also under evaluation in Phase 2 trials for postpartum depression and bipolar disorder type II with current depressive episodes in Europe. - The FDA has placed a clinical hold on GH Research's IND application in the U.S. for GH001, pending resolution of inhalation toxicology concerns related to the delivery device.
• GH Research reported a net loss of $12.1 million in Q3, driven by increased R&D spending on clinical trials for its 5-MeO-DMT therapies. • The company completed enrollment for the Phase 2b trial of inhaled mebufotenin (GH001) in treatment-resistant depression, with top-line data expected in late 2024 or early 2025. • The FDA has placed a clinical hold on GH Research's investigational new drug application for GH001 due to insufficient risk assessment data. • A proof-of-concept trial in bipolar II disorder will be discontinued due to recruitment challenges, while a separate trial in postpartum depression remains on track.
• Executives from Atai Life Sciences, Cybin, and GH Research addressed psychedelic trial design challenges at a recent investor event, focusing on Lykos Therapeutics' FDA rejection. • Atai's CEO, Srini Rao, emphasized that the FDA's standards for psychedelics are consistent with other drug classes, citing Janssen's Spravato as a successful precedent. • Cybin's CSO, Amir Inamdar, critiqued Lykos' psychotherapeutic approach, raising concerns about ethical considerations and the feasibility of psychotherapy during active dosing sessions. • Inamdar also said that Cybin is not really doing psychedelic-assisted psychotherapy, because patients are uninstructable during active dosing therapy sessions.
