mebufotenin inhaled (GH001) / GH Research - LARVOL DELTA

Evaluation of the peak experience scale as a rapid assessment tool for the strength of a psychoactive experience with 5-MeO-DMT. (PubMed, Front Psychol) - "Data were gathered from three separate studies in which a 5-MeO-DMT formulation (GH001) was administered via pulmonary inhalation to healthy volunteers and patients with treatment resistant depression (N = 84) as either single doses (0 [placebo], 2, 6, 12, 18 mg) or an incremental individualized dosing regimen (IDR)...The PES is concluded to be an effective tool to rapidly assess the strength of the psychedelic experience with 5-MeO-DMT. The PES could prove useful to gain fast insight into the strength of a psychedelic dose in individual patients and potentially guide dose and re-dose selection of rapid-acting psychedelics."

Journal • CNS Disorders • Depression • Psychiatry

A Trial of GH001 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - P2 | N=81 | Completed | Sponsor: GH Research Ireland Limited | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry

GH Research Reports Full Year 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for completion of last patient visit in the open-label extension in Q1 2025...'We are preparing to engage with the FDA in advance of providing a full response to the IND hold which we are on track to submit in mid-2025.'"

IND • Trial status • CNS Disorders • Depression

Phase 2 Clinical Trial of GH001 in Bipolar II Disorder (clinicaltrials.gov) - P2 | N=6 | Terminated | Sponsor: GH Research Ireland Limited | N=15 ➔ 6 | Trial completion date: Dec 2023 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Nov 2024; Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bipolar Disorder • CNS Disorders • Depression • Psychiatry

Phase 2 Clinical Trial of GH001 in Postpartum Depression (clinicaltrials.gov) - P2 | N=10 | Terminated | Sponsor: GH Research Ireland Limited | N=15 ➔ 10 | Recruiting ➔ Terminated; Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.

Enrollment change • Trial termination • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placebo-adjusted MADRS Reduction (GlobeNewswire) - P2b | N=80 | NCT05800860 | Sponsor: GH Research Ireland Limited | "Primary endpoint met, GH001 led to an ultra-rapid anti-depressant effect with a significant placebo-adjusted MADRS reduction from baseline of -15.5 on Day 8 (p<0.0001); The majority of the patients treated with GH001 achieved remission with a 57.5% remission rate on Day 8 compared with 0% in the placebo group (p<0.0001); All other secondary endpoints were met with clinically and statistically significant improvements on Day 8, compared with placebo; During the double-blind part, GH001 was well tolerated and no serious adverse events (SAE) were reported. There was no evidence of treatment-emergent suicidal ideation or behavior. As of January 22, 2025, no SAEs have been reported throughout the open label extension (OLE)...Patients who had remission on Day 8 after their first active treatment had a 91.7% remission rate at 6 months..."

P2b data • CNS Disorders • Depression

GH Research to Provide Update on Phase 2b Trial with GH001 in TRD (GlobeNewswire) - "GH Research PLC...announced that it will host a conference call and live webcast on Monday, February 3, 2025, at 8.00 a.m. EST to provide an update on data from the randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD)."

P2b data • Depression • Major Depressive Disorder

A Trial of GH001 in Patients with Treatment-resistant Depression (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: GH Research Ireland Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: GH Research Ireland Limited | Not yet recruiting ➔ Recruiting

Enrollment open

Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: GH Research Ireland Limited

New P1 trial

Phase 2 Clinical Trial of GH001 in Postpartum Depression (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: GH Research Ireland Limited | Trial completion date: Dec 2023 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

A Trial of GH001 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: GH Research Ireland Limited

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Trial of GH001 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: GH Research Ireland Limited | Phase classification: P2b ➔ P2

Phase classification • CNS Disorders • Depression • Mood Disorders • Psychiatry

GH Research Reports Second Quarter 2023 Financial Results and Provides Business Updates (GlobeNewswire) - "As previously announced, we expect to submit an IND with the U.S. FDA for GH001 in TRD, delivered with our proprietary aerosol delivery device, in the third quarter of 2023. Pending clearance by the FDA, we expect to initiate a Phase 1 clinical pharmacology trial of GH001 delivered with our proprietary aerosol delivery device in healthy volunteers (GH001-HV-106) in the fourth quarter of 2023....Our Phase 2a proof-of-concept clinical trial of GH001 in postpartum depression (GH001-PPD-203) is ongoing and, as previously announced, is expected to be completed in the fourth quarter of 2023. Our Phase 2a proof-of-concept clinical trial of GH001 in bipolar II disorder with a current depressive episode (GH001-BD-202) is recruiting slower than previously projected and we now expect this trial to be completed in the first quarter of 2024."

IND • New P1 trial • Trial completion date • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders

A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. (PubMed, Front Psychiatry) - P1/2 | "Administration of GH001 to a cohort of 16 patients with TRD was well tolerated and provided potent and ultra-rapid antidepressant effects. Individualized dosing with up to three doses of GH001 on a single day was superior to single dose administration.Clinical Trial registration: Clinicaltrials.gov Identifier NCT04698603."

Journal • P1/2 data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Phase 2 Clinical Trial of GH001 in Bipolar II Disorder (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: GH Research Ireland Limited

New P2 trial • Bipolar Disorder • CNS Disorders • Depression • Psychiatry

Phase 2 Clinical Trial of GH001 in Postpartum Depression (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: GH Research Ireland Limited

New P2 trial • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

A Trial of GH001 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - P2b | N=80 | Recruiting | Sponsor: GH Research Ireland Limited

New P2b trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

A phase 1, dose-ranging trial to assess the safety and psychoactive effects of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation in healthy volunteers (ECNP 2022) - "At this maximum individual dose level, the mean PE score was higher (PE score 89.3) than in all dose groups of Part A.Conclusion : Administration of GH001 was well tolerated. Individualized dosing with up to three doses on a single day may be preferable over single dose administration for clinical applications that aim to enhance the short-term psychoactive effects to elicit an optimized therapeutic response."

Clinical • P1 data • CNS Disorders • Depression • Psychiatry

A phase 1/2 trial of a vaporized 5-Methoxy-N,N-Dimethyltryptamine formulation, in patients with treatment-resistant depression (ECNP 2022) - "The mean MADRS change from baseline to day 7 was -21.0 (-65%) and -12.8 (-41%) for the 12 and 18 mg groups, respectively, and -24.4 (-76%) for the IDR.Administration of GH001 to a cohort of 16 patients with TRD was well tolerated and provided potent and ultra-rapid antidepressant effects. Individualized dosing with up to three doses on a single day was superior to single dose administration."

Clinical • P1/2 data • CNS Disorders • Depression • Mood Disorders • Psychiatry

A phase 1, dose-ranging trial to assess the safety and psychoactive effects of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation in healthy volunteers (ECNP 2022) - "At this maximum individual dose level, the mean PE score was higher (PE score 89.3) than in all dose groups of Part A.Conclusion : Administration of GH001 was well tolerated. Individualized dosing with up to three doses on a single day may be preferable over single dose administration for clinical applications that aim to enhance the short-term psychoactive effects to elicit an optimized therapeutic response."

Clinical • P1 data • CNS Disorders • Depression • Psychiatry

A phase 1/2 trial of a vaporized 5-Methoxy-N,N-Dimethyltryptamine formulation, in patients with treatment-resistant depression (ECNP 2022) - "The mean MADRS change from baseline to day 7 was -21.0 (-65%) and -12.8 (-41%) for the 12 and 18 mg groups, respectively, and -24.4 (-76%) for the IDR.Administration of GH001 to a cohort of 16 patients with TRD was well tolerated and provided potent and ultra-rapid antidepressant effects. Individualized dosing with up to three doses on a single day was superior to single dose administration."

Clinical • P1/2 data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Clinical Study of GH001 in Depression (clinicaltrials.gov) - P1/2; N=16; Completed; Sponsor: GH Research Ireland Limited; Recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Pharmacokinetics of GH001 in Healthy Volunteers (clinicaltrials.gov) - P1; N=46; Completed; Sponsor: GH Research Ireland Limited

Clinical • New P1 trial

A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. (PubMed, Front Pharmacol) - "Vital signs at 1 and 3 h after administration were not affected and adverse events were generally mild and resolved spontaneously. Individualized dose escalation of 5-MeO-DMT may be preferable over single dose administration for clinical applications that aim to maximize the experience to elicit a strong therapeutic response."

Clinical • Journal • P1 data • CNS Disorders • Depression • Psychiatry