CLINICAL TRIALS PROFILE FOR BUFOTENIN

Clinical Trials for Bufotenin

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT05163691 ↗	Pharmacokinetics of GH001 in Healthy Volunteers	Completed	GH Research Ireland Limited	Phase 1	The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001. As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.
NCT05753956 ↗	Safety and Pharmacokinetics of GH002 in Healthy Volunteers	Recruiting	GH Research Ireland Limited	Phase 1	The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.
NCT05800860 ↗	A Trial of GH001 in Patients With Treatment-resistant Depression	Recruiting	GH Research Ireland Limited	Phase 2	The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin [5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT]) in patients with treatment-resistant depression (TRD). The study is comprised of a 7-day double-blind (DB) part (Part 1) and a 6-month open-label extension (OLE) part (Part 2). Patients will be randomized to receive GH001 or placebo in a 1:1 ratio. The primary endpoint is the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 7.
NCT05804708 ↗	Phase 2 Clinical Trial of GH001 in Postpartum Depression	Recruiting	GH Research Ireland Limited	Phase 2	This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 female participants with clinically diagnosed postpartum depression (PPD) will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.

Clinical Trial Conditions for Bufotenin

Condition Name

Condition Name for
Intervention	Trials
Healthy Volunteers	2
Bipolar II Disorder	1
Postpartum Depression	1
Treatment-resistant Depression	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Depressive Disorder	2
Depression	2
Disease	1
Depression, Postpartum	1

Clinical Trial Locations for Bufotenin

Trials by Country

Trials by Country for
Location	Trials
Netherlands	4
Ireland	1
Germany	1
United Kingdom	1

Clinical Trial Progress for Bufotenin

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	4
Completed	1

Clinical Trial Sponsors for Bufotenin

Sponsor Name

Sponsor Name for
Sponsor	Trials
GH Research Ireland Limited	5

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	5