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.

Clinical Trial Conditions for Bufotenin

Condition Name

Condition Name
Intervention	Trials
Healthy Volunteers	2
Bipolar II Disorder	1
Postpartum Depression	1

Condition MeSH

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

Clinical Trial Locations for Bufotenin

Trials by Country

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

Clinical Trial Progress for Bufotenin

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	4
Completed	1

Clinical Trial Sponsors for Bufotenin

Sponsor Name

Sponsor Name
Sponsor	Trials
GH Research Ireland Limited	5

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	5