A phase I, open-label, single-dose, mass balance study to investigate the absorption, distribution, metabolism, and excretion of COMP360 [14C]-psilocybin in healthy male participants

Start Date12 Dec 2024

Sponsor / Collaborator

COMPASS Pathfinder Ltd.

CTIS2023-505268-12-00

/ RecruitingPhase 3

A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression - COMP 006

Start Date09 Feb 2024

Sponsor / Collaborator

COMPASS Pathfinder Ltd.

ISRCTN16636661

/ RecruitingPhase 1

A phase I, open-label, randomised-sequence, two-way crossover study to assess the relative oral bioavailability of 25 mg and 5 mg strength capsules of COMP360 in healthy volunteers

Start Date24 Oct 2022

Sponsor / Collaborator

COMPASS Pathfinder Ltd.

100 Clinical Results associated with COMPASS Pathfinder Ltd.

0 Patents (Medical) associated with COMPASS Pathfinder Ltd.

Literatures (Medical) associated with COMPASS Pathfinder Ltd.

01 Mar 2025·Journal of Affective Disorders

The role of the psychedelic experience in psilocybin treatment for treatment-resistant depression

Article

Author: Schoevers, Robert A ; Mistry, Sunil ; Páleníček, Tomáš ; Somers, Metten ; Kelly, John R ; Tsai, Joyce ; Young, Allan H ; Licht, Rasmus W ; DeBattista, Charles ; Dunlop, Boadie W ; Feifel, David ; Alvarez, Oscar ; Meyer, Thomas D ; Carhart-Harris, Robin ; Marwood, Lindsey ; Croal, Megan ; Husain, Muhammad I ; Simmons, Hollie ; Malievskaia, Ekaterina ; Wahba, Mourad ; Hellerstein, David J ; Repantis, Dimitris ; Williams, Sam ; Teoh, Emma ; Young, Matthew B ; Chai-Rees, Jamie ; Kirlic, Namik ; Aaronson, Scott T ; Zisook, Sidney ; Goodwin, Guy M ; Nowakowska, Ania

OBJECTIVETo determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression.METHODSFor treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support. The resulting psychedelic experience (Five-Dimensional Altered States of Consciousness questionnaire [5D-ASC] and Emotional Breakthrough Inventory [EBI]) were measured. These proximal variables and outcome 3 weeks post-administration (change in Montgomery-Åsberg Depression Rating Scale [MADRS]) were explored using correlation analysis.RESULTSThe mean intensity of psychedelic effects was dose-related, but distributions of scores for different doses overlapped considerably. Depression response correlated with select aspects of the psychedelic experience overall and for individual doses. At the 25 mg dose, 5D-ASC dimensions Oceanic Boundlessness (Pearson correlation coefficient r = -0.508) and Visual Restructuralization (r = -0.516), and EBI (r = -0·637) were the variables with the strongest correlation to the Week 3 change from Baseline in MADRS score.LIMITATIONSThe existence of correlation does not establish causation and exploratory findings require further replication, preferably in larger independent samples.CONCLUSIONSThe intensity of psychedelic experience overlaps widely across doses and mitigates the risk of unblinding to dose. Correlations between psychedelic experience and outcome suggest specificity in psilocybin's mechanism of action. Quality and intensity of psychedelic experience may be a measure of pharmacodynamic effect and reveal an effective dose response phenomenon for single oral doses.

12 Feb 2025·International Journal of Neuropsychopharmacology

THE PHARMACOLOGICALLY DIVERSE HUMAN BRAIN: HOW NEUROSIGNALLING SYSTEMS REGULATE NEUROTYPICAL AND NEURODIVERGENT RESTING-STATE NETWORKS

Author: Puts, Nicolaas A ; Murphy, Declan G M ; Franca, Lucas G S ; Mcalonan, Grainne M ; Daly, Eileen ; Dimitrov, Mihail ; Whelan, *Tobias Patrick ; Mulcrone, Naoise

AbstractBackgroundFunctionally inter-connected large-scale brain networks underpin complex human behaviour and a wide range of alterations in this landscape have been consistently reported in psychiatric and neurodevelopmental conditions, including autism. Evidence from preclinical and correlational human studies suggest that these differences arise from underlying differences in neurotransmitter systems. However, to directly assess how a given neurotransmitter system modulates functional connectivity, we need to change it and observe a shift in network connectivity.Aims & ObjectivesTo report on how resting-state connectivity is differentially modulated by different drug classes and how responses differ between autistic and non-autistic individuals.MethodsHere we establish a common framework to capture the modulation of functional connectivity within and between brain functional networks by neurosignalling systems targeted by a range of pharmacological probes. Alterations in functional connectivity are reported for seven cortical networks following activation of the serotonin, dopamine, opioid, cannabinoid and glutamate-GABA systems in neurodiverse (autistic and non-autistic) individuals. Reproducible differences in resting-state network functional connectivity, including both hyper- and hypoconnectivity of within- and between-network interactions, are reported in autism. Thus, we also assessed whether there are group-level network responsivity differences between autistic and non-autistic participants to drug challenge, or whether the response profile was primarily individual/ heterogeneous in either group.ResultsOne common finding across pharmacological probes was that networks with reproducible baseline differences in autism (e.g. sensory and attentional networks) were also those that respond differently to drug challenge. Broadly, the cannabinoid compounds (cannabidiol and cannabidivarin) decreased functional connectivity in autistic individuals compared to non-autistic controls. By contrast, the other compounds such as the GABAergic drugs AZD7325 & arbaclofen (which activate GABAA and GABAB receptors, respectively), increased functional connectivity in autistic individuals relative to non-autistic controls.Discussion & ConclusionThis is important to not only to advance our understanding of how neurotransmitter systems regulate fundamental functional networks in both the neurotypical and neurodivergent brain, but to provide a common framework for evaluating pre-existing and novel neuro-active compounds in the living human brain. We hope this work can be extended to form the basis of a human neuropharmacological reference library of neuro-active compounds across individuals and diagnoses.

01 Dec 2024·Journal of Psychiatric Research

The impact of antidepressant discontinuation prior to treatment with psilocybin for treatment-resistant depression

Article

Author: Goodwin, Guy M ; Young, Matthew B. ; Goodwin, Guy M. ; Young, Matthew B ; Croal, Megan ; Simmons, Hollie ; Mistry, Sunil ; Marwood, Lindsey ; Tsai, Joyce

It has been suggested that the recent use and discontinuation of antidepressant drugs compromises the action of psilocybin. As evidence is only available from small or uncontrolled samples, this post hoc analysis investigated this using data from the largest, phase II, randomized controlled trial of psilocybin treatment to date. Data from 233 participants with treatment-resistant depression (TRD) who received 25 mg, 10 mg, or 1 mg of investigational drug COMP360 psilocybin (a proprietary, pharmaceutical-grade synthetic psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.), administered with psychological support, were compared for groups of participants who either discontinued one or more antidepressant drugs during screening or entered the trial antidepressant drug free. Measures of depression symptom severity change during the antidepressant drug discontinuation period, baseline suicidality, acute subjective psychedelic effects, and the study's primary endpoint (change in depression symptom severity between Baseline and Week 3) are described for both groups. Antidepressant drug discontinuation was not related to worsening of depression severity before Baseline. Suicidality was comparable between groups at Baseline. Psilocybin treatment efficacy and the subjective psychedelic experience did not appear to be compromised by antidepressant drug discontinuation. Thus, it does not limit the feasibility of psilocybin treatment for the future. These findings also support the overall homogeneity of our findings with psilocybin treatment as a monotherapy for TRD. The prior contradictory reports may come to appear misleading.

100 Deals associated with COMPASS Pathfinder Ltd.

100 Translational Medicine associated with COMPASS Pathfinder Ltd.

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