psilocybin (COMP360) / Compass Pathways - LARVOL DELTA

Beyond the head twitch response: more effective tracking of psilocybin pharmacodynamics in rats with behavioural and electrophysiological measures (Neuroscience 2026) - "This work combined behavioural and electrophysiological methods to address this problem, using COMP360 (Compass’ proprietary synthetic crystalline form of psilocybin) as an exemplar compound.Plasma and brain PK of doses of 1mg/kg psilocybin via subcutaneous (sc) and oral (po) routes was measured in male Sprague Dawley rats...Cortical EEG measures provide information that complements both psilocin plasma and brain exposure measures and psychedelic-induced changes in behavioural state. Altogether the integrated behavioural and electrophysiological approach demonstrated here offers much more opportunity to learn more about comparative duration and quality of novel psychedelic drug effects in rats."

PK/PD data • Preclinical • CNS Disorders • Depression • Mood Disorders • Psychiatry

Novel Insights into the Neuropsychological Effects of Serotonergic Psychedelics and Their Underlying Molecular and Circuit Mechanisms (Neuroscience 2026) - "Chemogenetic inhibition of CA neurons in PrL recapitulated the effects of psilocybin.These findings suggest there are distinct neuropsychological effects associated with different psychedelics which may be relevant to their efficacy in treating emotional disorders. We also identify modulation of the PrL cortico-amygdala circuit as a key substrate for affective bias modification by psilocybin, an effect which could explain its antidepressant effects."

CNS Disorders • Depression

Next-Generation Pharmacotherapies for Unipolar Mood Disorders: A Leading Article on Phase II/III Drug Development Across Diverse Mechanisms. (PubMed, CNS Drugs) - "Following the US Food and Drug Administration (FDA) approval of esketamine and brexanolone in 2019, industry investment in therapeutics with novel mechanisms for mood and anxiety disorders has expanded, catalyzing a new wave of innovative interventions...The drug names discussed are ALTO-100, ALTO-203, ALTO-207, ALTO-300, BHV-7000, BI-1569912, BPL-003, COMP360, DT120, ELE-101, GATE-251, GH001, GM-1020, GM-2505, HLP003, MK-1942, NBI-1065845, NBI-1070770, NV-5138, PIPE-307, SEP-363856, SPT-300, VLS-01, and XEN1101. The US Clinical Trials registry (clinicaltrials.gov), MEDLINE, conference proceedings, and company communications such as press releases were consulted to obtain up-to-date trial information and reported outcomes. Overall, the therapeutic landscape shows an expanding range of clinical compounds under active development; nonetheless, persistent challenges remain, including approaches to therapeutics where functional unblinding may occur, the ways in which to..."

Journal • P2/3 data • Review • CNS Disorders • Mood Disorders • Psychiatry

The use of psychedelics in psychiatry (PubMed, Orv Hetil) - "At the same time, a synthetic psilocybin (COMP360) met its primary endpoint in two phase 3 trials in 2025-2026, representing the most advanced regulatory evidence in the field to date...Orv Hetil. 2026; 167(37): 1461-1467."

Journal • Review • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Psychedelics in psychiatry: comparative effectiveness, implementation, commercialization and safety lessons learned from intranasal esketamine. (PubMed, Expert Opin Drug Saf) - No abstract available

HEOR • Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Cortical E/I dynamics are shifted differently under psilocybin in autistic adults (OHBM 2026) - "Methods Data were derived from a broader study using COMP360 psilocybin, a proprietary synthetic formulation of crystalline psilocybin owned by Compass Pathways plc, London, United Kingdom...N.A.P. and JoM are supported through the Medical Research Council Centre for Neurodevelopmental Disorders."

Clinical • CNS Disorders • Epilepsy • Mental Retardation

Distinct brain network dynamics are elicited by psilocybin in autistic people (OHBM 2026) - "Methods In our ‘PSILAUT’ study 2 , resting-state fMRI data were acquired from non-autistic (n = 30) and autistic adults (n = 37) following a single low dose of 5 mg psilocybin (COMP360 psilocybin, a proprietary synthetic formulation of crystalline psilocybin owned by Compass Pathways plc, London, United Kingdom) or placebo, administered in a pseudo-randomised order across two separate visits...Elevated between-ICN connectivity in autistic participants after low dose psilocybin aligns with our prior static functional connectivity findings; this pattern has previously been elicited by higher doses of psilocybin (e.g. 25 mg) and is associated with treatment response in depression for example 5 . Thus, next steps are to explore the potential use of lower doses of psilocybin and evaluate whether facilitating more dynamic brain states with psilocybin has clinical utility in autism."

CNS Disorders • Cognitive Disorders • Depression

Psilocybin Modulates Functional Brain Connectivity Differently in Autistic and Non-Autistic Adults (OHBM 2026) - "We employed a randomised, double-blind, placebo-controlled, crossover study design to investigate the differential group effects of two acute low doses of psilocybin (2 mg and 5 mg COMP360 psilocybin, a proprietary synthetic formulation of crystalline psilocybin owned by Compass Pathways plc, London, United Kingdom) on weighted degree centrality (wDC), a network-level measure of resting-state functional connectivity...In addition, this work represents independent research part funded by the infrastructure of the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London, and the Medical Research Council Centre for Neurodevelopmental Disorders. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care."

Clinical • CNS Disorders • Depression

Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder (clinicaltrials.gov) - P2/3 | N=300 | Recruiting | Sponsor: COMPASS Pathways | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

PIVOT: Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: VA Office of Research and Development | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD (clinicaltrials.gov) - P3 | N=258 | Completed | Sponsor: COMPASS Pathways | Active, not recruiting ➔ Completed

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

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder (clinicaltrials.gov) - P3 | N=20 | Recruiting | Sponsor: Sharmin Ghaznavi | Trial completion date: Jun 2026 ➔ Jun 2028 | Trial primary completion date: Jun 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Silence is golden: Documenting the speech production of participants and support providers in psilocybin administration sessions for the treatment of post-traumatic stress disorder. (PubMed, J Psychopharmacol) - P2 | "The relative absence of verbal interaction suggests that the monitoring and support used in Compass administration sessions can be differentiated from practice in many conventional psychotherapies, 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy trials, and psycholytic treatment paradigms with psychedelic drugs."

Journal • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Psychedelics produce enduring enhancement of reward responsiveness in male rats. (PubMed, Neuropsychopharmacology) - "Ketamine and psilocybin have shown promising evidence in ameliorating anhedonic symptoms in clinical trials...Neither the non-psychedelic 5-HT2A agonist lisuride (0.1-1 mg/kg) nor the SSRI fluoxetine (0.3-3 mg/kg) exerted positive effects in the PRT...While positive effects on reward responsiveness may be common across psychedelics, differences in time course suggest that their enhancement of hedonic function may vary. The PRT is a useful tool to comparatively assess the effects of potential treatments for anhedonia, although the clinical implications of these data require further validation."

Journal • Preclinical • CNS Disorders • Mental Retardation • Psychiatry

Psilocybin therapy for adult females with anorexia nervosa: pilot study. (PubMed, Br J Psychiatry) - "This study further provides preliminary support for the feasibility, safety and potential efficacy of this intervention to treat adult females with anorexia nervosa, and warrants further investigation in larger and more rigorously designed studies."

Journal • Anorexia • Pain • Psychiatry

Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile (Businesswire) - "Data from positive COMP006 Phase 3 trial demonstrates durable benefit through at least 6 months further validating COMP360’s differentiated profile in highly chronic TRD; Across two highly statistically significant positive Phase 3 trials, COMP360 is the first classic psychedelic to consistently demonstrate rapid onset, significant durability and reproducibility of effect in TRD, one of psychiatry’s most difficult conditions in which to demonstrate efficacy; COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings; Rolling NDA submission and initial review underway and final submission expected to be completed in Q4; Commercial launch-readiness on track for end of 2026, with launch expected in first half of 2027"

FDA filing • Launch US • P3 data • Depression

Symposium 7: Novel pharmacological strategies and eating disorders (CINP 2026) - "Recent breakthroughs in the biological understanding of eating disorders and the development of innovative pharmacological approaches have stimulated pharmacological research activities and clinical considerations in this field [1].Currently, the use of typical and atypical psychedelics (e.g., psilocybin and ketamine), and glucagon-like peptide-1 agonists (GLP-1A, e.g., liraglutide, tirzepatide, and retatrutide) in people with eating disorders is hotly debated in the scientific and clinical community and in the public [2-4].The first speaker, Dr...In this trial, 60 adults with a diagnosis of depression and AN will be randomized to receive four weeks of oral ketamine 60 mg to 180 mg (2 x weekly) or placebo.The second speaker, Guy Goodwin, will report the results of a proof-of-concept study that tested the efficacy and safety of psilocybin (COMP360) administered with the Compass Psychological Support Model [5] in participants with AN...He will introduce consensus..."

Anorexia • CNS Disorders • Depression • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa: a proof-of-concept study (CINP 2026) - "Despite the promising rapid symptomatic improvement and favourable safety profile, the trial encountered several challenges. Recruitment proved difficult, resulting in the target sample size not being achieved. Furthermore, dropout rates were high in the control arm, which may have affected the robustness and generalisability of the findings."

Clinical • Anorexia

The Effect of Anorexia Nervosa Severity and High-Dose Psilocybin on Visual Long-Term Potentiation (OHBM 2026) - P1/2 | "Methods Twenty-one adult females with a primary DSM-5 diagnosis of AN in the PANOREXIA study (NCT04505189) underwent 3 psilocybin (COMP360: a proprietary, pharmaceutical-grade, synthetic psilocybin formulation, optimised for stability and purity, developed by COMPASS Pathfinder Ltd, United Kingdom) dosing sessions in a fixed-order (dose 1: 1 mg, dose 2: 25 mg, dose 3: 25 mg), alongside therapy...This tentative evidence partially replicates the P2 potentiation observed following ketamine treatment in MDD patients...We would like to thank the Clinical Data Systems team at the Imperial Clinical Trials Unit for their support. All authors affiliated with the Imperial College London Division of Psychiatry are supported by the National Institute of Health Research (NIHR) Imperial Biomedical Research Collaboration."

Anorexia • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • BDNF

Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder (clinicaltrials.gov) - P2/3 | N=300 | Not yet recruiting | Sponsor: COMPASS Pathways

New P2/3 trial • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

COMP 006: A Phase III study to investigate two initial administrations of COMP360 in treatment-resistant depression (clinicaltrialsregister.eu) - P2/3 | N=126 | Active, not recruiting | Sponsor: Compass Pathfinder Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Mood Disorders • Psychiatry

Psilocybin ameliorates neuropathic pain-like behaviour in mice and facilitates gabapentin-mediated analgesia. (PubMed, Commun Biol) - "Such a translation is notable in chronic pain management, where most analgesics require chronic dosing and lose efficacy through tolerance. These findings establish psilocybin as a potential therapeutic addition for pain management by enabling longer-lasting changes in pain-processing networks and enhancing the utility of established treatments."

Journal • Preclinical • Neuralgia • Pain

The role of therapeutic alliance in psilocybin treatment for treatment-resistant depression: A post hoc path analysis. (PubMed, J Affect Disord) - P2 | "The therapeutic alliance appeared to facilitate the psychedelic experience, and these experiences in turn had stronger nominally significant direct effects on clinical outcomes. The effects of the alliance itself on therapeutic efficacy were either limited or absent."

Journal • Retrospective data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment. (PubMed, EClinicalMedicine) - P2 | "This qualitative study was nested within a quantitative, open-label phase 2 trial assessing the safety and tolerability of COMP360 psilocybin in adults with PTSD...Future work should include larger controlled studies and use mixed methods to explore how symptom change, functional outcomes, and patient narratives interact. Compass Pathways, plc."

Journal • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Compass Pathways Announces FDA Acceptance of IND Application for PTSD... (Businesswire) - "The phase 2b/3 multicenter, randomized, double-blind, controlled study, with an open label extension, aims to investigate the efficacy, safety, and tolerability of COMP360 in participants with PTSD."

IND • New P2/3 trial • Post-traumatic Stress Disorder