psilocybin (COMP360) / Compass Pathways - LARVOL DELTA

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

The Relationship Between Participant Pretreatment Clinical Presentation and the Quality of Psilocybin Experience: A Retrospective Analysis. (PubMed, J Clin Psychopharmacol) - P2 | "These findings challenge the assumption that pretreatment characteristics are major determinants of the acute psychedelic experience. While some traits may modestly modulate aspects of the experience, dose remains the largest driver."

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

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (clinicaltrials.gov) - P3 | N=572 | Active, not recruiting | Sponsor: COMPASS Pathways | Recruiting ➔ Active, not recruiting

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

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

New P3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

The impact of COMP360 psilocybin on anhedonia: post-hoc analyses from a phase IIb randomised controlled trial (ECNP 2025) - "In participants with TRD, post-hoc analysis found that COMP360 25mg improved items of the MADRS and PANAS most relevant to anhedonic symptoms of depression in the largest study of psilocybin completed to date. A nominally greater efficacy was found for 25mg compared to 10mg and 1mg, supporting a dose-related effect. Future studies should prospectively assess these effects."

Clinical • P2b data • Retrospective data • CNS Disorders • Depression • Major Depressive Disorder • Psychiatry

An open-label study of single-dose COMP360 psilocybin for post-traumatic stress disorder: safety, tolerability, and secondary efficacy outcomes (ECNP 2025) - "A single 25mg administration of COMP360 psilocybin was generally well-tolerated with no TESAEs. A rapid and durable clinically meaningful reduction in clinician- and participant- reported symptoms was observed. Response and remission rates were high and sustained across the trial."

Clinical • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry • Suicidal Ideation

PSILOBSD: Psilocybin rTMS for Treatment Resistant Depression (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: University of Texas at Austin | Not yet recruiting ➔ Recruiting

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

Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial. (PubMed, J Psychopharmacol) - P2 | "Psilocybin at a dose of 25 mg, administered with psychological support, may be safe, well-tolerated and associated with symptomatic improvement in adults with PTSD. Further investigation is warranted."

Journal • CNS Disorders • Depression • Fatigue • Mood Disorders • Pain • Post-traumatic Stress Disorder • Psychiatry

Short- and long-term modulation of rat prefrontal cortical activity following single doses of psilocybin. (PubMed, Mol Psychiatry) - "LFP 1-, 2- and 6-days post-psilocybin showed gradually-emerging increases in beta and low-gamma (20-60 Hz) power, specific to the infralimbic cortex. These findings reveal features of psychedelic action not readily detectable in human brain imaging, implicating infralimbic network oscillations as potential biomarkers of psychedelic-induced network plasticity over multi-day timescales."

Journal • Preclinical

A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder (clinicaltrials.gov) - P2 | N=102 | Active, not recruiting | Sponsor: COMPASS Pathways | Trial completion date: Nov 2024 ➔ Sep 2025 | Trial primary completion date: Oct 2024 ➔ Sep 2025 | Recruiting ➔ Active, not recruiting

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

The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Sheppard Pratt Health System | Active, not recruiting ➔ Completed

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

PSILAUT: Psilocybin in Adults With and Without Autism Spectrum Disorder (clinicaltrials.gov) - P=N/A | N=67 | Completed | Sponsor: King's College London | Recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Aug 2024 | Trial primary completion date: Sep 2025 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

Can We Re-Medicalise the Psychedelic Experience? (CINP-AsCNP 2025) - "COMP360 was generally well-tolerated; in both studies over 90% of adverse events were either mild or moderate in severity. Suicidality remains a concern in TRD studies. These results suggested that COMP360 has potential to become an important contribution to the treatment for TRD."

CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Clinical conceptualisation of PTSD in psilocybin treatment: disrupting a pre-determined and over-determined maladaptive interpretive framework. (PubMed, Ther Adv Psychopharmacol) - "A clinical narrative illustrates how psilocybin's unique psychopharmacological properties and catalysed subjective effects may facilitate therapeutic progress by disrupting this rigid and restricting framework. Finally, we offer recommendations for the safe administration of psilocybin for traumatised patients in medical research settings, emphasising the importance of rigorous and trauma-informed protocols and comprehensive patient care."

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

Therapeutic emergence of dissociated traumatic memories during psilocybin treatment for anorexia nervosa. (PubMed, J Eat Disord) - "PT may hold promise not only in the treatment of eating disorders but also trauma-related disorders, including PTSD and dissociative amnesia. Potential mechanisms of psilocybin's facilitation of remembering and processing traumatic material is reviewed."

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

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (clinicaltrials.gov) - P3 | N=568 | Recruiting | Sponsor: COMPASS Pathways | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Feb 2026

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

Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD (clinicaltrials.gov) - P3 | N=255 | Active, not recruiting | Sponsor: COMPASS Pathways | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2025 ➔ Jun 2025

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

Participants' Experience of Psychedelic Integration Groups and Processes: A Qualitative Thematic Analysis. (PubMed, Psychedelic Med (New Rochelle)) - "Specifically, future studies should explore the development of standardized protocols and facilitator training programs to enhance the safety and efficacy of these groups. This research is crucial to inform policy and practice, ensuring that individuals seeking integration support and aftercare following psychedelic use have access to well-designed and delivered interventions."

Journal

Compass Pathways Establishes Strategic Collaboration with HealthPort to Inform the Potential Delivery of COMP360 Synthesized Psilocybin Treatment in Underserved Communities (Businesswire) - "Compass Pathways plc...announced today it is entering into a strategic collaboration with HealthPort, a multi-site comprehensive community health organization. HealthPort employs an integrated model centered around social determinants of health and this collaboration will help inform the potential delivery of COMP360 synthesized psilocybin treatment in underserved communities, if FDA approved. This agreement with HealthPort expands the set of collaborations that Compass has established representing a broad spectrum of settings where people living with treatment resistant depression (TRD) receive their care in the United States."

Commercial • Depression

Compass Pathways Announces Completion of Recruitment for the Phase 3 COMP005 Trial of COMP360 Psilocybin for Treatment-Resistant Depression (Businesswire) - "Compass Pathways plc...announced the completion of recruitment in the COMP005 phase 3 trial for treatment resistant depression (TRD). The final participants are completing pre-dosing activities, including washout from anti-depressant medications, if necessary, and those eligible will receive a dose of either 25 mg of COMP360 or placebo....Top-line 6-week (primary endpoint) COMP005 data is expected late in the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026."

Enrollment closed • P3 data • Depression

The Safety and Efficacy of Psilocybin in Patients with Treatment-resistant Depression and Chronic Suicidal Ideation (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Sheppard Pratt Health System | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ May 2025 | Trial primary completion date: Apr 2024 ➔ May 2025

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

Compass Pathways Announces Publication of Results from COMP004 Study on COMP360 Psilocybin for Treatment-Resistant Depression (Businesswire) - P=Obs | N=66 | COMP004 (NCT04519957) | Sponsor: COMPASS Pathways | "The COMP004 study's findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses....Durable improvement in symptoms observed. The analysis of all patients in COMP001 revealed a longer time to relapse for patients receiving 25 mg compared with 10mg and 1 mg, with the median time to a depressive event of 92 days for the 25 mg dose group, 83 days for the 10 mg and 62 days for the 1 mg group. Extended benefit for a subgroup. A post hoc analysis revealed a substantial difference in time to depressive event for those who enrolled in COMP004 from COMP001 in the 25 mg group compared to the 10mg and 1mg groups, with median times of 189 days for the 25 mg group, 43 days for the 10 mg group, and 21 days for the 1 mg group."

Observational data • Depression

Results From a Long-Term Observational Follow-Up Study of a Single Dose of Psilocybin for a Treatment-Resistant Episode of Major Depressive Disorder. (PubMed, J Clin Psychiatry) - P=N/A | "Background: The largest randomized study of psilocybin to date demonstrated the efficacy of COMP360 25 mg (Compass Pathways' investigational proprietary pharmaceutical-grade synthesized psilocybin formulation) in participants with treatment-resistant depression (COMP 001), compared with 10 mg and 1 mg doses...Larger long-term studies are required to confirm these findings and provide clarity on the longer-term effects of psilocybin. Trial Registration: ClinicalTrials.gov identifier: NCT04519957."

Clinical • Journal • Observational data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Compass Pathways Announces Fourth Quarter and Full-Year 2024 Financial Results and Business Highlights (Businesswire) - "Top-line 6-week (primary endpoint) COMP005 data is on track for the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026."

P3 data • Depression