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Psilocybin

Phase 3Small molecule

COMPASS Pathways

Psilocybin is a naturally occurring compound from certain mushrooms that is being studied in clinical trials to help treat depression, anxiety, and PTSD by altering brain activity and potentially helping people process difficult emotions.[1] Psilocybin is currently being investigated across 63 indications[3], with its most advanced program in Phase 3.[1]

Psilocybin is one of 790 small molecule programs targeting Opioid Use Disorder. It is currently in Phase 3.

63

Indications

223

Total Trials

113

Active Trials

789

Competitors

Pipeline

Status by Indication[3][1]

Indication

Opioid Use DisorderRecruiting

Chronic PainRecruiting

Post-Traumatic Stress DisorderCompleted

Psilocybin-Assisted PsychotherapyNot yet recruiting

AdultsRecruiting

SeizureActive, not recruiting

Autism Spectrum DisorderActive, not recruiting

Prolonged Grief DisorderRecruiting

Advanced CancerActive, not recruiting

Older Adults (65-85 Years)Recruiting

Opioid Use DisorderPhase 2

Recruiting

Chronic PainPhase 2

Recruiting

Post-Traumatic Stress DisorderPhase 2

Completed

Psilocybin-Assisted PsychotherapyPhase 2

Not yet recruiting

AdultsPhase 1

Recruiting

SeizurePreclinical

Active, not recruiting

Autism Spectrum DisorderPreclinical

Active, not recruiting

Prolonged Grief DisorderPhase 1

Recruiting

Advanced CancerPhase 2

Active, not recruiting

Older Adults (65-85 Years)Phase 1

Recruiting

Showing 10 of 62 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Psilocybin

COMPASS Pathways

Adenocard

Methylthioninium Chloride

PProvepharm SAS

Duragesic-100

Tricor

Nubain

AAultman Health Foundation

Rilvegostomig

Beta Blocker

WWeill Medical College of Cornell University

Tianeptine

Ablavar

LLantheus Medical Imaging

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Neuropathic Pain

NCT06731335

Phase 1Recruiting

Cannabis Use Disorder

NCT06660381

Phase 1Recruiting

Prep

NCT06815653

Phase 1Not yet recruiting

Irritable Bowel Syndrome

NCT06760533

Phase 3Active, not recruiting

Treatment Resistant Depression

NCT05711940

Phase 1Active, not recruiting

Treatment Resistant Depression

NCT06731621

Clinical

Trials by Indication[1]

Psilocybin38 trials

Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

Completed·JJoshua Woolley·Phase 1·NCT02950467·30 enrolled

Visual Surround Suppression and Perceptual Expectation Under Psilocybin

Terminated·UUniversity of Minnesota·Phase 1·NCT04424225·10 enrolled

Effects of Repeated Psilocybin Dosing in OCD

Active, not recruiting·YYale University·Phase 1·NCT05370911·30 enrolled

Show 35 more trials

Psilocybin-assisted Therapy for Phantom Limb Pain

Completed·UUniversity of California, San Diego·Phase 1·NCT05224336·10 enrolled

The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density

Completed·SSection for Affective Disorders; Northern Stockholm Psychiatry·Phase 2·NCT04630964·35 enrolled

Psilocybin and Spiritual Practice

Completed·JJohns Hopkins University·Phase 1·NCT00802282·75 enrolled

A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers

Completed·MMycoMedica Life Sciences PBC·Phase 1·NCT07050368·20 enrolled

Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

Completed·UUniversity of Utah·Phase 1·NCT04522804·12 enrolled

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT05381974

The Effects of Psilocybin on Shared Experience in Film Processing

Not yet recruiting·WWestern University, Canada·N/A·NCT06529939·30 enrolled

Precision Functional Brain Mapping in Psilocybin

Completed·WWashington University School of Medicine·Phase 1·NCT04501653·11 enrolled

Psilocybin With Intracranial Neural Sensing

Enrolling by invitation·JJoshua Woolley, MD, PhD·Phase 1·NCT06919640·20 enrolled

Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer

Recruiting·SSunstone Medical·Phase 2·NCT05947383·56 enrolled

Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter

Not yet recruiting·NNYU Langone Health·Phase 2·NCT07296328·25 enrolled

Persisting Effects of Psilocybin

Completed·JJohns Hopkins University·Phase 1/2·NCT02971605·13 enrolled

Exploratory Study of Low Dose Psilocybin

Withdrawn·UUniversity of Alabama at Birmingham·Phase 1·NCT05227742

Comparative Acute Effects of LSD, Psilocybin and Mescaline

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT04227756·32 enrolled

Wellcome Leap Psilocybin for OUD

Recruiting·—·Phase 2·NCT06786325·36 enrolled

Consciousness, Psilocybin, and Well-Being

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT05592379·6 enrolled

Psilocybin-facilitated Treatment for Cocaine Use

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT02037126·40 enrolled

UW Psilocybin Pharmacokinetics Study

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT02163707·12 enrolled

Mood and Cognitive Effects of Psilocybin in Healthy Participants

Withdrawn·OOptimi Health Corporation·Phase 1·NCT05252598

Effect of SSRIs on Response to Psilocybin Therapy

Withdrawn·CCybin Therapeutics Inc.·Phase 2·NCT05594667

Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants

Recruiting·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT06899334·24 enrolled

Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness

Recruiting·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT06796361·16 enrolled

Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT05523401·24 enrolled

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

Active, not recruiting·UUniversity of California, San Francisco·Phase 1·NCT05317689·20 enrolled

Frontline Clinician Psilocybin Study

Completed·UUniversity of Washington·Phase 3·NCT05163496·30 enrolled

Psychopharmacology of Psilocybin in Cancer Patients

Completed·JJohns Hopkins University·Phase 2·NCT00465595·56 enrolled

Bioavailability Study of Psilocybin in Normal Adults

Withdrawn·UUniversity of Wisconsin, Madison·Phase 1·NCT05467761

Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT03604744·28 enrolled

Naturalistic Study of Microdosing With Psilocybin

Completed·NNational Council of Scientific and Technical Research, Argentina·N/A·NCT05160220·34 enrolled

Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects

Recruiting·MMedical University of Vienna·Phase 1·NCT07490353·85 enrolled

Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients

Completed·UUniversity of Zurich·Phase 2·NCT04141501·37 enrolled

State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma

Recruiting·—·Phase 2·NCT06888128·15 enrolled

PRoMiSS: Psilocybin and the Role of Music in Set and Setting

Recruiting·JJohns Hopkins University·Phase 1·NCT07180108·100 enrolled

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07227909·83 enrolled

Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)

Recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT06692192·60 enrolled

Treatment Resistant Depression17 trials

Psilocybin Versus Ketamine in Treatment-Resistant Depression

Unknown status·NNational Institute of Mental Health, Czech Republic·Phase 2·NCT05383313·60 enrolled

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Active, not recruiting·SSheppard Pratt Health System·Phase 2·NCT04433858·27 enrolled

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Completed· COMPASS Pathways logo

COMPASS Pathways·Phase 2·NCT03775200·233 enrolled

Show 14 more trials

The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

Completed· COMPASS Pathways logo

COMPASS Pathways·Phase 2·NCT04739865·19 enrolled

Psilocybin for Treatment-Resistant Depression

Completed·BBrain and Cognition Discovery Foundation·Phase 2·NCT05029466·30 enrolled

Effect of Psilocybin on the Positive Valence System in Treatment-resistant Depression

Completed·—·N/A·NCT06650800·10 enrolled

Psilocybin for Hospitalized Patients with Treatment-resistant Depression

Recruiting·UUniversity Hospital, Ghent·Phase 2·NCT06378229·100 enrolled

Psilocybin rTMS for Treatment Resistant Depression

Recruiting·UUniversity of Texas at Austin·Phase 2·NCT06132178·100 enrolled

Psilocybin-Assisted Therapy in Treatment-Resistant Depression

Recruiting·UUniversity of North Carolina, Chapel Hill·Phase 3·NCT06303739·23 enrolled

Psilocybin for Treatment-Resistant Depression

Active, not recruiting·UUniversity of Colorado, Denver·Phase 2·NCT06230757·40 enrolled

Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression

Recruiting·—·Phase 2·NCT07183748·20 enrolled

Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression: A Pilot Randomized Clinical Trial

Recruiting·CCentre for Addiction and Mental Health·Phase 2·NCT07211438·40 enrolled

A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

Active, not recruiting· COMPASS Pathways logo

COMPASS Pathways·Phase 3·NCT05711940·572 enrolled

A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression

Completed· COMPASS Pathways logo

COMPASS Pathways·Phase 3·NCT05624268·258 enrolled

Psilocybin for Treatment-Resistant Depression in Autism: a Pilot Trial With Pre-Post Brain and Cognitive Measurement to Understand Mechanism

Active, not recruiting·CCentre for Addiction and Mental Health·Phase 1·NCT06731621·20 enrolled

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial

Recruiting·CCentre for Addiction and Mental Health·Phase 2·NCT06518720·16 enrolled

Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)

Recruiting·CCentre for Addiction and Mental Health·Phase 2·NCT06512220·12 enrolled

Major Depressive Disorder10 trials

A Study of Psilocybin for Major Depressive Disorder (MDD)

Completed·UUsona Institute·Phase 2·NCT03866174·104 enrolled

The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder

Unknown status·MMaryland Oncology Hematology, PA·Phase 2·NCT04593563·30 enrolled

Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder

Active, not recruiting·JJohns Hopkins University·Phase 2·NCT04620759·90 enrolled

Show 7 more trials

Effects of Psilocybin in Major Depressive Disorder

Completed·JJohns Hopkins University·Phase 2·NCT03181529·27 enrolled

Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT06592833·60 enrolled

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

Active, not recruiting· COMPASS Pathways logo

COMPASS Pathways·Phase 2·NCT05733546·102 enrolled

Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder

Not yet recruiting·CCentre for Addiction and Mental Health·Phase 2·NCT07405606·30 enrolled

Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers

Completed·KKhyber Medical University Peshawar·Phase 2·NCT06746441·60 enrolled

Psilocybin for Major Depressive Disorder

Withdrawn·WWashington University School of Medicine·Phase 2·NCT05675800

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder

Recruiting·SSharmin Ghaznavi·Phase 3·NCT06247839·20 enrolled

Depression8 trials

Does Psilocybin Require Psychedelic Effects to Treat Depression?

Recruiting·CCentre for Addiction and Mental Health·Phase 2·NCT05710237·60 enrolled

Psilocybin and Depression

Unknown status·UUniversity of Helsinki·Phase 2·NCT03380442·60 enrolled

Low-Income Group Psilocybin Assisted Therapy for Depression

Completed·MMatthew Hicks·N/A·NCT06372197·20 enrolled

Show 5 more trials

PET Synaptogenesis After Psilocybin In DEpression Recovery

Withdrawn·WWashington University School of Medicine·Phase 2·NCT05601648

Psilocybin-assisted CBT for Depression

Completed·UUniversity of California, Los Angeles·Phase 1·NCT05227612·16 enrolled

RCT of Psilocybin-assisted CBT for Depression

Recruiting·UUniversity of California, Los Angeles·Phase 1/2·NCT07281352·50 enrolled

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06801041·20 enrolled

An Investigation of Strategies to Understand and Optimize the Antidepressant Effects of Psilocybin (The OPTIMIZE Study)

Recruiting·CCharles Raison·Phase 2·NCT06512194·141 enrolled

Alcohol Use Disorder7 trials

Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Active, not recruiting·PPeggy C Nopoulos·Phase 2·NCT05421065·20 enrolled

Psilocybin-assisted Therapy for Alcohol Use Disorder

Not yet recruiting·UUniversity of Sydney·Phase 2·NCT06444243·90 enrolled

Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Active, not recruiting·AAnders Fink-Jensen, MD, DMSci·Phase 2·NCT04718792·10 enrolled

Show 4 more trials

Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial

Recruiting·UUniversity of Iowa·Phase 2·NCT06405607·80 enrolled

Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

Completed·AAnders Fink-Jensen, MD, DMSci·Phase 2·NCT05416229·60 enrolled

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

Recruiting·NNYU Langone Health·Phase 2·NCT06349083·200 enrolled

Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder: A Double-Blind, Dose-Comparison Concurrent Control Randomized Trial

Not yet recruiting·BBrigham and Women's Hospital·Phase 2·NCT07296094·36 enrolled

84 more indications

Post-Traumatic Stress Disorder6 trials

Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

Active, not recruiting·OOhio State University·Phase 2·NCT05554094·15 enrolled

The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

Completed· COMPASS Pathways logo

COMPASS Pathways·Phase 2·NCT05312151·22 enrolled

Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

Withdrawn·JJohns Hopkins University·Phase 1·NCT05562973

Show 3 more trials

Evaluation of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans

Unknown status·CCombat Stress·Phase 2·NCT05876481·8 enrolled

Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder

Unknown status·HHalucenex Life Sciences Inc.·Phase 2·NCT05243329·20 enrolled

Psilocybin and MDMA for Post-traumatic Stress Disorder (PTSD)

Recruiting·JJohns Hopkins University·Phase 1·NCT06989957·40 enrolled

Anorexia Nervosa5 trials

Effects of Psilocybin in Anorexia Nervosa

Completed·JJohns Hopkins University·Phase 1·NCT04052568·22 enrolled

Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study

Completed· COMPASS Pathways logo

COMPASS Pathways·Phase 2·NCT05481736·32 enrolled

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

Completed·UUniversity of California, San Diego·Phase 2·NCT04661514·16 enrolled

Show 2 more trials

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Completed·IImperial College London·Phase 1/2·NCT04505189·21 enrolled

The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults

Recruiting·RRegion Skane·Phase 2·NCT07169747·40 enrolled

Anxiety5 trials

Psilocybin Cancer Anxiety Study

Completed·NNYU Langone Health·Phase 1·NCT00957359·29 enrolled

A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer

Completed·UUniversity of Washington·Phase 1·NCT06644170·15 enrolled

Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 1/2·NCT00302744·12 enrolled

Show 2 more trials

Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer

Completed·UUniversity of Washington·Phase 1/2·NCT05847686·55 enrolled

A Phase 2a Study of Group Retreat Psilocybin Therapy for Cancer-Related Anxiety and Depression

Active, not recruiting·UUniversity of Washington·Phase 2·NCT07336238·18 enrolled

Opioid Use Disorder3 trials

Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

Withdrawn·JJohns Hopkins University·Phase 2·NCT05242029

Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

Withdrawn·JJohns Hopkins University·Phase 2·NCT06005662

Psilocybin for Opioid Use Disorder (OUD)

Recruiting·NNYU Langone Health·Phase 2·NCT06796062·480 enrolled

Chronic pain3 trials

Psilocybin-facilitated Treatment for Chronic Pain

Recruiting·UUniversity of Alabama at Birmingham·Phase 1·NCT05068791·30 enrolled

Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain

Completed·EEmory University·Phase 1·NCT05506982·11 enrolled

Psilocybin as a Treatment for Chronic Pain in Smokers

Recruiting·YYale University·Phase 1·NCT07118332·10 enrolled

Fibromyalgia3 trials

Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

Completed·KKevin Boehnke·Phase 2·NCT05128162·17 enrolled

The Impact of Psilocybin on Pain in Fibromyalgia Patients

Recruiting·MMaastricht University·N/A·NCT06368492·35 enrolled

Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action

Unknown status·IImperial College London··NCT05548075·20 enrolled

Methamphetamine Use Disorder3 trials

Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder

Active, not recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT05322954·12 enrolled

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Recruiting·PPortland VA Research Foundation, Inc·Phase 1/2·NCT04982796·30 enrolled

Psilocybin Recovery Intervention for Stopping Methamphetamine Use

Not yet recruiting·NNicky Mehtani, MD, MPH·Phase 2·NCT07756736·30 enrolled

Psilocybin-Assisted Psychotherapy3 trials

Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

Recruiting·UUniversity of Calgary·Phase 2·NCT05995769·128 enrolled

Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

Unknown status·CClairvoyant Therapeutics·Phase 2·NCT05646303·128 enrolled

Understanding Music and Mindfulness Preferences in Psilocybin-Assisted Psychotherapy

Not yet recruiting·KKyle Greenway·Phase 2·NCT07373535·16 enrolled

Alcohol Dependence2 trials

A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence

Completed·NNYU Langone Health·Phase 2·NCT02061293·95 enrolled

Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

Completed·UUniversity of New Mexico·Phase 2·NCT01534494·10 enrolled

Effectiveness2 trials

The Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Religious Professionals

Completed·NNYU Langone Health·Phase 1·NCT02421263·12 enrolled

Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion

Completed·JJohns Hopkins University·Phase 1·NCT02243813·24 enrolled

Pilot Study2 trials

Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care

Completed·—·Phase 2·NCT04950608·15 enrolled

Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators

Completed·JJohns Hopkins University·Phase 1·NCT01988311·10 enrolled

Headache2 trials

Repeat Dosing of Psilocybin in Migraine Headache

Completed·YYale University·Phase 1·NCT04218539·18 enrolled

Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

Terminated·BBeckley Psytech Limited·Phase 1·NCT04905121·4 enrolled

Tics2 trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants

Completed·MMycoMedica Life Sciences PBC·Phase 1·NCT06326606·24 enrolled

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants

Completed·MMycoMedica Life Sciences PBC·Phase 1·NCT06643637·16 enrolled

Major Depression2 trials

Anesthesia-Masked Psilocybin Therapy for Major Depression

Not yet recruiting·SStanford University·Phase 2·NCT07479550·10 enrolled

A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans

Recruiting·VVA Office of Research and Development·Phase 3·NCT07226232·240 enrolled

Post-Traumatic Stress Disorder, PTSD2 trials

Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence

Not yet recruiting·UUniversity of Calgary·Phase 2·NCT06885996·76 enrolled

Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder

Recruiting·TTel-Aviv Sourasky Medical Center·Phase 1·NCT07737054·13 enrolled

Obsessive-Compulsive Disorder2 trials

Effects of Psilocybin in Obsessive Compulsive Disorder

Active, not recruiting·JJohns Hopkins University·Phase 1·NCT05546658·35 enrolled

Evaluating the Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant Obsessive-compulsive Disorder: An Open-label Clinical Trial

Active, not recruiting·CCentre for Addiction and Mental Health·Phase 1·NCT06299319·10 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression

Completed·—·Phase 2·NCT04670081·144 enrolled

Anorexia1 trial

Study of Psilocybin for Anorexia in Young Adults

Recruiting·MMarissa Raymond-Flesch, MD, MPH·Phase 2·NCT06399263·40 enrolled

Cocaine Use Disorder1 trial

Safety Profile of Psilocybin for Cocaine Use Disorder

Recruiting·UUniversity of California, Los Angeles·Phase 1·NCT06102434·10 enrolled

Cardiac Repolarization1 trial

An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics

Completed·UUsona Institute·Phase 1·NCT05478278·60 enrolled

Transdiagnostic1 trial

Open-Label Psilocybin Study in Transdiagnostic Population

Recruiting·YYale University·Phase 1·NCT06442423·50 enrolled

Melanoma1 trial

Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma

Withdrawn·MMultidisciplinary Association for Psychedelic Studies·Phase 2·NCT00979693

Neuropathic Pain1 trial

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

Recruiting·UUnity Health Toronto·Phase 2·NCT06731335·30 enrolled

Cognitive impairment1 trial

Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

Active, not recruiting·CCentre for Addiction and Mental Health·Phase 2·NCT06041152·10 enrolled

Suicidal Ideation1 trial

The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation

Completed·SSheppard Pratt Health System·Phase 2·NCT05220410·20 enrolled

Interaction1 trial

Investigating the Interaction of Psilocybin and Context of Its Administration in Healthy Volunteers

Recruiting·RRobin Carhart-Harris, PhD, MA·Phase 2·NCT06626139·120 enrolled

Cannabis Use Disorder1 trial

Psilocybin-assisted Treatment for Cannabis Use Disorder

Recruiting·JJohns Hopkins University·Phase 1·NCT06660381·12 enrolled

Bipolar Disorder1 trial

The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

Unknown status·SSheppard Pratt Health System·Phase 2·NCT04433845·15 enrolled

Lyme disease1 trial

Effects of Psilocybin in Post-Treatment Lyme Disease

Completed·JJohns Hopkins University·Phase 1·NCT05305105·20 enrolled

Single Dose1 trial

Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults

Recruiting·UUniversity of California, Berkeley·Phase 1·NCT06367738·40 enrolled

Cluster headache1 trial

Prophylactic Effects of Psilocybin on Chronic Cluster Headache

Terminated·GGitte Moos Knudsen·Phase 1/2·NCT04280055·10 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Completed·NNew York State Psychiatric Institute·Phase 2·NCT04656301·12 enrolled

Seizure1 trial

Evaluation of the Effect of a Single Dose of Psilocybin on Neural Correlates of Cognitive Control in Patients With Psychogenic Nonepileptic Seizures

Completed·—·N/A·NCT06647056·4 enrolled

Palliative Care1 trial

Pragmatic Trial of Psilocybin Therapy in Palliative Care

Recruiting·—·Phase 2·NCT05403086·100 enrolled

COVID-191 trial

PAPR: PAP + MBSR for Front-line Healthcare Provider COVID-19 Related Burnout

Completed·UUniversity of Utah·Phase 1·NCT05557643·24 enrolled

Randomized1 trial

Psilocybin-Assisted Randomized Therapy

Not yet recruiting·EEmory University·Phase 2·NCT07332143·150 enrolled

Non-Small Cell Lung Cancer1 trial

Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer

Recruiting·AAlan Davis·Phase 2·NCT07216404·10 enrolled

Social Behavior1 trial

Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans

Completed·UUniversity of Zurich·Phase 1·NCT06081179·122 enrolled

PrEP1 trial

Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs

Recruiting·UUniversity College, London·Phase 1·NCT06815653·40 enrolled

Biomarkers1 trial

The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.

Not yet recruiting·GGabriella Gobbi·Phase 1·NCT07433452·50 enrolled

OCD1 trial

PsilOCD: A Pharmacological-Challenge Feasibility Study

Completed·IImperial College London·Phase 1·NCT06258031·19 enrolled

Healing1 trial

Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability

Recruiting·JJohns Hopkins University·Phase 1·NCT07053917·20 enrolled

Severe Alcohol Use Disorder1 trial

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder

Recruiting·—·Phase 2·NCT06160232·62 enrolled

Methamphetamine1 trial

Psilocybin for Methamphetamine Addiction

Recruiting·KKevin Murnane·Phase 1·NCT06899594·20 enrolled

TED1 trial

Psychedelic-assisted Group Program for First Responders

Recruiting·EEmpower Research Inc·Phase 1/2·NCT06471959·32 enrolled

Neuroimaging1 trial

A Randomized Neuroimaging Trial of Psilocybin in Depression

Recruiting·SSunnybrook Health Sciences Centre·Phase 2·NCT06072898·50 enrolled

Double-blind1 trial

Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study.

Completed·YYale University·Phase 1·NCT03356483·31 enrolled

Fragile X Syndrome1 trial

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome

Suspended·NNova Mentis Life Science Corp·Phase 2·NCT05832255·10 enrolled

Borderline personality disorder1 trial

Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder

Completed·UUniversity of Chicago·Phase 2·NCT05399498·9 enrolled

Cognition1 trial

The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function

Not yet recruiting·MManoj Doss·Phase 1/2·NCT07079852·48 enrolled

Autism Spectrum Disorder1 trial

Psilocybin in Adults With and Without Autism Spectrum Disorder

Completed·KKing's College London·N/A·NCT05651126·67 enrolled

Irritable Bowel Syndrome1 trial

Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)

Not yet recruiting·NNYU Langone Health·Phase 1·NCT06760533·10 enrolled

Alzheimer's Disease1 trial

Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer's Disease

Not yet recruiting·NNational Institute on Aging (NIA)·Phase 2·NCT07721467·200 enrolled

Older Adults (65-85 Years)1 trial

A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT07516405·40 enrolled

Advanced Cancer1 trial

Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Randomized Controlled Trial

Not yet recruiting·UUniversity Health Network, Toronto·Phase 2·NCT07820033·46 enrolled

Bipolar1 trial

Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder: A Randomized Controlled Trial

Recruiting·LLakshmi N Yatham·Phase 2·NCT06943573·90 enrolled

Anhedonia1 trial

Targeting Reward Circuits: Psilocybin as a Novel Therapy for Residual Anhedonia

Recruiting·NNYU Langone Health·Phase 1·NCT07607938·90 enrolled

Depression, Anxiety1 trial

TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06200155·48 enrolled

Concussion1 trial

A Randomized Double-blinded Controlled Trial for the Treatment of Persisting Symptoms After Concussion With Psilocybin-assisted Therapy: A Safety and Feasibility Trial

Recruiting·UUniversity of Calgary·Phase 1·NCT06615908·40 enrolled

Older Adults (50-90 Years)1 trial

A Double Blind, Randomized Trial Investigating the Safety, Feasibility, and Mechanisms of Psychedelics in Healthy Older Adults With Low Well-being as Moderated by Biomarkers for Preclinical Alzheimer's Disease

Recruiting·JJennifer Mitchell·Phase 1·NCT07386730·80 enrolled

Breast Cancer1 trial

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT06430541·20 enrolled

Depressive Symptoms1 trial

Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease

Recruiting·JJohns Hopkins University·Phase 1·NCT04123314·20 enrolled

Chronic Low Back Pain1 trial

Psilocybin and Affective Function in Chronic Lower Back Pain Depression

Recruiting·JJohns Hopkins University·Phase 1·NCT06355414·40 enrolled

Investigating the Importance of the Subjective Psychedelic Experience1 trial

The Role of the Subjective Experience in Supporting Positive Effects Following Psilocybin: a Randomized, Controlled Clinical Trial Using Risperidone in Healthy Adults

Recruiting·UUniversity of Calgary·Phase 2·NCT06768944·128 enrolled

Mood1 trial

PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Recruiting·JJohns Hopkins University·Preclinical·NCT07610135·20 enrolled

Pancreas Cancer1 trial

An Exploratory Pilot Study of Palliadelic Treatment to Reduce Psychological Distress in People With Pancreatobiliary and Other Advanced Gastrointestinal Cancers

Completed·UUniversity of Nebraska·Phase 1·NCT05220046·18 enrolled

Chronic Low Back Pain (CLBP)1 trial

Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes

Not yet recruiting·YYale University·Phase 2·NCT07306364·45 enrolled

Longevity1 trial

An Examination of Psilocybin Effects on Biomarkers of Longevity, Healthy Aging, and Purpose in Life

Not yet recruiting·CCharles Raison·Phase 1·NCT07719088·50 enrolled

Alcohol Use Disorder (AUD)1 trial

PsiloStudy: A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

Active, not recruiting·NNathan Brashares Sackett·Phase 2·NCT06853912·40 enrolled

Stress1 trial

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

Recruiting·RRachel Yehuda·Phase 2·NCT06899165·100 enrolled

Bipolar II Disorder1 trial

Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality

Recruiting·TThe University of Texas Health Science Center, Houston·Phase 2·NCT06706232·10 enrolled

Generalized Anxiety Disorder (GAD)1 trial

A Phase 2a, Placebo-Controlled Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder

Recruiting·QQueen's University·Phase 2·NCT06969170·50 enrolled

Amyotrophic Lateral Sclerosis1 trial

Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

Recruiting·JJohns Hopkins University·Phase 1·NCT06656702·24 enrolled

Spinal Cord Injury1 trial

Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury

Recruiting·JJames J. Peters Veterans Affairs Medical Center·Preclinical·NCT07251491·30 enrolled

Bipolar Depression1 trial

Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression: An Emotional-Processing fMRI Pilot Study

Active, not recruiting·UUniversity Health Network, Toronto·Phase 1·NCT06506019·30 enrolled

Parkinson disease1 trial

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

Recruiting·JJoshua Woolley, MD, PhD·Phase 2·NCT06455293·60 enrolled

Mental Health1 trial

An Exploratory Study of Feasibility, Efficacy, and Mechanisms of Mindfulness-Assisted Psychedelic Therapy

Recruiting·UUniversity of Southern California·Phase 2·NCT06233344·40 enrolled

Pain Management1 trial

Single Dose Psilocybin for a Post-surgical Trauma Inpatient Population for Pain, Mood, and Opioid Use Disorder

Not yet recruiting·TTrent Emerick·Phase 1·NCT07406828·70 enrolled

Opioid-Related Disorders1 trial

Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer

Recruiting·YYvan Beaussant, MD, MSci·Phase 2·NCT06001749·15 enrolled

PTSD1 trial

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Not yet recruiting·UUniversity of New Mexico·Phase 2·NCT07745569·150 enrolled

Chronic Pelvic Pain1 trial

Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study

Not yet recruiting·OOregon Health and Science University·Phase 1·NCT06988319·15 enrolled

Psychedelic Experiences1 trial

Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin

Recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT05866471·108 enrolled

Functional Neurological Disorder1 trial

Probing the Functional Magnetic Resonance Imaging Response to Psilocybin in Functional Neurological Disorder (PsiFUND)

Completed·KKing's College London·Preclinical·NCT05723276·20 enrolled

Unspecified6 trials

Optimizing Microdosing and Meditation

Withdrawn·NNational University of Natural Medicine·N/A·NCT06560658

Neural and Physiological Correlates of Psychedelic Sub-states

Active, not recruiting·RRobin Carhart-Harris, PhD, MA·Phase 1·NCT05698511·12 enrolled

Investigation of Psychedelic Effects in Psychoactive Substances

Recruiting·JJohns Hopkins University·Phase 1·NCT06772753·50 enrolled

Show 3 more trials

Psilocybin Administration With 5-HT1a Blockade

Recruiting·JJohns Hopkins University·Phase 1·NCT07565493·18 enrolled

Pilot Study on the Effects of Psilocybin on Belief Updating and Insight Formation

Not yet recruiting·BBrown University·Phase 1·NCT07818564·24 enrolled

Changes in Self-awareness Induced by Psychoactive Substances: an Experimental Study With Psilocybin.

Recruiting·PPontifícia Universidade Católica do Rio de Janeiro·Phase 1·NCT07732166·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 223 trial records for Psilocybin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Psilocybin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Psilocybin. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — COMPASS Pathways company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: 5-HT2A Agonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: COMPASS Pathways

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