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A promising future for psychedelic medicine

THE FDA APPROVAL PIPELINE

In recent decades, there has been a resurgence of clinical research into the potential health benefits of psychedelic chemicals. Several clinical trials involving ketamine, psilocybin, and MDMA have even received Fast Track or Breakthrough Therapy designations from the FDA. These designations expedite development and review of new drugs that fill unmet needs or have preliminary clinical evidence indicating substantial improvement over available therapies.

The FDA drug approval process begins with pre-clinical drug development and animal testing, followed by three phases of clinical trials. Phase 1 focuses on the safety of the drug, Phase 2 focuses on effectiveness, and Phase 3 involves large-scale testing of safety and effectiveness with thousands of patients.

There are 1,000+ clinical trials of psychedelic chemicals in the U.S. National Library of Medicine’s clinical trial database. We’ve highlighted some of the most promising ones below.

Something we’re missing? Let us know at pipeline@mindbloom.co

Clinical Trials for Psychedelics

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Pre-clinical
Phase 1
Phase 2
Phase 3
Approved
Ketamine
Treatment-resistant depression (intranasal esketamine)
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Phase - Approved

A Long-term, Safety and Efficacy Study of Intranasal Esketamine (Spravato) in Treatment-resistant Depression

Janssen Research & Development, LLC

This open-label, multicenter study assessed the long-term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).

Spravato (esketamine) nasal spray was approved by the FDA on March 5, 2019.

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Major depressive disorder (intravenous ketamine)
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Phase - 2/3

Rapid Antidepressant Effects of Ketamine in Major Depression

National Institute of Mental Health (NIMH)

Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants.

This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder.

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PTSD (intravenous ketamine)
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Phase - 2/3

Ketamine as a Rapid Treatment for Post-traumatic Stress Disorder (PTSD)

Icahn School of Medicine at Mount Sinai

The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg) decreases symptoms of PTSD.

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Suicidal ideation (intranasal ketamine)
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Phase - 1/3

Intranasal racemic ketamine for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD)

Seelos Therapeutics

A phase 1 study evaluating the pharmacokinetics, pharmacodynamics, and drug-drug interactions of Seelos’s SLS-002 ketamine program is expected in early 2020. In this study, 48 healthy volunteers will be randomized to receive a combination of SLS-002 and one of two anxiety medications.

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Psilocybin
Treatment-resistant depression
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Phase - 2/3

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

COMPASS Pathways

This randomized controlled trial of psilocybin therapy for treatment-resistant depression will be the largest clinical study of its kind and is taking place in a number of clinical trial sites across Europe and North America. The trial is a Phase 2b dose-ranging study with 216 patients.

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Major depressive disorder
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Phase - 2/3

A Study of Psilocybin for Major Depressive Disorder (MDD)

Usona Institute

Eighty participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo.

The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 8 post-dose.

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Alcohol dependence
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Phase - 2/3

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

NYU Langone Health

Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment.

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Cancer anxiety
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Phase - 1/3

Psilocybin Cancer Anxiety Study

NYU Langone Health

The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness.

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Demoralization in AIDS survivors
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Phase - 1/3

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

University of California, San Francisco

The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).

This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.

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MDMA
PTSD (MDMA-assisted psychotherapy)
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Phase - 3/3

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD

Multidisciplinary Association for Psychedelic Studies

This multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy versus psychotherapy with placebo in participants diagnosed with at least severe posttraumatic stress disorder (PTSD).

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Updates

Hair Primordiums Research Status Update: Interview with Organ Technologies
Interview with Organ Technologies, CEO and one of the lead researchers on Dr. Tsuji’s team, presenting the latest updates on the project status, timelines, and future plans for commercialization.

Hair Primordiums Research Status Update: Interview with Organ Technologies
Interview with Organ Technologies, CEO and one of the lead researchers on Dr. Tsuji’s team, presenting the latest updates on the project status, timelines, and future plans for commercialization.

Hair Primordiums Research Status Update: Interview with Organ Technologies
Interview with Organ Technologies, CEO and one of the lead researchers on Dr. Tsuji’s team, presenting the latest updates on the project status, timelines, and future plans for commercialization.

Hair Primordiums Research Status Update: Interview with Organ Technologies
Interview with Organ Technologies, CEO and one of the lead researchers on Dr. Tsuji’s team, presenting the latest updates on the project status, timelines, and future plans for commercialization.

Hair Primordiums Research Status Update: Interview with Organ Technologies
Interview with Organ Technologies, CEO and one of the lead researchers on Dr. Tsuji’s team, presenting the latest updates on the project status, timelines, and future plans for commercialization.

Psychedelic Medicine Pipeline