United States

Key Insights

1
No psychedelic is broadly approved in the US for psychiatric use; esketamine is approved for treatment-resistant depression, while ketamine remains off-label and MDMA lacks FDA approval.
2
Blossom logs 488 US trials, 160 active, across 242 organisations; psilocybin, ketamine and placebo dominate, with LSD, ibogaine and MDMA still in active studies.
3
The US set the regulatory template in 2023, when the FDA issued its first draft guidance for clinical trials with psychedelic drugs.
4
Momentum is being driven by NIDA and the FDA: NIDA is expanding psychedelic funding, while the FDA’s 2024 MDMA advisory review signalled higher scrutiny, not retreat.

Medical Only (Private)

Reimbursed Care Access

In the United States, a limited medical framework exists for ketamine-derived treatments (FDA‑approved esketamine/SPRAVATO with REMS requirements and wide off‑label IV/IM ketamine use in private clinics), while classical psychedelics such as psilocybin and MDMA remain unapproved at the federal level but are the focus of advanced clinical trials and regulatory submissions. Most other compounds (DMT, 5‑MeO‑DMT, ibogaine, ayahuasca, mescaline, 2C‑X) are federally scheduled or controlled and have no authorized medical use outside approved research; access therefore is mainly via clinical trials or state/local policy experiments. [https://spravatorems.com|SPRAVATO REMS] [https://maps.org/2023/12/13/maps-celebrates-submission-of-new-drug-application-to-fda-for-mdma-assisted-therapy-for-ptsd/|MAPS NDA announcement] [https://www.forbes.com/sites/ajherrington/2025/08/23/dea-forwards-psilocybin-rescheduling-petition-to-hhs-for-review/|Forbes on psilocybin rescheduling action]

Full guide →

Quick Indicators

Active Trials

159

Total Trials

491

Organizations

287

Events

107

Reimbursement Guide→All Countries→Clinical Trials→Research Papers→

Organizations

100

Research Events

Clinical Trials

Active and completed clinical trials investigating psychedelic-assisted therapies in United States.

Not yet recruitingPhase I

Psilocybin After Trauma Surgery for Pain

Started: July 1, 2026

Not yet recruitingPhase II

Anesthesia-Masked Psilocybin Therapy for Major Depression

Started: July 1, 2026

Not yet recruitingPhase III

Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression

Started: June 1, 2026

Not yet recruitingPhase II

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

Started: June 1, 2026

Not yet recruitingPhase II

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

Started: May 4, 2026

Not yet recruitingPhase II

Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder

Started: May 1, 2026

United States

Key Insights

Reimbursed Care Access

Quick Indicators

Organizations

AIM Youth Mental Health

AbbVie

Advanced Integrative Medical Science Institute

Aetna

Alchemy

Alex Criddle

Alma Institute

Altered States Integration

America's Poison Centers

American Academy of Child Adolescent Psychiatry.

American Foundation for Suicide Prevention

American Psychiatric Association

Anne and Don Fizer Foundation

Apollo Neuroscience, Inc.

Arizona Biomedical Research Commission (ABRC)

AtaiBeckley

Autism Psychedelic Community

Avadel CNS Pharmaceuticals, LLC

Awaken Aba

Ayahuasca Wisdom

Baylor College of Medicine

Beckley Academy

Being True to You

Berkeley University

Berry Consultants

Bonfire

Braeburn Inc.

Brain & Behavior Research Foundation

Brigham and Women's Hospital

Bronx VA Medical Center

Bronx Veterans Medical Research Foundation

Brooke Army Medical Center

Burroughs Wellcome

CH TAC LLC

CIIS

CUIMC

California Pacific Medical Center Research Institute

Carey and Claudia Turnbull Family Foundation

Ceiba

Center for Medicinal Cannabis Research

Center for the Evaluation of Value and Risk in Health (CEVR)

Center for the Neuroscience of Psychedelics

Ceruvia Lifesciences

Chacruna

Changa Institute

Changing Minds

Children's National Research Institute

Cigna Healthcare

Citeline

Clinical Cognitive Facilitator Training

Clinilabs Drug Development Corporation

College of DuPage

Colorado DORA Natural Medicine Program

Colorado Department of Natural Medicine (DOR)

Colorado Natural Medicine Advisory Board

Columbia University

Congressionally Directed Medical Research Programs

Council On Spiritual Practices

Council on Spiritual Practices Fund at the San Francisco Foundation

DOSED

Defense Advanced Research Projects Agency (DARPA)

Definium Therapeutics

Delix Therapeutics

Denver Health and Hospital Authority

Double Blind

Drug Safety Navigator

Duke University

ERT: Clinical Trial Technology Solutions

Earth Medicine Center

Embodied Philosophy

Emory University

EmpathBio, Inc.

Enovex Pharmacy

Entheogen Institute

Essentia Health