Clinical Trials

Numerous clinical trials evaluate pregnenolone across central nervous system and metabolic disorders, including substance use, major depression, bipolar disorder, cognitive decline, and Gulf War illness. Spanning Early Phase 1 through Phase 4 in recruiting, completed, or suspended statuses, these studies are sponsored by academic and federal entities such as Yale University, NIDA, NIAAA, and the VA. Notably, several Phase 2 trials focus on its therapeutic potential for substance dependence and Gulf War illness symptoms.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07734701 NOT_YET_RECRUITING
Alcohol Use Disorder (AUD); Major Depressive Disorder (MDD)
Sherwood Brown, MD, PhD
 2026-10 PHASE2
NCT05935761 NOT_YET_RECRUITING
Chronic Low Back Pain
VA Office of Research and Development
 2026-09-01 PHASE2
NCT07685964 NOT_YET_RECRUITING
Cannabis Use Disorder; Major Depressive Disorder (MDD)
University of Texas Southwestern Medical Center
 2026-09 PHASE1; PHASE2
NCT05781009 RECRUITING
Alcohol Use Disorder
Yale University
 2024-01-08 PHASE2
NCT06188923 RECRUITING
Anxiety and Depression
VA Office of Research and Development
 2025-08-14 PHASE2
NCT07216690 RECRUITING
Cannabis Intoxication
Johns Hopkins University
 2026-04-24 PHASE2
NCT06238700 RECRUITING
Depression
Beth Israel Deaconess Medical Center
 2026-05-01
NCT05570812 RECRUITING
Major Depressive Disorder; Anxiety Depression; HIV
Massachusetts General Hospital
 2023-03-03 PHASE2
NCT05671692 SUSPENDED
Traumatic Brain Injury; TBI
Christine Marx, MD
 2024-09-06 PHASE2
NCT02627508 COMPLETED
Autism Spectrum Disorder; Autism
Stanford University
 2016-01-29 PHASE2
NCT04762316 COMPLETED
Uterine Fibroids Affecting Pregnancy
Trieu, Nguyen Thi, M.D.
 2019-01-01 PHASE4
NCT03799562 COMPLETED
Posttraumatic Stress Disorder
VA Office of Research and Development
 2019-06-27 PHASE2
NCT03505905 COMPLETED
Major Depressive Disorder; Menopause; Perimenopause
University of Texas Southwestern Medical Center
 2018-09-01 PHASE1; PHASE2
NCT05781009 Recruiting
Alcohol Use Disorder
Yale University|National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2024-01-08 Phase 2
NCT03953612 COMPLETED
Cocaine-Related Disorders
Yale University
 2019-03-12 EARLY_PHASE1
NCT02582905 COMPLETED
Alcohol Use Disorder; Bipolar Disorder; Schizoaffective Disorder Bipolar Type
Sherwood Brown, MD, PhD
 2016-05 PHASE4
NCT03872128 COMPLETED
Alcohol Use Disorder
Yale University
 2018-09-27 PHASE1
NCT05903716 Recruiting
Acne Vulgaris
Marmara University
 2022-09-15 --
NCT03645096 COMPLETED
Major Depressive Disorder
University of Texas Southwestern Medical Center
 2019-09-01 PHASE1
NCT02826577 TERMINATED
Perceived Social Isolation
University of Chicago
 2017-05-01 PHASE2
NCT04464148 WITHDRAWN
Post Traumatic Stress Disorder; Alcohol Use Disorder
University of Texas Southwestern Medical Center
 2021-12 PHASE1
NCT04791124 Unknown status
Down Syndrome
Parc de Salut Mar|Aelis Farma|Starlab
 2021-01-11 --
NCT03801629 Completed
Drug Effect
Yale University
 2019-09-12 Phase 1
NCT02576912 COMPLETED
Healthy
Yale University
 2015-02 PHASE1
NCT03953612 Completed
Cocaine-Related Disorders
Yale University|National Institute on Drug Abuse (NIDA)
 2019-03-12 Early Phase 1
NCT01956279 COMPLETED
Fatigue; Musculoskeletal Pain; Cognitive Decline
VA Office of Research and Development
 2013-10-01 PHASE2
NCT01949753 UNKNOWN
Obsessive-compulsive Disorder (OCD)
Universitätsklinikum Hamburg-Eppendorf
 2013-09 PHASE2
NCT03157778 COMPLETED
Obesity
University Hospital, Bordeaux
 2017-05-30
NCT02811939 COMPLETED
Healthy
Yale University
 2016-04-07 PHASE1
NCT01898013 COMPLETED
Lower Back Pain
Durham VA Medical Center
 2013-09-13 PHASE2
NCT02439814 COMPLETED
Marijuana Dependence
Medical University of South Carolina
 2015-06 PHASE2
NCT01336413 COMPLETED
Brain Injuries, Traumatic
VA Office of Research and Development
 2013-10 PHASE2
NCT00728728 COMPLETED
Schizophrenia; Schizoaffective Disorder
VA Office of Research and Development
 2009-12 PHASE2
NCT00615511 COMPLETED
Schizophrenia; Schizoaffective Disorder
Weill Medical College of Cornell University
 2007-06 PHASE2
NCT01831986 UNKNOWN
Schizophrenia; Schizoaffective Disorder
Sha'ar Menashe Mental Health Center
 2011-01
NCT01881737 COMPLETED
Autistic Disorder
Stanford University
 2011-07 PHASE2
NCT01409096 COMPLETED
Bipolar Disorder; Major Depressive Disorder
University of Texas Southwestern Medical Center
 2010-03 PHASE4
NCT00894842 COMPLETED
Schizophrenia
National Research Foundation, Singapore
 2009-06 PHASE2; PHASE3
NCT00900900 COMPLETED
Substance Withdrawal Syndrome
Jed E. Rose
 2009-07 PHASE2
NCT00847600 COMPLETED
Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorders
Sha'ar Menashe Mental Health Center
 2009-03 PHASE4
NCT00993629 WITHDRAWN
Post-traumatic Stress Disorder; Major Depressive Disorder
US Department of Veterans Affairs
 2010-01 PHASE2
NCT00623506 COMPLETED
Traumatic Brain Injury
Durham VA Medical Center
 2008-01
NCT00608686 UNKNOWN
Alcohol Intoxication
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2004-05 PHASE1
NCT00560781 COMPLETED
Stress Disorders, Post-Traumatic
Durham VA Medical Center
 2006-04
NCT00560937 COMPLETED
Schizophrenia
Durham VA Medical Center
 2005-06
NCT00223197 COMPLETED
Bipolar Disorder; Major Depressive Disorder; Substance Abuse
University of Texas Southwestern Medical Center
 2004-02 PHASE4
NCT00174889 COMPLETED
Schizophrenia
Sha'ar Menashe Mental Health Center
 2005-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the Pregnenolone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pregnenolone functions as an endogenous neurosteroid precursor that modulates central nervous system ion channels, altering GABAergic and glutamatergic neurotransmission. By suppressing downstream neuroinflammatory pathways and stabilizing neuronal membrane excitability, it mitigates central nervous system dysfunction, providing therapeutic relevance in clinical conditions such as depression, fatigue, and substance use disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.