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Pregnenolone

Phase 2Small molecule

VVA Office of Research and Development

Pregnenolone is a natural hormone precursor that some people take as a supplement to potentially improve memory, mood, and cognitive function, though scientific evidence for these effects is limited.[1] Pregnenolone is currently being investigated across 5 indications[3], with its most advanced program in Phase 2.[1]

Pregnenolone is one of 42 small molecule programs targeting Autism. It is currently in Phase 2.

5

Indications

28

Total Trials

8

Active Trials

41

Competitors

Pipeline

Status by Indication[3][1]

Indication

AutismCompleted

Cannabis Use DisorderNot yet recruiting

Cannabis IntoxicationRecruiting

Alcohol Use Disorder (AUD)Not yet recruiting

DepressedRecruiting

AutismPhase 2

Completed

Cannabis Use DisorderPreclinical

Not yet recruiting

Cannabis IntoxicationPhase 2

Recruiting

Alcohol Use Disorder (AUD)Phase 2

Not yet recruiting

DepressedPhase 2

Recruiting

Competition

Competitive Landscape

37 competitors in Autism

#DrugCompanyPhaseTrials

Savella

Vyvanse

Abilify

Risperdal

Lioresal

Depakote

Minocin

Strattera

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Invega

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

Timeline

Expected Milestones

Q1 2028

Phase 2Recruiting

Depressed

NCT05570812

Q3 2028

Phase 2Recruiting

Alcohol Use Disorder

NCT05781009

PreclinicalNot yet recruiting

Cannabis Use Disorder

NCT07685964

Phase 2Recruiting

Anxiety

NCT06188923

Q1 2029

Phase 2Recruiting

Cannabis Intoxication

NCT07216690

Q4 2029

Phase 2Not yet recruiting

Chronic Low Back Pain

NCT05935761

Clinical

Trials by Indication[1]

Schizophrenia3 trials

Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia

Completed·NNational Research Foundation, Singapore·Phase 2/3·NCT00894842·120 enrolled

Pregnenolone in the Management of Schizophrenia Patients

Completed·SSha'ar Menashe Mental Health Center·Phase 1·NCT00174889·60 enrolled

Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia

Completed·—·N/A·NCT00560937·28 enrolled

Post-Traumatic Stress Disorder3 trials

Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

Withdrawn·UUS Department of Veterans Affairs·Phase 2·NCT00993629

Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT04464148

Neurosteroid Intervention for PTSD in Iraq/Afghanistan-era Veterans

Completed·VVA Office of Research and Development·Phase 2·NCT03799562·97 enrolled

Veterans2 trials

Adjunctive Pregnenolone in Veterans With Mild TBI

Completed·—·N/A·NCT00623506·30 enrolled

Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans

Suspended·—·Phase 2·NCT05671692·108 enrolled

Autism2 trials

A Study of Pregnenolone in the Treatment of Individuals With Autism

Completed·SStanford University·Phase 2·NCT01881737·15 enrolled

Pilot Trial of Pregnenolone in Autism

Active, not recruiting·SStanford University·Phase 2·NCT02627508·40 enrolled

Depression2 trials

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1/2·NCT03505905·73 enrolled

Development of Pregnenolone as a Treatment for Depression

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT03645096·34 enrolled

16 more indications

Alcohol Use Disorder1 trial

Pregnenolone for the Treatment of Alcohol Use Disorder

Recruiting·YYale University·Phase 2·NCT05781009·150 enrolled

Brain Injury1 trial

Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans

Completed·VVA Office of Research and Development·Phase 2·NCT01336413·53 enrolled

Bipolar Disorder1 trial

Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders

Completed·—·Phase 4·NCT02582905·96 enrolled

Depressed1 trial

Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV

Recruiting·MMassachusetts General Hospital·Phase 2·NCT05570812·120 enrolled

Gulf War Illness1 trial

Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)

Completed·VVA Office of Research and Development·Phase 2·NCT01956279·170 enrolled

Bipolar Depression1 trial

Study Using Pregnenolone to Treat Bipolar Depression

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT01409096·80 enrolled

Cocaine Use Disorder1 trial

The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders

Completed·YYale University·Phase 1·NCT03953612·58 enrolled

Chronic pain1 trial

Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans

Completed·—·Phase 2·NCT01898013·94 enrolled

Marijuana1 trial

Pregnenolone and Marijuana Dependence

Completed·MMedical University of South Carolina·Phase 2·NCT02439814·21 enrolled

Major Depressive Disorder1 trial

Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00223197·75 enrolled

Chronic Low Back Pain1 trial

Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial

Not yet recruiting·VVA Office of Research and Development·Phase 2·NCT05935761·108 enrolled

Alcohol Use Disorder (AUD)1 trial

Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy

Not yet recruiting·SSherwood Brown, MD, PhD·Phase 2·NCT07734701·100 enrolled

Cannabis Intoxication1 trial

Pregnenolone as a Treatment for Cannabis Intoxication

Recruiting·JJohns Hopkins University·Phase 2·NCT07216690·20 enrolled

Anxiety1 trial

A New Intervention to Improve Function in Veterans With Anxiety and Depression

Recruiting·VVA Office of Research and Development·Phase 2·NCT06188923·84 enrolled

Cannabis Use Disorder1 trial

Advancing Pregnenolone as a Novel Therapy for Co-Occurring Cannabis Use Disorder and Depression

Not yet recruiting·UUniversity of Texas Southwestern Medical Center·Preclinical·NCT07685964·20 enrolled

Unspecified1 trial

Effects of Pregnenolone on Perceived Social Isolation

Terminated·UUniversity of Chicago·Phase 2·NCT02826577·34 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Pregnenolone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pregnenolone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pregnenolone. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — VA Office of Research and Development company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: VVA Office of Research and Development

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