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Drug

Pregnenolone

In clinical development
Emerging researchLate-stage developmentRising momentum
RxNorm114052ChEMBLCHEMBL253363UNII73R90F7MQ8
3
Research papers
6
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Pregnenolone as a Treatment for Cannabis Intoxication

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q2 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-06Results expected Q3 2028 · ClinicalTrials.gov

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

Clinical trial2026-06-04Results expected Q4 2029 · ClinicalTrials.gov

Randomized Controlled Pilot Trial of Pregnenolone in Autism

Clinical trial2026-03-17Completed · ClinicalTrials.gov

Pregnenolone for the Treatment of Alcohol Use Disorder

Clinical trial2026-02-02Results expected Q3 2028 · ClinicalTrials.gov

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

Clinical trial2026-01-22Results posted · ClinicalTrials.gov

In Vivo Targeting of Neuroactive Steroid and Immune Networks for Depression in People Living With HIV

Clinical trial2025-09-12Results expected Q2 2027 · ClinicalTrials.gov

Neurosteroid Intervention for PTSD in Iraq/Afghanistan-era Veterans

Clinical trial2025-07-14Completed · ClinicalTrials.gov

Identification of gut bacteria reductases that biotransform steroid hormones.

Research2025-07-08Nature communications

Brief report: an open-label study of the neurosteroid pregnenolone in adults with autism spectrum disorder.

Research2014-11-01Journal of autism and developmental disorders

The molecular biology, biochemistry, and physiology of human steroidogenesis and its disorders.

Research2010-11-04Endocrine reviews

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pregnenolone
RxNorm CUI
114052
ChEMBL ID
CHEMBL253363
UNII
73R90F7MQ8

Clinical trials

28 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
28
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
6
Recruiting
6
Late-stage (III+)
18
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 28
Early Phase 11Phase 13Phase 1 / 22Phase 216Phase 2 / 31Phase 43Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders

CompletedPH IVSherwood Brown, MD, PhDn=962023

A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression

CompletedPH IVUniversity of Texas Southwestern Medical Centern=802011

A Double-blind Placebo Controlled Trial of Pregnenolone for Depression in Patients With Bipolar Disorders or Recurrent Major Depressive Disorder and a History of Substance Abuse

CompletedPH IVUniversity of Texas Southwestern Medical Centern=752006

A 10-week, Randomized, Double-Blind, Placebo-Controlled Trial of a Neurocognition Enhancing Agent(Pregnenolone) in Patients With Schizophrenia.

CompletedPH II/IIINational Research Foundation, Singaporen=1202011

Recent completions

Trials that read out recently, adding to the completed evidence base.

Randomized Controlled Pilot Trial of Pregnenolone in Autism

CompletedPH IIStanford Universityn=402026

Neurosteroid Intervention for PTSD in Iraq/Afghanistan-era Veterans

CompletedPH IIVA Office of Research and Developmentn=962025

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

CompletedPH I/IIUniversity of Texas Southwestern Medical Centern=732024

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

CompletedPH IYale Universityn=582023

Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders

CompletedPH IVSherwood Brown, MD, PhDn=962023

NCCIH Development of Pregnenolone as a Treatment for Depression R61 Phase

CompletedPH IUniversity of Texas Southwestern Medical Centern=342022

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20112025
Major research themes5
Bacteria1Bacterial Proteins1Gastrointestinal Microbiome1Oxidoreductases1Steroids1
Journals, researchers & institutions
Top journals
  • Endocrine reviews1
  • Journal of autism and developmental disorders1
  • Nature communications1
Leading researchers
  • Arp G1
  • Auchus RJ1
  • Dufault-Thompson K1
  • Fung LK1
  • Grant MR1
  • Haddad F1
  • Hall B1
  • Hardan AY1
Leading institutions
free-text, unnormalised
  • Center for Bioinformatics and Computational Biology1
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development1
  • Maitreyi College University of Delhi1
  • National Institutes of Health1
  • Stanford University1
  • University of California San Francisco1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials