Pregnenolone
US-FDASourced from openFDA
GET
/api/v1/drug/pregnenoloneIndications
Sourced from openFDA- For temporary relief of symptoms due to menopausal hot flashes, loss of libido; may enhance calcium metabolism, feelings of well-being and mental clarity.ICD-10: N95.1
Dosage & administration
Sourced from openFDADIRECTIONS: Three sprays per day. Hold in mouth for two minutes.
Warnings & precautions
Sourced from openFDAIf pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Ear Discomfort1100%
- 2Platelet Count Decreased1100%
Literature
Recent PubMed references pinned to Pregnenolone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Pregnenolone promotes immune evasion through blocking endogenous retrovirus expression.Cell metabolism · 2026 · Huang C, Tao H, Zhou Y, et al.PMID 41579859DOI 10.1016/j.cmet.2025.12.020
- Guanine and pregnenolone sulfate are associated with incident type 2 diabetes in two independent populations.Frontiers in endocrinology · 2025 · Barranco-Altirriba M, Granado-Casas M, Yanes O, et al.PMID 41416067DOI 10.3389/fendo.2025.1706886
- Gut microbiota affects the role of mPXR agonist PCN in alleviating sepsis-induced liver injury by regulating YAP activation.International immunopharmacology · 2026 · Wu C, Hu S, Li D, et al.PMID 41406837DOI 10.1016/j.intimp.2025.116013
- Pregnenolone Bioproduction in Engineered Methylobacteria: Design and Elaboration.International journal of molecular sciences · 2025 · Tekucheva D, Poshekhontseva V, Fedorov D, et al.PMID 41303458DOI 10.3390/ijms262210975
- Pregnenolone Carbamate Derivatives as Selective Cholinesterase Inhibitors: Multimodal Evaluation Including DNA and HSA Interactions.Archiv der Pharmazie · 2025 · Akca S, Ilkar Erdagi S, Ozbagci DI, et al.PMID 41189504DOI 10.1002/ardp.70140
- The ExPAND Study: A Prospective Association Study into Endometriosis-Associated Pain, Neurosteroid Synthesis, and TRPM3.Biomolecules · 2025 · Persoons E, Bafort C, Van Mechelen P, et al.PMID 41154581DOI 10.3390/biom15101352
- Pregnenolone sulfate enables synapse-specific metaplastic gating of heterosynaptic GABAergic plasticity.British journal of pharmacology · 2026 · Wiera G, Mozrzymas JWPMID 40973988DOI 10.1111/bph.70194
- Pregnenolone Reduces L-Dopa-Induced Dyskinesias in Female Parkinsonian Monkeys.Movement disorders : official journal of the Movement Disorder Society · 2025 · Bourque M, Morissette M, Bortolato M, et al.PMID 40880175DOI 10.1002/mds.30280
Clinical trials
The 10 most recently updated of 45 ClinicalTrials.gov registrations naming Pregnenolone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Composition for Treating Uterine Fibroid (SB-UF)Completed · Phase 4 · Interventional · 66 enrolled · Trieu, Nguyen Thi, M.D.NCT04762316updated 2026-06-08
- Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II TrialNot yet recruiting · Phase 2 · Interventional · 108 enrolled · VA Office of Research and DevelopmentNCT05935761updated 2026-06-04
- Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese MenCompleted · Interventional · 25 enrolled · University Hospital, BordeauxNCT03157778updated 2026-05-22
- Study on Allopregnanolone and Depression in Women Across the Menopause TransitionRecruiting · Interventional · 80 enrolled · Beth Israel Deaconess Medical CenterNCT06238700updated 2026-05-14
- Novel Intervention for Chronic Complex TBI in OEF/OIF/OND VeteransSuspended · Phase 2 · Interventional · 108 enrolled · Christine Marx, MDNCT05671692updated 2026-05-13
- Pregnenolone as a Treatment for Cannabis IntoxicationRecruiting · Phase 2 · Interventional · 20 enrolled · Johns Hopkins UniversityNCT07216690updated 2026-05-01
- A New Intervention to Improve Function in Veterans With Anxiety and DepressionRecruiting · Phase 2 · Interventional · 84 enrolled · VA Office of Research and DevelopmentNCT06188923updated 2026-04-23
- Pilot Trial of Pregnenolone in AutismCompleted · Phase 2 · Interventional · 40 enrolled · Stanford UniversityNCT02627508updated 2026-03-30
- Precision Medicine Approach for Early Dementia & Mild Cognitive ImpairmentCompleted · Phase 3 · Interventional · 73 enrolled · Alzheimer's Prevention and Reversal Project, Inc.NCT05894954updated 2026-02-18
- Pregnenolone for the Treatment of Alcohol Use DisorderRecruiting · Phase 2 · Interventional · 150 enrolled · Yale UniversityNCT05781009updated 2026-02-02
Frequently asked questions
- What is Pregnenolone used for?
- According to FDA labeling, Pregnenolone carries indications including: For temporary relief of symptoms due to menopausal hot flashes, loss of libido; may enhance calcium metabolism, feelings of well-being and mental clarity.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
Note. Data for
pregnenolone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.