Drug

Dehydroepiandrosterone

Approved · EMA

Emerging researchLate-stage developmentCooling momentum

Also known as 3-beta-hydroxy-5-androsten-17-one, 3beta-hydroxyandrost-5-en-17-one, Androstenolone, DHA - Dehydroepiandrosterone+9 more

3-beta-hydroxy-5-androsten-17-one, 3beta-hydroxyandrost-5-en-17-one, Androstenolone, DHA - Dehydroepiandrosterone, DHEA, DHEA - Dehydroepiandrosterone, Intrarosa, PRASTERONE, dehydroepiandrosterone (prasterone), prasterone (DHEA), Dehydro-3-epiandrosterone, Dehydroandrosterone, Dehydroisoandrosterone.

RxNorm3143 ChEMBLCHEMBL90593 ATCA14AA07 ATCG03XX01UNII459AG36T1B

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

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

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

Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation

Clinical trial2026-04-21Results expected Q4 2026 · ClinicalTrials.gov

GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.

Clinical trial2026-03-02Primary completion · ClinicalTrials.gov

Effects of DHEA in Pulmonary Hypertension

Clinical trial2025-11-05Results posted · ClinicalTrials.gov

The Effects of the Selective Serotonin Reuptake Inhibitor, Fluoxetine and/or DHEA, on Neuroendocrine, Autonomic Nervous System and Metabolic Counterregulatory Responses During Repeated Hypoglycemia in T1DM Individuals

Clinical trial2025-10-06Results expected Q3 2026 · ClinicalTrials.gov

Effect of Intravaginal Prasterone on Genitourinary Syndrome in Women in Menopause With Previous Breast Cancer or Currently Under Treatment With Endocrine Therapy for Breast Cancer With Aromatase Inhibitor +/- LHRHa

Clinical trial2024-11-19Results expected Q1 2027 · ClinicalTrials.gov

Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review.

Research2024-09-10Annals of internal medicine

Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds

Clinical trial2023-12-01Primary completion · ClinicalTrials.gov

Effects of gut microbiota on omega-3-mediated ovary and metabolic benefits in polycystic ovary syndrome mice.

Research2023-07-14Journal of ovarian research

Approval: Intrarosa (EMA)

Regulatory2018-01-08EMA

Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks.

Research2016-03-10The Journal of steroid biochemistry and molecular biology

Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study.

Research2016-03-01Hormone molecular biology and clinical investigation

Profile

Identifiers & mechanism

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

Canonical name

Dehydroepiandrosterone

Aliases & brands

3-beta-hydroxy-5-androsten-17-one3beta-hydroxyandrost-5-en-17-oneAndrostenoloneDHA - DehydroepiandrosteroneDHEADHEA - DehydroepiandrosteroneIntrarosaPRASTERONEdehydroepiandrosterone (prasterone)prasterone (DHEA)Dehydro-3-epiandrosteroneDehydroandrosteroneDehydroisoandrosterone

RxNorm CUI

3143

ChEMBL ID

CHEMBL90593

ATC codes

A14AA07G03XX01

UNII

459AG36T1B

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-01-08

Latest approval

2018-01-08

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-01-08Approval

Approval: Intrarosa (EMA)

Indication: Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

68 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

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 68

Early Phase 13Phase 16Phase 1 / 21Phase 215Phase 2 / 36Phase 325Phase 45Phase N / A7

Late-stage studies

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

GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.

Active, not recruitingPH IVUniversity Hospital, Ghentn=1602027

Open-Label Vulvoscopy Photography Study of Changes in Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Administration of 6.5 Mg Vaginal Prasterone in Menopausal Women With Moderate to Severe Dyspareunia

CompletedPH IVSan Diego Sexual Medicinen=182020

Evaluation of the Role of Combined Dehydropeiandrosterone and Growth Hormone in Women With Expected Poor Ovarian Response Undergoing ICSI: A Double Blind Placebo Controlled Study.

Unknown statusPH IVCairo Universityn=2302018

Dehydroepiandrosterone (DHEA)Supplementations Pre-IVF Cycles Improve the Outcome of Diminished Ovarian Reserve（DOR）Patients by the Increased Level of BMP-15(Bone Morphogenetic Protein 15) in Follicular Micro-environment

CompletedPH IVShangHai Ji Ai Genetics & IVF Instituten=782016

Sex Steroids in Sjögren's Syndrome: Effect of Substitution Treatment on Fatigue

Unknown statusPH IVUniversity of Helsinkin=1072009

Recent completions

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

Effects of DHEA in Pulmonary Hypertension

CompletedPH IIRhode Island Hospitaln=262024

CompletedPH IVSan Diego Sexual Medicinen=182020

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3

CompletedPH IUniversity of Maryland, Baltimoren=502018

Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial

CompletedPH IIIAlliance for Clinical Trials in Oncologyn=4642017

Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve

CompletedPH ILaboratorios Andromaco S.A.n=942016

Prospective, Randomized, Open-label and Comparative Study to Determine the Pharmacokinetic Parameters of Vaginal Rings That Contain DHEA, Testosterone, or the Combination of Both Androgens, in Comparison With Oral Administration of DHEA and Transdermal Administration of Testosterone, in Postmenopausal Women

CompletedPH ILaboratorios Andromaco S.A.n=462016

Research activity

14 papers

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

Publications over time

20152024

Most influential

Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.

Menopause (New York, N.Y.) · 2016 · 135 cites

Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy.

The journal of sexual medicine · 2015 · 58 cites

Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone).

Menopause (New York, N.Y.) · 2015 · 58 cites

Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women.

Menopause (New York, N.Y.) · 2015 · 53 cites

Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks.

The Journal of steroid biochemistry and molecular biology · 2016 · 49 cites

Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study.

Maturitas · 2015 · 38 cites

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Estrogens

Studied across 5 of the same disease areas as Dehydroepiandrosterone in the shared literature.

5 shared diseases1 shared paper

Ospemifene

Studied across 3 of the same disease areas as Dehydroepiandrosterone in the shared literature.

3 shared diseases1 shared paper

Tamoxifen

Studied across 3 of the same disease areas as Dehydroepiandrosterone in the shared literature.

3 shared diseases1 shared paper

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
Regulatory event sources are credited in the Regulatory Timeline above.