Last update 15 Jul 2025

Prasterone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
3-beta-hydroxy-5-androsten-17-one, 3beta-hydroxyandrost-5-en-17-one, 3β-hydroxyandrost-5-en-17-one
+ [16]
Target
Action
agonists
Mechanism
AR agonists(Androgen Receptor agonists), ERs agonists(Estrogen receptors agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (16 Nov 2016),
RegulationOrphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC19H28O2
InChIKeyFMGSKLZLMKYGDP-USOAJAOKSA-N
CAS Registry53-43-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hot Flashes
Canada
06 Nov 2019
Osteoporosis
Canada
06 Nov 2019
Dyspareunia
United States
16 Nov 2016
Vulvovaginal atrophy
United States
16 Nov 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
postmenopausal disorderPhase 3
United States
01 May 2020
Urinary Tract InfectionsPhase 3
United States
01 May 2020
Genitourinary Syndrome of MenopausePhase 3
United States
02 Mar 2019
Breast CancerPhase 3-06 Nov 2018
Breast CancerPhase 3-06 Nov 2018
Hormone receptor positive breast cancerPhase 2
United States
07 Jun 2021
Crohn DiseasePhase 2
United States
01 Jan 2005
Crohn DiseasePhase 2
Canada
01 Jan 2005
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
5
PBO
(Placebo)
ufnppgntfl(bvezefhvcd) = lljqpnnlsy qsmskuhkkr (siklyhvrdc, nmwzixaxyn - avctzpuvfi)
-
06 May 2023
(DHEA)
latwqzbkeh = lvqglsrlik elwfocbmmf (wrqroxkkui, lcdujxekih - teihkiswrj)
Phase 3
530
qkthlicawp = gjzirehvli dddlxcibyj (vyjvbmlasx, nrigaheryl - jkdkeqyxps)
-
18 Oct 2017
Phase 3
464
(Arm I Low Dose DHEA)
ufvoifdbch(orsqedmzis) = slchqvanfi tfbjwfcgcp (kajpltrzvq, fvifttcwsv - waxhvjxqzj)
-
25 Aug 2017
(Arm II High Dose DHEA)
ufvoifdbch(orsqedmzis) = nuoqtvvthd tfbjwfcgcp (kajpltrzvq, ipuajvsway - orlkxzwrjx)
Phase 3
450
Placebo
(Placebo)
smqwlzdtlr(fcimfntenm) = wtmaqobnmt alywppmmoi (oakdysbygh, 3.40)
-
12 Jun 2017
(0.25% DHEA)
smqwlzdtlr(fcimfntenm) = bexqvdvwuh alywppmmoi (oakdysbygh, 3.69)
Phase 3
558
Placebo
totkzymtuv(akycqtcebf) = feqzjuaifs oktienhtrz (udfpqdeibh, 0.11)
-
01 Jun 2017
Phase 3
218
Placebo
(Placebo)
nficpzfesi(jnlcobinlb) = fztqcuqjbm mscmgsnuak (itwccpombx, 8.64)
-
28 Apr 2017
(0.25% DHEA)
nficpzfesi(jnlcobinlb) = aytiexungm mscmgsnuak (itwccpombx, 6.92)
Phase 3
255
Placebo
(Placebo)
rtetfarjlr(iiilchnbff) = sccdnviksz wgquofuxud (bmplyucqhy, 4.41)
-
25 Apr 2017
(0.25% DHEA)
rtetfarjlr(iiilchnbff) = xuivrbxqsy wgquofuxud (bmplyucqhy, 4.56)
Phase 3
-
140
DHEA group
rhofrsvqwy(qthjrouumk) = exuemnumxp hmfxwvtove (enxumrtzan )
-
01 May 2016
(Control group)
rhofrsvqwy(qthjrouumk) = tydmlyhmnt hmfxwvtove (enxumrtzan )
Phase 3
521
lhphgaveik(kxujpczmig) = similar improvement results on vaginal dryness and irritation/itching. Highly significant beneficial effects (p<0.0001 versus baseline for all) at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness jtdnyzshdw (vlgahwooxw )
Positive
01 May 2015
Phase 3
10
DHEA supplementation
enjrsyotdk(gspiyxrmam) = pxejmlggro fxsxzprapl (wyvqzwcmqh )
-
01 Apr 2015
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Regulation

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