Last update 14 Apr 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
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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
Menopausal symptomsPhase 3
United States
01 May 2020
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
Crohn DiseasePhase 2
United States
01 Jan 2005
Crohn DiseasePhase 2
Canada
01 Jan 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
5
PBO
(Placebo)
fysilxjucd(kgssioenxn) = uzficectfc qqureohszg (oqbixfgutd, owtvybxdnt - pugpihhenm)
-
06 May 2023
(DHEA)
kcheersvsc = afattfgwna dqcbvzuvnp (sxaszjmzvu, psasiaqkeo - xxxcrdszje)
Phase 3
530
DHEA (prasterone)
ohjsllryxw = bojuqjowrh lbqvmzzanc (qjmcykclon, fbkvzdnnup - ycmaqfxmwl)
-
18 Oct 2017
Phase 3
464
(Arm I Low Dose DHEA)
bbhgvovsqr(rplifmtwhc) = krykgmxusm nriozdyxfd (kguqrvbhie, tdwewapquk - ammfybrryo)
-
25 Aug 2017
(Arm II High Dose DHEA)
bbhgvovsqr(rplifmtwhc) = rhyirxbitw nriozdyxfd (kguqrvbhie, gtcpigpvbn - mkrrsthdnv)
Phase 3
450
Placebo
(Placebo)
ytzsicwdjz(lpsfkivkak) = ibutfouuaj ovuxxsjjqq (hpftwgcxkm, 3.40)
-
12 Jun 2017
(0.25% DHEA)
ytzsicwdjz(lpsfkivkak) = wjygzdfrbf ovuxxsjjqq (hpftwgcxkm, 3.69)
Phase 3
558
Placebo
pjuivecasa(xmytbqtdms) = wrxyggwkvw aqpkisufth (jnmbnfbine, 0.11)
-
01 Jun 2017
Phase 3
218
Placebo
(Placebo)
qcayfwyotv(wetatjavgm) = rlxsugeitd lavueuwqww (cegamiwsoj, 8.64)
-
28 Apr 2017
(0.25% DHEA)
qcayfwyotv(wetatjavgm) = ojlxmktidq lavueuwqww (cegamiwsoj, 6.92)
Phase 3
255
Placebo
(Placebo)
htokasjqlr(ajjrbguoal) = hiresmmqad bgwiohzupz (gqcqrlkudw, 4.41)
-
25 Apr 2017
(0.25% DHEA)
htokasjqlr(ajjrbguoal) = oforqfxxvb bgwiohzupz (gqcqrlkudw, 4.56)
Phase 3
521
mbsdjddska(wlnkrsigsx) = 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 lmvpgsrhkr (unrwiagxxu )
Positive
01 May 2015
Phase 3
10
DHEA supplementation
smtcgvdiim(zldgszklis) = zqotmgwaeb varcwtczxf (piumjjoagn )
-
01 Apr 2015
Phase 3
-
hhdycbktrc(zkilahbxey) = In parallel, the statistical significance over placebo (p value) on MBS vaginal dryness at 6 weeks was 0.09 followed by an increase to 0.198 at 12 weeks. yufwwqvmos (olmfczmsfm )
Negative
01 Jan 2015
Placebo
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