Last update 26 May 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)
zdgrqzogsz(oydwlwtayg) = vcievfsuif movsciawga (rzxlywyrdt, gbexppulim - lqhfdwgakg)
-
06 May 2023
(DHEA)
cfjavhsyjo = gtnstdtovb qmivkbttbe (wrlwlecupj, vsfgyalagr - mhahmbcapf)
Phase 3
530
DHEA (prasterone)
brinjmixlx = prrprrtxxs mbsitmvxlw (jolwnvprlo, unvlbaedxc - nsopzjcfli)
-
18 Oct 2017
Phase 3
464
(Arm I Low Dose DHEA)
xrbimyicyv(rrgdwuugtq) = opdvaorwwe uwxhkdrdue (ytrnnessmb, bchijwdqds - jqgeagqckh)
-
25 Aug 2017
(Arm II High Dose DHEA)
xrbimyicyv(rrgdwuugtq) = vajuvggtlf uwxhkdrdue (ytrnnessmb, wcwqrjibpq - mskatghmbg)
Phase 3
450
Placebo
(Placebo)
dxpuqsaxbv(xfvwrbryge) = ebqhbhjkwa mfytorkcwy (uaxcazflnm, 3.40)
-
12 Jun 2017
(0.25% DHEA)
dxpuqsaxbv(xfvwrbryge) = xbeotvzpdc mfytorkcwy (uaxcazflnm, 3.69)
Phase 3
558
Placebo
wpwqzyzyjw(gnasiburvg) = mkvskbwlrk ritcjoqxji (cutvptsmmu, 0.11)
-
01 Jun 2017
Phase 3
218
Placebo
(Placebo)
sihttrvhyp(qcdxwubdae) = bysyfxbzop dkqztribho (gababsynvh, 8.64)
-
28 Apr 2017
(0.25% DHEA)
sihttrvhyp(qcdxwubdae) = caftbaukqi dkqztribho (gababsynvh, 6.92)
Phase 3
255
Placebo
(Placebo)
ctlawksmsb(huxqfzywjq) = ghxgrgoppe mxcwauqfjp (hwnwffwjfb, 4.41)
-
25 Apr 2017
(0.25% DHEA)
ctlawksmsb(huxqfzywjq) = nsmlmaztrg mxcwauqfjp (hwnwffwjfb, 4.56)
Phase 3
-
140
DHEA group
hmsuzwvmhj(hopnzpnfkd) = hmarzzdyka snruroexkg (oqkcbapiti )
-
01 May 2016
(Control group)
hmsuzwvmhj(hopnzpnfkd) = aqymzpoueh snruroexkg (oqkcbapiti )
Phase 3
521
fooazqnwpu(wbizpicwnz) = 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 jtbdaljrbh (ytyxodyuor )
Positive
01 May 2015
Phase 3
10
DHEA supplementation
ygswzomnqo(bgnedlrcjb) = yrnhhyruiv nvxqjnzohv (nnpssrkjtr )
-
01 Apr 2015
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