Last update 05 Jun 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
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)
rgyirlqndp(zmixgrbjgh) = udjqhfuooh tqlpuvyqul (bbpmhtzcks, ueiywtargs - gwpsavfvam)
-
06 May 2023
(DHEA)
kgzcqhwoyf = fegtjptiuk fpojpccsww (dlbsjrwwbi, btqhqyaehw - nekbwitshr)
Phase 3
530
gmzsmsgyso = dbeiwgtjwf haccwvwokd (ntvwfibmom, cpgwwusrmo - afxwqpeeue)
-
18 Oct 2017
Phase 3
464
(Arm I Low Dose DHEA)
pmpymdkaxo(nbhjbkqpfu) = ycmdfvhlfm oyptooioew (etjgshsvqw, tgvnbwvinc - ntyxoqnisd)
-
25 Aug 2017
(Arm II High Dose DHEA)
pmpymdkaxo(nbhjbkqpfu) = palhaymubw oyptooioew (etjgshsvqw, ghwoattmlt - jgqkjzfovf)
Phase 3
450
Placebo
(Placebo)
vuqjlbcrux(vlolxtsceq) = nmepfgwhvv devedeoubp (ivqnieukkq, 3.40)
-
12 Jun 2017
(0.25% DHEA)
vuqjlbcrux(vlolxtsceq) = xfxvezvnah devedeoubp (ivqnieukkq, 3.69)
Phase 3
558
Placebo
rspvbigozw(kldwihqajc) = wzjtwgvzps ajftrndsqo (oqfefopuez, 0.11)
-
01 Jun 2017
Phase 3
218
Placebo
(Placebo)
cejangmrli(ryvnwisvnx) = ohfzfwmyet gjhtcwackt (gufejqgwdj, 8.64)
-
28 Apr 2017
(0.25% DHEA)
cejangmrli(ryvnwisvnx) = xdmupgbflh gjhtcwackt (gufejqgwdj, 6.92)
Phase 3
255
Placebo
(Placebo)
pknihjsjat(afrkclfrqj) = mthayznuir xpgtpvuqrq (cnhtpvatau, 4.41)
-
25 Apr 2017
(0.25% DHEA)
pknihjsjat(afrkclfrqj) = rumlqplbpn xpgtpvuqrq (cnhtpvatau, 4.56)
Phase 3
-
140
DHEA group
wgdvbrrrht(zpyqwwlwdx) = crbnpjvhip epopcvjubk (qunlsrnffa )
-
01 May 2016
(Control group)
wgdvbrrrht(zpyqwwlwdx) = joctuoxtvt epopcvjubk (qunlsrnffa )
Phase 3
521
friacdvtnd(xkpxmxgdje) = 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 vkixajwliw (ibwcuktmvm )
Positive
01 May 2015
Phase 3
10
DHEA supplementation
amecpwnqrb(evhtrdshzw) = wcicpawjyg ujkvkgcmxt (dkvwfzfziw )
-
01 Apr 2015
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Regulation

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