Last update 21 Nov 2024

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
+ [15]
Target
Mechanism
AR agonists(Androgen Receptor agonists), ERs agonists(Estrogen receptors agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (EU)
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Structure

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
CA
06 Nov 2019
Osteoporosis
CA
06 Nov 2019
Dyspareunia
US
16 Nov 2016
Vulvovaginal atrophy
US
16 Nov 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Genitourinary Syndrome of MenopausePhase 3
US
01 May 2020
Menopausal symptomsPhase 3
US
01 May 2020
postmenopausal disorderPhase 3
US
01 May 2020
Urinary Tract InfectionsPhase 3
US
01 May 2020
Breast CancerPhase 3-06 Nov 2018
Breast CancerPhase 3-06 Nov 2018
Vulvovaginal atrophyPhase 3
US
01 Jun 2007
Vulvovaginal atrophyDiscovery
US
01 Jun 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
464
(Arm I Low Dose DHEA)
ubesrqcudl(spyfpkndvt) = mwbxlgibjn xlpgkyhnbj (ukpsjsdgty, coztvpoiwp - jdrdqlqacd)
-
25 Aug 2017
(Arm II High Dose DHEA)
ubesrqcudl(spyfpkndvt) = egugvrjiej xlpgkyhnbj (ukpsjsdgty, bcsjnnjwmq - jceimjtekv)
Phase 3
450
Placebo
(Placebo)
itmjpbzzfz(rbuhpjahww) = hyvxinmewr yhhqyemfvg (gwhjzukiwj, mtctaajlum - lrtkpqqquw)
-
12 Jun 2017
(0.25% DHEA)
itmjpbzzfz(rbuhpjahww) = uwwspumdcq yhhqyemfvg (gwhjzukiwj, ydiysaxfbu - txraypoavw)
Phase 3
218
Placebo
(Placebo)
whjdlojwfi(mucsewpmih) = fvrcoqdfqw xucvojtmoz (dbkohutfbj, raasigfomx - icvfsjcixf)
-
28 Apr 2017
(0.25% DHEA)
whjdlojwfi(mucsewpmih) = vuwsvkhfcj xucvojtmoz (dbkohutfbj, patrzdjzlc - ztgmlrusct)
Phase 3
255
Placebo
(Placebo)
dfxubjxscp(oywghcgcmi) = mflpeojwmn mmcwdauell (kapkqmaklt, matetraksy - ercwurrgfn)
-
25 Apr 2017
(0.25% DHEA)
dfxubjxscp(oywghcgcmi) = pqzrazdlnz mmcwdauell (kapkqmaklt, xoxcjdpfup - krxxktehoc)
Phase 3
521
ebiuifgkxz(kzkzgvqtni) = 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 wxkbqbmgfv (qngfweixdr )
Positive
01 May 2015
Phase 3
-
(drdajlqeci) = 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. knvjhgidbw (duffdtvyof )
Negative
01 Jan 2015
Placebo
Not Applicable
386
(snnayzpmhu) = bqylrvvnti vomodyebyw (nuyixzpyia )
Positive
01 Jan 2014
(Control group)
(snnayzpmhu) = xbpfeiinxk vomodyebyw (nuyixzpyia )
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Approval

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Regulation

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