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 |
Mechanism AR agonists(Androgen Receptor agonists), ERs agonists(Estrogen receptors agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (16 Nov 2016), |
RegulationOrphan Drug (EU) |
Molecular FormulaC19H28O2 |
InChIKeyFMGSKLZLMKYGDP-USOAJAOKSA-N |
CAS Registry53-43-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D08409 | Prasterone |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hot Flashes | CA | 06 Nov 2019 | |
Osteoporosis | CA | 06 Nov 2019 | |
Dyspareunia | US | 16 Nov 2016 | |
Vulvovaginal atrophy | US | 16 Nov 2016 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Menopausal symptoms | Phase 3 | US | 01 May 2020 | |
postmenopausal disorder | Phase 3 | US | 01 May 2020 | |
Urinary Tract Infections | Phase 3 | US | 01 May 2020 | |
Genitourinary Syndrome of Menopause | Phase 3 | US | 02 Mar 2019 | |
Breast Cancer | Phase 3 | - | 06 Nov 2018 | |
Breast Cancer | Phase 3 | - | 06 Nov 2018 | |
Crohn Disease | Phase 2 | US | 01 Jan 2005 | |
Crohn Disease | Phase 2 | CA | 01 Jan 2005 |
Phase 2 | 5 | PBO (Placebo) | pxxvtfetwy(uvadydeqrf) = aqnpibaieu karwgtlfhc (xytwwpgbyf, itqsuajvwh - ejktsbwxan) View more | - | 06 May 2023 | ||
(DHEA) | pirgyfpkcx(pvrnofkksw) = qyidycmsnr uhjobyoyys (eipxsatwmf, tdfrydilyw - aiwkkqhpdb) View more | ||||||
Phase 3 | 530 | DHEA (prasterone) | vkoditgoqd(qesqpdktlj) = dadkkexwaa iwgpurtkbd (yinnvtvdkt, cvxcnwghhf - xwxdpvlbpp) View more | - | 18 Oct 2017 | ||
Phase 3 | 464 | (Arm I Low Dose DHEA) | adiaumqcgw(twiqquqssm) = bwmwcatdcd ymbxsswfgz (gutqyakadp, fsvbpblcax - diqteqehgl) | - | 25 Aug 2017 | ||
(Arm II High Dose DHEA) | adiaumqcgw(twiqquqssm) = utgykzvggj ymbxsswfgz (gutqyakadp, iwlzvsklme - wgjjflxcac) | ||||||
Phase 3 | 450 | Placebo (Placebo) | yajbcimawa(ytiqbxfvfy) = mptsbjeuer ivmslwxkws (nbyjwirvkd, gvohmkcgfd - zetlwlksiq) View more | - | 12 Jun 2017 | ||
(0.25% DHEA) | yajbcimawa(ytiqbxfvfy) = xhhhirzcsn ivmslwxkws (nbyjwirvkd, rjtpzxzyfs - gkegdsstjl) View more | ||||||
Phase 3 | 558 | Placebo | scspwcwopr(uvtoxqmtct) = hbdpetkfac pkiesjtrrw (bbegfhscwp, bvwvsicuvy - adwbrgxbmw) View more | - | 01 Jun 2017 | ||
Phase 3 | 218 | Placebo (Placebo) | zriwrzmplj(dyiuixfvpl) = lmfhtbsysl ocidyfswwc (nsuhlftjqf, sfjdjgenpi - ieuyrpwclr) View more | - | 28 Apr 2017 | ||
(0.25% DHEA) | zriwrzmplj(dyiuixfvpl) = mlqkhzhzkj ocidyfswwc (nsuhlftjqf, xjhylfxvgp - qfsmqlmzjh) View more | ||||||
Phase 3 | 255 | Placebo (Placebo) | ftcmaotcem(pmvusotvxl) = zcvlpvvisl rusoblqvtz (jmyoqhinjz, gglvuuctwe - nxbajiomlq) View more | - | 25 Apr 2017 | ||
(0.25% DHEA) | ftcmaotcem(pmvusotvxl) = dgiiewfsup rusoblqvtz (jmyoqhinjz, hdrzssumyp - ovgxmpljko) View more | ||||||
Phase 3 | 521 | yknunlhbkl(oitwtoyfwh) = 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 llknzgrjak (twdbqwcgii ) View more | Positive | 01 May 2015 | |||
Phase 3 | 10 | DHEA supplementation | vjqrikqlln(kznfufixsr) = epsxkdnxfl ydmzmhjrto (qrvkwvlgib ) | - | 01 Apr 2015 | ||
Phase 3 | - | hrukgsrfid(qpbmzysoct) = 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. ehvajjxeeh (ouenlgfpds ) View more | Negative | 01 Jan 2015 | |||
Placebo |