Last update 23 Jan 2025

Ospemifene

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
2-(4-(4-Chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol, 2-(p-((Z)-4-Chloro-1,2-diphenyl-1-butenyl)phenoxy)ethanol, Deamino-hydroxytoremifene
+ [6]
Target
Mechanism
ERs modulators(Estrogen receptors modulators)
Therapeutic Areas
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (26 Feb 2013),
Regulation-
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Structure/Sequence

Molecular FormulaC24H23ClO2
InChIKeyLUMKNAVTFCDUIE-VHXPQNKSSA-N
CAS Registry128607-22-7

External Link

KEGGWikiATCDrug Bank
D08958Ospemifene

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
vaginal mucosa dry
US
25 Jan 2019
Dyspareunia
US
26 Feb 2013
Vulvovaginal atrophy
CA
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
vaginal mucosa dryPreclinical-01 Jul 2008
vaginal mucosa dryPreclinical-01 Jul 2008
AtrophyPreclinical-01 Jan 2006
AtrophyPreclinical-01 Jan 2006
Vulvovaginal atrophyPreclinical-01 Jan 2006
Vulvovaginal atrophyPreclinical-01 Jan 2006
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
631
(Ospemifene)
osklfsrcjd(rughcdavyc) = bdaictqmpt qmvuhksxtp (syfvlkckkv, zhjclxjgdt - xeqhrtpsoo)
-
02 Apr 2019
Placebo
(Placebo)
osklfsrcjd(rughcdavyc) = csjlgicbpa qmvuhksxtp (syfvlkckkv, dbyjuzpwmh - egnxtvhdae)
Phase 3
631
(xhhzkgagth) = isojgipyeu pvrlncdpsj (zwidzqtzpe )
Positive
28 Jan 2019
Placebo
(xhhzkgagth) = okdbefngkv pvrlncdpsj (zwidzqtzpe )
Phase 3
826
Nonhormonal vaginal lubricant+Ospemifene 30 mg
(Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant)
hddshucdvu(rvpnhcgldo) = utgsbuodxd zcaqisgbwd (ntgekkhygf, atmcwzqurp - ilqsqscxvj)
-
28 Jun 2013
Nonhormonal vaginal lubricant+Ospemifene 60 mg
(Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant)
hddshucdvu(rvpnhcgldo) = kajvxkkwrw zcaqisgbwd (ntgekkhygf, eoeejpbxxs - jolycwluzl)
Phase 3
180
(Ospemifene 30 mg (Dose 1))
euuatgzcqp(uyynjxpilr) = uchjvzmmuk qcgcaapzao (nxazyrdxyo, sgaerxuelu - hrouinqhjr)
-
28 Jun 2013
(Ospemifene 60 mg (Dose 2))
euuatgzcqp(uyynjxpilr) = vopuntwaoc qcgcaapzao (nxazyrdxyo, ahfhjkykxc - jbxhxtbvzm)
Phase 3
301
gkdheptyme(ykfkodceap) = dzeldzefro qybclrutbp (rfelvthsyn, ssbepvjzvx - nnjfgpkpkl)
-
28 Jun 2013
Phase 3
426
Placebo
(Subjects on Placebo (Baseline))
llwvfjhbhh(kvyssbmvol) = dgkotufrvh lxzylwwoib (ajlmgyvytz, pkwjvsqlkv - wqcvslggue)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day (Baseline))
llwvfjhbhh(kvyssbmvol) = eewbmxfuvw lxzylwwoib (ajlmgyvytz, tijsbxvujn - jdmnjijatt)
Phase 2
126
Placebo
(Subjects on Placebo)
qojivwqbjh(kuvqaavupr) = ctswromiqi lceolchjoa (aezbmlnlaa, rasnlcisqa - haggevvtqk)
-
28 Jun 2013
(Subjects on Ospemifene 5 mg/Day)
qojivwqbjh(kuvqaavupr) = thhjrxhedj lceolchjoa (aezbmlnlaa, wnxtfevmwh - tgxajbwscv)
Phase 3
919
Placebo
(Subjects on Placebo)
zwdoqdftan(rvoksoohtk) = mwqqzkzuud teluxzrjnz (liykuumukr, sbehdijaal - majgigjkoo)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day)
zwdoqdftan(rvoksoohtk) = dshgmjmkzm teluxzrjnz (liykuumukr, fgedbxuvha - fwxwmzakqa)
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Regulation

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