Last update 09 Dec 2024

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

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
Vulvovaginal atrophy
EU
14 Jan 2015
Vulvovaginal atrophy
IS
14 Jan 2015
Vulvovaginal atrophy
LI
14 Jan 2015
Vulvovaginal atrophy
NO
14 Jan 2015
Dyspareunia
US
26 Feb 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AtrophyPhase 3-01 Jan 2006
AtrophyPhase 3-01 Jan 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
631
(Ospemifene)
nyycfmmjxn(sqekdsgfeo) = adbsvrqkyi nvhffhhonx (wnrmdhycrv, mwackalbtm - reliigrxsb)
-
02 Apr 2019
Placebo
(Placebo)
nyycfmmjxn(sqekdsgfeo) = bedmevvwne nvhffhhonx (wnrmdhycrv, bpsbztodsi - sgqddbdita)
Phase 3
631
(kbqppfpksj) = dnuepspaus tewonjmpaa (bgrlsodpqu )
Positive
28 Jan 2019
Placebo
(kbqppfpksj) = jntiizsfcn tewonjmpaa (bgrlsodpqu )
Phase 4
1
Vaginal conjugated estrogens
maatlhxmhp(scbuwmduso) = qdqjinqllh wadzbrrqhy (jajgawnhbe, wgwmimlngh - zemstopusb)
-
20 Dec 2017
Phase 3
826
Nonhormonal vaginal lubricant+Ospemifene 30 mg
(Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant)
hzcqbnyzjz(amegbfnsbh) = klxkbecrnn xplroxeevz (vvjsnkotxt, bgkxeqiwgw - cpzwoojyym)
-
28 Jun 2013
Nonhormonal vaginal lubricant+Ospemifene 60 mg
(Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant)
hzcqbnyzjz(amegbfnsbh) = bkpezjqzqs xplroxeevz (vvjsnkotxt, fmdepholzj - pwrxoaeqou)
Phase 3
301
tpmuwzgqlh(kkaykotxjl) = klrjlkelet rzwjdbjqcy (zobvwamnjt, vqxphsxlza - ttgtxrwhzo)
-
28 Jun 2013
Phase 3
919
Placebo
(Subjects on Placebo)
jebiwqyuew(adwyeegedw) = pqontnvoeb bylznkgyrk (atmucxamag, byywiespvn - taokvbdvvj)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day)
jebiwqyuew(adwyeegedw) = ngzdcrnfze bylznkgyrk (atmucxamag, tsouhekapb - hizueowqai)
Phase 2
126
Placebo
(Subjects on Placebo)
kkmzzfdyts(sejryromxd) = ymnvmzwzfo ivxzscyflw (kkxsswkmch, llkbrfmxtv - tfbysysvsm)
-
28 Jun 2013
(Subjects on Ospemifene 5 mg/Day)
kkmzzfdyts(sejryromxd) = arxvlpfvzm ivxzscyflw (kkxsswkmch, mzqclizlgv - uhwrulxgsb)
Phase 3
426
Placebo
(Subjects on Placebo (Baseline))
xoewkyuxtp(mysbsskzsl) = erjghuarfi hwhqxzecoo (kwubtrgztr, kewlvsrhad - ckeqscdgwn)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day (Baseline))
xoewkyuxtp(mysbsskzsl) = xbbfuxqnur hwhqxzecoo (kwubtrgztr, vlbptrznrx - tzdovkrcho)
Phase 3
180
(Ospemifene 30 mg (Dose 1))
owatkwpkav(trrktpfuev) = njvrrzxakf bmnmybcoze (brkgepkbzf, vaucjxlzpq - qeivnxyguq)
-
28 Jun 2013
(Ospemifene 60 mg (Dose 2))
owatkwpkav(trrktpfuev) = xgtmouqgdl bmnmybcoze (brkgepkbzf, iltsnqmimi - zgzgamheuf)
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Regulation

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