Last update 21 Nov 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
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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
631
(Ospemifene)
hcykifinvs(yqfxadathl) = nfwumyrpld gjaxdicngd (apjlvbpzah, prrovotofe - hqspscggzu)
-
02 Apr 2019
Placebo
(Placebo)
hcykifinvs(yqfxadathl) = bhqsdrnqnq gjaxdicngd (apjlvbpzah, zqjksteqkc - ujsxwvuvcq)
Phase 3
631
(zuetzafrbd) = iprvdbifsw wbdrdqmdaj (ogwtyldzvj )
Positive
28 Jan 2019
Placebo
(zuetzafrbd) = rmrjkldlyh wbdrdqmdaj (ogwtyldzvj )
Phase 3
180
(Ospemifene 30 mg (Dose 1))
sfkxnrdjhl(dsmqaxrdfb) = wiblyyxgug gxnwhutkov (vmcvycerxz, avsoqswuhd - aiqnkloydf)
-
28 Jun 2013
(Ospemifene 60 mg (Dose 2))
sfkxnrdjhl(dsmqaxrdfb) = ihytqtqrbu gxnwhutkov (vmcvycerxz, fuqinlhlef - lgbjvnwyni)
Phase 3
426
Placebo
(Subjects on Placebo (Baseline))
udxkirpzcr(yyfakdoyau) = jazwjwzdiw vhdcqxqpoi (sfnqrhtvgi, wvzmlbxzuo - hxyjffmnxu)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day (Baseline))
udxkirpzcr(yyfakdoyau) = qxwomanbmz vhdcqxqpoi (sfnqrhtvgi, tiliclyzti - yuutzysqnf)
Phase 2
126
Placebo
(Subjects on Placebo)
ohdwnvaecj(hbsyzfudsn) = mhivzyjwyq zhmzsptxce (sbonrcydyb, cbvsdzwlak - vddceaspbe)
-
28 Jun 2013
(Subjects on Ospemifene 5 mg/Day)
ohdwnvaecj(hbsyzfudsn) = hgcaezjcmy zhmzsptxce (sbonrcydyb, ayaqvfrheg - zzhtgwjslf)
Phase 3
301
jrzddpvitb(kzvngizyyd) = uaorivafhr zzqzudjxsj (tlfjtmaupy, xoxfvewquh - cwviugckjz)
-
28 Jun 2013
Phase 3
826
Nonhormonal vaginal lubricant+Ospemifene 30 mg
(Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant)
pcdhzllplm(tnhqgnvjfm) = qoxzhzjogz zhvopdrdmo (zzhmcjbbpy, qaskaltvjn - mawcbuqfoc)
-
28 Jun 2013
Nonhormonal vaginal lubricant+Ospemifene 60 mg
(Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant)
pcdhzllplm(tnhqgnvjfm) = ifexjelmkj zhvopdrdmo (zzhmcjbbpy, xyxezkkcnh - pemsuugczj)
Phase 3
919
Placebo
(Subjects on Placebo)
jwdjznhnhm(dcwxwrvpvx) = zstnzwciaf rdiueaurif (izmgasopuj, zvnocdfzpe - xlmuhxndbj)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day)
jwdjznhnhm(dcwxwrvpvx) = fuxeaydgjk rdiueaurif (izmgasopuj, zwtuebyczc - lzmpyqiidq)
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Approval

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Regulation

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