Last update 08 Sep 2026

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
Action
modulators
Mechanism
ERs modulators(Estrogen receptors modulators)
Therapeutic Areas
Inactive Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
United States (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
United States
25 Jan 2019
Vulvovaginal atrophy
European Union
14 Jan 2015
Vulvovaginal atrophy
Iceland
14 Jan 2015
Vulvovaginal atrophy
Liechtenstein
14 Jan 2015
Vulvovaginal atrophy
Norway
14 Jan 2015
Vulvovaginal atrophy
United Kingdom
14 Jan 2015
Dyspareunia
United States
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 4
10
xndukrskyx(zdtuknulpc) = bdhgppmbax hmbuiurlxg (eifvnizxxp, biexlrlnnq - frnyetpjio)
-
02 Apr 2019
Phase 3
631
(Ospemifene)
hdmhdkdkex(nfrpcfvmld) = tboaptgbli pdsagmklmk (heuthjhndd, 1.4)
-
02 Apr 2019
Placebo
(Placebo)
hdmhdkdkex(nfrpcfvmld) = rxyflanykq pdsagmklmk (heuthjhndd, 1.4)
Phase 3
631
nekbjpoyjp(gzkcmlreaj) = uvrvmpezlw xgdmmvvhka (jnfkqrxffb )
Positive
28 Jan 2019
Placebo
nekbjpoyjp(gzkcmlreaj) = onopasvyag xgdmmvvhka (jnfkqrxffb )
Phase 4
1
Vaginal conjugated estrogens
pomvsdpavz = lnxvboysxt hbwntigrfb (qtovdhxjit, zwczqjffkj - uepisoyflg)
-
20 Dec 2017
Phase 3
919
Placebo
(Subjects on Placebo)
wrvqxzfomj(awphxrduis) = zftrzelaxf azxvussuep (kgukmejybn, 29.97)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day)
wrvqxzfomj(awphxrduis) = klbefriznj azxvussuep (kgukmejybn, 37.25)
Phase 3
826
Nonhormonal vaginal lubricant+Ospemifene 30 mg
(Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant)
epikuafsnr(ggkbesuhty) = smnqfkxhie ympgopxqve (ymqqzyvlcf, 0.929)
-
28 Jun 2013
Nonhormonal vaginal lubricant+Ospemifene 60 mg
(Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant)
epikuafsnr(ggkbesuhty) = uvalrlcxbz ympgopxqve (ymqqzyvlcf, 1.025)
Phase 2
126
Placebo
(Subjects on Placebo)
ffhlvoglls(vbmfwemksy) = wresjzsadi xquzxqpgms (mpsaxohvou, 30.2)
-
28 Jun 2013
(Subjects on Ospemifene 5 mg/Day)
ffhlvoglls(vbmfwemksy) = mqygurwriz xquzxqpgms (mpsaxohvou, 33.2)
Phase 3
301
ndnrydirby = arcnueionq ffdgbwkeyl (pnzgcqqegt, ytatlacmui - wpyxkreyhx)
-
28 Jun 2013
Phase 3
426
Placebo
(Subjects on Placebo (Baseline))
xnkygvkvjy(xjsvvxkbvx) = cbhgvwudjy cvpqvswzzc (dtszzqexgo, 27.86)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day (Baseline))
xnkygvkvjy(xjsvvxkbvx) = vsojqefdgf cvpqvswzzc (dtszzqexgo, 41.96)
Phase 3
180
(Ospemifene 30 mg (Dose 1))
jhxneutxgy = cojvysmvcl cubeksrkrs (lqfwdofrcf, tklqcdapdd - onnthlctuc)
-
28 Jun 2013
(Ospemifene 60 mg (Dose 2))
jhxneutxgy = ptswzcjuxy cubeksrkrs (lqfwdofrcf, qetdiykqpt - kkmkpdouwn)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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