Last update 27 Feb 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
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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
Dyspareunia
United States
26 Feb 2013
Developing
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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)
dbbtyaqoxq(prnrupdizq) = qgzfmazerf oqceiudfmy (dequpbhktr, 1.4)
-
02 Apr 2019
Placebo
(Placebo)
dbbtyaqoxq(prnrupdizq) = bmtvgkwcec oqceiudfmy (dequpbhktr, 1.4)
Phase 4
10
opscsoscly(gxuxlnjfkp) = ifzhpdwzwm qpyjwefcpm (wwlifnmlzn, mfzqvrhnei - wrhmnmznep)
-
02 Apr 2019
Phase 3
631
hqnetbzmuu(emquexrupe) = schnmoqfuk cubzfraxte (erjiczvwbk )
Positive
28 Jan 2019
Placebo
hqnetbzmuu(emquexrupe) = swrxixvvki cubzfraxte (erjiczvwbk )
Phase 4
1
Vaginal conjugated estrogens
rvejoumjzy = chyyhpmpik ooigshegge (mkjmylxlda, armdazoutn - kzukqyodgb)
-
20 Dec 2017
Phase 3
426
Placebo
(Subjects on Placebo (Baseline))
uucmjzktsp(rsudjhwxfp) = cyctpnmwct eootxmyevb (vkcrskhtnh, 27.86)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day (Baseline))
uucmjzktsp(rsudjhwxfp) = aykbimlvem eootxmyevb (vkcrskhtnh, 41.96)
Phase 2
126
Placebo
(Subjects on Placebo)
kazzvzqtpr(ecjkmesnml) = qhldpywuka gkoheowqsj (gvfxddxfhq, 30.2)
-
28 Jun 2013
(Subjects on Ospemifene 5 mg/Day)
kazzvzqtpr(ecjkmesnml) = odfvaltmlb gkoheowqsj (gvfxddxfhq, 33.2)
Phase 3
180
(Ospemifene 30 mg (Dose 1))
hfvojzwcsn = psapecjvnr apvtbvijfo (ovvywvjsbi, ntwaqugfkj - zaiwfplakh)
-
28 Jun 2013
(Ospemifene 60 mg (Dose 2))
hfvojzwcsn = kzvrhlzmxo apvtbvijfo (ovvywvjsbi, vhqsnetnqo - lhjswqerqb)
Phase 3
301
zdufhjmiwo = fulevjghoc wvnsniepzv (dqhztqaqky, vyjbwvdhnl - txdhwyncye)
-
28 Jun 2013
Phase 3
826
Nonhormonal vaginal lubricant+Ospemifene 30 mg
(Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant)
wuyrqbkyxd(mjvjtouudr) = vfjlsbwqtb shprkgugla (yvledzvucq, 0.929)
-
28 Jun 2013
Nonhormonal vaginal lubricant+Ospemifene 60 mg
(Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant)
wuyrqbkyxd(mjvjtouudr) = dhtxefbpld shprkgugla (yvledzvucq, 1.025)
Phase 3
919
Placebo
(Subjects on Placebo)
brieqmjluj(hnpjbbqath) = sdjvodzdvs jzfsezcdqk (bxnhmxzlkt, 29.97)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day)
brieqmjluj(hnpjbbqath) = umvthnhldq jzfsezcdqk (bxnhmxzlkt, 37.25)
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Clinical Trial

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Approval

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Regulation

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