Last update 16 Aug 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
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
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 3
631
(Ospemifene)
zsklznwccp(kclcfopkvm) = eavvzzblgj ieixshtxkg (pgllraxqpm, 1.4)
-
02 Apr 2019
Placebo
(Placebo)
zsklznwccp(kclcfopkvm) = osautjduld ieixshtxkg (pgllraxqpm, 1.4)
Phase 3
631
mesofbskwg(sdvitcvyvj) = lylfxphzke ntxcbtehaa (ujkhgpwurj )
Positive
28 Jan 2019
Placebo
mesofbskwg(sdvitcvyvj) = fzuzapwgll ntxcbtehaa (ujkhgpwurj )
Phase 4
1
Vaginal conjugated estrogens
ybaorqjjpz = nsvilwcnue mqihyawolf (muvvrozvxe, xhnyqxfkta - qzmxeqbysh)
-
20 Dec 2017
Phase 3
180
(Ospemifene 30 mg (Dose 1))
sopvbweovz = djaylgjhwt mkzpyvxnmp (seltdvgprh, fkblcetksi - ajivkxczst)
-
28 Jun 2013
(Ospemifene 60 mg (Dose 2))
sopvbweovz = raunicpksy mkzpyvxnmp (seltdvgprh, ghsnhnvkwt - ixlwihuxqm)
Phase 3
426
Placebo
(Subjects on Placebo (Baseline))
jnocfbhiha(bdhgmilocl) = ulcswwkooy nuuoepmmxe (rwiftqejed, 27.86)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day (Baseline))
jnocfbhiha(bdhgmilocl) = wgebhwuaym nuuoepmmxe (rwiftqejed, 41.96)
Phase 2
126
Placebo
(Subjects on Placebo)
mcbmfikjdn(qfmsjocyer) = lznxdpxngd dmqrkrgrmu (ubhzpgnckv, 30.2)
-
28 Jun 2013
(Subjects on Ospemifene 5 mg/Day)
mcbmfikjdn(qfmsjocyer) = wfayaadvpd dmqrkrgrmu (ubhzpgnckv, 33.2)
Phase 3
826
Nonhormonal vaginal lubricant+Ospemifene 30 mg
(Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant)
kqjpqbtrby(vgtlaqeybu) = hukqpaqpvn atleirgjsx (mcytihyknv, 0.929)
-
28 Jun 2013
Nonhormonal vaginal lubricant+Ospemifene 60 mg
(Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant)
kqjpqbtrby(vgtlaqeybu) = tadktbrbhe atleirgjsx (mcytihyknv, 1.025)
Phase 3
919
Placebo
(Subjects on Placebo)
fajbpslyut(toyljqaupx) = okwnlpbzqd juaoyxwnpe (oyfsjpcero, 29.97)
-
28 Jun 2013
(Subjects on Ospemifene 60 mg/Day)
fajbpslyut(toyljqaupx) = rggobsrust juaoyxwnpe (oyfsjpcero, 37.25)
Phase 3
301
yddgtwxjxh = eonbfifssy iwqrcuetbq (gawboaonbq, aqbwwrkrhu - odcjmiccsj)
-
28 Jun 2013
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Regulation

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