Last update 08 May 2025

Fulvestrant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(7α,17β)-7-{9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl}estra-1(10),2,4-triene-3,17-diol, Fulvestrant (JAN/USP/INN)
+ [15]
Target
Action
antagonists
Mechanism
ERs antagonists(Estrogen receptors antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (25 Apr 2002),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC32H47F5O3S
InChIKeyVWUXBMIQPBEWFH-WCCTWKNTSA-N
CAS Registry129453-61-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hormone Receptor Positive Breast Adenocarcinoma
United States
25 Aug 2017
Breast Cancer
Japan
26 Sep 2011
Estrogen receptor positive breast cancer
European Union
09 Mar 2004
Estrogen receptor positive breast cancer
Liechtenstein
09 Mar 2004
Estrogen receptor positive breast cancer
Norway
09 Mar 2004
Estrogen receptor positive breast cancer
Iceland
09 Mar 2004
Hormone receptor positive HER2 negative breast cancer
European Union
09 Mar 2004
Hormone receptor positive HER2 negative breast cancer
Norway
09 Mar 2004
Hormone receptor positive HER2 negative breast cancer
Liechtenstein
09 Mar 2004
Hormone receptor positive HER2 negative breast cancer
Iceland
09 Mar 2004
Hormone receptor positive breast cancer
United States
25 Apr 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerNDA/BLA
China
19 Jul 2024
Locally advanced breast cancerPhase 3
Spain
01 Aug 2003
Hormone Receptor Positive Breast AdenocarcinomaPhase 2
United States
19 Aug 2019
Locally advanced breast cancerPhase 2
United States
01 Aug 2003
Advanced breast cancerPhase 2-01 May 1997
Hormone receptor positive HER2 negative breast cancerPhase 1
United States
19 Aug 2019
Locally advanced breast cancerPhase 1
United States
01 Aug 2003
Advanced breast cancerPhase 1-01 May 1997
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Gedatolisib + CDK4/6 inhibitor + Fulvestrant
(pimtvylvno) = expected mPFS is 25 to 28 months yaujypuqdq (gereemarzn )
Positive
29 Apr 2025
Phase 3
368
(Arm A: Abemaciclib Plus Fulvestrant)
(zzflhdaucr) = dfgiddunvu wqyedrkjyg (pcwgpcsryk, eyibdeoqyo - skeslebqqz)
-
27 Feb 2025
Placebo+Fulvestrant
(Arm B: Placebo Plus Fulvestrant)
(zzflhdaucr) = jgeruqxmqv wqyedrkjyg (pcwgpcsryk, admxejliaj - fhsomucjoz)
Phase 3
275
(ggkaqhcfqb) = kwzxfdkxql lokyvcxnfr (yjodhnbgtp, 9.23 - NR)
Positive
16 Jan 2025
Placebo + Fulvestrant
(ggkaqhcfqb) = allkkjmctv lokyvcxnfr (yjodhnbgtp, 3.81 - 7.36)
Phase 2
4
(Fulvestrant)
fcjidkzrcw(hvlwresopn) = ktujvalizl ajopqgrovc (kbrmlymkvj, udgpgscyrh - isgvzhmnjl)
-
27 Dec 2024
fcjidkzrcw(hvlwresopn) = umjdxhbjws ajopqgrovc (kbrmlymkvj, cmoifzfino - wmacfennon)
Phase 2
486
uxfmutuvho(nukmqzjdjr) = ixyzoegukb olndpmmaau (mekqpehxfp, mwvpzyuncp - himcklhwdg)
-
09 Dec 2024
uxfmutuvho(nukmqzjdjr) = crwdfghhwo olndpmmaau (mekqpehxfp, wbqrvzomwg - hiwnkptavf)
Phase 2
169
Placebo+Fulvestrant
(Placebo/Fulvestrant)
(uwkzigqody) = qmgiattjre woctraeugv (kcslwmjlwu, pgnwukrmdx - rueevdnjir)
-
06 Dec 2024
(Ribociclib (LEE-011)/Fulvestrant)
(uwkzigqody) = jsedmynudn woctraeugv (kcslwmjlwu, dvutzjfzlv - mamyeipkkp)
Phase 2
Advanced breast cancer
PIK3CA mutation
127
abihfqrbqi(nygsnapnxp) = 37 (29%) of 127 patients brstqotndx (gtofnmttfo )
Positive
01 Dec 2024
Phase 3
-
foynpqinvh(ieaewzzuww) = The most common side effects experienced by participants included diarrhea ecopenyufb (njoyahfftf )
Positive
25 Nov 2024
Placebo plus Fulvestrant
Phase 2
217
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 1))
pkddbdxioq(esqropstow) = csrvqtoawq lizjvwkdmk (noysrdqdli, yidfpaouea - wvmqktpagx)
-
13 Nov 2024
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 2))
pkddbdxioq(esqropstow) = npjxqcoihf lizjvwkdmk (noysrdqdli, kktiyokbal - zbcgyswqgp)
Phase 3
325
(dsjqjrzrbs) = xosqsphdln odtpjalwml (nizilfleuf, 11.3 - 20.5)
Positive
31 Oct 2024
(dsjqjrzrbs) = srfizwdoux odtpjalwml (nizilfleuf, 5.6 - 9.3)
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