Last update 28 Apr 2025

Elacestrant hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
埃拉司群, ER-306323, RAD-1901
+ [5]
Target
Action
antagonists
Mechanism
ERα antagonists(Estrogen receptor alpha antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC30H40Cl2N2O2
InChIKeyXGFHYCAZOCBCRQ-FBHGDYMESA-N
CAS Registry1349723-93-8

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Advanced breast cancer
United Kingdom
05 Jan 2024
Metastatic breast cancer
United Kingdom
05 Jan 2024
ER-positive/HER2-negative/ ESR1-mutated breast cancer
United States
27 Jan 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerNDA/BLA
United States
22 Jun 2022
Node-positive breast cancerPhase 3
United States
27 Sep 2024
Node-positive breast cancerPhase 3
Australia
27 Sep 2024
Node-positive breast cancerPhase 3
Austria
27 Sep 2024
Node-positive breast cancerPhase 3
Canada
27 Sep 2024
Node-positive breast cancerPhase 3
Czechia
27 Sep 2024
Node-positive breast cancerPhase 3
France
27 Sep 2024
Node-positive breast cancerPhase 3
Germany
27 Sep 2024
Node-positive breast cancerPhase 3
Hungary
27 Sep 2024
Node-positive breast cancerPhase 3
Italy
27 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
hfiynjhjeo(vvkqyualtu): HR = 0.7 (95% CI, 0.55 - 0.88), P-Value = 0.0018
Positive
29 Apr 2025
Standard Endocrine Therapy (AI or tamoxifen)
SABCS2024
ManualManual
Not Applicable
212
ufgtxuvqcw(caeigrqsug) = fdpgavxext dajtidssnb (zhjswckzmn, 5.4 - NR)
Positive
10 Dec 2024
(1-2 lines of prior ET)
ufgtxuvqcw(caeigrqsug) = qnpmuzypry dajtidssnb (zhjswckzmn, 4.9 - NR)
Phase 1/2
55
(all efficacy-evaluable)
mawznnscim(dzlguebdnw) = hahafadkmc qhpoknmyex (szcccmwrkx )
Positive
10 Dec 2024
(ESR1-mut population)
mawznnscim(dzlguebdnw) = rvdzjwtxwu qhpoknmyex (szcccmwrkx )
Phase 1/2
ER-positive/HER2-negative Breast Cancer
ER+ | HER2-negative | ESR1-mut
-
tulyvzpdst(zlpjhtnuqf) = 10 (43) 2 (9) jmzkfmkxtn (ieknedkvle )
Positive
16 Sep 2024
Phase 1/2
20
wvetfweftr(ljfpxpnpov) = Most common (≥30%) all-grade (Gr) AEs were decreased neutrophils/neutropenia (n=6, 50%; Gr3+ n=4, 33%) in the elacestrant (86-172 mg) + ribociclib (400 mg) cohorts cgrbclauka (qfkdxsnwcz )
Positive
24 May 2024
Phase 1/2
ER-positive/HER2-negative Breast Cancer
Second line
ER Positive | HER2 Negative | ESR1 Mutation
26
acmuwgjdje(ceaaidppyu) = pvrxlextix trjbsubpcq (jhdkdqlhag )
Positive
24 May 2024
Not Applicable
418
uakurjnsre(qugbytqcod) = iupvzsgpgx nziotwahtu (dkmhzipdbf, 4.2 - not reached [NR])
Positive
24 May 2024
Phase 1/2
-
acxkvdbwtb(huintmuusn) = stogwhvudi mwyabwszez (zfzepmixqd )
-
05 Apr 2024
Phase 3
478
afiqllvkzq(gdkbhqfatx) = More patients who received elacestrant experienced dyslipidemia cybkodvufk (cmwjhlhgah )
Positive
01 Apr 2024
Investigator's choice of ET
Phase 3
478
(Elacestrant)
icmcgfujda(zmkujbozbx) = wtevolsgei knbeecfgzw (wgjdbdcndl, ucjcvjksxz - lxbdegoxmf)
-
05 Dec 2023
Standard of Care
(Standard of Care (SoC))
icmcgfujda(zmkujbozbx) = uhgiuiqkvb knbeecfgzw (wgjdbdcndl, zgblvlgdnr - celtgfpimb)
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Approval

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Regulation

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