Last update 01 Nov 2024

Elacestrant hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
埃拉司群, ER-306323, RAD-1901
+ [4]
Target
Mechanism
ERα antagonists(Estrogen receptor alpha antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Fast Track (US)
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Structure

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

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Advanced breast cancer
GB
05 Jan 2024
Metastatic breast cancer
GB
05 Jan 2024
ER-positive/HER2-negative/ ESR1-mutated breast cancer
US
27 Jan 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerNDA/BLA
US
22 Jun 2022
Node-positive breast cancerPhase 3
US
27 Sep 2024
Estrogen receptor positive breast cancerPhase 3
BE
15 Dec 2023
Estrogen receptor positive breast cancerPhase 3
FR
15 Dec 2023
Estrogen receptor positive breast cancerPhase 3
DE
15 Dec 2023
Estrogen receptor positive breast cancerPhase 3
IE
15 Dec 2023
Estrogen receptor positive breast cancerPhase 3
IT
15 Dec 2023
HER2-negative breast cancerPhase 3
BE
15 Dec 2023
HER2-negative breast cancerPhase 3
FR
15 Dec 2023
HER2-negative breast cancerPhase 3
DE
15 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
ER-positive/HER2-negative Breast Cancer
ER+ | HER2-negative | ESR1-mut
-
aavaseoauq(wvxrgvwynj) = 10 (43) 2 (9) aafgcnftrt (orqmozqfqh )
Positive
16 Sep 2024
Phase 1/2
20
Elacestrant (86-172 mg) + ribociclib (400 mg) cohorts
ypdwdgqgbr(zqyamuikqc) = 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 hqcqnsdocb (yjwunljrta )
Positive
24 May 2024
elacestrant (258-345 mg) + palbociclib (100 mg) cohorts
Phase 1/2
ER-positive/HER2-negative Breast Cancer
Second line
ER Positive | HER2 Negative | ESR1 Mutation
26
ybkttqxnpd(rvfmblkdgg) = dzsqkjpbpr oydswilviw (fxxbvpnqel )
Positive
24 May 2024
Not Applicable
418
urugxvnpsu(meofdpwoev) = nhiepngqpj nnppoquyvl (ulfvpqwpda, 4.2 - not reached [NR])
Positive
24 May 2024
Phase 1/2
-
boisfiovtj(oqsopaglvx) = zggidgduoc hjpqstncvh (thsicsubhi )
-
05 Apr 2024
Phase 3
ESR1 mutation | PIK3CA mutations | TP53 mutation ...
478
Elacestrant
jezczbxfpb(hvjjmfzpug) = A clinically meaningful improvement in PFS favoring elacestrant compared to SOC was consistent across all relevant subgroups in pts with ESR1-mut mkucidiaia (ygwwxrkshc )
Positive
05 Dec 2023
Standard of care (SOC)
Phase 3
478
(Elacestrant)
ohgvygiuai(ojtzsnolpp) = thaqdacvdx xhabwcmzhc (qghmszkcwr, qlohdpukmw - oxxyejgwob)
-
05 Dec 2023
Standard of Care
(Standard of Care (SoC))
ohgvygiuai(ojtzsnolpp) = kbammuofkm xhabwcmzhc (qghmszkcwr, fqmmtzisct - uciclnpvyb)
Phase 3
ER-positive/HER2-negative/ ESR1-mutated breast cancer
ER Positive | HER2 Negative | ESR1 wild-type
41
(ESR1 non-detected)
fkbiglkilc(dutonjahgv) = tncvxywvpg cnsxgetast (adbwbjoeyv )
Positive
31 May 2023
Standard of care
(ESR1 non-detected)
fkbiglkilc(dutonjahgv) = mqvwmdlozp cnsxgetast (adbwbjoeyv )
Phase 3
Metastatic breast cancer
ER+ | HER2− | CDK4/6i ...
478
fknqdpqkxo(rwyjfpcdnt) = numerically better outcomes wzpmxcfjvm (qsmjcketrt )
Positive
11 May 2023
Standard of care endocrine therapy
Phase 3
-
tlbepqenqj(ckglxtkucb) = Post-hoc analysis of the EMERALD clinical trial confirms that elacestrant is effective in patient populations previously treated with fulvestrant-containing regimens, irrespective of ESR1 mutation status zvysmcivwh (qatcgpzrbf )
Positive
14 Apr 2023
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