Drug Type Small molecule drug |
Synonyms 埃拉司群, ER-306323, RAD-1901 + [4] |
Target |
Mechanism ERα antagonists(Estrogen receptor alpha antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (27 Jan 2023), |
RegulationPriority Review (US), Fast Track (US) |
Molecular FormulaC30H40Cl2N2O2 |
InChIKeyXGFHYCAZOCBCRQ-FBHGDYMESA-N |
CAS Registry1349723-93-8 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11671 | Elacestrant hydrochloride | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | NDA/BLA | US | 22 Jun 2022 | |
Node-positive breast cancer | Phase 3 | US | 27 Sep 2024 | |
Estrogen receptor positive breast cancer | Phase 3 | BE | 15 Dec 2023 | |
Estrogen receptor positive breast cancer | Phase 3 | FR | 15 Dec 2023 | |
Estrogen receptor positive breast cancer | Phase 3 | DE | 15 Dec 2023 | |
Estrogen receptor positive breast cancer | Phase 3 | IE | 15 Dec 2023 | |
Estrogen receptor positive breast cancer | Phase 3 | IT | 15 Dec 2023 | |
HER2-negative breast cancer | Phase 3 | BE | 15 Dec 2023 | |
HER2-negative breast cancer | Phase 3 | FR | 15 Dec 2023 | |
HER2-negative breast cancer | Phase 3 | DE | 15 Dec 2023 |
Phase 1/2 | ER-positive/HER2-negative Breast Cancer ER+ | HER2-negative | ESR1-mut | - | aavaseoauq(wvxrgvwynj) = 10 (43) 2 (9) aafgcnftrt (orqmozqfqh ) View more | Positive | 16 Sep 2024 | ||
Phase 1/2 | ER-positive/HER2-negative Breast Cancer HER2 Positive | 20 | 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 ) View more | Positive | 24 May 2024 | ||
Phase 1/2 | 26 | ybkttqxnpd(rvfmblkdgg) = dzsqkjpbpr oydswilviw (fxxbvpnqel ) View more | Positive | 24 May 2024 | |||
Not Applicable | 418 | urugxvnpsu(meofdpwoev) = nhiepngqpj nnppoquyvl (ulfvpqwpda, 4.2 - not reached [NR]) View more | Positive | 24 May 2024 | |||
Phase 1/2 | - | boisfiovtj(oqsopaglvx) = zggidgduoc hjpqstncvh (thsicsubhi ) | - | 05 Apr 2024 | |||
Phase 3 | ESR1 mutation | PIK3CA mutations | TP53 mutation ... View more | 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) View more | - | 05 Dec 2023 | ||
Standard of Care (Standard of Care (SoC)) | ohgvygiuai(ojtzsnolpp) = kbammuofkm xhabwcmzhc (qghmszkcwr, fqmmtzisct - uciclnpvyb) View more | ||||||
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 ) View more | Positive | 31 May 2023 | |
Standard of care (ESR1 non-detected) | fkbiglkilc(dutonjahgv) = mqvwmdlozp cnsxgetast (adbwbjoeyv ) View more | ||||||
Phase 3 | 478 | fknqdpqkxo(rwyjfpcdnt) = numerically better outcomes wzpmxcfjvm (qsmjcketrt ) View more | Positive | 11 May 2023 | |||
Standard of care endocrine therapy | |||||||
Phase 3 | Hormone receptor positive breast cancer HR positive | - | 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 |