Drug · Small Molecule

Elacestrant

CI-DRUG-00000208Explore in graph →NCIt C120211 CHEMBL4297509 CIViC Approved

Regulatory

Approvals (2)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Malignant Breast Neoplasm	ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )] , with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy ( 1 )	approved	Jan 27, 2023	openfda

Data updated 13 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	24	18	5	33	2	EU, US	Jan 27, 2023	2015-01
Malignant Breast Neoplasm	Approved	Phase 3	14	12	5	21	2	EU, US	Jan 27, 2023	Apr 1, 2016
Malignant Uterine Corpus Neoplasm	Phase2	Phase 2	3	2	0	3	0	—	—	Oct 1, 2025

Computedclinicaltrials

Curated evidence

Clinical evidence (13)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–13 of 13 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ESR1 Mutation1
Elacestrant	Malignant Breast Neoplasm

Clinical trials

Trials with this intervention (35)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–35 of 35 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06075953	DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment	recruiting	Phase 2	400	QuantumLeap Healthcare CollaborativeOTHER	1	Sep 28, 2026	clinicaltrials
NCT06120283	BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors	recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Estrogen receptor alpha degrader
Targets: 1 gene
UNII: FM6A2627A8
Aliases: (6R)-6-(2-(Ethyl((4-(2- (ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)- 5,6,7,8-tetrahydronaphthalen-2-ol, Elacestrant, ER-306323, ORSERDU, RAD 1901, RAD-1901, RAD1901, SERD/SERM RAD1901

Data updated 16 hours agoSource updated unknown

Identifiers

Codes (2)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L02BA	Endocrine therapy
EMA product	EMEA/H/C/005898	Orserdu

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

ESR1 D538G1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	3	submitted	EID12219 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 D538G1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12219

In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC)

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 E380Q1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12224 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 E380Q1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12224

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 L469V1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12225 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 L469V1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12225

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 L536H1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12226 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 L536H1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12226

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 L536P1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12227 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 L536P1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12227

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 L536Q1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12229 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 L536Q1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12229

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 L536R1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12228 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 L536R1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12228

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 S463P1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12230 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 S463P1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12230

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 Y537C1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12222 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 Y537C1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12222

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 Y537D1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12223 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 Y537D1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12223

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 Y537N1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12221 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 Y537N1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12221

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic

ESR1 Y537S1
Elacestrant	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12220 In the randomized, open-label, phase 3 EMERALD trial (NCT03778931), the selective ER-degrader (SERD) elacestrant was assessed in ER+/HER2- breast cancer patients who had previously been treated with e… (full text at CIViC) PMID 35584336 · Bidard et al., 2022 · Open in CIViC	civic

ESR1 Y537S1

Elacestrant

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12220

PMID 35584336 · Bidard et al., 2022 · Open in CIViC

civic