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Drug

Elacestrant

Approved · FDA / EMA
ClassEstrogen receptor alpha degraderEmerging researchLate-stage development

Also known as (2R)-2-(2-(ethyl-((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxy-phenyl)tetralin-6-ol, Orserdu, (6R)-6-(2-(ethyl((4-(2- (ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)- 5,6,7,8-tetrahydronaphthalen-2-ol, 2-naphthalenol, 6-(2-(ethyl((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydro-, (6R)-.

RxNorm2628469ChEMBLCHEMBL4297509ATCL02BA04UNIIFM6A2627A8
1
Research papers
22
Active clinical trials
Estrogen receptor
Primary target
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II, Randomization, Unblinded Study of ELacestrant in Combination With Abemaciclib or Elacestrant Alone In p53 Wild Type, Estrogen Receptor-positive Advanced or recurrenT Endometrial Cancer (ELITE)

Clinical trial2026-07-16Results expected Q4 2028 · ClinicalTrials.gov

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Clinical trial2026-07-10Results expected Q4 2028 · ClinicalTrials.gov

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Clinical trial2026-07-08Results expected Q3 2029 · ClinicalTrials.gov

A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)

Clinical trial2026-06-29Results expected Q3 2027 · ClinicalTrials.gov

Label change: ELACESTRANT (NDA217639)

Regulatory2026-06-24FDA

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

Clinical trial2026-06-22Results expected Q1 2028 · ClinicalTrials.gov

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Clinical trial2026-06-12Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)

Clinical trial2026-06-12Results expected Q4 2029 · ClinicalTrials.gov

Label change: ELACESTRANT (NDA217639)

Regulatory2023-11-09FDA

Approval: Orserdu (EMA)

Regulatory2023-09-15EMA

Approval: ELACESTRANT (NDA217639)

Regulatory2023-01-27FDA

Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial.

Research2022-05-18Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Elacestrant
Aliases & brands
(2R)-2-(2-(ethyl-((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxy-phenyl)tetralin-6-olOrserdu(6R)-6-(2-(ethyl((4-(2- (ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)- 5,6,7,8-tetrahydronaphthalen-2-ol2-naphthalenol, 6-(2-(ethyl((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydro-, (6R)-
RxNorm CUI
2628469
ChEMBL ID
CHEMBL4297509
ATC codes
L02BA04
UNII
FM6A2627A8
Primary mechanism
Estrogen receptor alpha degrader
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Estrogen receptor
ESR1 · P03372
DEGRADEREstrogen receptor alpha degrader

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-01-27 → 2023-09-15)
Earliest approval
2023-01-27
Latest approval
2023-09-15
Authorities
FDA · EMA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2026-06-24Label change
Label change: ELACESTRANT (NDA217639)
Evidence ↗
2023-11-09Label change
Label change: ELACESTRANT (NDA217639)
Evidence ↗
2023-01-27ApprovalMulti-authority
Approval: ELACESTRANT (NDA217639)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-09-15ApprovalMulti-authority
Approval: Orserdu (EMA)
Indication: Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast… Show full indication

Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

28 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
28
registered trials across all phases
LATEST COMPLETION 2024
22
Active studies
20
Recruiting
5
Late-stage (III+)
3
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 28
Early Phase 11Phase 14Phase 1 / 28Phase 210Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse

RecruitingPH IIIEuropean Organisation for Research and Treatment of Cancer - EORTCn=2202035

Dynamic Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- Early Breast Cancer (ADAPTela)

RecruitingPH IIIKey trialWest German Study Groupn=1,5202033

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

RecruitingPH IIIKey trialStemline Therapeutics, Inc.n=4,2202032

A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+/HER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4/6 Inhibitors

RecruitingPH IIIMedSIRn=2402028

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

CompletedPH IIIStemline Therapeutics, Inc.n=4782024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes1
Breast Neoplasms1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Aftimos P1
  • Babu S1
  • Bardia A1
  • Bidard FC1
  • Bria E1
  • Cazzaniga M1
  • Conlan MG1
  • Cortés J1
Leading institutions
free-text, unnormalised
  • Centre Hospitalier de l'Ardenne-Site de Libramont1
  • Centre Jean Perrin1
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS1
  • Inova Schar Cancer Institute1
  • Institut Claudius Regaud1
  • Institut Curie1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.