Orserdu

(Elacestrant)

ApprovedSmall molecule

Orserdu is a small molecule that works as a Estrogen Receptor Alpha Degrader; Estrogen Receptor Alpha Degrader.[2] It is being used across 14 indications, with its most advanced program in Approved.[1]

Orserdu is one of 224 small molecule programs targeting Estrogen-Receptor Negative Breast Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

223

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Estrogen-Receptor Negative Breast CancerApproved

Breast NeoplasmActive, not recruiting

Breast CarcinomaApproved

Hot FlashesApproved

Hormone-Receptor-Positive Breast CancerRecruiting

ER+ Breast CancerRecruiting

Ductal Carcinoma in SituRecruiting

Breast NeoplasmsRecruiting

Breast Cancer MetastaticActive, not recruiting

Advanced Breast CancerRecruiting

Estrogen-Receptor Negative Breast CancerApproved

Approved

Breast NeoplasmApproved

Active, not recruiting

Breast CarcinomaApproved

Approved

Hot FlashesApproved

Approved

Hormone-Receptor-Positive Breast CancerPreclinical

Recruiting

ER+ Breast CancerPhase 2

Recruiting

Ductal Carcinoma in SituPhase 2

Recruiting

Breast NeoplasmsPreclinical

Recruiting

Breast Cancer MetastaticPhase 1

Active, not recruiting

Advanced Breast CancerPhase 3

Recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Orserdu

SStemline Therapeutics, Inc.

Approved

15 2

Adenocard

Astellas

Preclinical

2 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Lexiscan

Astellas

Preclinical

1 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 9

Duragesic-100

CCephalon

Preclinical

2 10

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalRecruiting

Breast Neoplasms

NCT05386108

Q2 2027

Phase 2Recruiting

Breast Cancer

NCT07159451

Q3 2027

Phase 2Active, not recruiting

Breast Cancer

NCT05596409

Phase 2Recruiting

ER+ Breast Cancer

NCT06923527

Q4 2027

Phase 1Active, not recruiting

Breast Cancer Metastatic

NCT06691035

Clinical

Trials by Indication[1]

Breast Cancer15 trials

A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

Completed·SStemline Therapeutics, Inc.·Phase 1·NCT02338349·57 enrolled

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1/2·NCT05563220·435 enrolled

Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

Unknown status·CCriterium, Inc.·Phase 1/2·NCT04791384·44 enrolled

Show 12 more trials

A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer

Withdrawn·CContext Therapeutics Inc.·Phase 1/2·NCT06938711

ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

Not yet recruiting·—·Phase 1/2·NCT07198724·65 enrolled

Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy

Not yet recruiting·—·Phase 2·NCT07005882·21 enrolled

A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT07159451·140 enrolled

Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Completed·SStemline Therapeutics, Inc.·Phase 3·NCT03778931·478 enrolled

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

Active, not recruiting·SStemline Therapeutics, Inc.·Phase 2·NCT05596409·61 enrolled

Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

Active, not recruiting·SSOLTI Breast Cancer Research Group·Phase 2·NCT05982093·48 enrolled

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

Recruiting·SStemline Therapeutics, Inc.·Phase 3·NCT06492616·4,220 enrolled

A Phase 2 Open-Label, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Elacestrant Monotherapy for the Treatment of Japanese Participants With ER+/HER2- Advanced or Metastatic Breast Cancer With ESR1-mutation Following CDK4/6 Inhibitor Therapy

Recruiting·SStemline Therapeutics, Inc.·Phase 2·NCT07766018·70 enrolled

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

Recruiting·WWest German Study Group·Phase 3·NCT07242352·1,520 enrolled

An Open-Label, Phase 1b-2 Study of Elacestrant, in Combination With Onapristone in Patients With Estrogen Receptor-Positive, Progesterone Receptor-Positive, HER2-negative Advanced or Metastatic Breast Cancer (ELONA)

Terminated·CContext Therapeutics Inc.·Preclinical·NCT05618613·4 enrolled

Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study

Recruiting·IiOMEDICO AG··NCT07563595·500 enrolled

Advanced Breast Cancer3 trials

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

Recruiting·MMedSIR·Phase 3·NCT06382948·300 enrolled

Imaging to Re-evaluate Elacestrant Clinical Application

Not yet recruiting·JJules Bordet Institute·Phase 2·NCT07753954·160 enrolled

A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1·NCT06638307·240 enrolled

Uterine Sarcoma1 trial

Ph 2 Elacestrant in ER Positive Uterine Sarcomas

Not yet recruiting·—·Phase 2·NCT07467772·30 enrolled

HER21 trial

Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC

Recruiting·SSciClone Pharmaceuticals··NCT06544577·350 enrolled

Preoperative1 trial

Elacestrant in Preoperative Setting, a Window of Opportunity Study

Completed·SSOLTI Breast Cancer Research Group·Phase 1·NCT04797728·23 enrolled

9 more indications

ER Positive Breast Cancer1 trial

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

Recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT05512364·220 enrolled

Solid Tumor1 trial

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

Recruiting· BeiGene logo

BeiGene·Phase 1·NCT06120283·433 enrolled

Breast Neoplasms1 trial

An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Preclinical·NCT05386108·73 enrolled

Estrogen-Receptor Positive Breast Cancer1 trial

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)

Recruiting·KKristina A. Fanucci·Phase 2·NCT07222215·297 enrolled

Breast Cancer Metastatic1 trial

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT06691035·18 enrolled

Ductal Carcinoma in Situ1 trial

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study

Recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT06075953·400 enrolled

Endometrial Cancer1 trial

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)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07209449·75 enrolled

ER+ Breast Cancer1 trial

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)

Recruiting·YYale University·Phase 2·NCT06923527·50 enrolled

Hormone-receptor-positive Breast Cancer1 trial

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

Recruiting·EEllipses Pharma·Preclinical·NCT05573126·95 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 27, 2023

ORSERDU

NDA NDA217639

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Elacestrant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Elacestrant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Elacestrant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217639). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Orserdu. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Stemline Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Alpha Degrader; Estrogen Receptor Alpha Degrader[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SStemline Therapeutics, Inc.

Patent Landscape[5]

Patent Cliff

Oct 10, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7612114Aug 18, 2026

11779552Oct 10, 2034

10071066Oct 10, 2034

10420734Oct 3, 2036

11819480Feb 28, 2037

2 more patents

10745343Jan 5, 2038

10385008Jan 5, 2038

Orserdu

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Breast Cancer15 trials

Advanced Breast Cancer3 trials

Uterine Sarcoma1 trial

HER21 trial

Preoperative1 trial

ER Positive Breast Cancer1 trial

Solid Tumor1 trial

Breast Neoplasms1 trial

Estrogen-Receptor Positive Breast Cancer1 trial

Breast Cancer Metastatic1 trial

Ductal Carcinoma in Situ1 trial

Endometrial Cancer1 trial

ER+ Breast Cancer1 trial

Hormone-receptor-positive Breast Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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