NDAORALTABLETPriority Review
Approved
Jan 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ORSERDU (elacestrant) by Stemline Therapeutics is estrogen receptor antagonists [moa]. First approved in 2023.
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORSERDU (elacestrant) is an oral estrogen receptor antagonist approved in January 2023 for hormone receptor-positive breast cancer. It works by blocking estrogen receptor signaling, preventing cancer cell proliferation in ER+ tumors. This selective estrogen receptor degrader (SERD) represents a mechanistic advance in endocrine therapy for breast cancer.
$128MPart D
Peak11.2 years to LOEProduct is in peak revenue phase post-launch with moderate Part D uptake, suggesting stable commercial team size and ongoing field operations.
Mechanism of Action
Estrogen Receptor Antagonists
Pharmacologic Class:
Estrogen Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer
Started Dec 2026
50 enrolled
Advanced Endometrial CarcinomaMetastatic Endometrial CarcinomaRecurrent Endometrial Carcinoma+2 more
Medical Imaging to Re-evaluate Elacestrant Clinical Usage
Started Sep 2026
160 enrolled
ER+ / HER2- Advanced Breast Cancer
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
Started Aug 2026
70 enrolled
Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
Started Jun 2026
500 enrolled
Breast Cancer
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC
Started Apr 2026
1,520 enrolled
Breast CancerHR+/HER2- Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.