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 1h ago · AI intelligence enriched 1w 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 represents a novel mechanism within the ER antagonist class, offering an alternative to traditional endocrine therapies. The drug addresses unmet need in patients with ER+ disease who have limited options after prior treatment.
$128MPart D
Peak11.5 years to LOEEarly-stage post-launch brand in peak growth phase with modest Medicare claims; commercial team is likely scaling awareness and patient access programs.
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
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
Started May 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
Ph 2 Elacestrant in ER Positive Uterine Sarcomas
Started Mar 2026
30 enrolled
Uterine SarcomaUterine LeiomyosarcomaEndometrial Stromal Sarcoma+6 more
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Started Jan 2026
297 enrolled
Estrogen-receptor-positive Breast CancerMetastatic Breast CancerBreast Cancer+6 more
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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.