NDAORALTABLETPriority Review
Approved
Jan 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
19
Data completeness
6/8 — Strong
Priority Review
ORSERDU (elacestrant) by Stemline Therapeutics is estrogen receptor antagonists [moa]. Approved for breast cancer, estrogen receptor positive breast cancer, her2-negative breast cancer. First approved in 2023.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORSERDU (elacestrant) is an oral estrogen receptor antagonist approved by the FDA on January 27, 2023, for the treatment of hormone receptor-positive breast cancer. It represents a novel therapeutic approach within the estrogen receptor antagonist class, offering an alternative mechanism to traditional therapies. The product is currently in peak lifecycle stage, indicating strong market establishment and commercial activity.
$0.1BPart D
11.7 years to LOEMechanism of Action
Estrogen Receptor Antagonists
Pharmacologic Class:
Estrogen Receptor Antagonist
Indications (3)
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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.