NDAORALTABLET
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
6/8 — Strong
INLURIYO (imlunestrant) by Eli Lilly and Company is estrogen receptor antagonists [moa]. Approved for estrogen receptor antagonist [epc]. First approved in 2025.
Drug data last refreshed 6h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INLURIYO (imlunestrant) is an oral estrogen receptor antagonist approved by the FDA on September 25, 2025, for the treatment of estrogen receptor-positive breast cancer. It represents a novel small-molecule approach to blocking estrogen signaling in hormone-responsive tumors. The drug is indicated for patients with ER+ disease and represents a new mechanism in the endocrine therapy landscape.
Growth13.1 years to LOE
As a newly launched product with 13+ years of patent protection, INLURIYO will require significant commercial infrastructure and team investment to establish market presence in the competitive ER+ breast cancer space.
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 (6)
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
Started May 2026
600 enrolled
Breast Neoplasms
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Started Oct 2022
8,000 enrolled
Breast Neoplasms
A Study of Imlunestrant (LY3484356) in Healthy Women
Started Sep 2022
20 enrolled
Healthy
A Study of Imlunestrant (LY3484356) in Female Healthy Participants
Started Jul 2022
113 enrolled
Healthy
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
Started Jul 2022
27 enrolled
Hepatic InsufficiencyHealthy
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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.