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Research Report
Imlunestrant: A Comprehensive Clinical and Scientific Review of a Next-Generation Oral SERD for ER-Positive Breast Cancer
Executive Summary
Imlunestrant (LY3484356) is an investigational, next-generation, orally bioavailable, and brain-penetrant Selective Estrogen Receptor Degrader (SERD) developed by Eli Lilly and Company.[1] It represents a significant potential advancement in the therapeutic armamentarium for estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, the most common subtype of the disease. As a pure estrogen receptor (ER) antagonist, Imlunestrant’s mechanism of action involves the induction of degradation of both wild-type and mutant forms of the estrogen receptor alpha (ERα), thereby abrogating the primary signaling pathway that drives tumor proliferation and survival in this malignancy.[4]
The pivotal Phase 3 EMBER-3 clinical trial has established two distinct and clinically meaningful roles for Imlunestrant in the treatment of advanced breast cancer. First, as a monotherapy, Imlunestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care (SOC) endocrine therapy in patients whose tumors harbor an activating mutation in the estrogen receptor gene (ESR1). In this biomarker-selected population, Imlunestrant reduced the risk of disease progression or death by 38%.[7] Second, and of broader clinical significance, the all-oral combination of Imlunestrant with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenio®) significantly improved PFS by 43% when compared to Imlunestrant alone in the overall patient population, irrespective of
ESR1 mutation status.[7]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/25 | Not Applicable | Not yet recruiting | |||
2022/08/24 | Phase 3 | Recruiting | |||
2022/08/22 | Phase 1 | Active, not recruiting | |||
2022/08/22 | Phase 1 | Completed | |||
2022/07/06 | Phase 1 | Completed | |||
2022/06/30 | Phase 1 | Completed | |||
2022/04/01 | Phase 1 | Active, not recruiting | |||
2021/08/05 | Phase 1 | Completed | |||
2021/07/23 | Phase 3 | Active, not recruiting | |||
2021/04/12 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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