Inluriyo

(Imlunestrant)

Phase 3Small molecule

Eli Lilly

Inluriyo is one of 58 small molecule programs targeting Breast Neoplasms. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Breast NeoplasmsActive, not recruiting

Anatomic Stage I Breast Cancer AJCC V8Recruiting

Breast CancerActive, not recruiting

Breast NeoplasmsPhase 3

Active, not recruiting

Anatomic Stage I Breast Cancer AJCC V8Phase 2

Recruiting

Breast CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Inluriyo

Eli Lilly

Phase 3

3 2

Adenocard

Astellas

Preclinical

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 5

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 6

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 7

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 8

Bisphosphonate

Amgen

Preclinical

2 9

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 10

4SCAR T Cells

SShenzhen Geno-Immune Medical Institute

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Breast Cancer

NCT05307705

Q3 2027

Phase 3Active, not recruiting

Breast Neoplasms

NCT04975308

Q4 2029

Phase 2Recruiting

Breast Neoplasms

NCT07287098

Q3 2030

PreclinicalRecruiting

Breast Cancer

NCT05768139

Clinical

Trials by Indication[1]

Breast Cancer3 trials

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05514054·8,000 enrolled

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT05307705·260 enrolled

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Recruiting· Eli Lilly logo

Eli Lilly·Preclinical·NCT05768139·880 enrolled

Breast Neoplasms2 trials

preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07287098·600 enrolled

EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04975308·874 enrolled

Function1 trial

A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05440344·27 enrolled

Female1 trial

A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05444556·113 enrolled

Women1 trial

A Study of Imlunestrant (LY3484356) in Healthy Women

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05509816·20 enrolled

1 more indication

Anatomic Stage I Breast Cancer AJCC v81 trial

Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT07191717·42 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 25, 2025

INLURIYO

NDA NDA218881

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Imlunestrant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Imlunestrant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Imlunestrant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218881). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Inluriyo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Eli Lilly

Patent Landscape[5]

Patent Cliff

Jul 11, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11117902Jul 11, 2039

10654866Jul 11, 2039

Inluriyo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2029

Q3 2030

Trials by Indication[1]

Breast Cancer3 trials

Breast Neoplasms2 trials

Function1 trial

Female1 trial

Women1 trial

Anatomic Stage I Breast Cancer AJCC v81 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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