Inluriyo

(Imlunestrant)

Phase 2Small molecule

Eli Lilly

Inluriyo is one of 59 small molecule programs targeting Breast Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Breast NeoplasmsRecruiting

Breast CancerPhase 2

Active, not recruiting

Breast NeoplasmsPhase 2

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Inluriyo

Eli Lilly

Phase 2

5 2

Megace

Bristol-Myers Squibb

Preclinical

4 3

MS Contin

Merck & Co.

Preclinical

2 4

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Spravato

WWim Janssens

Preclinical

2 7

Acupan

YYonsei University

Preclinical

1 8

Avastin

Roche

Preclinical

4 9

Paracetamol

GSK

Preclinical

1 10

Zoladex

Luye Pharma Group Ltd.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Breast Cancer

NCT05307705

Q3 2027

Phase 3Active, not recruiting

Breast Cancer

NCT04975308

Q4 2029

Phase 2Recruiting

Breast Neoplasms

NCT07287098

Q3 2030

PreclinicalRecruiting

Breast Cancer

NCT05768139

Clinical

Trials by Indication[1]

Breast Cancer5 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

Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial

Not yet recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT07191717·42 enrolled

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04975308·874 enrolled

Show 2 more trials

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT05307705·193 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

Women1 trial

A Study of Imlunestrant (LY3484356) in Healthy Women

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05509816·20 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

Breast Neoplasms1 trial

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

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 2[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 Cancer5 trials

Women1 trial

Function1 trial

Female1 trial

Breast Neoplasms1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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