Dashboard PDUFA PDUFA History Dilution Watch Downside Radar Missed Milestones Earnings Big Movers Blog

🎤 Upcoming Biotech Conferences

Loading conferences...

Free to browse, no account needed Follow the companies behind these drugs with free AI briefings, catalyst countdowns and dilution alerts.

Start 7-day free trial → Log in

Imlunestrant · Inluriyo, LY-3484356

Small molecule · Degrader of estrogen receptor alpha (ESR1) · developed by Eli Lilly And Co

Approved FDA, Sep 2025

LLY Developer

1 Registered trials

What is Imlunestrant?

Imlunestrant is an orally available selective estrogen receptor degrader that binds estrogen receptor alpha and induces its degradation, blocking ER-dependent gene transcription and proliferation of ER-positive cancer cells.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Inluriyo, LY-3484356
Drug type: Small molecule
Targets: estrogen receptor alpha (ESR1)
Mechanism: Degrader of estrogen receptor alpha (ESR1)
Pathways: ER-dependent gene transcription, estrogen receptor signaling
Therapy area: Oncology
Developer: Eli Lilly And Co (LLY)
FDA status: Approved as Inluriyo (September 25, 2025), NDA218881 · FDA label
UNII: 9CXQ3PF69U

✅ FDA-approved uses

ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

From the indications section of the FDA label (version of Jun 4, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07287098	Phase 2	Breast Neoplasms	Recruiting	LLY

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Breast Neoplasms

Other drugs acting on ESR1

Camizestrant FDA approved Ethinyl Estradiol/Levonorgestrel FDA approved Segesterone Acetate and Ethinyl Estradiol FDA approved Tamoxifen FDA approved Vepdegestrant FDA approved Giredestrant Phase 1/2 Zuclomiphene Phase 2

More from Eli Lilly And Co

Abemaciclib FDA approved Baricitinib FDA approved Donanemab FDA approved Dulaglutide FDA approved Lebrikizumab FDA approved Mirikizumab FDA approved Orforglipron FDA approved Pirtobrutinib FDA approved Selpercatinib FDA approved Tirzepatide FDA approved Brenipatide Phase 3 Clazakizumab Phase 2

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the LLY page.

Follow LLY, the company behind Imlunestrant

See LLY's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

LLY catalysts and pipeline →

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z