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| Trade names | Inluriyo |
| Other names | LY3484356, LY-3484356 |
| AHFS/Drugs.com | Inluriyo |
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| Routes of administration | By mouth |
| Drug class | Estrogen receptor antagonist |
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| Formula | C29H24F4N2O3 |
| Molar mass | 524.516 g·mol−1 |
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Imlunestrant, sold under the brand name Inluriyo, is an anti-cancer medication used for the treatment of breast cancer.[1] It is an is an estrogen receptor antagonist.[1] It is used as the salt, imlunestrant tosylate.[2] It is taken by mouth.[1] It was developed by Eli Lilly and Company.[2]
The most common adverse events and laboratory abnormalities include decreased hemoglobin, musculoskeletal pain, decreased calcium, decreased neutrophils, increased AST, fatigue, diarrhea, increased ALT, increased triglycerides, nausea, decreased platelets, constipation, increased cholesterol, and abdominal pain.[2]
Imlunestrant was approved for medical use in the United States in September 2025.[2]
Imlunestrant is indicated for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.[1][2]
Efficacy was evaluated in EMBER-3 (NCT04975308), a randomized, open-label, active-controlled, multi-center trial that enrolled 874 participants with ER-positive, HER2-negative locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor either alone or in combination with a CDK4/6 inhibitor.[2] Participants were excluded if they were eligible to receive a PARP inhibitor.[2]
Participants were randomized 1:1:1 to imlunestrant, an investigator's choice of endocrine therapy (fulvestrant or exemestane), or an additional investigational combination regimen.[2] Randomization was stratified by previous treatment with a CDK4/6 inhibitor, presence of visceral metastasis, and geographic region.[2] ESR1 mutational status was determined by blood circulating tumor deoxyribonucleic acid (ctDNA) analysis using the Guardant360 CDx assay and was limited to specific ESR1 mutations in the ligand-binding domain.[2]
The US Food and Drug Administration granted the application of imlunestrant fast track designation.[2]
Imlunestrant was approved for medical use in the United States in September 2025.[2][3]
Imlunestrant is the international nonproprietary name.[4]
Imlunestrant is sold under the brand name Inluriyo.[1]
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