Imlunestrant
Chemical compound
From Wikipedia, the free encyclopedia
Imlunestrant, sold under the brand name Inluriyo, is an anti-cancer medication used for the treatment of breast cancer.[1] It is an estrogen receptor antagonist.[1] It is used as the salt, imlunestrant tosylate.[4] It is taken by mouth.[1] It was developed by Eli Lilly and Company.[4]
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| Pronunciation | /ˌɪmlʊˈnɛstrənt/ IM-luu-NES-trənt |
| Trade names | Inluriyo |
| Other names | LY3484356, LY-3484356 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625104 |
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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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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.[4]
Imlunestrant was approved for medical use in the United States in September 2025,[4] and in the European Union in January 2026.[2][3]
Medical uses
History
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.[4] Participants were excluded if they were eligible to receive a PARP inhibitor.[4]
Participants were randomized 1:1:1 to imlunestrant, an investigator's choice of endocrine therapy (fulvestrant or exemestane), or an additional investigational combination regimen.[4] Randomization was stratified by previous treatment with a CDK4/6 inhibitor, presence of visceral metastasis, and geographic region.[4] 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.[4]
The US Food and Drug Administration granted the application of imlunestrant fast track designation.[4]
Society and culture
Legal status
Imlunestrant was approved for medical use in the United States in September 2025.[4][5]
In November 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Inluriyo, intended for the treatment of adults with locally advanced or metastatic breast cancer with an activating ESR1-mutation.[2] The applicant for this medicinal product is Eli Lilly Nederland B.V.[2] Imlunestrant was authorized for medical use in the European Union in January 2026.[2][3]
Names
Imlunestrant is the international nonproprietary name.[6]
Imlunestrant is sold under the brand name Inluriyo.[1]
