{"entity":{"id":"imlunestrant","kind":"drug","name":"Imlunestrant","aka":[],"tldr":"Imlunestrant is Lilly's oral oestrogen-receptor degrader, approved in 2025 for ESR1-mutant breast cancer and shown to work with abemaciclib regardless of mutation.","summary":"EMBER-3: monotherapy PFS benefit confined to ESR1-mutant tumours (HR 0.62; OS 34.5 vs 23.1 months in update); imlunestrant + abemaciclib beat imlunestrant alone in all patients (PFS 10.9 vs 5.5 months, HR 0.59). FDA approved 25 September 2025 for ESR1-mutant disease after ≥1 endocrine line. EMBER-4 tests it as adjuvant therapy.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Imlunestrant"}],"tags":[],"related":["esr1-mutation-ctdna"],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy"],"targets":["estrogen-receptor"],"drugs":[],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":["esr1-mutation","oral-serd"],"trials":["ember-3","nct07287098","nct05514054"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Inluriyo","code":"LY3484356","modality":"Oral SERD","mechanism":"Brain-penetrant oral SERD; pure antagonist that degrades ER.","approvals":[{"region":"US","year":2025,"indication":"ER+/HER2- ESR1-mutated advanced breast cancer after ≥1 line of endocrine therapy"},{"region":"EU","year":2026,"indication":"ESR1-mutant ER+/HER2- mBC; 9 Jan 2026"}],"mechanismSteps":[],"dosing":{"route":"Oral","schedule":"400 mg once daily (approved as monotherapy); combination with abemaciclib studied","monitoring":"Liver enzymes; diarrhoea with abemaciclib"},"toxicity":[{"event":"Diarrhoea (with abemaciclib)","anyGradePct":86,"grade3PlusPct":8},{"event":"Nausea (monotherapy)","anyGradePct":17},{"event":"Fatigue","anyGradePct":23}],"access":[],"regulatoryEvents":[{"date":"2025-09-25","type":"approval","region":"US","note":"Approved as Inluriyo","source":"https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1"},{"date":"2026-09-18","type":"approval","region":"US","note":"With abemaciclib, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-combination-abemaciclib-er-positive-her2-negative-esr1-mutated-advanced-or"}]},"route":"/drugs/imlunestrant/","neighbours":{"biomarker":[{"id":"esr1-mutation-ctdna","kind":"biomarker","name":"ESR1 mutation (ligand-binding domain, usually in ctDNA)","route":"/biomarkers/esr1-mutation-ctdna/"}],"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"},{"id":"oral-serds","kind":"technology","name":"Oral SERDs","route":"/technologies/oral-serds/"}],"target":[{"id":"estrogen-receptor","kind":"target","name":"Estrogen receptor (ERα)","route":"/targets/estrogen-receptor/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"term":[{"id":"esr1-mutation","kind":"term","name":"ESR1 mutation","route":"/terms/esr1-mutation/"},{"id":"oral-serd","kind":"term","name":"Oral SERD","route":"/terms/oral-serd/"}],"trial":[{"id":"nct07287098","kind":"trial","name":"A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer","route":"/trials/nct07287098/"},{"id":"nct05514054","kind":"trial","name":"A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer","route":"/trials/nct05514054/"},{"id":"ember-3","kind":"trial","name":"EMBER-3","route":"/trials/ember-3/"}],"pairing":[{"id":"oral-serd-plus-cdk46-after-esr1","kind":"pairing","name":"Oral SERD + CDK4/6 inhibitor after ESR1 emergence","route":"/pairings/oral-serd-plus-cdk46-after-esr1/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}],"pathway":[{"id":"breast-cancer-signalling","kind":"pathway","name":"Breast cancer (KEGG map)","route":"/pathways/breast-cancer-signalling/"}]}}