{"entity":{"id":"elacestrant","kind":"drug","name":"Elacestrant","aka":[],"tldr":"Elacestrant was the first oral oestrogen-receptor degrader (2023), for ESR1-mutant breast cancer detected by blood test.","summary":"Elacestrant is an oral selective oestrogen receptor degrader (SERD) that binds ER-alpha and promotes its degradation, retaining activity against ESR1 mutations. Taken as 345 mg once daily with food, it was approved in 2023, the first oral SERD, for ESR1-mutant ER-positive, HER2-negative advanced breast cancer after at least one endocrine therapy. In EMERALD the progression-free survival benefit was confined to ESR1-mutant disease, and the Guardant360 CDx blood test is the companion diagnostic, so eligibility is decided by liquid biopsy. Stemline/Menarini markets it. Imlunestrant (Lilly, Inluriyo, 2025) and camizestrant (AstraZeneca, SERENA-6 ctDNA-guided switch) followed, and whether to switch when an ESR1 mutation first appears in blood is the live question. For a newcomer: an oestrogen-blocking pill chosen by a blood test.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Elacestrant","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Elacestrant"}],"tags":[],"related":["er-status","esr1-mutation-ctdna"],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy","liquid-biopsy"],"targets":["estrogen-receptor"],"drugs":[],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07766018","nct05596409","nct05563220","nct06492616","nct05386108","nct05573126"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Orserdu","modality":"Oral SERD","mechanism":"Oral selective ER degrader.","approvals":[{"region":"US","year":2023,"indication":"ESR1-mutant ER+/HER2- advanced breast cancer after ≥1 endocrine therapy"}],"mechanismSteps":["Oral SERD binds ERα","Receptor conformation changes and ER is degraded","ESR1-mutant, ligand-independent receptors are removed","ER-dependent transcription stops"],"dosing":{"route":"Oral","schedule":"345 mg once daily with food","modifications":"Reduce to 258 then 172 mg for grade 3 toxicity","monitoring":"Lipids at baseline and periodically","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Nausea","note":"EMERALD: 35% any grade"},{"event":"Musculoskeletal pain"},{"event":"Vomiting"},{"event":"Fatigue"},{"event":"Dyspepsia"},{"event":"Hypercholesterolaemia"}],"access":[{"country":"US","reimbursement":"Medicare Part D (oral); commercial plans per formulary, often with prior authorisation","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for ESR1-mutated ER+/HER2- advanced breast cancer (2024)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2023-01-27","type":"approval","region":"US","note":"ESR1-mutated ER+/HER2- advanced breast cancer after ≥1 endocrine therapy (EMERALD): first oral SERD","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-09","type":"approval","region":"EU","note":"EMA approval","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/elacestrant/","neighbours":{"biomarker":[{"id":"er-status","kind":"biomarker","name":"ER status (oestrogen receptor by IHC)","route":"/biomarkers/er-status/"},{"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":"fes-pet","kind":"technology","name":"FES PET (oestrogen receptor imaging)","route":"/technologies/fes-pet/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"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":"menarini","kind":"company","name":"Menarini / Stemline","route":"/companies/menarini/"}],"trial":[{"id":"nct07766018","kind":"trial","name":"A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer","route":"/trials/nct07766018/"},{"id":"nct06492616","kind":"trial","name":"A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence","route":"/trials/nct06492616/"},{"id":"nct05596409","kind":"trial","name":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study","route":"/trials/nct05596409/"},{"id":"emerald","kind":"trial","name":"EMERALD","route":"/trials/emerald/"},{"id":"nct05563220","kind":"trial","name":"Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer","route":"/trials/nct05563220/"},{"id":"nct05573126","kind":"trial","name":"Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer","route":"/trials/nct05573126/"},{"id":"nct05386108","kind":"trial","name":"Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer","route":"/trials/nct05386108/"}],"term":[{"id":"esr1-mutation","kind":"term","name":"ESR1 mutation","route":"/terms/esr1-mutation/"},{"id":"hormone-therapy","kind":"term","name":"Hormone therapy","route":"/terms/hormone-therapy/"},{"id":"oral-serd","kind":"term","name":"Oral SERD","route":"/terms/oral-serd/"},{"id":"serd","kind":"term","name":"Selective oestrogen receptor degrader (SERD)","route":"/terms/serd/"}],"pathway":[{"id":"breast-cancer-signalling","kind":"pathway","name":"Breast cancer (KEGG map)","route":"/pathways/breast-cancer-signalling/"},{"id":"chemical-carcinogenesis-receptor-activation","kind":"pathway","name":"Chemical carcinogenesis - receptor activation","route":"/pathways/chemical-carcinogenesis-receptor-activation/"},{"id":"er-signaling","kind":"pathway","name":"Oestrogen receptor signalling","route":"/pathways/er-signaling/"},{"id":"resistance-routes-map","kind":"pathway","name":"Resistance routes: how a blocked pathway comes back","route":"/pathways/resistance-routes-map/"},{"id":"transcription-addiction","kind":"pathway","name":"Transcriptional machinery & addiction","route":"/pathways/transcription-addiction/"}],"person":[{"id":"aditya-bardia","kind":"person","name":"Aditya Bardia","route":"/people/aditya-bardia/"},{"id":"francois-clement-bidard","kind":"person","name":"François-Clément Bidard","route":"/people/francois-clement-bidard/"}],"paper":[{"id":"paper-emerald-elacestrant-jco-2022","kind":"paper","name":"EMERALD: elacestrant versus standard endocrine therapy after a CDK4/6 inhibitor","route":"/key-papers/paper-emerald-elacestrant-jco-2022/"}],"drug":[{"id":"guardant360-cdx","kind":"drug","name":"Guardant360 CDx","route":"/drugs/guardant360-cdx/"}],"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/"}]}}