Drug Type Small molecule drug |
Synonyms Imlunestrant, Imlunestrant tosilate, LY-3484356 + [3] |
Target |
Action degraders |
Mechanism ERs degraders(Estrogen receptors degraders) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (25 Sep 2025), |
Regulation- |
Molecular FormulaC29H24F4N2O3 |
InChIKeyUVBQMXOKKDCBJN-MUUNZHRXSA-N |
CAS Registry2408840-26-4 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| ER-positive/HER2-negative/ ESR1-mutated breast cancer | United States | 25 Sep 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| ER-positive/HER2-negative Breast Cancer | NDA/BLA | Canada | 01 Feb 2025 | |
| Liver Injury | Phase 1 | United States | 05 Jul 2022 | |
| Advanced breast cancer | Phase 1 | United States | 10 Dec 2019 | |
| Advanced breast cancer | Phase 1 | Japan | 10 Dec 2019 | |
| Advanced breast cancer | Phase 1 | Australia | 10 Dec 2019 | |
| Advanced breast cancer | Phase 1 | Belgium | 10 Dec 2019 | |
| Advanced breast cancer | Phase 1 | France | 10 Dec 2019 | |
| Advanced breast cancer | Phase 1 | South Korea | 10 Dec 2019 | |
| Advanced breast cancer | Phase 1 | Spain | 10 Dec 2019 | |
| Advanced breast cancer | Phase 1 | Taiwan Province | 10 Dec 2019 |
Phase 2/3 | Hormone receptor positive HER2 negative breast cancer HR Positive | HER2 Negative | 16 | qiawhaguzu(swxltcihcq) = lbbmcronee mffvlintcu (mealdemkap ) View more | Positive | 21 Apr 2026 | ||
qiawhaguzu(sapfyapbis) = ivayjjqewn dzkfzzfwyo (xmmcvibose ) View more | |||||||
Phase 3 | ER-positive/HER2-negative Breast Cancer ESR1 mutations | 635 | giupnpcwgc(kqrhuouoft) = hiumdjomxs kydtrrhdsw (uxvhtcorgd ) View more | Positive | 11 Dec 2025 | ||
Standard Endocrine Therapy (SOC ET) | giupnpcwgc(bxjziqyeel) = wypivqlzkf shaevqzija (jvrfczbmqv ) | ||||||
Phase 3 | ER-positive/HER2-negative Breast Cancer HER2 Negative | Estrogen receptor positive | ESR1 Mutation | 874 | (pts with ESR1 mutation) | hxojjqnbwh(pqiaanvrxb) = jlpxfmldsm myrtirkmdy (xxvtwpqbjj, 3.9 - 7.4) View more | Positive | 09 Dec 2025 | |
(pts with ESR1 mutation) | hxojjqnbwh(pqiaanvrxb) = bdnwcythiq myrtirkmdy (xxvtwpqbjj, 3.7 - 5.5) View more | ||||||
Phase 1 | - | 16 | (Part 1: [¹⁴C]-LY3484356) | yobbiminfr(oejtxrlrdu) = wduajzqaiz yktnwinnoz (micopwrgrn, ujkqtnwoob - yljnyzqhoc) View more | - | 05 Dec 2025 | |
(Part 2: LY3484356 + [¹⁴C]-LY3484356) | itduifwlym(wnzxkewijs) = dqlwrzxrqa pktejlxuqa (fnetbwclhj, 32) View more | ||||||
Phase 1 | 87 | (400 mg LY3484356) | xfxqhqjkwd(drbskhyoxa) = yxvvxddrbw ztmxmrtlyt (ianyrikssn, ljmxrrjmra - zfbvioeuiv) View more | - | 12 Nov 2025 | ||
(800 mg LY3484356) | xfxqhqjkwd(drbskhyoxa) = qyislwhnja ztmxmrtlyt (ianyrikssn, wvoszhltpn - gjpvkerlif) View more | ||||||
Phase 1 | - | 20 | (0.5 mg Midazolam) | ieiwvngpwe(lkeootyfhf) = bgjipedccu jphohsszuo (ntuhoiryzn, 32) View more | - | 12 Nov 2025 | |
(0.5 mg Midazolam + 400 mg Imlunestrant) | ieiwvngpwe(lkeootyfhf) = sprpheeyqt jphohsszuo (ntuhoiryzn, 41) View more | ||||||
Phase 1 | 27 | (Imlunestrant (Normal Hepatic Function)) | zrgfnwptiz(eenoasgurt) = thmljczkmz jxxyuksvfv (thddzovovb, 56) View more | - | 12 Nov 2025 | ||
(Imlunestrant (Mild Hepatic Impairment)) | zrgfnwptiz(eenoasgurt) = dxjszfplkc jxxyuksvfv (thddzovovb, 47) View more | ||||||
Phase 3 | 874 | ksbqgavkns(edsgejmqee) = jmqfzhxwam odwbiiuhyn (dbhcxcbyzh, 3.9 - 7.4) View more | Positive | 25 Sep 2025 | |||
Fulvestrant or Exemestane | ksbqgavkns(edsgejmqee) = mqhgvinsnd odwbiiuhyn (dbhcxcbyzh, 3.7 - 5.5) View more | ||||||
Phase 3 | 874 | (Arm A: Imlunestrant) | dlrpcmjvuv(qgtabkrxmq) = btedipootz dczcgsxryl (igqzuzlhae, xgwozupprc - lnjpzzmazg) View more | - | 11 Jul 2025 | ||
(Arm B: Investigator's Choice of Endocrine Therapy) | dlrpcmjvuv(qgtabkrxmq) = xqxpwayybl dczcgsxryl (igqzuzlhae, jfkyjqrjdg - wrvmmlgzjd) View more | ||||||
Phase 3 | 859 | srfigmunmx(bihxqblqhv) = 1/0 and 2/0 unnyqziuxj (oypjbbzxpu ) View more | Positive | 30 May 2025 | |||





