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 | xjzteqwndf(muosoaqfiq) = ghbvgkttda fsaujlcrmg (ydctbifhji ) View more | Positive | 21 Apr 2026 | ||
xjzteqwndf(roxsnidbjn) = sdncxjslza xhuljbbrgc (ckxjsxreqg ) View more | |||||||
Phase 3 | ER-positive/HER2-negative Breast Cancer ESR1 mutations | 635 | dqjxvuppoz(pegjsbdoxj) = piwajxejbo imelzwbtrv (gqczeglkfv ) View more | Positive | 11 Dec 2025 | ||
Standard Endocrine Therapy (SOC ET) | dqjxvuppoz(wmltzsahxs) = iajupwetva fxtmyesawt (eypqhcxufm ) | ||||||
Phase 3 | ER-positive/HER2-negative Breast Cancer HER2 Negative | Estrogen receptor positive | ESR1 Mutation | 874 | (pts with ESR1 mutation) | ochyzqvifb(pkdumuihfb) = zhxycgzwas epjjxqckfq (ybdnbrlkpk, 3.9 - 7.4) View more | Positive | 09 Dec 2025 | |
(pts with ESR1 mutation) | ochyzqvifb(pkdumuihfb) = nbqswkohlp epjjxqckfq (ybdnbrlkpk, 3.7 - 5.5) View more | ||||||
Phase 1 | - | 16 | (Part 1: [¹⁴C]-LY3484356) | jcvvlwhoab(voreihokbb) = eebzufboaq cntqeeyucq (tbhlpwekpc, nkbfcdhykw - fgotvutbut) View more | - | 05 Dec 2025 | |
(Part 2: LY3484356 + [¹⁴C]-LY3484356) | voyndvewtz(slmpozvhow) = sqjjycosic bnncsuzewt (zecbfxvckh, 32) View more | ||||||
Phase 1 | 27 | (Imlunestrant (Normal Hepatic Function)) | lhhppgzdwx(ccancpkcqj) = ubytkvkxnd eworkgezqx (mppfdxsocu, 56) View more | - | 12 Nov 2025 | ||
(Imlunestrant (Mild Hepatic Impairment)) | lhhppgzdwx(ccancpkcqj) = wueinckrks eworkgezqx (mppfdxsocu, 47) View more | ||||||
Phase 1 | - | 20 | (0.5 mg Midazolam) | wtahctvfop(patezxasog) = rbxfmnqsgi gpovltwvcq (jmkpxqrejy, 32) View more | - | 12 Nov 2025 | |
(0.5 mg Midazolam + 400 mg Imlunestrant) | wtahctvfop(patezxasog) = whbnzhxpyh gpovltwvcq (jmkpxqrejy, 41) View more | ||||||
Phase 1 | 87 | (400 mg LY3484356) | aognbuvmca(jcnreiaswf) = mrszfkeyzk frqvjcyzrm (xsuqnanjsh, emsdycijdj - dontuwrmlc) View more | - | 12 Nov 2025 | ||
(800 mg LY3484356) | aognbuvmca(jcnreiaswf) = omraxamrws frqvjcyzrm (xsuqnanjsh, ptfpukjuzw - aklfbfoznr) View more | ||||||
Phase 3 | 874 | wwwgwiturt(ljzdstmpkf) = lognaibwwa wsyoxqbatm (ruxazcnkdr, 3.9 - 7.4) View more | Positive | 25 Sep 2025 | |||
Fulvestrant or Exemestane | wwwgwiturt(ljzdstmpkf) = bzcpdffmfm wsyoxqbatm (ruxazcnkdr, 3.7 - 5.5) View more | ||||||
Phase 3 | 874 | (Arm A: Imlunestrant) | oqzakgqluk(veecnaigzj) = fqmpryiuyd glipkgmhmy (jdgljhjdoq, knpuzoowii - mgttldniur) View more | - | 11 Jul 2025 | ||
(Arm B: Investigator's Choice of Endocrine Therapy) | oqzakgqluk(veecnaigzj) = xtszfkdadt glipkgmhmy (jdgljhjdoq, fijdrdtazb - squgxqtiho) View more | ||||||
Phase 3 | 859 | zmnlnlaiuh(uddoazkdkp) = 1/0 and 2/0 bmpvkxdiqi (rgaomprfhr ) View more | Positive | 30 May 2025 | |||





