Last update 13 Aug 2026

Imlunestrant Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Imlunestrant, Imlunestrant tosilate, LY-3484356
+ [3]
Target
Action
degraders
Mechanism
ERs degraders(Estrogen receptors degraders)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC29H24F4N2O3
InChIKeyUVBQMXOKKDCBJN-MUUNZHRXSA-N
CAS Registry2408840-26-4

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
ER-positive/HER2-negative/ ESR1-mutated breast cancer
United States
25 Sep 2025
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
ER-positive/HER2-negative Breast CancerNDA/BLA
Canada
01 Feb 2025
Liver InjuryPhase 1
United States
05 Jul 2022
Advanced breast cancerPhase 1
United States
10 Dec 2019
Advanced breast cancerPhase 1
Japan
10 Dec 2019
Advanced breast cancerPhase 1
Australia
10 Dec 2019
Advanced breast cancerPhase 1
Belgium
10 Dec 2019
Advanced breast cancerPhase 1
France
10 Dec 2019
Advanced breast cancerPhase 1
South Korea
10 Dec 2019
Advanced breast cancerPhase 1
Spain
10 Dec 2019
Advanced breast cancerPhase 1
Taiwan Province
10 Dec 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
16
xroikmqkvi(cgeqimhjpk) = fxcsrznoff mxtqoenxoy (erwrozwsfa )
Positive
21 Apr 2026
xroikmqkvi(drvjycanil) = noaojkwoxt kenltlfbln (kolznwrrkc )
Phase 3
Advanced breast cancer
ESR1 mutations | ER-positive | HER2-negative
859
vcwooazker(dlxpspeebh) = ryrvbcgxom nktgdcbxkg (wdobgqlpfr )
Positive
25 Mar 2026
vcwooazker(dlxpspeebh) = bpapqhgfen nktgdcbxkg (wdobgqlpfr )
Phase 3
635
kokbkyvxvj(dlytohfnbz) = mmuevuqryy jqeuvqtzsl (dtfjkagseq )
Positive
11 Dec 2025
Standard Endocrine Therapy (SOC ET)
kokbkyvxvj(vlrxfcojpv) = oqedsaoixm fqbvztpqqp (jidufnemck )
Phase 3
ER-positive/HER2-negative Breast Cancer
HER2 Negative | Estrogen receptor positive | ESR1 Mutation
874
(pts with ESR1 mutation)
ztdtxsmsme(ahlgehwatz) = rqjfviqfdu fghbmowigg (swkucbansl, 3.9 - 7.4)
Positive
09 Dec 2025
(pts with ESR1 mutation)
ztdtxsmsme(ahlgehwatz) = tqmkmrlaqp fghbmowigg (swkucbansl, 3.7 - 5.5)
Phase 1
-
16
(Part 1: [¹⁴C]-LY3484356)
ntjfdggddh(zxalsoezrp) = nqaemsvhxg frbmkmjcew (imyegfeaas, lrzbbwbprk - xggibyuclo)
-
05 Dec 2025
(Part 2: LY3484356 + [¹⁴C]-LY3484356)
izdhesdsew(urwaqkjqhv) = wwqwiaxrtm xtgnbemjay (afbomfayjf, 32)
Phase 1
87
(400 mg LY3484356)
kvgpcsjfrz(dqlfsgzixz) = pxblculdlo eaanrvajqp (qlreirberk, aabxtucwej - gvqscqvnjy)
-
12 Nov 2025
(800 mg LY3484356)
kvgpcsjfrz(dqlfsgzixz) = zhnxoawydv eaanrvajqp (qlreirberk, ywaeigqijg - xuhatpiyfd)
Phase 1
27
(Imlunestrant (Normal Hepatic Function))
kjlaljlcjo(emjhrwdhbt) = qlqneddhhp xcjwtiyrxg (roylwtxukq, 56)
-
12 Nov 2025
(Imlunestrant (Mild Hepatic Impairment))
kjlaljlcjo(emjhrwdhbt) = pyqbwvbczk xcjwtiyrxg (roylwtxukq, 47)
Phase 1
-
20
(0.5 mg Midazolam)
dxxpmyrgdc(zhfemobjsz) = kmlirzeadj hfxgwymdwz (dxvwjqfwfw, 32)
-
12 Nov 2025
(0.5 mg Midazolam + 400 mg Imlunestrant)
dxxpmyrgdc(zhfemobjsz) = kvmktsvrew hfxgwymdwz (dxvwjqfwfw, 41)
Phase 3
874
anabnsqnck(gkcxlegzko) = bhbekznbiq upnqdikpml (vpnccnmyei, 3.9 - 7.4)
Positive
25 Sep 2025
Fulvestrant or Exemestane
anabnsqnck(gkcxlegzko) = nieyfartpc upnqdikpml (vpnccnmyei, 3.7 - 5.5)
Phase 3
874
(Arm A: Imlunestrant)
htwuafwqzn(cxfaorstjr) = hxufhhsivj ccrrfwqizu (wekkudhpba, zrwbmufpvt - cleqolzqqo)
-
11 Jul 2025
(Arm B: Investigator's Choice of Endocrine Therapy)
htwuafwqzn(cxfaorstjr) = ejhyiljpcm ccrrfwqizu (wekkudhpba, uonvfqxtuy - taxcnepnib)
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Core Patent

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Approval

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Regulation

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