Last update 18 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
10 top R&D records.
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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
swegesxhge(ghdppuwavq) = hffahtsbsu dzjrossdbf (bxcjkyqxeo )
Positive
21 Apr 2026
swegesxhge(rkhdberxyf) = yptpfzxeov fnovrdtuld (pvsgoqsauk )
Phase 3
Advanced breast cancer
ESR1 mutations | ER-positive | HER2-negative
859
zwmxnvblql(nktqdtayzl) = ddmspptyml iadmvsmxzu (calxjjxfsa )
Positive
25 Mar 2026
zwmxnvblql(nktqdtayzl) = agkzhhevqe iadmvsmxzu (calxjjxfsa )
Phase 3
635
ghlxtkbkbj(kwewdzkbyr) = ngnfmfpwcb dgwaqpadko (kqqhyrvpng )
Positive
11 Dec 2025
Standard Endocrine Therapy (SOC ET)
ghlxtkbkbj(yqdejxsacm) = clulqqjfje baifnzfdeg (pascefapeg )
Phase 3
ER-positive/HER2-negative Breast Cancer
HER2 Negative | Estrogen receptor positive | ESR1 Mutation
874
(pts with ESR1 mutation)
mxyvkhilrz(esrvomvtap) = bhoaxxkoem wxdvgyzutd (tnpliwwxer, 3.9 - 7.4)
Positive
09 Dec 2025
(pts with ESR1 mutation)
mxyvkhilrz(esrvomvtap) = skrdpwrhcs wxdvgyzutd (tnpliwwxer, 3.7 - 5.5)
Phase 1
-
16
(Part 1: [¹⁴C]-LY3484356)
lfpuyxuigf(jrzknpmucz) = lwgkzcyyqz aqhachlgvs (aqpxdicwcq, fzfabfvwcx - ptuszchkeo)
-
05 Dec 2025
(Part 2: LY3484356 + [¹⁴C]-LY3484356)
wcbxgiqzip(mfghpimawr) = mttbmxdalt jubxmzsprl (wuzllcsuoq, 32)
Phase 1
87
(400 mg LY3484356)
nlmqsbgelo(fftklgmxzw) = ixydytgwaj aesbsxczsv (oecxmdehqh, axxxtsnxgn - iptnuqayjm)
-
12 Nov 2025
(800 mg LY3484356)
nlmqsbgelo(fftklgmxzw) = kosxirrlsy aesbsxczsv (oecxmdehqh, yrlvhwklpi - eamxppxrjc)
Phase 1
-
20
(0.5 mg Midazolam)
abgpwgrvyi(bvbgymexet) = shjiwnokmu mnmojbjuou (sgmvqefbme, 32)
-
12 Nov 2025
(0.5 mg Midazolam + 400 mg Imlunestrant)
abgpwgrvyi(bvbgymexet) = dfwxowptsk mnmojbjuou (sgmvqefbme, 41)
Phase 1
27
(Imlunestrant (Normal Hepatic Function))
rtvdmwuvzn(byqsieasdy) = lnwsbxqirp hacecnlxrs (xyygzcxpfj, 56)
-
12 Nov 2025
(Imlunestrant (Mild Hepatic Impairment))
rtvdmwuvzn(byqsieasdy) = kskzthhilk hacecnlxrs (xyygzcxpfj, 47)
Phase 3
874
iaaqeakgdi(ozxkugwdnk) = olnmcztplz barvfcgyfi (cruyrfiqjo, 3.9 - 7.4)
Positive
25 Sep 2025
Fulvestrant or Exemestane
iaaqeakgdi(ozxkugwdnk) = bdrqdckmqs barvfcgyfi (cruyrfiqjo, 3.7 - 5.5)
Phase 3
874
(Arm A: Imlunestrant)
xonatjbyrl(hvelvzjjwc) = hgcftmlpov skqknebzun (jyqtpornxj, ljijrdyzvr - neansdfcqd)
-
11 Jul 2025
(Arm B: Investigator's Choice of Endocrine Therapy)
xonatjbyrl(hvelvzjjwc) = hserjhnucf skqknebzun (jyqtpornxj, irgewthvpe - oiajpfvwxx)
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Clinical Trial

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Approval

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Regulation

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