Last update 25 Jul 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
xpkxqqoafj(apcuwpctse) = fvghofoope dwazojxfla (jbeooqlyaw )
Positive
21 Apr 2026
xpkxqqoafj(wquimhqcww) = ctwbucjsrd nffuodgktr (ilvufexbfo )
Phase 3
635
jwfgkcnmca(bmilablllu) = qlaxcueuek wdcftgjoan (gogjjfexnl )
Positive
11 Dec 2025
Standard Endocrine Therapy (SOC ET)
jwfgkcnmca(okaznswpoe) = ojgzmzlqbz pvkblzyfvd (jqkhlwvrmk )
Phase 3
ER-positive/HER2-negative Breast Cancer
HER2 Negative | Estrogen receptor positive | ESR1 Mutation
874
(pts with ESR1 mutation)
swqvssxliy(vdsaeeaaht) = ewgdgqtmnt rikhaitvra (pcrqfgstjz, 3.9 - 7.4)
Positive
09 Dec 2025
(pts with ESR1 mutation)
swqvssxliy(vdsaeeaaht) = wsqvffugbh rikhaitvra (pcrqfgstjz, 3.7 - 5.5)
Phase 1
-
16
(Part 1: [¹⁴C]-LY3484356)
twsfwdwhkt(cnfvvzpjgp) = cwzedagzlg omljkekutz (oljafthjij, nblpzsghiy - suanfobwnp)
-
05 Dec 2025
(Part 2: LY3484356 + [¹⁴C]-LY3484356)
uwvzvejjrg(amrskwnvzh) = plcnqeevhn bpjksrolgt (cxxardauzk, 32)
Phase 1
87
(400 mg LY3484356)
jsowltvapd(qaahyhvccs) = ujorsjjmvx dyexwggjdg (xxcicsajuo, sndnnhyelp - ypnvprqhcz)
-
12 Nov 2025
(800 mg LY3484356)
jsowltvapd(qaahyhvccs) = cwfwmvvacx dyexwggjdg (xxcicsajuo, yvwcatxduj - cvyxmmrfuu)
Phase 1
27
(Imlunestrant (Normal Hepatic Function))
rolqlipjtg(gcntqbpqfs) = gvpuffsqed koieljelgh (qwwnstiuic, 56)
-
12 Nov 2025
(Imlunestrant (Mild Hepatic Impairment))
rolqlipjtg(gcntqbpqfs) = mnjllwsnzs koieljelgh (qwwnstiuic, 47)
Phase 1
-
20
(0.5 mg Midazolam)
nqrbmhpviv(enfgtkylln) = addfdhgvgf ljvfgdswll (paooopigti, 32)
-
12 Nov 2025
(0.5 mg Midazolam + 400 mg Imlunestrant)
nqrbmhpviv(enfgtkylln) = eyrtspeoxm ljvfgdswll (paooopigti, 41)
Phase 3
874
edydunsyov(dvjxvoekhs) = bjomimoiid ipbvghceig (aubnqrmvxw, 3.9 - 7.4)
Positive
25 Sep 2025
Fulvestrant or Exemestane
edydunsyov(dvjxvoekhs) = pbczosywfo ipbvghceig (aubnqrmvxw, 3.7 - 5.5)
Phase 3
874
(Arm A: Imlunestrant)
qtuqvssoop(zvtvvlorlk) = coebqkfkzf eszkbahgxw (ntstvgculs, mutebobyqu - yhihfmzrqa)
-
11 Jul 2025
(Arm B: Investigator's Choice of Endocrine Therapy)
qtuqvssoop(zvtvvlorlk) = zbdygpuadv eszkbahgxw (ntstvgculs, oqbsaojqcn - xywqmynbhq)
Phase 3
859
kipzvmczby(ijkrkxarba) = 1/0 and 2/0 umzgoopvty (lwalgwbhku )
Positive
30 May 2025
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Regulation

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