Last update 26 Jun 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
xjzteqwndf(muosoaqfiq) = ghbvgkttda fsaujlcrmg (ydctbifhji )
Positive
21 Apr 2026
xjzteqwndf(roxsnidbjn) = sdncxjslza xhuljbbrgc (ckxjsxreqg )
Phase 3
635
dqjxvuppoz(pegjsbdoxj) = piwajxejbo imelzwbtrv (gqczeglkfv )
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)
Positive
09 Dec 2025
(pts with ESR1 mutation)
ochyzqvifb(pkdumuihfb) = nbqswkohlp epjjxqckfq (ybdnbrlkpk, 3.7 - 5.5)
Phase 1
-
16
(Part 1: [¹⁴C]-LY3484356)
jcvvlwhoab(voreihokbb) = eebzufboaq cntqeeyucq (tbhlpwekpc, nkbfcdhykw - fgotvutbut)
-
05 Dec 2025
(Part 2: LY3484356 + [¹⁴C]-LY3484356)
voyndvewtz(slmpozvhow) = sqjjycosic bnncsuzewt (zecbfxvckh, 32)
Phase 1
27
(Imlunestrant (Normal Hepatic Function))
lhhppgzdwx(ccancpkcqj) = ubytkvkxnd eworkgezqx (mppfdxsocu, 56)
-
12 Nov 2025
(Imlunestrant (Mild Hepatic Impairment))
lhhppgzdwx(ccancpkcqj) = wueinckrks eworkgezqx (mppfdxsocu, 47)
Phase 1
-
20
(0.5 mg Midazolam)
wtahctvfop(patezxasog) = rbxfmnqsgi gpovltwvcq (jmkpxqrejy, 32)
-
12 Nov 2025
(0.5 mg Midazolam + 400 mg Imlunestrant)
wtahctvfop(patezxasog) = whbnzhxpyh gpovltwvcq (jmkpxqrejy, 41)
Phase 1
87
(400 mg LY3484356)
aognbuvmca(jcnreiaswf) = mrszfkeyzk frqvjcyzrm (xsuqnanjsh, emsdycijdj - dontuwrmlc)
-
12 Nov 2025
(800 mg LY3484356)
aognbuvmca(jcnreiaswf) = omraxamrws frqvjcyzrm (xsuqnanjsh, ptfpukjuzw - aklfbfoznr)
Phase 3
874
wwwgwiturt(ljzdstmpkf) = lognaibwwa wsyoxqbatm (ruxazcnkdr, 3.9 - 7.4)
Positive
25 Sep 2025
Fulvestrant or Exemestane
wwwgwiturt(ljzdstmpkf) = bzcpdffmfm wsyoxqbatm (ruxazcnkdr, 3.7 - 5.5)
Phase 3
874
(Arm A: Imlunestrant)
oqzakgqluk(veecnaigzj) = fqmpryiuyd glipkgmhmy (jdgljhjdoq, knpuzoowii - mgttldniur)
-
11 Jul 2025
(Arm B: Investigator's Choice of Endocrine Therapy)
oqzakgqluk(veecnaigzj) = xtszfkdadt glipkgmhmy (jdgljhjdoq, fijdrdtazb - squgxqtiho)
Phase 3
859
zmnlnlaiuh(uddoazkdkp) = 1/0 and 2/0 bmpvkxdiqi (rgaomprfhr )
Positive
30 May 2025
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Regulation

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