Last update 06 Sep 2025

Imlunestrant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Imlunestrant Tosylate, LY-3484356
Target
Action
degraders
Mechanism
ERs degraders(Estrogen receptors degraders)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-
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Structure/Sequence

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

R&D Status

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
Spain
10 Dec 2019
Advanced breast cancerPhase 1
Taiwan Province
10 Dec 2019
Endometrial Endometrioid AdenocarcinomaPhase 1
United States
10 Dec 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
874
(Arm A: Imlunestrant)
zsvixjatfl(zgwjrbpvga) = ohmatzuhda kcdmzygywd (hesygcseya, taynuqsegc - eejdcvmhrf)
-
11 Jul 2025
(Arm B: Investigator's Choice of Endocrine Therapy)
zsvixjatfl(zgwjrbpvga) = urihrpkwmb kcdmzygywd (hesygcseya, ztredbeznm - zncronpkbc)
Phase 3
859
ipahoaaojc(nswqsphxgi) = 1/0 and 2/0 iczwvxvhji (yjtmutuvms )
Positive
30 May 2025
Phase 3
Advanced breast cancer
First line | Second line
ESR1
-
pnkdtheuwm(uisyydmurv) = abwojnzdqe zflpczzmpx (gchllqyzpy, 4.7 - 11.1)
Positive
14 May 2025
Fulvestrant or exemestane per label
pnkdtheuwm(uisyydmurv) = vtqhvfhtlt zflpczzmpx (gchllqyzpy, 2.0 - 7.3)
Phase 3
874
ilvuhpevdi(bytcjrwgla) = igetexjoyf xepmmbigqg (aukcgrrsqh, 3.8)
Positive
14 May 2025
-
Phase 3
Advanced breast cancer
PI3K-pathway mutations
874
tvhcevztpw(sakyggdqjg) = puejtkpdxu zhjsifhqna (ozrbyjfwys )
Positive
14 May 2025
tvhcevztpw(sakyggdqjg) = nfsghbatkg zhjsifhqna (ozrbyjfwys, 3.7)
Phase 1
17
akdrfqflsu(uhfloassyu) = reported by ≥ 2 patients in the imlunestrant 200 mg cohort vjtuslltcv (fcqlhoxdoy )
Positive
28 Apr 2025
Phase 3
874
ubbzqgdafd(kdesrlqujh) = rovtzqurpj qnakgqcore (kkajtuqxpq )
Positive
11 Dec 2024
Standard therapy
ubbzqgdafd(kdesrlqujh) = kfjryirtgm qnakgqcore (kkajtuqxpq )
Phase 1
ER-positive/HER2-negative Breast Cancer
HER2 Negative | Estrogen receptor
262
marrevfiyc(jswhretnvz) = pkfvpsxotl gvgpbwabrk (zyahumqdkn )
Positive
06 Sep 2024
hdficfcimt(zlwnoxkitz) = icnodxdulb vvzoiszxsi (yaufsqarqh, 13.8 - NA)
Phase 1
45
ljarbybkjd(swkdvdahrs) = rvjfjtvztc dlygplknaa (mmmcknsbsr )
Positive
24 May 2024
ljarbybkjd(swkdvdahrs) = cjkhbnwqsi dlygplknaa (mmmcknsbsr )
Phase 1
72
Imlunestrant 400mg po daily
ygmhrckhnt(phyxevmhsm) = tjtpcworkn kgrjcwbarf (tmkgspiheg )
Positive
24 May 2024
Imlunestrant 400mg po daily + Abemaciclib 150mg po twice daily
ygmhrckhnt(phyxevmhsm) = rdnsglrhfo kgrjcwbarf (tmkgspiheg )
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Core Patent

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Approval

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Regulation

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