Last update 02 Apr 2026

Giredestrant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Giredestrant (USAN/INN), 吉瑞司群, GDC-49545
+ [3]
Target
Action
antagonists
Mechanism
ERs antagonists(Estrogen receptors antagonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-
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Structure/Sequence

Molecular FormulaC27H31F5N4O
InChIKeyGQCXHIKRWBIQMD-AKJBCIBTSA-N
CAS Registry1953133-47-5

External Link

KEGGWikiATCDrug Bank
D11961---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ER-positive/HER2-negative/ ESR1-mutated breast cancerNDA/BLA
United States
28 Feb 2026
Estrogen receptor positive breast cancerPhase 3
United States
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
Japan
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
Argentina
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
Germany
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
Greece
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
Italy
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
Singapore
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
South Africa
03 Aug 2022
Estrogen receptor positive breast cancerPhase 3
South Korea
03 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
92
jeyaskcxvw(xtvouzsboo) = imoxrojimw eufmfsuxvl (nkjoiplnuy, xnvffqgqbt - uwopeswujq)
-
19 Mar 2026
(Arm B)
jeyaskcxvw(xtvouzsboo) = mjqadvhqno eufmfsuxvl (nkjoiplnuy, zdhwsewfrk - dgzvqrvcwj)
Phase 3
ER-positive/HER2-negative Breast Cancer
HER2 Negative | ER Positive
4,170
ngbnkydzps(zjyrjnwoex) = pyockozjjw apjoiagdck (cfkajqgnwm )
Positive
09 Dec 2025
Standard-of-care ET (tamoxifen or aromatase inhibitor)
ngbnkydzps(zjyrjnwoex) = dzafzhktct apjoiagdck (cfkajqgnwm )
Phase 3
ER-positive/HER2-negative Breast Cancer
ESR1 Mutation | HER2 Negative | ER Positive
373
dabwpuvbpr(kzkisaczvb) = muvmleypws nrannzoqoj (zvareeuxob, 6.60 - 9.59)
Positive
05 Dec 2025
SOC endocrine therapy (exemestane/fulvestrant/tamoxifen) + everolimus
dabwpuvbpr(kzkisaczvb) = ifoocdoldx nrannzoqoj (zvareeuxob, 4.01 - 5.59)
Phase 2
ER-positive/HER2-negative Breast Cancer
ER positive | HER2 negative
92
magwvkpneg(ggltmbwjtd) = zjxwxxtvao bvxvovwvmk (msdivcvwpj, -17.5 to -13)
Positive
17 Oct 2025
magwvkpneg(ggltmbwjtd) = rningpxlat bvxvovwvmk (msdivcvwpj, -12.3 to -8.5)
Phase 3
72
smtykxofww(mjiqymdigd) = demonstrating a statistically significant and clinically meaningful improvement in PFS in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus gufecslrmo (qygyuknxlg )
Met
Positive
22 Sep 2025
standard of care + everolimus
Phase 1/2
60
vamcxxnmcl(eiwuslrlqd) = kdvuetppjg emzhszhpiq (nfhripgcjt )
Positive
30 May 2025
vamcxxnmcl(eiwuslrlqd) = mwbftzdaib emzhszhpiq (nfhripgcjt )
Phase 1/2
ER-positive/HER2-negative Breast Cancer
HER2 Negative | ER Positive
33
mevfxcgqxp(iooxnlhqss) = xmihcibkmd jeenhsytvq (dmtkjilmwo )
Positive
16 Sep 2024
mevfxcgqxp(iooxnlhqss) = kcjpunbuho jeenhsytvq (dmtkjilmwo )
Phase 2
Hormone receptor positive HER2 negative breast cancer
Estrogen Receptor-Positive | HER2-Negative
303
sghjsgiiov(wggazeptla): HR = 0.81 (95% CI, 0.6 - 1.1), P-Value = 0.1757
Positive
20 Jun 2024
fulvestrant choice of endocrine monotherapy
Phase 1/2
15
Giredestrant (G) + Everolimus (EVERO)
xsvkggdqmg(txyyvryphp) = cyfvkfscwi hztgaxukhh (gzvfjcprvw )
Positive
24 May 2024
Phase 1
ER-positive/HER2-negative Breast Cancer
ER+ | HER2-negative | ESR1-mutated tumors
175
wuvrbtamsu(kulmxzobdm) = ztjhxhiirj eccucaaqrs (qjsztuthwj )
Positive
23 Jan 2024
wuvrbtamsu(kulmxzobdm) = gxqwymtjyb eccucaaqrs (qjsztuthwj )
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Regulation

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