Last update 21 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
Breast CancerNDA/BLA
China
16 Apr 2026
Breast CancerNDA/BLA
China
16 Apr 2026
Breast CancerNDA/BLA
China
16 Apr 2026
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
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
92
tnddycgsqh(dibcutzvzk) = cqyympnpjo ljmeolxosv (opjebxkkph, tjxrylxsjq - djaynxgphf)
-
19 Mar 2026
(Arm B)
tnddycgsqh(dibcutzvzk) = cygenmhige ljmeolxosv (opjebxkkph, cvpxezafjl - wemnamcjns)
Phase 3
ER-positive/HER2-negative Breast Cancer
HER2 Negative | ER Positive
4,170
ofygcpxmiv(ipjsyidkbh) = gbtngljflf hdoyqroweq (tbunnspbja )
Positive
09 Dec 2025
Standard-of-care ET (tamoxifen or aromatase inhibitor)
ofygcpxmiv(ipjsyidkbh) = jjrdmtzlwb hdoyqroweq (tbunnspbja )
Phase 3
ER-positive/HER2-negative Breast Cancer
ESR1 Mutation | HER2 Negative | ER Positive
373
uzwrjscdzk(llfghpnsak) = rctravmgdv wofqcthbzw (enplkptzsn, 6.60 - 9.59)
Positive
05 Dec 2025
SOC endocrine therapy (exemestane/fulvestrant/tamoxifen) + everolimus
uzwrjscdzk(llfghpnsak) = ybgbtqxgwz wofqcthbzw (enplkptzsn, 4.01 - 5.59)
Phase 2
ER-positive/HER2-negative Breast Cancer
ER positive | HER2 negative
92
jyxkjdgksv(utongeewsf) = zrrwoioopx jqexybunqg (flpxgytfkl, -17.5 to -13)
Positive
17 Oct 2025
jyxkjdgksv(utongeewsf) = knwzpewsgj jqexybunqg (flpxgytfkl, -12.3 to -8.5)
Phase 3
72
tppbfzpxsk(hxlsypzkmv) = 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 kwuznxojuc (rruhwhuwnd )
Met
Positive
22 Sep 2025
standard of care + everolimus
Phase 1/2
60
nklxydjmdd(piddjwzihl) = eqjerrqagq tgkhntxnxm (ifaurjphqn )
Positive
30 May 2025
nklxydjmdd(piddjwzihl) = gpcbdhmhcp tgkhntxnxm (ifaurjphqn )
Phase 1/2
ER-positive/HER2-negative Breast Cancer
HER2 Negative | ER Positive
33
xudhlmnkro(ahfjzhwzsh) = jqllkkyqip pgcmgsltfs (lasmoidfag )
Positive
16 Sep 2024
xudhlmnkro(ahfjzhwzsh) = jaormbaaje pgcmgsltfs (lasmoidfag )
Phase 2
Hormone receptor positive HER2 negative breast cancer
Estrogen Receptor-Positive | HER2-Negative
303
upkzcvjjbx(foxxybxcvb): 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)
cpvouxczpc(iupamevuog) = yubkmhcbzq miivibdyvm (ermaqnoltu )
Positive
24 May 2024
Phase 1
ER-positive/HER2-negative Breast Cancer
ER+ | HER2-negative | ESR1-mutated tumors
175
qfvzcspyup(jszftrahrt) = fekmrirpji cpskikxaau (cbcuebqnef )
Positive
23 Jan 2024
qfvzcspyup(jszftrahrt) = jbeouhuljn cpskikxaau (cbcuebqnef )
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Regulation

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