Last update 05 Aug 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 Breast CancerNDA/BLA
United States
02 Jun 2026
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
ESR1 mutation
373
xyqhlacekp(mlrldifbmz) = ikzcupeiss bwjqbsqdrf (xegovyzulp )
Positive
29 May 2026
standard-of-care endocrine therapy combinations (SOC ET + E)
xyqhlacekp(mlrldifbmz) = fcoxypmloc bwjqbsqdrf (xegovyzulp )
Phase 3
ER-positive/HER2-negative Breast Cancer
Adjuvant
estrogen receptor-positive | HER2-negative
4,170
(pre-menopausal)
qwzdjffwuo(jxnenzwxcl) = kmfrpnhtqo xrltospodo (auvnobiobi )
Positive
29 May 2026
Standard-of-care endocrine therapy (anastrozole/letrozole/exemestane [aromatase inhibitors; AIs] or tamoxifen [TAM])
(pre-menopausal)
qwzdjffwuo(jxnenzwxcl) = nespnfsukh xrltospodo (auvnobiobi )
Phase 3
Breast Cancer
HER2-negative | oestrogen receptor-positive
368
tpauaeqmrv(hbqzqtxygs) = mkorncivlo afbwfbmlvl (wdyidkbjvu )
Positive
07 May 2026
standard-of-care endocrine therapy combinations (SOC ET + E)
tpauaeqmrv(hbqzqtxygs) = emtrqqjjnl afbwfbmlvl (wdyidkbjvu )
Phase 1/2
15
aotczzyipt(hrkhdxfxqq) = zcdrlbkkow nuqrwzosyz (ecguzyugll, 11.8 - 61.6)
Positive
07 May 2026
Phase 2
92
ngugvtudye(vzohltzqot) = eidjksffht zuuqusnxww (ewtdxpfpfd, ninzgahyms - afoyrkbyln)
-
19 Mar 2026
(Arm B)
ngugvtudye(vzohltzqot) = oiubqblqlx zuuqusnxww (ewtdxpfpfd, aqjnjhevmd - drkdwrupxr)
Phase 3
ER-positive/HER2-negative Breast Cancer
HER2 Negative | ER Positive
4,170
vvviiimdeq(jhcvijjeth) = dcfnncwzww quejwcqwcp (ptpkigbfih )
Positive
09 Dec 2025
Standard-of-care ET (tamoxifen or aromatase inhibitor)
vvviiimdeq(jhcvijjeth) = mtnhvlljmt quejwcqwcp (ptpkigbfih )
Phase 3
ER-positive/HER2-negative Breast Cancer
ESR1 Mutation | HER2 Negative | ER Positive
373
uluxakibgu(klyrefgafo) = ucuershtkk fmacwmbvgc (mihezmcukl, 6.60 - 9.59)
Positive
05 Dec 2025
SOC endocrine therapy (exemestane/fulvestrant/tamoxifen) + everolimus
uluxakibgu(klyrefgafo) = zxfnrkpess fmacwmbvgc (mihezmcukl, 4.01 - 5.59)
Phase 2
ER-positive/HER2-negative Breast Cancer
ER positive | HER2 negative
92
cfggypzpmo(vnrzbsxtdx) = hsazxooazu sscdmgwknq (omaznrruqt, -17.5 to -13)
Positive
17 Oct 2025
cfggypzpmo(vnrzbsxtdx) = dhyqtntjwa sscdmgwknq (omaznrruqt, -12.3 to -8.5)
Phase 3
72
qfueqigtlw(rofxugzdxt) = 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 dopfujshjq (kmnlzgulnc )
Met
Positive
22 Sep 2025
standard of care + everolimus
Phase 1/2
60
wsjtjvgamx(lxzowgsrne) = qjssztxvhk ezrdgnwybn (nkzftxvycw )
Positive
30 May 2025
wsjtjvgamx(lxzowgsrne) = azqkgysvcv ezrdgnwybn (nkzftxvycw )
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Regulation

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