Giredestrant

also known as GDC-9545 · RO-7197597

Small molecule targets ESR1 via depletion

Developed for: breast cancer · estrogen-receptor positive breast cancer · endometrial cancer · female breast carcinoma · ovarian cancer
Investigated by: Hoffmann-La Roche · Genentech, Inc. · MedSIR · Pfizer · Alliance Foundation Trials, LLC. · ETOP IBCSG Partners Foundation
+6 more
· Eli Lilly and Company · European Network of Gynaecological Oncological Trial Groups (ENGOT) · Fondazione Oncotech · Foundation Medicine · GOG Foundation · Gilead Sciences

Trials 23 · a red edge is where a trial was stopped

today NCT07541079 · Ph 3 NCT07214662 · Ph 1 NCT06259929 · Ph 2 NCT05708235 · Ph 2 NCT05896566 · Ph 2 NCT06065748 · Ph 3 NCT05659563 · Ph 2 NCT05634499 · Ph 2 NCT05306340 · Ph 3 NCT05296798 · Ph 3 NCT04486352 · Ph 1/2 NCT04931342 · Ph 2 NCT04961996 · Ph 3 NCT04802759 · Ph 1/2 NCT04680273 · Ph 1 NCT04576455 · Ph 2 NCT04546009 · Ph 3 NCT04436744 · Ph 2 NCT04274075 · Ph 1 NCT03916744 · Ph 1 NCT03424005 · Ph 1/2 NCT03332797 · Ph 1

201820192020202120222023202420252026202720282029203020312032

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 15 trials
Phase 1	NCT07214662	Jan 2026 → Jun 2030 expected	breast cancer	Genentech, Inc.	Recruiting	No outcome recorded
Phase 1	NCT04680273	Jan → Apr 2021	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT04274075	Mar → Apr 2020	—	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT03916744	Jul 2019 → May 2021	breast cancer	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT03332797	Nov 2017 → Jul 2027 expected	breast cancer	Genentech, Inc.	Active not recruiting	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT04486352	Oct 2021 → Oct 2026 expected	endometrial cancer	Alliance Foundation Trials, LLC.	Recruiting	No outcome recorded
Phase 1/2	NCT04802759	Jun 2021 → May 2029 expected	estrogen-receptor positive breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 1/2	NCT03424005	Mar 2018 → Sep 2030 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 28 trials
Phase 2	NCT06259929	Jan 2025 → Apr 2026 overdue	breast cancer	Fondazione Oncotech	Recruiting	No outcome recorded
Phase 2	NCT05708235	Apr 2024 → Jun 2028 expected	breast cancer	MedSIR	Recruiting	No outcome recorded
Phase 2	NCT05896566	Jan 2024 → Sep 2025	breast cancer	ETOP IBCSG Partners Foundation	Completed	No outcome recorded
Phase 2	NCT05659563	Jul 2023 → Jan 2025	breast cancer	MedSIR	Completed	No outcome recorded
Phase 2	NCT05634499	Jun 2023 → Aug 2026 overdue	endometrial cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 2	NCT04931342	Oct 2021 → Feb 2028 expected	ovarian cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 2	NCT04576455	Nov 2020 → Feb 2022 overdue	estrogen-receptor positive breast cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 2	NCT04436744	Sep 2020 → Jul 2021	female breast carcinoma	Hoffmann-La Roche	Completed	No outcome recorded
Phase 36 trials
Phase 3	NCT07541079	Aug 2026 → Jun 2032 expected	breast cancer	Genentech, Inc.	Recruiting	No outcome recorded
Phase 3	NCT06065748	Dec 2023 → Feb 2027 expected	estrogen-receptor positive breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 3	NCT05306340	Aug 2022 → Jul 2025 overdue	estrogen-receptor positive breast cancer	Genentech, Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT05296798	Jul 2022 → Oct 2027 expected	breast cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT04961996	Aug 2021 → Aug 2025 overdue	breast cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT04546009	Oct 2020 → Jan 2026 overdue	estrogen-receptor positive breast cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase not stated1 trial
—	NCT07643831	—	estrogen-receptor positive breast cancer	Genentech, Inc.	Available	No outcome recorded

Also used as a comparator or background therapy in 1 trial

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1/2	NCT07100106 Background	Oct 2025 → Aug 2028 expected	breast cancer	Genentech, Inc.	Recruiting	No outcome recorded

Press releases naming this drug 6 releases

Date	Issuer	Release
2026-06-02	Roche Global Development	FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting roche.com ↗
2026-02-20	Roche Global Development	FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer roche.com ↗
2025-12-10	Roche Global Development	Roche’s giredestrant reduced risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer roche.com ↗
2025-11-18	Roche Global Development	[Ad hoc announcement pursuant to Art. 53 LR] Roche’s giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer roche.com ↗
2025-10-18	Roche Global Development	Roche’s phase III evERA data showed giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer roche.com ↗
2025-09-22	Roche Global Development	Positive phase III results show Roche’s giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer roche.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 26 sources stand behind the page.

Field	Value	Cited text
Known as	Giredestrant	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03424005 ↗ 20 NCT04546009 ↗ NCT04931342 ↗ NCT05306340 ↗ NCT05659563 ↗ NCT06259929 ↗ NCT04486352 ↗ NCT03916744 ↗ NCT05634499 ↗ NCT07643831 ↗ NCT05896566 ↗ NCT04576455 ↗ NCT05296798 ↗ NCT05708235 ↗ NCT07214662 ↗ NCT07100106 ↗ NCT04961996 ↗ NCT06065748 ↗ NCT04436744 ↗ NCT07541079 ↗ NCT04802759 ↗
Known as	GDC-9545	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03332797 ↗ 2 NCT04680273 ↗ NCT04274075 ↗
Known as	RO-7197597	ChEMBL registry synonym — accepted as the source's own label CHEMBL4650316 ↗
Action	Deplete	“Estrogen receptor alpha degrader” CHEMBL4650316 ↗
Action	Inhibit	“Giredestrant is a potent, orally bioavailable, small-molecule selective estrogen receptor antagonist and degrader (SERD)” PMID 38305868 ↗ Feb 2024
Modality	Small molecule	“Giredestrant is a potent, orally bioavailable, small-molecule selective estrogen receptor antagonist and degrader (SERD)” PMID 38305868 ↗ Feb 2024
Route	Oral	“GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.” NCT03332797 ↗
Target	ESR1	“Estrogen receptor alpha degrader” CHEMBL4650316 ↗