Drugs / Giredestrant
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2026-06-01 | “announced today that the United States (US) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant” roche.com ↗ “the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant” gene.com ↗ “The US FDA recently accepted the NDA for giredestrant in combination with everolimus for those with ESR1-mutated, ER-positive advanced breast cancer” roche.com ↗ “the U.S. Food and Drug Administration (FDA) accepted Genentech’s New Drug Application (NDA) for giredestrant in combination with everolimus” gene.com ↗ “the US Food and Drug Administration (FDA) accepted Roche’s New Drug Application (NDA) for giredestrant in combination with everolimus” roche.com ↗ “the U.S. Food and Drug Administration (FDA) accepted Genentech’s New Drug Application (NDA) for giredestrant” gene.com ↗ “the US Food and Drug Administration (FDA) accepted Roche’s New Drug Application (NDA) for giredestrant” roche.com ↗ “FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer” roche.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2026-02-19 | “the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant” gene.com ↗ “The U.S. FDA recently accepted the New Drug Application for giredestrant based on the positive evERA data.” gene.com ↗ “The U.S. FDA recently accepted the NDA for giredestrant in combination with everolimus” gene.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07867262 | Dec 2026 → Aug 2030 expected | breast cancer | Genentech, Inc. | Not yet recruiting | No outcome recorded |
| 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 29 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07054190 | Sep 2025 → Jul 2027 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| 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 | Active not 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 | Met primary |
| Phase 2 | NCT05634499 | Jun 2023 → Aug 2026 | endometrial cancer | Hoffmann-La Roche | Completed | 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 | Missed primary |
| Phase 2 | NCT04436744 | Sep 2020 → Jul 2021 | female breast carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 37 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT07827573 | Oct 2026 → Nov 2028 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Hoffmann-La Roche | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07541079 | Aug 2026 → Jun 2032 expected | breast cancer | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06065748 | Dec 2023 → Apr 2028 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05306340 | Aug 2022 → Jul 2025 overdue | estrogen-receptor positive breast cancer | Genentech, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT05296798 | Jul 2022 → Jun 2028 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 | Met primary |
| Phase 3 | NCT04546009 | Oct 2020 → Jan 2026 overdue | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Active not recruiting | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT07100106 Background | Oct 2025 → Aug 2028 expected | breast cancer | Genentech, Inc. | Recruiting | No outcome recorded |
| — | NCT07643831 Background | — | estrogen-receptor positive breast cancer | Genentech, Inc. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Hoffmann-La Roche | Results Roche’s giredestrant combination significantly improved progression-free survival in ER-positive advanced breast cancer in phase III evERA data published in The New England Journal of Medicine roche.com ↗
Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus1 |
| 2026-09-30 | Genentech, Inc. | Results Genentech’s Giredestrant Combination Significantly Improved Progression-Free Survival in ER-Positive Advanced Breast Cancer in Phase III evERA Data Published in The New England Journal of Medicine gene.com ↗
Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus |
| 2026-06-02 | Hoffmann-La Roche | Regulatory 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 ↗
Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States (US) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant, an investigational oral selective oestrogen receptor degrader (SERD), as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II, and III breast cancer. |
| 2026-06-01 | Genentech, Inc. | Regulatory FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant |
| 2026-05-19 | Hoffmann-La Roche | Results Roche to present new data at ASCO 2026, reinforcing giredestrant's potential to transform the treatment paradigm in early breast cancer roche.com ↗
Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease |
| 2026-05-18 | Genentech, Inc. | Results Genentech to Present New Data at ASCO 2026, Reinforcing Giredestrant's Potential to Transform the Treatment Paradigm in Early Breast Cancer gene.com ↗
Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease |
| 2026-03-09 | Hoffmann-La Roche | Results [Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase III persevERA study in ER-positive advanced breast cancer roche.com ↗
The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. |
| 2026-03-08 | Genentech, Inc. | Results Genentech Provides Update on Phase III persevERA Study in ER-Positive Advanced Breast Cancer gene.com ↗
The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. |
| 2026-02-20 | Hoffmann-La Roche | Regulatory FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer roche.com ↗ |
| 2026-02-19 | Genentech, Inc. | Regulatory FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. |
| 2025-12-10 | Hoffmann-La Roche | Results Roche’s giredestrant reduced risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer roche.com ↗
At the pre-specified interim analysis, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (invasive disease-free survival [iDFS]) compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014). |
| 2025-12-10 | Genentech, Inc. | Results Genentech’s Giredestrant Reduced Risk of Invasive Disease Recurrence or Death by 30% in ER-Positive Early-Stage Breast Cancer gene.com ↗
At the pre-specified interim analysis, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (invasive disease-free survival [iDFS]) compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014). |
| 2025-11-18 | Hoffmann-La Roche | Results [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 ↗
The study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy. |
| 2025-11-17 | Genentech, Inc. | Results Genentech’s Giredestrant Becomes the First Oral SERD to Show Superior Invasive Disease-Free Survival in Early Breast Cancer gene.com ↗
The study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy. |
| 2025-10-18 | Hoffmann-La Roche | Results Roche’s phase III evERA data showed giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer roche.com ↗
Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus. |
| 2025-10-17 | Genentech, Inc. | Results Genentech’s Phase III evERA Data Showed Giredestrant Significantly Improved Progression-Free Survival in People With ER-Positive Advanced Breast Cancer gene.com ↗
Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus. |
| 2025-10-13 | Hoffmann-La Roche | Results Roche data at ESMO 2025 showcase advances in science and cancer care across multiple tumour types roche.com ↗
The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations. |
| 2025-10-12 | Genentech, Inc. | Results Genentech Data at ESMO 2025 Showcase Advances in Science and Cancer Care Across Multiple Tumor Types gene.com ↗
The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations. |
| 2025-09-22 | Hoffmann-La Roche | Results Positive phase III results show Roche’s giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer roche.com ↗
The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus. |
| 2025-09-21 | Genentech, Inc. | Results Positive Phase III Results Show Genentech’s Giredestrant Significantly Improved Progression-Free Survival in ER-Positive Advanced Breast Cancer gene.com ↗
The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus. |
All press releases naming this drug 20 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Giredestrant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04931342 ↗ |
| Known as | GDC-9545 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03332797 ↗ |
| 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 ↗ |