Drugs / Camizestrant
Camizestrant
also known as
AZD9833 · AZ-14066724 · CAMIZESTRANT (AZD9833) · CPD 28 · ESTROGEN RECEPTOR ANTAGONIST 2
Other / unclassified targets ESR1 via depletion
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Her2-receptor negative breast cancer 1 milestone | |||||
| Filed | US (FDA) | — | Her2-receptor negative breast cancer | — | “In July 2025, the FDA accepted the New Drug Application (NDA) for camizestrant in combination with a CDK4/6 inhibitor” astrazeneca.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Etcamah | — | 2026-07-20 | europa.eu ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06547164 | Aug 2024 → Aug 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05790304 | Feb 2023 → Feb 2024 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05551897 | Oct → Dec 2022 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05438303 | Jun → Dec 2022 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05364255 | May → Jun 2022 | estrogen-receptor positive breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04818632 | Nov 2021 → Sep 2023 | estrogen-receptor positive breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04541433 | Sep 2020 → Jul 2022 | estrogen-receptor positive breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04546347 | Sep 2020 → Jan 2021 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03616587 | Oct 2018 → Sep 2024 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06188520 | Dec 2023 → Aug 2027 expected | estrogen-receptor positive breast cancer, ovarian serous adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04644068 | Nov 2020 → May 2027 expected | biliary tract cancer, breast cancer, cervical cancer, colorectal cancer +8 | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT07840443 | Oct 2026 → Oct 2028 expected | endometrial cancer | University Health Network, Toronto | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07427394 | May 2026 → Dec 2027 expected | female breast carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT07195227 | Mar 2026 → Feb 2028 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT04588298 | Nov 2020 → Jun 2023 | Her2-receptor negative breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT04214288 | Apr 2020 → Aug 2022 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07647328 | Jun 2026 → Feb 2029 expected | breast carcinoma by gene expression profile | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06380751 | Aug 2024 → Dec 2029 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05952557 | Oct 2023 → Mar 2030 expected | breast carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05774951 | Mar 2023 → Apr 2027 expected | breast carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT04964934 | Jun 2021 → Jun 2025 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT04711252 | Jan 2021 → Jun 2026 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | Alexion Pharmaceuticals, Inc. | Results Update on SERENA-4 Phase III trial of Etcamah in combination with palbociclib in upfront 1st-line advanced ER-positive breast cancer astrazeneca.com ↗
The SERENA-4 Phase III trial of AstraZeneca’s Etcamah (camizestrant) in combination with palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, did not meet the primary endpoint of progression-free survival (PFS), however a numerical improvement was observed in the upfront 1st-line treatment of patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer who have not received any systemic treatment for advanced disease. |
| 2026-09-04 | Alexion Pharmaceuticals, Inc. | Regulatory Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer astrazeneca.com ↗ |
| 2026-07-23 | AstraZeneca | Regulatory Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2026-06-02 | AstraZeneca | Results Camizestrant combination delayed time to first progression by 55% and to second progression by 37% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 trial astrazeneca.com ↗
Median PFS2 was 25.7 months for the camizestrant combination compared with 19.1 months for the AI combination. |
| 2026-05-27 | AstraZeneca | Regulatory US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data astrazeneca.com ↗ |
| 2026-05-22 | AstraZeneca | Regulatory Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2026-04-30 | AstraZeneca | Regulatory Update on FDA Advisory Committee vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer astrazeneca.com ↗
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote in favor of the benefit risk profile of AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation, based on the SERENA-6 Phase III trial. |
| 2025-06-01 | AstraZeneca | Results Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗
Results showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31–0.60; p<0.00001) as assessed by investigator. |
| 2025-05-21 | AstraZeneca | Results AstraZeneca’s record seventh year of plenary data at ASCO furthers ambition to redefine breast cancer care and transform outcomes in gastric cancer astrazeneca.com ↗
This is the first positive Phase III trial for a next-generation oral SERD in this 1st-line setting and the first positive Phase III trial for camizestrant. |
| 2025-02-26 | AstraZeneca | Results Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗ |
| 2022-12-08 | AstraZeneca | Results Camizestrant significantly delayed disease progression in advanced ER-positive breast cancer, adding at least 3.5 months benefit versus Faslodex astrazeneca.com ↗ |
| 2022-10-26 | AstraZeneca | Results Capivasertib plus Faslodex significantly improved progression-free survival vs. Faslodex in CAPItello-291 Phase III trial in advanced HR-positive breast cancer astrazeneca.com ↗
In addition to these results, the Company is also announcing today results from the SERENA-2 Phase II trial of camizestrant, the next-generation oral selective estrogen receptor degrader (ngSERD) in advanced estrogen receptor (ER)-positive breast cancer. |
| 2022-10-26 | AstraZeneca | Results Camizestrant significantly improved progression-free survival vs. Faslodex in SERENA-2 Phase II trial in advanced ER-positive breast cancer astrazeneca.com ↗
The results from SERENA-2 show that camizestrant provides a significant improvement in progression-free survival compared to fulvestrant, which has been used to treat patients with HR-positive breast cancer for almost twenty years. |
| 2020-12-03 | AstraZeneca | Results AstraZeneca demonstrates growing leadership in breast cancer at SABCS with data from its innovative medicines and robust pipeline astrazeneca.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | camizestrant | “PURPOSE: SERENA-3 is a presurgical window-of-opportunity (WOO) trial exploring the pharmacodynamic effects of camizestrant in postmenopausal women with newly diagnosed estrogen...” PMID 41628308 ↗ Jan 202615“Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a...” PMID 39481395 ↗ Nov 2024 “Switching to camizestrant at ESR1 mutation emergence before disease progression” PMID 42442380 ↗ Jul 2026 “Camizestrant is also called AZD9833.” NCT04711252 ↗ |
| Known as | AZ-14066724 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650365 ↗ |
| Known as | AZD9833 | “Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .” NCT06380751 ↗ |
| Known as | CAMIZESTRANT (AZD9833) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650365 ↗ |
| Known as | CPD 28 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650365 ↗ |
| Known as | ESTROGEN RECEPTOR ANTAGONIST 2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650365 ↗ |
| Action | Deplete | “Estrogen receptor alpha degrader” CHEMBL4650365 ↗ |
| Action | Inhibit | “CONCLUSIONS: Camizestrant is a next-generation oral selective ER antagonist and degrader (SERD) and pure ER antagonist with a tolerable safety profile.” PMID 38729567 ↗ May 2024 |
| Modality | Other / unclassified | “Oral SERD Molecule” NCT04644068 ↗ |
| Route | Oral | “AZD9833 tablets will be administered orally.” NCT04214288 ↗ |
| Target | ESR1 | “Estrogen receptor alpha degrader” CHEMBL4650365 ↗ |