Camizestrant
Also known as Etcamah
ASTRAZENECA PLC AZN · Breast Cancer, Early Breast Cancer; Advanced Breast Cancer; ER-Positive HER2-Negative Breast Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
Approved
NDA220359,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Breast Cancer, Early Breast Cancer; Advanced Breast Cancer; ER-Positive HER2-Negative Breast Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 220359 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220359 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 31 Mar 20234 linked trials
- Filed Completed
- Approved Current stageFirst approval 4 Sep 2026
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Camizestrant. Editors add each one with its source.
Filed application
No filed application is on record for Camizestrant. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Camizestrant.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07647328ClinicalTrials.gov record for NCT07647328 (opens in a new tab)SERAFA-1 | A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer | Phase 3 | Recruiting | 150 (estimated) | 28 Feb 2029 (estimated) | No |
| NCT06380751ClinicalTrials.gov record for NCT06380751 (opens in a new tab)EvoPAR-BR01 | Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer | Phase 3 | Recruiting | 788 (estimated) | 18 Dec 2029 (estimated) | No |
| NCT05952557ClinicalTrials.gov record for NCT05952557 (opens in a new tab)CAMBRIA-2 | An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) | Phase 3 | Active, not recruiting | 5,511 (actual) | 4 Mar 2030 (estimated) | No |
Publications listing CAMBRIA-2 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05774951ClinicalTrials.gov record for NCT05774951 (opens in a new tab)CAMBRIA-1 | A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy | Phase 3 | Recruiting | 4,300 (estimated) | 20 Apr 2027 (estimated) | No |
Publications listing CAMBRIA-1 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA220359Action letter for NDA220359 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Etcamah (EMEA/H/C/006494)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- AstraZeneca AB
- Active substance (INN)
- camizestrant
- ATC code
- L02BA05
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Etcamah (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 220359 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07647328 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06380751 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05952557 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05774951 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA220359 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.