AZD9833

Phase 2Small molecule

AstraZeneca

AZD9833 is one of 5 small molecule programs targeting ER+ HER2- Advanced Breast Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

ER+ HER2- Advanced Breast CancerActive, not recruiting

Advanced ER-Positive HER2-Negative Breast CancerActive, not recruiting

ER+ HER2- Advanced Breast CancerPhase 1

Active, not recruiting

Advanced ER-Positive HER2-Negative Breast CancerPhase 2

Active, not recruiting

Competition

Competitive Landscape

11 competitors in ER+ HER2- Advanced Breast Cancer

#DrugCompanyPhaseTrials

Etcamah

AstraZeneca

Preclinical

1 2

Kisqali

Novartis

Preclinical

1 3

Ibrance

Pfizer

Preclinical

1 4

Verzenio

Eli Lilly

Preclinical

1 5

AZD9833

AstraZeneca

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Active, not recruiting

Advanced ER-Positive HER2-Negative Breast Cancer

NCT04214288

Phase 1Active, not recruiting

ER+ HER2- Advanced Breast Cancer

NCT03616587

Q3 2028

Phase 3Active, not recruiting

HER2-Negative Breast Cancer

NCT04964934

Q1 2029

Phase 3Active, not recruiting

HER2-Negative Breast Cancer

NCT04711252

Clinical

Trials by Indication[1]

Breast Cancer2 trials

A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04541433·10 enrolled

A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04588298·135 enrolled

HER2-negative Breast Cancer2 trials

SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04711252·1,371 enrolled

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04964934·315 enrolled

Midazolam1 trial

Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05438303·59 enrolled

Tics1 trial

A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04546347·32 enrolled

Recovery1 trial

A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05364255·6 enrolled

3 more indications

Advanced ER-Positive HER2-Negative Breast Cancer1 trial

SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04214288·240 enrolled

ER+ HER2- Advanced Breast Cancer1 trial

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT03616587·396 enrolled

Unspecified1 trial

AZD9833 China PK Study

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04818632·28 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for AZD9833. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AZD9833 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AZD9833. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: AstraZeneca

AZD9833

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2028

Q1 2029

Trials by Indication[1]

Breast Cancer2 trials

HER2-negative Breast Cancer2 trials

Midazolam1 trial

Tics1 trial

Recovery1 trial

Advanced ER-Positive HER2-Negative Breast Cancer1 trial

ER+ HER2- Advanced Breast Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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