AZD9833

Phase 3Small molecule

AstraZeneca

AZD9833 is one of 38 small molecule programs targeting HER2-negative Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

HER2-Negative Breast CancerActive, not recruiting

ER+ HER2- Advanced Breast CancerActive, not recruiting

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

Breast CancerActive, not recruiting

HER2-Negative Breast CancerPhase 3

Active, not recruiting

ER+ HER2- Advanced Breast CancerPhase 1

Active, not recruiting

Advanced ER-Positive HER2-Negative Breast CancerPhase 2

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

AZD9833

AstraZeneca

Phase 3

3 2

Voltaren

Novartis

Preclinical

1 3

Lexiscan

Astellas

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 5

Tricor

JJagotec

Preclinical

1 6

Tianeptine

Pfizer

Preclinical

1 7

Ablavar

LLantheus Medical Imaging

Preclinical

2 8

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 9

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 10

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Breast Cancer

NCT04711252

Clinical

Trials by Indication[1]

Breast Cancer3 trials

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04711252·1,370 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

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

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

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

3 more indications

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

HER2-negative Breast Cancer1 trial

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

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 3[1]
Company: AstraZeneca

AZD9833

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2028

Q1 2029

Trials by Indication[1]

Breast Cancer3 trials

Midazolam1 trial

Tics1 trial

Recovery1 trial

Advanced ER-Positive HER2-Negative Breast Cancer1 trial

ER+ HER2- Advanced Breast Cancer1 trial

HER2-negative Breast Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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