Saruparib

Phase 3Small molecule

AstraZeneca

Saruparib is one of 161 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

160

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Pancreatic CancerActive, not recruiting

Prostate CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Small Cell Lung CancerActive, not recruiting

Advanced Breast CancerRecruiting

Advanced or Metastatic Solid TumorRecruiting

Breast CancerPhase 3

Active, not recruiting

Pancreatic CancerPhase 1

Active, not recruiting

Prostate CancerPhase 3

Active, not recruiting

Ovarian CancerPhase 1/Phase 2

Active, not recruiting

Small Cell Lung CancerPhase 2

Active, not recruiting

Advanced Breast CancerPhase 3

Recruiting

Advanced or Metastatic Solid TumorPhase 1

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Saruparib

AstraZeneca

Phase 3

11 2

Halaven

Eisai

Preclinical

38 3

Trodelvy

Gilead

Preclinical

37 4

Tecentriq

Roche

Preclinical

36 5

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 6

Tricor

JJagotec

Preclinical

1 7

Chantix

PPrism Pharmaceuticals

Preclinical

1 8

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 9

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

1 10

Recombinant Human Chorionic Gonadotropin

Merck & Co.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Advanced or Metastatic Solid Tumor

NCT06713369

Q1 2028

Phase 1/2Recruiting

Combination Therapy

NCT05797168

Phase 1Recruiting

Pancreatic Cancer

NCT04005690

Q3 2029

Phase 1/2Not yet recruiting

Solid Tumours

NCT07446855

Q4 2029

Phase 2Recruiting

Small Cell Lung Cancer

NCT06769126

Clinical

Trials by Indication[1]

Prostate Cancer3 trials

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06120491·1,800 enrolled

A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06952803·700 enrolled

An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men With Newly Diagnosed Prostate Cancer (ASCERTAIN)

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05938270·113 enrolled

Clinical Pharmacology1 trial

Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT06899061·41 enrolled

Combination Therapy1 trial

Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT05797168·506 enrolled

Ovarian Cancer1 trial

A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT07060365

Small Cell Lung Cancer1 trial

Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT06769126·900 enrolled

4 more indications

Solid Tumours1 trial

Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours

Not yet recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT07446855·180 enrolled

Pancreatic Cancer1 trial

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04005690·90 enrolled

Advanced Breast Cancer1 trial

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06380751·500 enrolled

Advanced or Metastatic Solid Tumor1 trial

A Phase I, Open-label Study to Assess the Absolute Bioavailability of Saruparib (AZD5305) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Saruparib ([14C]-AZD5305) in Patients With Advanced Solid Malignancies

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT06713369·8 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Saruparib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Saruparib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Saruparib. 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

Saruparib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q3 2029

Q4 2029

Trials by Indication[1]

Prostate Cancer3 trials

Clinical Pharmacology1 trial

Combination Therapy1 trial

Ovarian Cancer1 trial

Small Cell Lung Cancer1 trial

Solid Tumours1 trial

Pancreatic Cancer1 trial

Advanced Breast Cancer1 trial

Advanced or Metastatic Solid Tumor1 trial

References

Drug Info

Quick Facts

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