Saruparib

Phase 3Small molecule

Saruparib is one of 153 small molecule programs targeting Advanced or Metastatic Solid Tumor. It is currently in Phase 3.

Indications

Total Trials

Active Trials

152

Competitors

Pipeline

Status by Indication[3][1]

Indication

Advanced or Metastatic Solid TumorRecruiting

Advanced Breast CancerRecruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Not yet recruiting

Solid TumoursRecruiting

Metastatic Castration-Sensitive Prostate CancerActive, not recruiting

Locally Advanced Pancreatic Ductal AdenocarcinomaRecruiting

Small Cell Lung CancerRecruiting

Ovarian CancerWithdrawn

Advanced or Metastatic Solid TumorPhase 1

Recruiting

Advanced Breast CancerPhase 3

Recruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Phase 3

Not yet recruiting

Solid TumoursPreclinical

Recruiting

Metastatic Castration-Sensitive Prostate CancerPhase 3

Active, not recruiting

Locally Advanced Pancreatic Ductal AdenocarcinomaPhase 1

Recruiting

Small Cell Lung CancerPhase 2

Recruiting

Ovarian CancerPhase 2

Withdrawn

Competition

Competitive Landscape

232 competitors in Ovarian Cancer

#DrugCompanyPhaseTrials

Avastin

Roche

Phase 3

88 2

Gemzar

Johnson & Johnson

Phase 3

33 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

24 4

Femara

Novartis

Phase 3

8 5

Imfinzi

AstraZeneca

Phase 3

8 6

Opdivo

Bristol-Myers Squibb

Phase 3

8 7

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

23 8

Neulasta

Amgen

Phase 3

2 9

Taxotere

Elahere

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

Q3 2027

PreclinicalRecruiting

Breast Cancer

NCT05123482

Q1 2028

Phase 1Recruiting

Locally Advanced Pancreatic Ductal Adenocarcinoma

NCT04005690

Q2 2028

Phase 1Active, not recruiting

Advanced Solid Malignancies

NCT06899061

Clinical

Trials by Indication[1]

Ovarian Cancer2 trials

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Withdrawn· AstraZeneca logo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

A Modular Phase I/IIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT05797168·602 enrolled

Prostate Cancer2 trials

A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).

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

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

Breast Cancer1 trial

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT05123482·460 enrolled

Solid Tumours1 trial

A Modular Open-label, Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Repair Defective Solid Tumours

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT07446855·180 enrolled

6 more indications

Locally Advanced Pancreatic Ductal Adenocarcinoma1 trial

A Window of Opportunity Strategy for Targeted Pathway Inhibition in Patients With Pancreatic Ductal Adenocarcinoma

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 or Plus Endocrine Therapy, 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·NCT06380751·788 enrolled

Advanced Solid Malignancies1 trial

A Modular Phase I, Open-label Study to Assess the Safety, Pharmacokinetics, and Drug Interaction Potential and Relative Bioavailability of Saruparib in Patients With Advanced Solid Malignancies

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT06899061·41 enrolled

Metastatic Castration-sensitive Prostate Cancer1 trial

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06120491·1,898 enrolled

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05

Not yet recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07711002·1,330 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 — 13 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

Q3 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Ovarian Cancer2 trials

Prostate Cancer2 trials

Small Cell Lung Cancer1 trial

Breast Cancer1 trial

Solid Tumours1 trial

Locally Advanced Pancreatic Ductal Adenocarcinoma1 trial

Advanced Breast Cancer1 trial

Advanced Solid Malignancies1 trial

Metastatic Castration-sensitive Prostate Cancer1 trial

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

Advanced or Metastatic Solid Tumor1 trial

References

Drug Info

Quick Facts

Related News