Saruparib History and Updates

43 events · 2019 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
43
Trial Milestones
0
Pivotal Publications
Saruparib — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20202021202220232024202520262027202820292030203120322033Trial: NCT07711002 2026-10-01 → 2031-06-17 (primary completion)Trial: NCT07446855 2026-03-17 → 2030-03-29 (primary completion)Trial: NCT06769126 2025-11-06 → 2028-12-31 (primary completion)Trial: NCT07060365 2025-09-02 → 2025-12-19 (primary completion)Trial: NCT06952803 2025-08-06 → 2033-03-31 (primary completion)Trial: NCT06713369 2025-04-02 → 2026-10-02 (primary completion)Trial: NCT06899061 2025-03-25 → 2026-02-03 (primary completion)Trial: NCT06380751 2024-08-01 → 2029-12-18 (primary completion)Trial: NCT06120491 2023-11-21 → 2028-01-11 (primary completion)Trial: NCT05938270 2023-09-21 → 2026-08-17 (primary completion)Trial: NCT05797168 2023-06-05 → 2028-08-04 (primary completion)Trial: NCT05123482 2021-10-18 → 2027-09-29 (primary completion)Trial: NCT04005690 2019-08-01 → 2026-06-01 (primary completion)today (2026-08-24)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-08-24Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Saruparib since 2019, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07711002
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy With
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06120491
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06120491
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06769126
Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06380751
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negati
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06380751
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT07446855
Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07711002
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy With
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06952803
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 M

Past events

2026
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05938270
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05938270
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT07446855
Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06899061
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
2025
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT07060365
A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06769126
Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT07060365
A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06952803
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 M
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06899061
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
2024
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06380751
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negati
2023
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06120491
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05938270
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate
2021
2019

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.