Saruparib
Also known as AZD5305
ASTRAZENECA PLC AZN · Advanced Breast Cancer; Metastatic Castration-Sensitive Prostate Cancer; Metastatic Hormone-Sensitive Prostate Cancer (mHSPC); Prostate Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Advanced Breast Cancer; Metastatic Castration-Sensitive Prostate Cancer; Metastatic Hormone-Sensitive Prostate Cancer (mHSPC); Prostate Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 21 Nov 20234 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Saruparib. Editors add each one with its source.
Filed application
No filed application is on record for Saruparib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Saruparib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07711002ClinicalTrials.gov record for NCT07711002 (opens in a new tab)EvoPAR-PR05 | Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) | Phase 3 | Recruiting | 1,330 (estimated) | 30 May 2031 (estimated) | No |
| NCT06952803ClinicalTrials.gov record for NCT06952803 (opens in a new tab)EvoPAR-PR02 | 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 | Phase 3 | Recruiting | 700 (estimated) | 31 Mar 2033 (estimated) | No |
| NCT06380751ClinicalTrials.gov record for NCT06380751 (opens in a new tab)EvoPAR-BR01 | Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer | Phase 3 | Recruiting | 788 (estimated) | 18 Dec 2029 (estimated) | No |
| NCT06120491ClinicalTrials.gov record for NCT06120491 (opens in a new tab)EvoPAR-PR01 | Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents | Phase 3 | Active, not recruiting | 1,898 (actual) | 30 Sep 2027 (estimated) | No |
Publications listing EvoPAR-PR01 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Saruparib.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT06952803 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07711002 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06380751 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06120491 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.