{"id":"saruparib-azd5305","safety":{"commonSideEffects":[{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Leukopenia"}]},"_chembl":{"chemblId":"CHEMBL5095220","moleculeType":"Small molecule","molecularWeight":"406.49"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PARP inhibitors like saruparib trap PARP enzymes on DNA damage sites, preventing single-strand break repair and leading to double-strand breaks in cancer cells. This is particularly effective in tumors with BRCA1/2 mutations or homologous recombination deficiency, where alternative DNA repair pathways are compromised. The mechanism exploits synthetic lethality, where PARP inhibition becomes lethal in cells already deficient in homologous recombination repair.","oneSentence":"Saruparib is a PARP inhibitor that blocks poly(ADP-ribose) polymerase enzymes to prevent DNA repair and induce cancer cell death.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:52:43.784Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"BRCA1/2-mutant ovarian cancer"},{"name":"BRCA1/2-mutant breast cancer"},{"name":"Homologous recombination deficient tumors"}]},"trialDetails":[{"nctId":"NCT05123482","phase":"PHASE1, PHASE2","title":"A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2021-10-18","conditions":"Breast Cancer, Biliary Tract Carcinoma, Ovarian Cancer","enrollment":460},{"nctId":"NCT06380751","phase":"PHASE3","title":"Saruparib (AZD5305) Plus Camizestrant 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","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2024-08-01","conditions":"Advanced Breast Cancer","enrollment":500},{"nctId":"NCT06952803","phase":"PHASE3","title":"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","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-08-06","conditions":"Prostate Cancer","enrollment":700},{"nctId":"NCT06713369","phase":"PHASE1","title":"AZD5305 hADME in Patients With Advanced Solid Malignancies","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-04-02","conditions":"Locally Advanced or Metastatic Solid Tumor","enrollment":8},{"nctId":"NCT05797168","phase":"PHASE1, PHASE2","title":"Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2023-06-05","conditions":"Ovarian Cancer, Lung Adenocarcinoma, Endometrial Cancer","enrollment":506},{"nctId":"NCT04005690","phase":"EARLY_PHASE1","title":"Targeted Pathway Inhibition in Patients With Pancreatic Cancer","status":"RECRUITING","sponsor":"OHSU Knight Cancer Institute","startDate":"2019-08-01","conditions":"Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8","enrollment":90},{"nctId":"NCT05938270","phase":"PHASE1","title":"A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2023-09-21","conditions":"Prostate Cancer","enrollment":120},{"nctId":"NCT06769126","phase":"PHASE2","title":"Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study","status":"RECRUITING","sponsor":"SWOG Cancer Research Network","startDate":"2025-11-06","conditions":"Extensive Stage Lung Small Cell Carcinoma, Lung Small Cell Carcinoma, A Subtype, Lung Small Cell Carcinoma, I Subtype","enrollment":900},{"nctId":"NCT06120491","phase":"PHASE3","title":"Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2023-11-21","conditions":"Metastatic Castration-Sensitive Prostate Cancer","enrollment":1800},{"nctId":"NCT07336446","phase":"PHASE1, PHASE2","title":"A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs","status":"NOT_YET_RECRUITING","sponsor":"AstraZeneca","startDate":"2026-01-05","conditions":"Prostate Cancer","enrollment":300}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":16,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Saruparib","Darolutamide is also known as Nubeqa","AZD5305"],"phase":"phase_3","status":"active","brandName":"Saruparib (AZD5305)","genericName":"Saruparib (AZD5305)","companyName":"AstraZeneca","companyId":"astrazeneca","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Saruparib (AZD5305) is a small molecule being studied in clinical trials for various subtypes of lung small cell carcinoma and prostate cancer. It is being investigated in combination with darolutamide and as a standalone treatment, with no treatment serving as a control in some trials.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}