{"id":"hrs-8080-tablet-dalpiciclib-isethionate","safety":{"commonSideEffects":[{"rate":null,"effect":"Neutropenia"},{"rate":null,"effect":"Leukopenia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CDK4/6 inhibitors like dalpiciclib work by binding to and inhibiting cyclin-dependent kinases 4 and 6, which are critical regulators of the G1/S cell cycle checkpoint. By preventing the phosphorylation of retinoblastoma (Rb) protein, the drug halts cell cycle progression and induces G1 arrest, thereby suppressing proliferation of cancer cells. This mechanism is particularly effective in hormone receptor-positive breast cancers and other CDK4/6-dependent malignancies.","oneSentence":"Dalpiciclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that blocks cell cycle progression by preventing phosphorylation of the retinoblastoma protein.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:53.813Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, HER2-negative breast cancer (in combination with endocrine therapy)"}]},"trialDetails":[{"nctId":"NCT07354022","phase":"PHASE3","title":"A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2026-03-04","conditions":"Locally Advanced or Metastatic Breast Cancer","enrollment":912},{"nctId":"NCT06167694","phase":"PHASE1, PHASE2","title":"Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2023-12-20","conditions":"Unresectable or Metastatic Breast Cancer","enrollment":146}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"HRS-8080 Tablet ; Dalpiciclib Isethionate","genericName":"HRS-8080 Tablet ; Dalpiciclib Isethionate","companyName":"Shandong Suncadia Medicine Co., Ltd.","companyId":"shandong-suncadia-medicine-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Dalpiciclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that blocks cell cycle progression by preventing phosphorylation of the retinoblastoma protein. Used for Hormone receptor-positive, HER2-negative breast cancer (in combination with endocrine therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}