{"id":"darolutamide-intermittent","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":{"chemblId":"CHEMBL4297185","moleculeType":"Small molecule","molecularWeight":"398.85"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Darolutamide competitively binds to the androgen receptor with high affinity and specificity, preventing activation by testosterone and dihydrotestosterone. This blocks the transcription of androgen-responsive genes essential for prostate cancer cell proliferation. The intermittent dosing schedule aims to reduce cumulative toxicity while maintaining therapeutic efficacy in hormone-sensitive prostate cancer.","oneSentence":"Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting prostate cancer cell growth and survival.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:40.373Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-metastatic castration-resistant prostate cancer (nmCRPC)"},{"name":"Metastatic hormone-sensitive prostate cancer (mHSPC)"}]},"trialDetails":[{"nctId":"NCT07142551","phase":"PHASE2","title":"Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response","status":"RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2026-03-09","conditions":"Metastatic Castration-resistant Prostate Cancer","enrollment":60},{"nctId":"NCT05974774","phase":"PHASE3","title":"Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors","status":"RECRUITING","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"2025-05-23","conditions":"Prostate Cancer","enrollment":1600},{"nctId":"NCT06177015","phase":"PHASE3","title":"Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC","status":"RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2023-12-11","conditions":"Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy","enrollment":200}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Darolutamide"],"phase":"phase_3","status":"active","brandName":"Darolutamide intermittent","genericName":"Darolutamide intermittent","companyName":"The First Affiliated Hospital with Nanjing Medical University","companyId":"the-first-affiliated-hospital-with-nanjing-medical-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting prostate cancer cell growth and survival. Used for Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic hormone-sensitive prostate cancer (mHSPC).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}