{"id":"darolutamide-oral-tablet","safety":{"commonSideEffects":[{"rate":"25–35","effect":"Fatigue"},{"rate":"20–30","effect":"Hot flashes"},{"rate":"15–25","effect":"Hypertension"},{"rate":"10–15","effect":"Rash"},{"rate":"10–15","effect":"Diarrhea"},{"rate":"10–15","effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Darolutamide competitively binds to the ligand-binding domain of the androgen receptor with high affinity and selectivity, preventing activation by testosterone and dihydrotestosterone. This blocks downstream signaling that drives proliferation and survival of androgen-dependent prostate cancer cells. It is a non-steroidal antiandrogen with improved blood-brain barrier penetration compared to earlier-generation agents.","oneSentence":"Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting androgen-driven prostate cancer cell growth.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:32:13.510Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-metastatic castration-resistant prostate cancer (nmCRPC)"},{"name":"Metastatic hormone-sensitive prostate cancer (mHSPC)"}]},"trialDetails":[{"nctId":"NCT05348876","phase":"PHASE4","title":"A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)","status":"RECRUITING","sponsor":"Bayer","startDate":"2022-08-03","conditions":"Non-metastatic Castration-resistant Prostate Cancer","enrollment":50},{"nctId":"NCT05794906","phase":"PHASE3","title":"A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2023-04-03","conditions":"Biochemically Recurrent Prostate Cancer","enrollment":985},{"nctId":"NCT05526248","phase":"PHASE2","title":"A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-12-19","conditions":"Biochemically Recurrent Prostate Cancer","enrollment":28},{"nctId":"NCT06463457","phase":"PHASE2","title":"Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Atish Choudhury, MD","startDate":"2024-12-13","conditions":"Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer","enrollment":33},{"nctId":"NCT07450599","phase":"PHASE2","title":"A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.","status":"NOT_YET_RECRUITING","sponsor":"Bayer","startDate":"2026-04-15","conditions":"High-Risk Localized Prostate Cancer","enrollment":250},{"nctId":"NCT05617885","phase":"PHASE1","title":"Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Praful Ravi, MB BCHir, MRCP","startDate":"2023-08-09","conditions":"Metastatic Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Cancer","enrollment":9},{"nctId":"NCT04736199","phase":"PHASE3","title":"Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-02-23","conditions":"Prostatic Neoplasms","enrollment":669},{"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":"NCT06894511","phase":"PHASE2","title":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-09-11","conditions":"Metastatic Castration Resistant Prostate Cancer (mCRPC)","enrollment":7},{"nctId":"NCT06627530","phase":"PHASE4","title":"COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brazilian Clinical Research Institute","startDate":"2025-02-17","conditions":"Prostate Cancer","enrollment":144},{"nctId":"NCT05059236","phase":"PHASE2","title":"A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. 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Hospital","companyId":"santa-chiara-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting androgen-driven prostate cancer cell growth. Used for Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic hormone-sensitive prostate cancer (mHSPC).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}