{"id":"odm-201-tablet-a","brandName":"ODM-201 Tablet A","genericName":"ODM-201 Tablet A","companyId":"orion-corporation-orion-pharma","companyName":"Orion Corporation, Orion Pharma","phase":"marketed","status":"active","modality":"Small molecule","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"ODM-201 (darolutamide) is an androgen receptor antagonist developed by Orion Corporation and marketed as a tablet formulation for prostate cancer. The drug selectively binds to the androgen receptor ligand-binding domain, blocking androgen signaling in castration-resistant and hormone-sensitive prostate cancer cells with high potency and rapid dissociation kinetics. Approved by EMA and MHRA, darolutamide is indicated across multiple prostate cancer settings including non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic hormone-sensitive prostate cancer (mHSPC), and high-risk localized disease, with clinical differentiation driven by favorable pharmacokinetics, CNS penetration, and demonstrated survival benefits in Phase 3 trials (ARAMIS, ARASENS, ARADES). The drug competes directly with enzalutamide and apalutamide in the AR-antagonist class, with commercial significance reflected in peak sales estimates exceeding $1B globally. Ongoing Phase 3 trials explore combination strategies with radiotherapy, immunotherapy, and novel AR-targeting agents, positioning darolutamide as a cornerstone therapy in multi-modal prostate cancer treatment paradigms.","enrichmentLevel":3,"visitCount":2,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ODM-201 is a non-steroidal androgen receptor inhibitor that competitively blocks androgen binding to the androgen receptor in prostate cancer cells. By preventing androgen signaling, it suppresses the growth and proliferation of castration-resistant prostate cancer cells. The drug is designed to have improved blood-brain barrier penetration compared to earlier-generation androgen receptor antagonists.","oneSentence":"ODM-201 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"},"administration":{},"safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hot flushes"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Rash"}]},"trials":[],"indications":{"approved":[{"name":"Castration-resistant prostate cancer (CRPC)"}]},"commercial":null,"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[],"genericFilers":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"labelChanges":[],"nice":null,"revenue":null,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}