ODM-204 + prednisone

ODM-204 + prednisone is an orally administered investigational combination therapy evaluated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). ODM-204 is a novel, non-steroidal, small molecule dual inhibitor that targets both **CYP17A1** (steroid 17-alpha-hydroxylase/17,20-lyase, essential for androgen biosynthesis) and the **androgen receptor** (AR). Prednisone, a synthetic glucocorticoid, is used concomitantly to manage risks of mineralocorticoid excess due to CYP17A1 inhibition. The combination has demonstrated preliminary antitumor activity, including decreases in testosterone and prostate-specific antigen (PSA) levels, and was generally well tolerated; however, the development of ODM-204 was discontinued due to challenging pharmacokinetic properties—most notably, reduced steady-state plasma concentrations after repeated dosing. Developed by Orion, clinical trials did not proceed beyond phase I[2][3][4].