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ODM-201 Tablet A

Orion Corporation, Orion Pharma · FDA-approved active Small molecule

ODM-201 is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting androgen-driven prostate cancer cell growth.

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.

At a glance

Generic nameODM-201 Tablet A
SponsorOrion Corporation, Orion Pharma
Drug classAndrogen receptor antagonist
TargetAndrogen receptor (AR)
ModalitySmall molecule
Therapeutic areaOncology
PhaseFDA-approved

Mechanism of action

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.

Approved indications

Common side effects

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