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Phase 3
Development Phase
0
Upcoming Catalysts
0
Historical Events
3
Regulatory Approvals
No catalyst events have been recorded for this drug yet.
0 competitors in Progressive Metastatic Prostate Cancer
View Full LandscapeTarget Indication
Progressive Metastatic Prostate Cancer
Clinical Trial
NCT02294461Last updated: 12/24/2025
No patent data available. Pre-approval drugs may not have Orange Book listings.
Enzalutamide Viatris
Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
View on EMAXtandi
Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
View on EMA