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Press Release

Darolutamide: Global Drug Analysis 2017 with Forecasts to 2026 - Strong Competition from Xtandi, Zytiga and Apalutamide -

Research and Markets
Posted on: 15 Feb 18

The "Drug Analysis: Darolutamide" drug pipelines has been added to's offering.

Darolutamide is a non-steroidal oral androgen receptor (AR) antagonist in development by Bayer for the treatment of prostate cancer. Darolutamide potently inhibits the binding of androgens to ARs, blocking nuclear translocation of ARs and AR-mediated gene expression. The AR signaling pathway is the primary pathway that drives prostate cancer growth.

Darolutamide will have to demonstrate improved efficacy and tolerability or be priced competitively to gain market share in an increasingly crowded prostate cancer market. Darolutamide is an AR antagonist similar to established AR inhibitor Xtandi (enzalutamide; Pfizer/Astellas). Bayer is currently investigating darolutamide in high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in two Phase III trials. Late-phase data are needed to determine the commercial potential of darolutamide, but, if approved, the drug will face strong competition from Xtandi as well as from blockbuster hormonal therapy Zytiga (abiraterone acetate; Johnson & Johnson/AstraZeneca).

Xtandi has proven efficacious in nmCRPC in the Phase III PROSPER study, and Zytiga was recently approved for use in mHSPC patients following success in the Phase III LATITUDE trial. Further, darolutamide will face direct competition from late-phase AR inhibitor apalutamide (Johnson & Johnson) in both the nmCRPC and mHSPC populations.

Key Topics Covered:

Product Profiles

Darolutamide: Prostate cancer

List of Figures

Figure 1: Darolutamide for prostate cancer - SWOT analysis

Figure 2: Drug assessment summary of darolutamide for prostate cancer

Figure 3: Drug assessment summary of darolutamide for prostate cancer

Figure 4: Darolutamide sales for prostate cancer across the US, Japan, and five major EU markets, by country, 2017-26

List of Tables

Table 1: Darolutamide drug profile

Table 2: Darolutamide Phase III trials in prostate cancer

Table 3: Darolutamide Phase I/II data in prostate cancer

Table 4: Darolutamide sales for prostate cancer across the US, Japan, and five major EU markets, by country ($m), 2017-26

For more information about this drug pipelines report visit

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Business Wire

Last updated on: 15/02/2018

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