Nubeqa® is the commercial brand name of Darolutamide Tablets, an orally active novel androgen receptor inhibitor developed by Bayer. It competitively binds to androgen receptors, blocks receptor nuclear translocation and DNA binding, suppresses androgen-driven signaling pathways and inhibits proliferation of prostate cancer cells.
Main Indications
Treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis;
Treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.
Clinical Research
Global multicenter phase III ARAMIS pivotal trial fully validated significant metastasis-free survival benefit of darolutamide versus placebo for high-risk nmCRPC patients;
Global multicenter phase III ARASENS trial confirmed remarkable overall survival improvement for mHSPC patients receiving darolutamide combined with androgen deprivation therapy;
Long-term open-label extension cohorts demonstrated sustained anti-tumor efficacy under continuous twice-daily oral administration;
Dose-finding research verified balanced anti-tumor efficacy and favorable safety profile of the 300 mg twice-daily standard regimen;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic prostate cancer populations.
Common Side Effects
Common mild adverse reactions: Fatigue, arthralgia, rash, decreased appetite, fall and hypertension;
Laboratory abnormalities: Transient mild elevation of liver transaminases;
Severe but uncommon risks: Seizure, ischemic cardiovascular events, fracture and interstitial lung disease.
Approval Status in China
Original drug Nubeqa® (Darolutamide Tablets) was officially approved for marketing in China in 2021, with the specification of 300 mg per tablet, 120 tablets per box. It is currently a prescription targeted anti-prostate cancer drug included in China’s Category B medical insurance catalogue.
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