Darolutamide, sold under the brand name Nubeqa, is an antiandrogen medication which is used in the treatment of non-metastatic castration-resistant prostate cancer in men. It is specifically approved to treat non-metastatic castration-resistant prostate cancer (nmCRPC) in conjunction with surgical or medical castration. The medication is taken by mouth twice per day with food.Side effects of darolutamide added to castration may include fatigue, asthenia, pain in the arms and legs, and rash. Darolutamide is a nonsteroidal antiandrogen (NSAA), and acts as a selective antagonist of the androgen receptor (AR). It has been referred to as a second- or third-generation NSAA.Darolutamide was patented in 2011  and was approved for medical use in USA in July 2019, in the European Union in March 2020  and in Australia in July 2020. Medical uses
Darolutamide is approved for use concurrently with a gonadotropin-releasing hormone (GnRH) agonist or antagonist or bilateral orchiectomy in the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in men. It is used at a dosage of 600 mg orally twice per day (1,200 mg/day total) with food. In individuals with severe renal impairment or moderate hepatic impairment, darolutamide is used at a dosage of 300 mg orally twice per day (600 mg/day total) with food.
Darolutamide was associated with greater benefits than placebo for all secondary end points, including overall survival (hazard ratio 0.69; 95% CI: 0.53-0.88; P=0.003), time to pain progression (median 40.3 months vs. 25.4 months; hazard ratio 0.65; 95% CI: 0.53-0.79; P<0.001), time to cytotoxic chemotherapy (hazard ratio 0.43; 95% CI: 0.31-0.60), and time to a symptomatic skeletal event (hazard ratio 0.43; 95% CI: 0.22-0.84). Society and culture
Generic names
Darolutamide is the generic name of the medication and its INN and USAN. It is also known by its developmental code names ODM-201 and BAY-1841788. Brand names
Darolutamide is marketed under the brand name Nubeqa. Availability
Darolutamide is available in the United States and the European Union. Research
Darolutamide monotherapy is being studied in comparison to androgen deprivation therapy with GnRH agonist or antagonist monotherapy in men with treatment-naive prostate cancer. As of 2018, it is entering a phase II clinical trial for this indication. This study is expected for completion in 2021 or 2022.Darolutamide is being studied for the treatment of breast cancer in women. As of November 2019, it is in phase II clinical trials for this indication. References
External links
"Darolutamide". Drug Information Portal. U.S. National Library of Medicine.