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.[8][4][5][9][10] It is specifically approved to treat non-metastatic castration-resistant prostate cancer (nmCRPC) in conjunction with surgical or medical castration.[4] The medication is taken by mouth twice per day with food.[4]
Side effects of darolutamide added to castration may include fatigue, asthenia, pain in the arms and legs, and rash.[4] Darolutamide is a nonsteroidal antiandrogen (NSAA), and acts as a selective antagonist of the androgen receptor (AR).[4][9][10] It has been referred to as a second- or third-generation NSAA.[11][12]
Darolutamide was patented in 2011 [13] and was approved for medical use in USA in July 2019,[8][14] in the European Union in March 2020 [5] in Australia in July 2020.[15] and in Canada in 2020,
^"Nubeqa Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 4 March 2020. Retrieved 16 August 2020.
^"Product Monograph" (PDF). hres.ca. Retrieved 25 October 2023.
^"Summary Basis of Decision (SBD) for Nubeqa". Health Canada. 23 October 2014. Retrieved 29 May 2022.
^ abcdefghijklmn"Nubeqa- darolutamide tablet, film coated". DailyMed. 31 July 2019. Retrieved 22 November 2019.
^ abc"Nubeqa EPAR". European Medicines Agency (EMA). 29 January 2020. Retrieved 16 August 2020.
^"Nubeqa Product information". Union Register of medicinal products. Retrieved 3 March 2023.
^ abFizazi K, Massard C, Bono P, Jones R, Kataja V, James N, et al. (August 2014). "Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial" (PDF). The Lancet. Oncology. 15 (9): 975–85. doi:10.1016/S1470-2045(14)70240-2. PMID 24974051.
^ ab This article incorporates text from this source, which is in the public domain: "FDA approves darolutamide for non-metastatic castration-resistant prostate cancer". U.S. Food and Drug Administration (FDA) (Press release). 31 July 2019. Archived from the original on 23 November 2019. Retrieved 22 November 2019.
^ abFizazi K, Albiges L, Loriot Y, Massard C (2015). "ODM-201: a new-generation androgen receptor inhibitor in castration-resistant prostate cancer". Expert Review of Anticancer Therapy. 15 (9): 1007–17. doi:10.1586/14737140.2015.1081566. PMC 4673554. PMID 26313416.
^ abMoilanen AM, Riikonen R, Oksala R, Ravanti L, Aho E, Wohlfahrt G, et al. (July 2015). "Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies". Scientific Reports. 5: 12007. Bibcode:2015NatSR...512007M. doi:10.1038/srep12007. PMC 4490394. PMID 26137992.
^Shore ND (June 2017). "Darolutamide (ODM-201) for the treatment of prostate cancer". Expert Opinion on Pharmacotherapy. 18 (9): 945–952. doi:10.1080/14656566.2017.1329820. PMID 28490267. S2CID 20624649.
^Crawford ED, Schellhammer PF, McLeod DG, Moul JW, Higano CS, Shore N, et al. (November 2018). "Androgen Receptor Targeted Treatments of Prostate Cancer: 35 Years of Progress with Antiandrogens". The Journal of Urology. 200 (5): 956–966. doi:10.1016/j.juro.2018.04.083. PMID 29730201. S2CID 19162538.
^Cite error: The named reference WO2011051540A1 was invoked but never defined (see the help page).
^ This article incorporates text from this source, which is in the public domain: "Drug Trials Snapshots: Nubeqa". U.S. Food and Drug Administration (FDA). 9 August 2019. Archived from the original on 23 November 2019. Retrieved 22 November 2019.
^"AusPAR: Darolutamide". Therapeutic Goods Administration (TGA). 3 August 2020. Retrieved 22 September 2020.
Darolutamide, sold under the brand name Nubeqa, is an antiandrogen medication which is used in the treatment of non-metastatic castration-resistant prostate...
nonsteroidal antiandrogen (NSAA) and the major active metabolite of darolutamide (ODM-201, BAY-1841788), an NSAA which is used in the treatment of prostate...
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This article incorporates text from this source, which is in the public domain: "FDA approves darolutamide for non-metastatic castration-resistant prostate cancer". U.S. Food and Drug Administration (FDA) (Press release). 31 July 2019. Archived from the original on 23 November 2019. Retrieved 22 November 2019.
