Darolutamide (Nubeqa)

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General information

Class/mechanism: Antiandrogen; non-steroidal androgen receptor inhibitor, non-steroidal antiandrogen (NSAA) that competitively inhibits androgens by binding to androgen receptors and exhibiting antitumor activity by blocking testosterone-induced nuclear translocation of androgen receptors.[1][2][3][4]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 7/30/2019: Initial approval for non-metastatic castration-resistant prostate cancer. (Based on ARAMIS)
  • 8/5/2022: FDA approved "in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC)." (Based on ARASENS)

Also known as

  • Code name: BAY-1841788, ODM-201
  • Brand name: Nubeqa


  1. 1.0 1.1 Darolutamide (Nubeqa) package insert
  2. Darolutamide (Nubeqa) package insert (locally hosted backup)
  3. Nubeqa manufacturer's website
  4. Moilanen AM, Riikonen R, Oksala R, Ravanti L, Aho E, Wohlfahrt G, Nykänen PS, Törmäkangas OP, Palvimo JJ, Kallio PJ. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. 2015 Jul 3;5:12007. link to original article PubMed
  5. Darolutamide (Nubeqa) patient drug information (Chemocare)
  6. Darolutamide (Nubeqa) patient drug information (UpToDate)