Nubeqa FDA Approval History
Last updated by Judith Stewart, BPharm on June 5, 2025.
FDA Approved: Yes (First approved July 30, 2019)
Brand name: Nubeqa
Generic name: darolutamide
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer
Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) used in the treatment of prostate cancer.
- Nubeqa is indicated for the treatment of adult patients with:
- non-metastatic castration-resistant prostate cancer (nmCRPC)
- metastatic castration-sensitive prostate cancer (mCSPC)
- metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. - Nubeqa tablets are administered orally, twice a day, with food.
- Warnings and precautions associated with Nubeqa include ischemic heart disease, seizures, and embryo-fetal toxicity.
- Common adverse reactions (>10% with a ≥2% increase over placebo):
- in nmCRPC and mCSPC patients include fatigue; and laboratory test abnormalities include increased AST, decreased neutrophil count, increased bilirubin, and increased ALT.
- in mCSPC patients when used in combination with docetaxel include constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension; and common laboratory test abnormalities (≥30%) include anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia.
Development timeline for Nubeqa
Further information
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