About NUBEQA® (darolutamide)
Introducing NUBEQA (darolutamide) in Prostate Cancer | NUBEQA’s (darolutamide) safety profile | NUBEQA (darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) | NUBEQA (darolutamide) for non-metastatic castration-resistant prostate cancer (nmCRPC) | NUBEQA (darolutamide) MOA and distinct molecular structure | NUBEQA’s Dosing | NUBEQA’s Resources
Refer to full Summary of Product Characteristics (SmPC) before prescribing.
Introducing NUBEQA (darolutamide) - Efficacy that doesn’t compromise your patient’s QoL
NUBEQA (darolutamide) is indicated for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease, or with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy, or with mHSPC in combination with docetaxel.
Choose NUBEQA (darolutamide) for efficacy that doesn’t compromise your patients’ QoL.
Clinically proven in Phase III studies across three indications in mHSPC and nmCRPC.
mHSPC | ARANOTE§ (without chemo)
- Established efficacy: Clinically proven - Significantly reduce the risk of radiographic progression or death by 46%* when adding NUBEQA to ADT
- Maintain your patients' QoL: The only second generation ARI in mHSPC with lower levels of fatigue and fewer discontinuations versus placebo when added to ADT in a Phase III clinical trial
- Treat with confidence: NUBEQA offers a distinct molecular structure, reduced blood-brain barrier penetration and fewer drug-drug interactions versus other second generation ARIs
§ ARANOTE is a randomised, double-blind, placebo-controlled, Phase III trial involving patients with mHSPC. Patients (N=669) were randomly assigned in a 2:1 ratio to receive NUBEQA + ADT (n=446) or placebo + ADT + docetaxel (n=223). The primary endpoint was rPFS, with OS and time to mCRPC as a secondary endpoint (list of secondary endpoints is not exhaustive). NUBEQA + ADT significantly reduced the risk of progression or death by 46% versus placebo +ADT (HR: 0.54; 95% CI: 0.41-0.71; P<0.0001), with median rPFS not reached in the NUBEQA + ADT group versus 25.0 months in the placebo+ ADT group. The rPFS rates at 24 months were 70.3% in the NUBEQA + ADT group and 52.1% in the placebo + ADT group.
* Absolute risk at 2 years: 18.2% ; HR: 0.54; 95% CI: 0.41‒0.71; p<0.0001.
Refer to full Summary of Product Characteristics (SmPC) before prescribing.
NUBEQA (darolutamide) Safety Profile
- In the ARAMIS, ARASENS, and ARANOTE trials, most treatment-emergent adverse events with NUBEQA occurred at rates similar to those seen with placebo
- In the pooled analysis of NUBEQA + ADT trials (ARAMIS and ARANOTE), the most common adverse reactions in patients receiving NUBEQA + ADT were fatigue/asthenic conditions (13.7%). The most common serious adverse reactions were ischaemic heart disease (1.9%), cardiac arrhythmias (1.8%), pneumonia (1.5%), urinary retention (1.3%), urinary tract infection (1.1%) and fractures (1.0%)
- The most common adverse reactions in patients receiving NUBEQA in combination with docetaxel were rash (17.3%) alanine aminotransferase (ALT) increased (15.8%), aspartate aminotransferase increased (14.0%) and hypertension (13.8%)
- For the full list of adverse events, please refer to the Summary of Product Characteristics (SmPC)
- NUBEQA also interacts with fewer drugs versus other second generation ARIs, offering confidence when treating patients who require concomitant medications
NUBEQA (darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC)
- Extend survival and radiographic progression-free survival. Maintain your patients’ QoL. Choose NUBEQA for your patients with mHSPC
- The only second generation ARI approved for mHSPC with and without docetaxel (doublet or triplet therapy)
NUBEQA (darolutamide) for non-metastatic castration-resistant prostate cancer (nmCRPC)
- Delay metastases. Extend survival. Maintain your patient’s QoL. Choose NUBEQA for your patients with high-risk nmCRPC
- The first NICE-recommended and SMC-accepted ARI for the treatment of nmCRPC
NUBEQA (darolutamide) MOA and distinct molecular structure
NUBEQA is an androgen receptor inhibitor (ARI) that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.
NUBEQA has a distinct molecular structure, which is key to its reduced blood–brain barrier penetration vs other second generation ARIs.
Medicines with reduced blood–brain barrier penetration have been shown to have reduced effects on the central nervous system.
NUBEQA’s (darolutamide) Dosing
NUBEQA is administered orally. The recommended dose of NUBEQA is two tablets taken twice daily, with food.
Tablet not to size
Where can I find further resources about NUBEQA to support me and my patients?
Discover resources to help support your patients, including case studies and prescribing checklists.
Abbreviations
ADT, androgen deprivation therapy; AR, androgen receptor; ARI, androgen receptor inhibitor; CI, confidence interval; mHSPC, metastatic hormone-sensitive prostate cancer; HR, hazard ratio; MFS, metastasis-free survival; MOA, Mechanism of Action; NICE, National Institute for Health and Care Excellence; nmCRPC, non-metastatic castration-resistant prostate cancer; OS, overall survival; PSA, prostate-specific antigen; QoL, quality of life; rPFS, radiographic progression-free survival; SMC, Scottish Medicines Consortium; SmPC, summary of product characteristics.
PP-NUB-GB-2538 | August 2025