NUBEQA

Peak

darolutamide

NDAORALTABLETPriority Review
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

(AR) inhibitor. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. A major metabolite, ketodarolutamide, exhibited similar in vitro activity to darolutamide. In addition, darolutamide functioned as a progesterone receptor (PR) antagonist…

Indications (1)

Clinical Trials (5)

NCT07450599Phase 2Not Yet Recruiting

A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.

Started Apr 2026
250 enrolled
High-Risk Localized Prostate Cancer
NCT07142551Phase 2Recruiting

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Started Mar 2026
60 enrolled
Metastatic Castration-resistant Prostate Cancer
NCT07395804N/ANot Yet Recruiting

How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany

Started Feb 2026
500 enrolled
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
NCT07344779N/ANot Yet Recruiting

A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice

Started Feb 2026
1,600 enrolled
Metastatic Hormone-Sensitive Prostate Cancer
NCT07190300Phase 1/2Recruiting

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Started Jan 2026
155 enrolled
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Loss of Exclusivity

LOE Date
Jun 17, 2042
198 months away
Patent Expiry
Jun 17, 2042
Exclusivity Expiry
Jun 3, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
9657003
Oct 27, 2030
SubstanceProduct
U-4210
10711013
Oct 27, 2030
SubstanceProduct
11046713
Oct 27, 2030
Substance
8975254
Mar 25, 2033
SubstanceProduct
U-4209
10835515
Jan 28, 2036
Product
U-2605