Darolutamide

Generic Name: Darolutamide

Brand Names: Nubeqa

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₉ClN_₆O_₂

CAS Number: 1297538-32-9

Unique Ingredient Identifier: X05U0N2RCO

Background: Darolutamide is a nonsteroidal androgen receptor antagonist for the treatment of castrate-resistant, non-metastatic prostate cancer (nmCRPC). This condition occurs in the majority of patients with advanced prostate cancer who have been treated with androgen receptor antagonists. Though prior treatment for prostate cancer has been successful for these patients, the cancer eventually progresses to become resistant to existing therapies. This warrants further treatment.

The goal of treatment with darolutamide is to delay the progression of prostate cancer to metastatic disease, increasing quality of life and life expectancy for those with advanced prostate cancer. Darolutamide was developed by Bayer HealthCare Pharmaceuticals Inc. and approved by the FDA on July 30th, 2019.

Indication: Darolutamide is indicated for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

Associated Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Non-Metastatic Castration-Resistant Prostate Cancer

Clinical Trials

Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

Phase 3

Withdrawn

Conditions: Metastatic Prostate Cancer

Interventions: Drug: Darolutamide
Drug: Radium-223

First Posted Date: 2023-03-16

Last Posted Date: 2023-09-14

Lead Sponsor: GenesisCare USA

Registration Number: NCT05771896

Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC

Phase 2

Recruiting

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Drug: Docetaxel or cabazitaxel
Drug: Darolutamide

First Posted Date: 2023-03-09

Last Posted Date: 2024-06-27

Lead Sponsor: Erasmus Medical Center

Target Recruit Count: 245

Registration Number: NCT05762536

Locations: 🇳🇱
Erasmus MC Cancer Institute, Rotterdam, Netherlands

Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

Phase 2

Active, not recruiting

Conditions: Salivary Gland Cancer

Interventions: Drug: Darolutamide
Drug: Goserelin

First Posted Date: 2023-01-23

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Center Hospital East

Target Recruit Count: 56

Registration Number: NCT05694819

Locations: 🇯🇵
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
🇯🇵
National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
🇯🇵
Tohoku University Hospital, Sendai, Miyagi, Japan

and more 9 locations

A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

Phase 3

Active, not recruiting

Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions: Drug: Standard ADT (androgen deprivation therapy)
Drug: Standard Darolutamide
Drug: Docetaxel

First Posted Date: 2023-01-09

Last Posted Date: 2025-02-17

Lead Sponsor: Jena University Hospital

Target Recruit Count: 250

Registration Number: NCT05676203

Locations: 🇦🇹
Ordensklinikum Linz GmbH, Elisabethinen, Linz, Austria
🇦🇹
Krankenhaus der Barmherzigen Brüder, Wien, Austria
🇩🇪
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Heidelberg, Baden-Württemberg, Germany

and more 40 locations

Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers

Phase 2

Recruiting

Conditions: Metastatic Salivary Gland Carcinoma
Unresectable Salivary Gland Carcinoma
Locally Advanced Salivary Gland Carcinoma
Recurrent Salivary Gland Carcinoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Darolutamide
Drug: Leuprolide Acetate
Procedure: Magnetic Resonance Imaging

First Posted Date: 2023-01-03

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 21

Registration Number: NCT05669664

Locations: 🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 23 locations

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Prostate Cancer
Non-metastatic Prostate Cancer
Prostate Cancer

Interventions: Drug: Darolutamide
Drug: Abemaciclib
Drug: GNRH-A Leuprolide Acetate
Drug: GNRH-A Goserelin
Drug: Degarelix

First Posted Date: 2022-11-16

Last Posted Date: 2024-08-20

Lead Sponsor: Praful Ravi, MB BCHir, MRCP

Target Recruit Count: 9

Registration Number: NCT05617885

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Phase 1

Recruiting

Conditions: Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Castration Resistant Prostatic Cancer

Interventions: Biological: JANX007
Drug: Darolutamide

First Posted Date: 2022-08-29

Last Posted Date: 2025-05-08

Lead Sponsor: Janux Therapeutics

Target Recruit Count: 272

Registration Number: NCT05519449

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
UCLA Department of Medicine, Los Angeles, California, United States

and more 15 locations

Study of ORIC-944 in Patients With Metastatic Prostate Cancer

Phase 1

Recruiting

Conditions: Metastatic Prostate Cancer

Interventions: Drug: ORIC-944
Drug: Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
Drug: Apalutamide (Erleada™) 60 mg or 240 mg tablets
Drug: Darolutamide (Nubeqa®) 300 mg tablets
Drug: Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets

First Posted Date: 2022-06-10

Last Posted Date: 2025-03-20

Lead Sponsor: ORIC Pharmaceuticals

Target Recruit Count: 42

Registration Number: NCT05413421

Locations: 🇺🇸
South Florida Oncology and Hematology, Plantation, Florida, United States
🇺🇸
First Urology, Jeffersonville, Indiana, United States
🇺🇸
University of Washington, Fred Hutchinson Cancer Center, Seattle, Washington, United States

and more 12 locations