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 in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Phase 3

Active, not recruiting

Conditions: Prostatic Neoplasms

Interventions: Drug: Placebo
Drug: Darolutamide (Nubeqa, BAY1841788)
Other: Androgen deprivation therapy (ADT)

First Posted Date: 2021-02-03

Last Posted Date: 2025-04-27

Lead Sponsor: Bayer

Target Recruit Count: 662

Registration Number: NCT04736199

Locations: 🇱🇹
National Cancer Institute, Vilnius, Lithuania
🇨🇳
Nantong tumor hospital, Nantong, Jiangsu, China
🇨🇳
The 2nd Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

and more 128 locations

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

Phase 1

Terminated

Conditions: Castrate Resistant Prostate Cancer

Interventions: Drug: Ipatasertib
Drug: Darolutamide
Drug: Androgen Deprivation Therapy

First Posted Date: 2021-02-03

Last Posted Date: 2023-11-13

Lead Sponsor: David VanderWeele

Target Recruit Count: 6

Registration Number: NCT04737109

Locations: 🇺🇸
Penn State Cancer Institute, Hershey, Pennsylvania, United States
🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer

Phase 2

Recruiting

Conditions: Prostate Cancer
Prostate Cancer Metastatic
Metastatic Cancer
Prostate Cancer Recurrent
Oligometastasis

Interventions: Drug: Darolutamide
Radiation: metastasis-directed treatment

First Posted Date: 2020-11-23

Last Posted Date: 2024-02-28

Lead Sponsor: University Hospital, Ghent

Target Recruit Count: 124

Registration Number: NCT04641078

Locations: 🇧🇪
AZ St-Jan Brugge, Brugge, Belgium
🇧🇪
AZ St-Lucas Gent, Gent, Belgium
🇧🇪
Ghent University Hospital, Ghent, Belgium

and more 5 locations

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Testosterone Cypionate
Drug: Darolutamide

First Posted Date: 2020-09-22

Last Posted Date: 2024-04-02

Lead Sponsor: Latin American Cooperative Oncology Group

Target Recruit Count: 51

Registration Number: NCT04558866

Locations: 🇧🇷
CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas), Rio De Janeiro, Brazil
🇧🇷
HMV - Hospital Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil
🇧🇷
Hospital Sírio-Libanês SP, São Paulo, Brazil

and more 3 locations

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

Phase 3

Active, not recruiting

Conditions: Prostate Carcinoma

Interventions: Drug: Goserelin Acetate
Drug: Darolutamide
Drug: Leuprolide Acetate
Drug: Placebo Administration
Other: Quality-of-Life Assessment
Drug: Triptorelin

First Posted Date: 2020-07-24

Last Posted Date: 2025-01-28

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 27

Registration Number: NCT04484818

Locations: 🇺🇸
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
Los Angeles County-USC Medical Center, Los Angeles, California, United States

and more 112 locations

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Phase 3

Recruiting

Conditions: Cancer

Interventions: Drug: Darolutamide (Nubeqa, BAY1841788)

First Posted Date: 2020-07-09

Last Posted Date: 2025-05-13

Lead Sponsor: Bayer

Target Recruit Count: 402

Registration Number: NCT04464226

Locations: 🇫🇷
Centre Jean Perrin, Clermont-ferrand, France
🇱🇻
P. Stradins Clinical University Hospital, Riga, Latvia
🇱🇻
Riga East Clinical University Hospital "Gailezers", Riga, Latvia

and more 368 locations

Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide

Phase 2

Active, not recruiting

Conditions: Hormone Sensitive Prostate Cancer
Prostate Cancer Metastatic
Non-metastatic Prostate Cancer
Metastatic Prostate Cancer
Prostate Cancer
Castrate Resistant Prostate Cancer

Interventions: Drug: Darolutamide
Drug: Enzalutamide

First Posted Date: 2020-04-06

Last Posted Date: 2025-05-01

Lead Sponsor: Alliance Foundation Trials, LLC.

Target Recruit Count: 111

Registration Number: NCT04335682

Locations: 🇺🇸
University of California - San Francisco at Mount Zion, San Francisco, California, United States
🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

and more 5 locations

Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

Phase 2

Recruiting

Conditions: PSA
Castrate Resistant Prostate Cancer
Advanced Prostate Carcinoma
Cancer of Prostate

Interventions: Drug: Darolutamide
Radiation: Radiotherapy

First Posted Date: 2020-03-24

Last Posted Date: 2024-12-19

Lead Sponsor: Trans Tasman Radiation Oncology Group

Target Recruit Count: 70

Registration Number: NCT04319783

Locations: 🇦🇺
Icon Cancer Centre Epworth, Richmond, Victoria, Australia
🇦🇺
Peter MacCallum Cancer Centre, Bendigo, Bendigo, Victoria, Australia
🇸🇬
National Cancer Centre Singapore, Singapore, Singapore

and more 14 locations

A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients

Phase 3

Terminated

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Drug: Enzalutamide during Lead-in Period
Drug: Lead-in Enzalutamide followed by Placebo/Enzalutamide
Drug: Darolutamide during Lead-in Period
Drug: Lead-in Darolutamide followed by Placebo/Darolutamide
Drug: Lead-in Enzalutamide followed by Radium-223/Enzalutamide
Drug: Lead-in Darolutamide followed by Radium-223/Darolutamide

First Posted Date: 2020-01-23

Last Posted Date: 2022-10-07

Lead Sponsor: MANA RBM

Target Recruit Count: 23

Registration Number: NCT04237584

Locations: 🇺🇸
Research Site, Myrtle Beach, South Carolina, United States

Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

Phase 2

Not yet recruiting

Conditions: Prostate Cancer

Interventions: Radiation: Radiation Therapy
Drug: Darolutamide
Drug: Degarelix

First Posted Date: 2019-11-25

Last Posted Date: 2024-01-24

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 208

Registration Number: NCT04176081

Locations: 🇨🇦
UHN Princess Margaret Hospital, Toronto, Ontario, Canada

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