MedPath

Darolutamide

Generic Name
Darolutamide
Brand Names
Nubeqa
Drug Type
Small Molecule
Chemical Formula
C19H19ClN6O2
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
Related News

Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

Phase 2
Terminated
Conditions
Prostatic Cancer, Castration-Resistant
Interventions
First Posted Date
2019-11-08
Last Posted Date
2023-08-04
Lead Sponsor
Bayer
Target Recruit Count
30
Registration Number
NCT04157088
Locations
🇺🇸

Oregon Health and Science University, Portland, Maine, United States

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

MidLantic Urology - Bala Cynwyd, Bala-Cynwyd, Pennsylvania, United States

and more 4 locations

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Phase 3
Active, not recruiting
Conditions
Prostate Cancer
Interventions
Drug: Placebo oral tablet
Drug: Luteinizing Hormone-Releasing Hormone Analog
Radiation: External Beam Radiotherapy
First Posted Date
2019-10-23
Last Posted Date
2023-07-28
Lead Sponsor
University of Sydney
Target Recruit Count
1100
Registration Number
NCT04136353
Locations
🇨🇦

Regional Health Authority B, Zone 2 Saint John Regional Hospital, Saint John, New Brunswick, Canada

🇨🇦

Ottawa Hospital Research Institute, Toronto, Ontario, Canada

🇨🇦

Odette Cancer Centre - Sunnybrook Hospital, Toronto, Ontario, Canada

and more 90 locations

Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

Phase 2
Recruiting
Conditions
Metastatic Prostate Cancer
Castration-resistant Prostate Cancer
Interventions
Radiation: SBRT
First Posted Date
2019-08-28
Last Posted Date
2024-12-04
Lead Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Target Recruit Count
66
Registration Number
NCT04070209
Locations
🇨🇦

Prostate Cancer Centre, Calgary, Alberta, Canada

🇨🇦

Centre of Applied Urology Research, Halifax, Nova Scotia, Canada

🇨🇦

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

and more 7 locations

INTREPId (INTermediate Risk Erection PreservatIon Trial)

Phase 2
Active, not recruiting
Conditions
Prostate Cancer
Interventions
Radiation: Radiation Therapy
First Posted Date
2019-07-18
Last Posted Date
2025-04-09
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
234
Registration Number
NCT04025372
Locations
🇺🇸

Stamford Hospital, Stamford, Connecticut, United States

🇺🇸

Beth Israel Deaconness Medical Center, Boston, Massachusetts, United States

🇺🇸

Brigham and Women Hospital, Boston, Massachusetts, United States

and more 8 locations

ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

First Posted Date
2019-04-04
Last Posted Date
2025-04-09
Lead Sponsor
Karolinska Institutet
Target Recruit Count
750
Registration Number
NCT03903835
Locations
🇳🇴

Akershus Universitetssykehus, Lørenskog, Norway

🇧🇪

OLV Ziekenhuis Aalst, Aalst, Belgium

🇧🇪

Ziekenhuis Oost-Limburg, Genk, Belgium

and more 29 locations

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1
Terminated
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma
Interventions
Biological: Bevacizumab
Procedure: Biospecimen Collection
Biological: Durvalumab
Biological: Ipilimumab
Biological: Nivolumab
Biological: Pembrolizumab
Biological: Pertuzumab
Other: Quality-of-Life Assessment
Biological: Trastuzumab Emtansine
First Posted Date
2019-03-18
Last Posted Date
2024-03-04
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT03878524
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.

Phase 1
Completed
Conditions
Cerebrovascular Circulation
Interventions
Other: Placebo
First Posted Date
2018-10-12
Last Posted Date
2020-10-30
Lead Sponsor
Bayer
Target Recruit Count
26
Registration Number
NCT03704519
Locations
🇬🇧

Centre for Neuroimaging Sciences, King's College, London, United Kingdom

Study to Evaluate CCS1477 in Advanced Tumours

Phase 1
Active, not recruiting
Conditions
Metastatic Castration-Resistant Prostate Cancer
Non-small Cell Lung Cancer
Metastatic Breast Cancer
Advanced Solid Tumors
Interventions
First Posted Date
2018-06-26
Last Posted Date
2025-04-30
Lead Sponsor
CellCentric Ltd.
Target Recruit Count
350
Registration Number
NCT03568656
Locations
🇫🇷

Institute Gustave Roussy, Villejuif, France

🇳🇱

Netherlands Cancer Institute (NKI), Amsterdam, Netherlands

🇪🇸

Hospital Vall d'Hebron, VHIO, Barcelona, Spain

and more 16 locations

Prostate Cancer Biomarker Enrichment and Treatment Selection

First Posted Date
2017-12-28
Last Posted Date
2025-03-17
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
200
Registration Number
NCT03385655
Locations
🇨🇦

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

🇨🇦

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

🇨🇦

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

and more 8 locations

Study on Androgen Receptor and Triple Negative Breast Cancer

Phase 2
Completed
Conditions
Triple Negative and Androgen Receptor Positive
Breast Cancer Female
Interventions
First Posted Date
2017-12-26
Last Posted Date
2022-11-21
Lead Sponsor
UNICANCER
Target Recruit Count
94
Registration Number
NCT03383679
Locations
🇫🇷

Centre François Baclesse, Caen, France

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy