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
A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)
- Conditions
- Non-metastatic Castration-resistant Prostate Cancer
- Interventions
- First Posted Date
- 2022-04-27
- Last Posted Date
- 2025-04-30
- Lead Sponsor
- Bayer
- Target Recruit Count
- 50
- Registration Number
- NCT05348876
- Locations
- 🇮🇳
HCG Oncology Center, Bengaluru, Karnataka, India
🇮🇳Tata Memorial Hospital, Mumbai, Maharashtra, India
🇮🇳MNJ Institute of Oncology & Regional Cancer Centre, Hyderabad, Andhra Pradesh, India
TT-702 in Patients With Advanced Solid Tumours.
- First Posted Date
- 2022-03-09
- Last Posted Date
- 2024-05-13
- Lead Sponsor
- Cancer Research UK
- Target Recruit Count
- 188
- Registration Number
- NCT05272709
- Locations
- 🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom
🇬🇧Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom
🇬🇧University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: Androgen deprivation therapy
- First Posted Date
- 2022-02-22
- Last Posted Date
- 2023-01-03
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Target Recruit Count
- 30
- Registration Number
- NCT05249712
- Locations
- 🇨🇳
Hongqian Guo, Nanning, Jiangsu, China
A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely
- Conditions
- Prostate Cancer
- Interventions
- First Posted Date
- 2022-01-21
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Bayer
- Target Recruit Count
- 13779
- Registration Number
- NCT05202301
- Locations
- 🇺🇸
Bayer, Whippany, New Jersey, United States
Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: Androgen deprivation therapy (ADT)
- First Posted Date
- 2021-12-28
- Last Posted Date
- 2025-04-15
- Lead Sponsor
- Bayer
- Target Recruit Count
- 70
- Registration Number
- NCT05171387
- Locations
- 🇨🇳
Many Locations, Multiple Locations, China
Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases
- Conditions
- Prostate Cancer
- Interventions
- First Posted Date
- 2021-11-11
- Last Posted Date
- 2024-03-12
- Lead Sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
- Target Recruit Count
- 152
- Registration Number
- NCT05116475
- Locations
- 🇫🇷
Pôle Santé Léonard de Vinci, Chambray-lès-Tours, France
A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- Other: ADT
- First Posted Date
- 2021-09-28
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Bayer
- Target Recruit Count
- 223
- Registration Number
- NCT05059236
- Locations
- 🇺🇸
Northwestern Medicine - Urology, Chicago, Illinois, United States
🇺🇸New Jersey Urology - Voorhees, Voorhees, New Jersey, United States
🇺🇸New Mexico Cancer Center - Albuquerque, Albuquerque, New Mexico, United States
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
- Conditions
- Prostate Adenocarcinoma
- Interventions
- First Posted Date
- 2021-09-20
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- NRG Oncology
- Target Recruit Count
- 2050
- Registration Number
- NCT05050084
- Locations
- 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona, United States
Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction
- First Posted Date
- 2021-06-14
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- St Vincent's Hospital, Sydney
- Target Recruit Count
- 22
- Registration Number
- NCT04925648
- Locations
- 🇦🇺
Kinghorn Cancer Centre, St. Vincent's Hospital, Sydney, New South Wales, Australia
🇦🇺Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
- Conditions
- Prostate Cancer Metastatic
- Interventions
- First Posted Date
- 2021-06-07
- Last Posted Date
- 2023-05-11
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 300
- Registration Number
- NCT04916613
- Locations
- 🇫🇷
CHU de la Martinique - Hôpital Albert Clarac, Fort-de-France, France
🇩🇪Universitätsmedizin Essen Hufelandstraße, Essen, Germany
🇩🇪University cancer center Hamburg-Eppendorf Martinistraße, Hamburg, Germany
Drug Development Updates
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