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 of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer
- Conditions
- Metastatic Castrate-resistant Prostate (CRPC) Cancer
- Interventions
- First Posted Date
- 2017-10-19
- Last Posted Date
- 2025-04-17
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Target Recruit Count
- 250
- Registration Number
- NCT03314324
- Locations
- 🇫🇷
Gustave Roussy, Villejuif, Val De Marne, France
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
- First Posted Date
- 2016-12-29
- Last Posted Date
- 2020-04-03
- Lead Sponsor
- Translational Research in Oncology
- Target Recruit Count
- 36
- Registration Number
- NCT03004534
- Locations
- 🇺🇸
Torrance Memorial Physician Network, Cancer Care Associates, Redondo Beach, California, United States
🇩🇪Universitatsklinikum Erlangen, Erlangen, Germany
🇨🇦Cross Cancer Institute, Edmonton, Alberta, Canada
ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer
- First Posted Date
- 2016-11-23
- Last Posted Date
- 2024-04-05
- Target Recruit Count
- 61
- Registration Number
- NCT02972060
- Locations
- 🇧🇪
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme, Brussels, Belgium
🇪🇸Hospital Universitario Virgen De La Victoria, Malaga, Spain
🇫🇷Gustave Roussy, Villejuif, France
ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.
- Conditions
- Prostate Cancer MetastaticProstate Cancer
- Interventions
- Other: Placebo
- First Posted Date
- 2016-10-14
- Last Posted Date
- 2024-03-13
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Target Recruit Count
- 92
- Registration Number
- NCT02933801
- Locations
- 🇨🇭
Hôpital du Valais (Sion et Martigny), Sion, Switzerland
🇫🇷Centre Eugène Marquis, Rennes, France
🇮🇹Istituto Nazionale dei Tumori - IRCCS Fondazione Pascale S.C., Napoli, Italy
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
- Conditions
- PharmacokineticsRenal InsufficiencyHepatic Insufficiency
- Interventions
- First Posted Date
- 2016-09-09
- Last Posted Date
- 2019-01-07
- Lead Sponsor
- Bayer
- Target Recruit Count
- 29
- Registration Number
- NCT02894385
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
- Conditions
- Castration-ResistantProstate Cancer Non-Metastatic
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-07-25
- Last Posted Date
- 2022-06-28
- Lead Sponsor
- Bayer
- Target Recruit Count
- 1509
- Registration Number
- NCT02200614
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
- First Posted Date
- 2011-09-05
- Last Posted Date
- 2017-02-20
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Target Recruit Count
- 76
- Registration Number
- NCT01429064
- Locations
- 🇫🇮
Turku University Hospital, Turku, Finland
🇺🇸The Urology Center of Colorado, Wheat Ridge, Colorado, United States
🇪🇪East-Tallinn Central Hospital, Tallinn, Estonia
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
- First Posted Date
- 2011-03-17
- Last Posted Date
- 2017-03-29
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Target Recruit Count
- 136
- Registration Number
- NCT01317641
- Locations
- 🇺🇸
Chesapeake Urology Research Associates, Baltimore, Maryland, United States
🇨🇿Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo, Znojmo, Czech Republic
🇫🇮Oulu University Hospital, Oulu, Finland
Drug Development Updates
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