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

Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Phase 2

Active, not recruiting

Conditions: Hormone Sensitive Prostate Cancer
Prostate Cancer
Advanced Prostate Cancer

Interventions: Drug: Darolutamide
Drug: Relugolix

First Posted Date: 2024-06-17

Last Posted Date: 2025-04-27

Lead Sponsor: Atish Choudhury, MD

Target Recruit Count: 33

Registration Number: NCT06463457

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

Not yet recruiting

Conditions: Prostate Cancer

Interventions: Drug: androgen deprivation therapy only
Drug: Darolutamide in addition to androgen deprivation therapy

First Posted Date: 2024-05-30

Last Posted Date: 2024-05-30

Lead Sponsor: Peking University Third Hospital

Target Recruit Count: 108

Registration Number: NCT06435702

Locations: 🇨🇳
Peking University Third Hospital, Beijing, Beijing, China

Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study

Not yet recruiting

Conditions: Prostate Cancer Metastatic to Bone
Prostate Cancer Metastatic
Oligometastatic Disease
Oligometastasis
Prostate Cancer
Prostate Neoplasm

First Posted Date: 2024-05-28

Last Posted Date: 2024-05-28

Lead Sponsor: Medical University of Vienna

Target Recruit Count: 500

Registration Number: NCT06430411

Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase 2

Recruiting

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Other: Standard of care
Drug: Darolutamide

First Posted Date: 2024-05-07

Last Posted Date: 2024-10-24

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 162

Registration Number: NCT06401980

Locations: 🇨🇭
Kantonsspital Baden, Baden, Switzerland
🇨🇭
Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, Switzerland
🇨🇭
Inselspital, Bern, Switzerland

and more 8 locations

Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial

Phase 2

Recruiting

Conditions: Recurrent Castration-Sensitive Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Recurrent Prostate Cancer
Castration-resistant Prostate Cancer

Interventions: Drug: Abiraterone
Drug: Apalutamide
Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Drug: Darolutamide
Drug: Degarelix
Other: Questionnaire Administration
Drug: Enzalutamide
Radiation: Stereotactic Body Radiation Therapy
Drug: Goserelin
Drug: Histrelin
Drug: Leuprolide
Procedure: Magnetic Resonance Imaging
Other: Patient Observation
Procedure: Positron Emission Tomography
Drug: Prednisone
Drug: Relugolix
Drug: Triptorelin

First Posted Date: 2024-04-23

Last Posted Date: 2025-05-15

Lead Sponsor: Mayo Clinic

Target Recruit Count: 220

Registration Number: NCT06378866

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

Recruiting

Conditions: Non-metastatic Castration-resistant Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer

Interventions: Drug: Darolutamide (Nubeqa, BAY1841788)

First Posted Date: 2024-03-27

Last Posted Date: 2025-05-21

Lead Sponsor: Bayer

Target Recruit Count: 600

Registration Number: NCT06334120

Locations: 🇰🇷
Multiple locations, Multiple Locations, Korea, Republic of

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Phase 2

Recruiting

Conditions: Prostate Cancer

Interventions: Drug: Darolutamide matched placebo
Drug: Darolutamide
Radiation: Radiotherapy
Drug: Zoladex 3.6Mg Implant
Drug: Zoladex LA
Drug: Decapeptyl sustained release 22.5 mg
Drug: Decapeptyl sustained release 11.25 mg
Drug: Depo-Eligard 45 mg
Drug: Depo-Eligard 22.5 mg
Drug: Depo-Eligard 7.5 mg
Drug: Firmagon 120 MG Injection
Drug: Firmagon 80 MG Injection
Drug: Docetaxel

First Posted Date: 2024-02-28

Last Posted Date: 2024-02-28

Lead Sponsor: Cancer Research Antwerp

Target Recruit Count: 493

Registration Number: NCT06282588

Locations: 🇧🇪
AZ Groeninge, Kortrijk, Belgium
🇧🇪
GZA Sint-Augustinus, Wilrijk, Antwerp, Belgium
🇧🇪
OLVZ Aalst, Aalst, Belgium

and more 8 locations

Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Phase 3

Recruiting

Conditions: Prostatic Cancer, Castration-Resistant

Interventions: Drug: Darolutamide 300 mg
Drug: Androgen deprivation therapy
Radiation: Stereotactic body radiation therapy

First Posted Date: 2024-02-26

Last Posted Date: 2024-12-20

Lead Sponsor: UNICANCER

Target Recruit Count: 336

Registration Number: NCT06276465

Locations: 🇫🇷
Groupe Hospitalier Bretagne Sud, Lorient, France
🇫🇷
Centre Azuréen de Cancérologie, Mougins, France
🇫🇷
CHU de Saint-Etienne, Saint-Étienne, France

and more 1 locations

An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

Completed

Conditions: Non-metastatic Castration-resistant Prostate Cancer
Non-metastatic Prostate Cancer

Interventions: Drug: Darolutamide (Nubeqa, BAY1841788)
Drug: Apalutamide
Drug: Enzalutamide

First Posted Date: 2024-01-12

Last Posted Date: 2024-04-09

Lead Sponsor: Bayer

Target Recruit Count: 1800

Registration Number: NCT06204302

Locations: 🇺🇸
Bayer, Whippany, New Jersey, United States

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Phase 1

Recruiting

Conditions: mCRPC (Metastatic Castration-resistant Prostate Cancer)
Genital Diseases, Male
Prostatic Disease
Prostatic Neoplasms, Castration-Resistant
Urogenital Diseases, Male
Prostate Cancer

Interventions: Drug: Gedatolisib
Drug: Darolutamide

First Posted Date: 2024-01-05

Last Posted Date: 2025-03-21

Lead Sponsor: Celcuity Inc

Target Recruit Count: 54

Registration Number: NCT06190899

Locations: 🇪🇸
Institut Catala d'Oncologia, Barcelona, Spain
🇪🇸
Hospital Clinic Barcelona, Barcelona, Spain
🇪🇸
Hospital General Universitario Gregorio Maranon, Madrid, Spain

and more 10 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy