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

Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Phase 3

Recruiting

Conditions: Metastatic Prostate Cancer
Intermitent Anti-androgen Therapy

Interventions: Drug: Darolutamide continuous
Drug: Darolutamide intermittent

First Posted Date: 2023-12-20

Last Posted Date: 2023-12-26

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 200

Registration Number: NCT06177015

Locations: 🇨🇳
Urology dpt, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Phase 2

Recruiting

Conditions: Advanced Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8

Interventions: Drug: Abiraterone
Procedure: Biospecimen Collection
Drug: Darolutamide
Drug: Prednisone

First Posted Date: 2023-12-15

Last Posted Date: 2024-12-18

Lead Sponsor: Mamta Parikh

Target Recruit Count: 75

Registration Number: NCT06173362

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

Phase 2

Suspended

Conditions: Adult Ovarian Granulosa Cell Tumor

Interventions: Procedure: Biospecimen Collection
Procedure: Chest Radiography
Procedure: Computed Tomography
Drug: Darolutamide
Drug: Exemestane
Drug: Leuprolide Acetate
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

First Posted Date: 2023-12-13

Last Posted Date: 2025-04-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 37

Registration Number: NCT06169124

Locations: 🇺🇸
West Michigan Cancer Center, Kalamazoo, Michigan, United States
🇺🇸
Ascension Borgess Cancer Center, Kalamazoo, Michigan, United States
🇺🇸
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States

and more 64 locations

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Phase 3

Recruiting

Conditions: Metastatic Castration-Sensitive Prostate Cancer

Interventions: Drug: Placebo
Drug: Saruparib
Drug: Abiraterone Acetate
Drug: Darolutamide
Drug: Enzalutamide

First Posted Date: 2023-11-07

Last Posted Date: 2025-05-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 1800

Registration Number: NCT06120491

Locations: 🇬🇧
Research Site, Truro, United Kingdom

An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

Completed

Conditions: Non-metastatic Castration-resistant Prostate Cancer

Interventions: Drug: Apalutamide
Drug: Darolutamide (BAY 1841788)
Drug: Enzalutamide

First Posted Date: 2023-08-28

Last Posted Date: 2024-12-27

Lead Sponsor: Bayer

Target Recruit Count: 1375

Registration Number: NCT06013475

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

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Phase 1

Active, not recruiting

Conditions: Prostatic Neoplasms

Interventions: Drug: Abemaciclib
Drug: Darolutamide
Drug: LHRH agonist/antagonist

First Posted Date: 2023-08-21

Last Posted Date: 2024-05-30

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 10

Registration Number: NCT05999968

Locations: 🇪🇸
Hospital General Universitario Gregorio Marañon, Madrid, Madrid, Comunidad De, Spain
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States
🇩🇪
Studienpraxis Urologie, Nürtingen, Baden-Württemberg, Germany

and more 10 locations

A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Phase 1

Recruiting

Conditions: Prostate Cancer

Interventions: Drug: Saruparib (AZD5305)
Other: No Treatment
Drug: Darolutamide

First Posted Date: 2023-07-10

Last Posted Date: 2025-04-27

Lead Sponsor: AstraZeneca

Target Recruit Count: 120

Registration Number: NCT05938270

Locations: 🇬🇧
Research Site, Newcastle upon Tyne, United Kingdom

A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer

Phase 2

Recruiting

Conditions: Prostate Cancer

Interventions: Drug: Darolutamide Oral Tablet [Nubeqa]

First Posted Date: 2023-06-13

Last Posted Date: 2023-08-07

Lead Sponsor: D'Or Institute for Research and Education

Target Recruit Count: 19

Registration Number: NCT05900973

Locations: 🇧🇷
Instituto D'Or de Pesquisa e Ensino, São Paulo, Brazil

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Phase 1

Recruiting

Conditions: Metastatic Castration-resistant Prostate Neoplasms

Interventions: Drug: JNJ-78278343
Drug: Cetrelimab
Drug: Cabazitaxel
Drug: Docetaxel
Drug: Apalutamide
Drug: Enzalutamide
Drug: Darolutamide
Drug: Abiraterone acetate plus prednisone (AAP)

First Posted Date: 2023-04-19

Last Posted Date: 2025-05-04

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 213

Registration Number: NCT05818683

Locations: 🇦🇺
Icon Cancer Centre Kurralta Park, Kurralta Park, Australia
🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Australia
🇺🇸
Perlmutter Cancer Center at NYU Langone Brooklyn, Brooklyn, New York, United States

and more 8 locations

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Phase 3

Recruiting

Conditions: Biochemically Recurrent Prostate Cancer

Interventions: Drug: Darolutamide (BAY1841788, Nubeqa)
Other: Placebo matching darolutamide
Other: ADT

First Posted Date: 2023-04-03

Last Posted Date: 2025-05-08

Lead Sponsor: Bayer

Target Recruit Count: 970

Registration Number: NCT05794906

Locations: 🇪🇸
Hospital Fundació Puigvert, Barcelona, Spain
🇵🇱
Centrum Medyczne iMed24, Krakow, Poland
🇵🇱
Medrise Sp. z o.o. Centrum Badan Klinicznych, Lublin, Poland

and more 297 locations

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