The compounds presented are investigational or are being investigated for uses that have not been approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities. This information is presented only for purposes of providing a general overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved uses.

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Darolutamide_sqrt

Compound Overview

Darolutamide* is a structurally distinct androgen receptor (AR) inhibitor with high-affinity binding to ARs, thereby preventing testosterone from binding and inhibiting nuclear translocation of the AR complex.1-3

*In collaboration with Orion Pharma.

Clinical Trials

Tumor Type(s)

Phase

Status

Description

NCT Number

Prostate Cancer

III

Active, Not Enrolling

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (DASL-HiCaP)

Prostate Cancer

III

Active, Not Enrolling

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Prostate Cancer

III

Active, Not Enrolling

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

Prostate Cancer

Non-interventional Study

Active, Not Enrolling

Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients

Prostate Cancer

Non-interventional Study

Now Enrolling

A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage

Prostate Cancer

Non-interventional Study

Now Enrolling

Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients

Prostate Cancer

Non-interventional Study

Now Enrolling

An Observational Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Low-volume Metastatic Hormone-sensitive Prostate Cancer

Prostate Cancer

Non-interventional Study

Active, Not Enrolling

ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer


The ongoing clinical trials listed on this website represent a comprehensive overview of Bayer's clinical pipeline in Oncology, including Bayer-sponsored research and collaborative research with academic centers, cooperative groups, and other global institutions.